Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-25 @ 1:51 PM
Study NCT ID:
NCT03104192
Status:
COMPLETED
Last Update Posted:
2022-11-29
First Post:
2017-04-03
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
MOWI Research Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011506', 'term': 'Proteins'}], 'ancestors': [{'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'john.batsis@gmail.com', 'phone': '603-650-5000', 'title': 'John A. Batsis, MD', 'organization': 'Dartmouth-Hitchcock'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 4, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 0, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 12, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 5, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cardiovascular', 'notes': 'Dyspnea, chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal', 'notes': 'Knee, Hip, neck, shoulder discomofort or any type that impacts joints/muscles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 17, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Neurological', 'notes': 'Headache, TIA, vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastrointestinal', 'notes': 'Bloating, diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constitutional', 'notes': 'fatigue, not feeling well', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Respiratory', 'notes': 'Chest cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Headache', 'notes': 'Temporal Artery biopsy (admission to hospital) for headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Chest pain', 'notes': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 14, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Grip Strength', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.2', 'spread': '5.1', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '5.2', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '3.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance, this was not a measure of evaluation'}, {'type': 'PRIMARY', 'title': 'Change in 5 Times Sit-to-Stand (STS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.9', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.7', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '2.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'STS measures lower limb strength (minimal change 2.3 s).', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated'}, {'type': 'PRIMARY', 'title': 'Change in Six-Minute Walk Test (6MWT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '47.5', 'spread': '83', 'groupId': 'OG000'}, {'value': '39.3', 'spread': '51.6', 'groupId': 'OG001'}, {'value': '31.8', 'spread': '27.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m', 'unitOfMeasure': 'Meters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated'}, {'type': 'PRIMARY', 'title': 'Change in Gait Speed (m/s)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.2', 'spread': '0.1', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s).', 'unitOfMeasure': 'M/s', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated'}, {'type': 'PRIMARY', 'title': 'Change in Late-Life Function and Disability Instrument (LLFDI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.6', 'spread': '8.6', 'groupId': 'OG000'}, {'value': '9.0', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '6.3', 'spread': '6.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function.', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated'}, {'type': 'SECONDARY', 'title': 'Change in Behavioral Activation (Patient Activation Measure)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'spread': '11.3', 'groupId': 'OG000'}, {'value': '18.8', 'spread': '14.5', 'groupId': 'OG001'}, {'value': '11.0', 'spread': '10.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks post study', 'description': 'Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors \\& outcomes. Higher points indicate better activation. Measures are scored 0-100 units. Scores below reflect changes between baseline and follow-up at 12-weeks. A positive change score indicates improvement in activation', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated'}, {'type': 'SECONDARY', 'title': 'Change in Subjective Health Status (PROMIS) Physical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'spread': '4.4', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '2.3', 'spread': '3.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12-weeks', 'description': 'Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher points indicate better health. Raw scores are scaled to 0-100. 50 is the mean, 10 points indicates 1 standard deviation. Positive change scores listed below indicate an improvement in subjective health', 'unitOfMeasure': 'Points', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated'}, {'type': 'SECONDARY', 'title': 'Change in Weight in kg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG003', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.3', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '-3.5238', 'spread': '9.11762', 'groupId': 'OG001'}, {'value': '-5.8', 'spread': '3.1', 'groupId': 'OG002'}, {'value': '-3.5', 'spread': '2.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change in weight in kg', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Waist Circumference in cm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG002', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.6', 'spread': '4.9', 'groupId': 'OG000'}, {'value': '-6.4', 'spread': '6.3', 'groupId': 'OG001'}, {'value': '-14.8', 'spread': '45.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks post study', 'description': 'Change in waist and hip circumference in cm', 'unitOfMeasure': 'Cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated'}, {'type': 'SECONDARY', 'title': 'Average Steps/Expenditure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '6494', 'spread': '3700', 'groupId': 'OG000'}, {'value': '5127', 'spread': '3467', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Mean steps over 12 week period of time', 'description': 'Average Steps will be measured over a 12 week period', 'unitOfMeasure': 'Steps', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated. For Aim 2A, no fitness device was provided to participants and hence cannot evaluate this outcome in that arm'}, {'type': 'SECONDARY', 'title': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'title': 'Low intensity activities per week', 'categories': [{'measurements': [{'value': '3.9', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '6.9', 'groupId': 'OG001'}]}]}, {'title': 'Moderate intensity activities per week', 'categories': [{'measurements': [{'value': '8.6', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '5.2', 'spread': '9.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Score between baseline and 12 weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types -', 'unitOfMeasure': 'activities per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Composition - Lean Mass', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.62', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-1.44', 'spread': '1.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured', 'unitOfMeasure': 'Kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'For MOWI Weight Loss Maintenance this was not evaluated. In 2A (Develop \\& Refine MOWI w/o Amulet was not measured. This technique was not available for MOWI 2A participants and hence not measured'}, {'type': 'SECONDARY', 'title': 'Change in Energy Expenditure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-251.6', 'spread': '579.9', 'groupId': 'OG000'}, {'value': '-206.8', 'spread': '608.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks', 'unitOfMeasure': 'kCal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Fasting Plasma Glucose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.2', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '-4', 'spread': '13.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Fasting Plasma Glucose', 'unitOfMeasure': 'mg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Participant Satisfaction Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.13', 'spread': '0.773', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI))', 'description': 'The Participant Satisfaction Questionnaire is a 12-item questionnaire which measures participant satisfaction with intervention participation using a Likert scale (0-5 point scale: very unsatisfied = 0 to very satisfied = 4). Total scores range 0-60: higher scores indicate greater satisfaction with the intervention.Three additional sub-items ask participants to rate their preference for the frequency of sessions, length of group meetings, and total number of group meetings using a Likert scale (-1 - 1 point scale: too few/too short = -1 to 1 = too much/too long). Each of these three items will be interpreted individually and not included in a summed total score. Additionally, this questionnaire includes 1 open-ended response item where participants are asked to leave any additional comments they may have regarding their level of satisfaction with the intervention.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only measured in maintenance arm'}, {'type': 'SECONDARY', 'title': 'Change in Credibility and Expectancy Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.623529', 'spread': '2.776583', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post', 'description': 'The Credibility and Expectancy Questionnaire is a 6-item questionnaire which measures expectancies regarding intervention participation and intervention rationale credibility using a Likert scale (0-10 point scale: responses are anchored to question stems such that, not at all logical/not at all effective/not at all confident/no credibility/not at all comfortable = 0 and very logical/very effective/very confident/high credibility = 10). Total scores range 0-50: higher scores indicate more favorable expectancies regarding participation in the intervention/greater perceived intervention credibility. Additionally, this questionnaire includes 1 open-ended response item that asks participants to leave any additional comments they may have regarding their expectations for the intervention', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only measured in this intervention'}, {'type': 'SECONDARY', 'title': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '11.4', 'groupId': 'OG000'}, {'value': '-5.4', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Score between baseline and 12 weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types -', 'unitOfMeasure': 'activities per week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'title': 'Not exercising activity duration per week', 'categories': [{'measurements': [{'value': '-2.2', 'spread': '9.7', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '9.0', 'groupId': 'OG001'}]}]}, {'title': 'Low intensity activity duration', 'categories': [{'measurements': [{'value': '1.7', 'spread': '7.7', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '4.9', 'groupId': 'OG001'}]}]}, {'title': 'Moderate intensity activity duration', 'categories': [{'measurements': [{'value': '7.3', 'spread': '9.6', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '7.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change Score between baseline and 12 weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types -', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'title': 'Low intensity caloric expenditure per week', 'categories': [{'measurements': [{'value': '5.3', 'spread': '29.5', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '19.2', 'groupId': 'OG001'}]}]}, {'title': 'Moderate intensity caloric expenditure', 'categories': [{'measurements': [{'value': '49.4', 'spread': '74.9', 'groupId': 'OG000'}, {'value': '13.8', 'spread': '44.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change in KCal between baseline and 12 weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types -', 'unitOfMeasure': 'kCal', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.6', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 12 weeks post study', 'description': 'Medication adherence, visual analog scale', 'unitOfMeasure': 'percentage of total sessions', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Food Craving Acceptance and Action Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.058824', 'spread': '6.832556', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'The Food Craving Acceptance and Action Questionnaire is a 10-item questionnaire which measures acceptance of food related cravings and urges using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of food related cravings and urges.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only measured in this arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Discomfort Intolerance Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.2941', 'spread': '4.63364', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'The Discomfort intolerance Scale is a 6-item questionnaire which measures general difficulty managing and regulating physical distress and discomfort using a Likert scale (1-6 point scale: not at all like me = 1 to very much like me = 6). Total scores range 6-36: higher scores indicate greater distress intolerance.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only measured in this arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Physical Activity Acceptance & Action Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.2941', 'spread': '8.54228', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'The Physical Activity Acceptance \\& Action Questionnaire is a 10-item scale which measures acceptance of physical and psychological discomfort in the context of physical activity using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of physical and psychological discomfort in the context of physical activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only measured in this arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Weight Control Strategies Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1241', 'spread': '0.7082', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': "The Weight Control Strategies Scale is a 30-item questionnaire which measures participants' use of behavioral weight control strategies using a Likert scale (1-4 point scale: never = 0 to always = 4). Total scores range 0-120: higher scores indicate greater use of weight control strategies.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'assessed only in this arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Voluntary Exercise Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'title': 'Aerobic', 'categories': [{'measurements': [{'value': '-3.1111', 'spread': '4.523', 'groupId': 'OG000'}]}]}, {'title': 'Strength', 'categories': [{'measurements': [{'value': '0.2222', 'spread': '3.42234', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': "The Voluntary Exercise Questionnaire is a brief 6-item questionnaire which measures participants' participation in aerobic and strength training activities over the past 3 months and past week. Two items use a Likert scale (1-7 point scale: never = 1 to 7 = very often) and four items ask participants to report frequency of exercise: 0 = 0 days per week to 7 = 7 days per week). Total score range 2-42: Higher scores indicate greater levels of aerobic and strength training activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only assessed in this arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'title': 'Amotivation subscale', 'categories': [{'measurements': [{'value': '-0.1324', 'spread': '0.5312', 'groupId': 'OG000'}]}]}, {'title': 'External regulation subscale', 'categories': [{'measurements': [{'value': '-0.3088', 'spread': '0.7317', 'groupId': 'OG000'}]}]}, {'title': 'Introjected regulation subscale', 'categories': [{'measurements': [{'value': '-0.6618', 'spread': '1.01912', 'groupId': 'OG000'}]}]}, {'title': 'Identified regulation subscale', 'categories': [{'measurements': [{'value': '-0.0588', 'spread': '0.38047', 'groupId': 'OG000'}]}]}, {'title': 'Integrated regulation subscale', 'categories': [{'measurements': [{'value': '0.2794', 'spread': '0.72824', 'groupId': 'OG000'}]}]}, {'title': 'Intrisic motivation subscale', 'categories': [{'measurements': [{'value': '-0.0294', 'spread': '0.64881', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'a 24-item assessment of external, introjected, identified, and intrinsic forms of regulation of exercise behavior. Higher scores indicated higher exercise behavior. each is scored on 5 points (0-120). Six subscales - each 4 items (score 0-20 each). A positive change score indicates higher forms of regulation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only assessed in this arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in PROMIS Emotional Distress Short Form Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8824', 'spread': '5.20675', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'an 8 item scale used to measure emotional distress/depression. higher score indicates higher distress. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent reduced emotional distress.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only assessed in this arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in PROMIS Social Isolation Short Form Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.5294', 'spread': '4.30287', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'An 8-item scale used to measure perceived social isolation.higher scores indicate higher isolation. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent high isolation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only assessed in this arm'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Change in Three Factor Eating Questionnaire Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}], 'classes': [{'title': 'Uncontrolled eating subscale', 'categories': [{'measurements': [{'value': '-0.823', 'spread': '14.17778', 'groupId': 'OG000'}]}]}, {'title': 'Cognitive restraint subscale', 'categories': [{'measurements': [{'value': '3.0864', 'spread': '18.19987', 'groupId': 'OG000'}]}]}, {'title': 'Emotional eating subscale', 'categories': [{'measurements': [{'value': '0.6173', 'spread': '20.68971', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': '18-item scale measuring eating behavior with 3 subscales (cognitive restraint, emotional eating, uncontrolled eating) using Likert scale (1-4 point scale). Items 1-16 on this scale are reverse scored. The scale score is then entered into the following formula: (cognitive restraint scale score - 3)/9. The outcome is then multiplied by 100. Higher scores indicate higher restraint, emotional eating or uncontrolled eating, respectively. Subscales aretransformed to 0-100 score\n\nTo calculate the emotional eating sub scale, reverse scored items 2, 4, 7, 10, 14 and 16 are summed and then averaged to generate a mean score. The mean score is then multiplied by 6 to generate a scale score. The scale score is then entered into the following formula: (emotional eating scale score - 6)/18. The outcome is then multiplied by 100.\n\nPositive change scores represent lower restraint, higher emotional eating or higher uncontrolled eating.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'only assessed in this arm'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.8', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '-1.32', 'spread': '4.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'insulin', 'unitOfMeasure': 'mIU/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in C-peptide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.67', 'groupId': 'OG000'}, {'value': '0.69', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'C-peptide', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.00', 'spread': '3.96', 'groupId': 'OG000'}, {'value': '-0.65', 'spread': '1.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'C-reactive protein', 'unitOfMeasure': 'mg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Tumor Necrosis Factor Alpha', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '-0.08', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'tumor necrosis factor alpha', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Interleukin 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'OG001', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.10', 'spread': '2.14', 'groupId': 'OG000'}, {'value': '-0.44', 'spread': '1.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Interleukin 6', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'FG001', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, + potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 min. The overall structure will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment.\n\nParticipants in "MOWI Weight Loss Maintenance" were separately enrolled in this Study and did not enter the Maintenance from one or more remaining arms included here.'}, {'id': 'FG002', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'FG003', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '23'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.\n\nDevelop \\& Refine MOWI w/o Amulet: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.'}, {'id': 'BG001', 'title': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.\n\nMOWI Weight Loss Maintenance: Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).'}, {'id': 'BG002', 'title': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.\n\nDevelop \\& Refine MOWI w Fitbit: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.'}, {'id': 'BG003', 'title': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.\n\nDevelop \\& Refine MOWI w Fitbit/Protein: The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '71.0', 'spread': '5.1', 'groupId': 'BG000'}, {'value': '72.7', 'spread': '4.35', 'groupId': 'BG001'}, {'value': '73.0', 'spread': '6.3', 'groupId': 'BG002'}, {'value': '72.9', 'spread': '4.4', 'groupId': 'BG003'}, {'value': '72.5', 'spread': '5.3', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '68', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-03', 'size': 1079339, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2019-05-23T09:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Two Arm Pilot Study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2020-01-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-04', 'studyFirstSubmitDate': '2017-04-03', 'resultsFirstSubmitDate': '2020-05-06', 'studyFirstSubmitQcDate': '2017-04-03', 'lastUpdatePostDateStruct': {'date': '2022-11-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-06-15', 'studyFirstPostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Compliance to Whey Protein Consumption as Measured by Percent of the Total Number of Sessions Whey Could Have Been Taken', 'timeFrame': 'Baseline, 12 weeks post study', 'description': 'Medication adherence, visual analog scale'}, {'measure': 'Change in Food Craving Acceptance and Action Questionnaire Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'The Food Craving Acceptance and Action Questionnaire is a 10-item questionnaire which measures acceptance of food related cravings and urges using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of food related cravings and urges.'}, {'measure': 'Change in Discomfort Intolerance Scale Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'The Discomfort intolerance Scale is a 6-item questionnaire which measures general difficulty managing and regulating physical distress and discomfort using a Likert scale (1-6 point scale: not at all like me = 1 to very much like me = 6). Total scores range 6-36: higher scores indicate greater distress intolerance.'}, {'measure': 'Change in Physical Activity Acceptance & Action Questionnaire Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'The Physical Activity Acceptance \\& Action Questionnaire is a 10-item scale which measures acceptance of physical and psychological discomfort in the context of physical activity using a Likert scale (1-7 point scale: never true = 1 to always true = 7). Total scores range 10-70: higher scores indicate greater acceptance of physical and psychological discomfort in the context of physical activity.'}, {'measure': 'Change in Weight Control Strategies Scale Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': "The Weight Control Strategies Scale is a 30-item questionnaire which measures participants' use of behavioral weight control strategies using a Likert scale (1-4 point scale: never = 0 to always = 4). Total scores range 0-120: higher scores indicate greater use of weight control strategies."}, {'measure': 'Change in Voluntary Exercise Questionnaire Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': "The Voluntary Exercise Questionnaire is a brief 6-item questionnaire which measures participants' participation in aerobic and strength training activities over the past 3 months and past week. Two items use a Likert scale (1-7 point scale: never = 1 to 7 = very often) and four items ask participants to report frequency of exercise: 0 = 0 days per week to 7 = 7 days per week). Total score range 2-42: Higher scores indicate greater levels of aerobic and strength training activity."}, {'measure': 'Change in Behavioural Regulation in Exercise Questionnaire (BREQ-3) Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'a 24-item assessment of external, introjected, identified, and intrinsic forms of regulation of exercise behavior. Higher scores indicated higher exercise behavior. each is scored on 5 points (0-120). Six subscales - each 4 items (score 0-20 each). A positive change score indicates higher forms of regulation.'}, {'measure': 'Change in PROMIS Emotional Distress Short Form Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'an 8 item scale used to measure emotional distress/depression. higher score indicates higher distress. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent reduced emotional distress.'}, {'measure': 'Change in PROMIS Social Isolation Short Form Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': 'An 8-item scale used to measure perceived social isolation.higher scores indicate higher isolation. All promis questionnaires raw scores are converted to a scaled score of 0-100. 50 is mean. 10 units on the scale indicate 1 Standard deviation. higher change scores represent high isolation.'}, {'measure': 'Change in Three Factor Eating Questionnaire Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI)', 'description': '18-item scale measuring eating behavior with 3 subscales (cognitive restraint, emotional eating, uncontrolled eating) using Likert scale (1-4 point scale). Items 1-16 on this scale are reverse scored. The scale score is then entered into the following formula: (cognitive restraint scale score - 3)/9. The outcome is then multiplied by 100. Higher scores indicate higher restraint, emotional eating or uncontrolled eating, respectively. Subscales aretransformed to 0-100 score\n\nTo calculate the emotional eating sub scale, reverse scored items 2, 4, 7, 10, 14 and 16 are summed and then averaged to generate a mean score. The mean score is then multiplied by 6 to generate a scale score. The scale score is then entered into the following formula: (emotional eating scale score - 6)/18. The outcome is then multiplied by 100.\n\nPositive change scores represent lower restraint, higher emotional eating or higher uncontrolled eating.'}], 'primaryOutcomes': [{'measure': 'Change in Grip Strength', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Assessed by a Jamar dynamometer. Sensor-based Thera-bands will measure data on strength change.'}, {'measure': 'Change in 5 Times Sit-to-Stand (STS)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'STS measures lower limb strength (minimal change 2.3 s).'}, {'measure': 'Change in Six-Minute Walk Test (6MWT)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'A surrogate for cardiovascular fitness that measures distance (normal 400-700m) related to function. A clinically important difference is 50-55m'}, {'measure': 'Change in Gait Speed (m/s)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Gait speed is measured by the time it takes to walk 20 meters. Gait speed predicts disability and mortality (significant change 0.1 m/s).'}, {'measure': 'Change in Late-Life Function and Disability Instrument (LLFDI)', 'timeFrame': 'Baseline, 12 weeks', 'description': 'LLFDI consists of a 32-item function and 16-item disability (life-task) scales that correlate with gait speed and lower limb function. Higher points indicate better function. Individual raw scores range from 0 to 80, scaled scores are 0 to 100. Each was assessed at baseline and at 12 weeks. We report the differences between baseline/follow-up. Positive score change reflect improved physical function.'}], 'secondaryOutcomes': [{'measure': 'Change in Behavioral Activation (Patient Activation Measure)', 'timeFrame': 'Baseline, 12 weeks post study', 'description': 'Patient Activation Measure (PAM) assesses knowledge, confidence and skill for managing health and grouped into 4 levels revealing insights into attitudes, motivators, behaviors \\& outcomes. Higher points indicate better activation. Measures are scored 0-100 units. Scores below reflect changes between baseline and follow-up at 12-weeks. A positive change score indicates improvement in activation'}, {'measure': 'Change in Subjective Health Status (PROMIS) Physical', 'timeFrame': 'Baseline, 12-weeks', 'description': 'Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Short Form. PROMIS is a 10-item instrument capturing physical, mental and social aspects of quality of life having undergone quantitative appraisal and is non-proprietary. Higher points indicate better health. Raw scores are scaled to 0-100. 50 is the mean, 10 points indicates 1 standard deviation. Positive change scores listed below indicate an improvement in subjective health'}, {'measure': 'Change in Weight in kg', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Change in weight in kg'}, {'measure': 'Change in Waist Circumference in cm', 'timeFrame': 'Baseline, 12 weeks post study', 'description': 'Change in waist and hip circumference in cm'}, {'measure': 'Average Steps/Expenditure', 'timeFrame': 'Mean steps over 12 week period of time', 'description': 'Average Steps will be measured over a 12 week period'}, {'measure': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Activities', 'timeFrame': 'Change Score between baseline and 12 weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types -'}, {'measure': 'Change in Body Composition - Lean Mass', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Lean mass was assessed using bioelectrical impedance for 2P and 2B. This technique was not available for MOWI 2A participants and hence not measured'}, {'measure': 'Change in Energy Expenditure', 'timeFrame': 'Baseline to 12 weeks', 'description': 'Resting metabolic rate, Change Score (kCal) from Baseline to 12 weeks'}, {'measure': 'Change in Fasting Plasma Glucose', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Fasting Plasma Glucose'}, {'measure': 'Change in Participant Satisfaction Questionnaire Score', 'timeFrame': 'Change score from pre/post (baseline - at end of initial MOWI 12 weeks; follow-up at end of Maintenance study 6 months post-end of MOWI))', 'description': 'The Participant Satisfaction Questionnaire is a 12-item questionnaire which measures participant satisfaction with intervention participation using a Likert scale (0-5 point scale: very unsatisfied = 0 to very satisfied = 4). Total scores range 0-60: higher scores indicate greater satisfaction with the intervention.Three additional sub-items ask participants to rate their preference for the frequency of sessions, length of group meetings, and total number of group meetings using a Likert scale (-1 - 1 point scale: too few/too short = -1 to 1 = too much/too long). Each of these three items will be interpreted individually and not included in a summed total score. Additionally, this questionnaire includes 1 open-ended response item where participants are asked to leave any additional comments they may have regarding their level of satisfaction with the intervention.'}, {'measure': 'Change in Credibility and Expectancy Questionnaire Score', 'timeFrame': 'Baseline (of maintenance intervention) and 6 months (into maintenance) - pre/post', 'description': 'The Credibility and Expectancy Questionnaire is a 6-item questionnaire which measures expectancies regarding intervention participation and intervention rationale credibility using a Likert scale (0-10 point scale: responses are anchored to question stems such that, not at all logical/not at all effective/not at all confident/no credibility/not at all comfortable = 0 and very logical/very effective/very confident/high credibility = 10). Total scores range 0-50: higher scores indicate more favorable expectancies regarding participation in the intervention/greater perceived intervention credibility. Additionally, this questionnaire includes 1 open-ended response item that asks participants to leave any additional comments they may have regarding their expectations for the intervention'}, {'measure': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Number of Not Exercising Activities', 'timeFrame': 'Change Score between baseline and 12 weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types -'}, {'measure': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS) - Change in Duration', 'timeFrame': 'Change Score between baseline and 12 weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types -'}, {'measure': 'Community Healthy Activities Model Program for Seniors Physical Activity Questionnaire (CHAMPS)', 'timeFrame': 'Change in KCal between baseline and 12 weeks', 'description': 'CHAMPS is a self-reported tool in older adults that assesses activity levels and types -'}, {'measure': 'Change in Insulin Level', 'timeFrame': 'Baseline, 12 weeks', 'description': 'insulin'}, {'measure': 'Change in C-peptide', 'timeFrame': 'Baseline, 12 weeks', 'description': 'C-peptide'}, {'measure': 'Change in C-reactive Protein', 'timeFrame': 'Baseline, 12 weeks', 'description': 'C-reactive protein'}, {'measure': 'Change in Tumor Necrosis Factor Alpha', 'timeFrame': 'Baseline, 12 weeks', 'description': 'tumor necrosis factor alpha'}, {'measure': 'Change in Interleukin 6', 'timeFrame': 'Baseline, 12 weeks', 'description': 'Interleukin 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['frail elderly', 'telemedicine', 'obesity', 'rural health', 'health promotion', 'weight loss'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '33653394', 'type': 'DERIVED', 'citation': 'Petersen CL, Christensen BC, Batsis JA. Weight management intervention identifies association of decreased DNA methylation age with improved functional age measures in older adults with obesity. Clin Epigenetics. 2021 Mar 2;13(1):46. doi: 10.1186/s13148-021-01031-7.'}], 'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/show/NCT03041831', 'label': 'Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Qualitative Assessment'}, {'url': 'https://clinicaltrials.gov/show/NCT03085589', 'label': 'Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Amulet Technology Development \\& Validation'}, {'url': 'https://clinicaltrials.gov/show/NCT03104205', 'label': 'Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Home-Based Pilot'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity.', 'detailedDescription': 'The national epidemic of obesity is also affecting older adults, and is associated with an increased risk of disability, nursing home placement and early mortality. Conventional weight loss programs have the potential to reduce body fat, but are difficult to access for older obese adults due to transportation and mobility challenges. The overarching goal of this study is to conduct a program of pilot research aimed at developing and evaluating a technology assisted wellness intervention for older adults with obesity.\n\nStudy Timeline:\n\nSeptember 2017 to June 2018:\n\nGoal: Conduct a pilot study of improving weight and physical function in older adults with obesity. An mHealth Obesity Wellness Intervention (MOWI) will integrate Amulet +/- Fitbi with a weekly individual dietician-led nutritional session, along with twice weekly physical therapist led group exercise session.\n\nParticipation Duration: Three times weekly for 3 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAll Aims:\n\n* Age ≥65 years\n* Body Mass Index (BMI) ≥ 30kg/m\\^2\n* Waist circumference ≥88cm in females or ≥102cm in males\n\nAims 2 \\& 3:\n\n* Have Wi-Fi high speed internet\n* Able to obtain medical clearance from doctor\n* Have less than a 5% weight loss in past 6 months\n* No advanced co-morbidity\n* No exercise restrictions\n* Not involved in other research studies that may interfere with participation\n\nExclusion Criteria:\n\n* Severe mental or life-threatening illness\n* Dementia\n* Substance use\n* History of bariatric surgery\n* Suicidal ideation\n* Unable to perform measures\n* Reside in nursing home\n* No advanced co-morbidity\n* No exercise restrictions\n* Not involved in other research studies that may interfere with participation\n\nAim 4 - had to have completed Aims 2 or 3'}, 'identificationModule': {'nctId': 'NCT03104192', 'briefTitle': 'MOWI Research Pilot', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Mobile Health Obesity Wellness Intervention in Rural Older Adults (MOWI): Research Pilot', 'orgStudyIdInfo': {'id': 'D16182_2'}, 'secondaryIdInfos': [{'id': 'K23AG051681', 'link': 'https://reporter.nih.gov/quickSearch/K23AG051681', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Develop & Refine MOWI w/o Amulet (2A)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults without the use of Amulet technology.', 'interventionNames': ['Behavioral: Develop & Refine MOWI w/o Amulet']}, {'type': 'EXPERIMENTAL', 'label': 'MOWI Weight Loss Maintenance', 'description': 'Evaluate the feasibility, acceptability, and potential effectiveness of an 8-session, tri-weekly, psychosocial skills group intervention to support weight loss maintenance post-MOWI.', 'interventionNames': ['Behavioral: MOWI Weight Loss Maintenance']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Develop & Refine MOWI w Fitbit (2B)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology.', 'interventionNames': ['Behavioral: Develop & Refine MOWI w Fitbit']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Develop & Refine MOWI w Fitbit/Protein (2P)', 'description': 'Develop and refine a mHealth obesity wellness intervention (MOWI) for rural, older, obese adults with the use of Fitbit technology augmented by whey protein.', 'interventionNames': ['Dietary Supplement: Develop & Refine MOWI w Fitbit/Protein']}], 'interventions': [{'name': 'Develop & Refine MOWI w/o Amulet', 'type': 'BEHAVIORAL', 'otherNames': ['MOWI 2A'], 'description': 'The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.', 'armGroupLabels': ['Develop & Refine MOWI w/o Amulet (2A)']}, {'name': 'MOWI Weight Loss Maintenance', 'type': 'BEHAVIORAL', 'otherNames': ['MOWI LT'], 'description': 'Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).', 'armGroupLabels': ['MOWI Weight Loss Maintenance']}, {'name': 'Develop & Refine MOWI w Fitbit', 'type': 'BEHAVIORAL', 'otherNames': ['MOWI 2B-2'], 'description': 'The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.', 'armGroupLabels': ['Develop & Refine MOWI w Fitbit (2B)']}, {'name': 'Develop & Refine MOWI w Fitbit/Protein', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['MOWI Protein-2'], 'description': 'The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.', 'armGroupLabels': ['Develop & Refine MOWI w Fitbit/Protein (2P)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'country': 'United States', 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'overallOfficials': [{'name': 'John A Batsis, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dartmouth-Hitchcock Medical Center / Dartmouth Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'John A. Batsis, MD', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}