Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2026-01-12 @ 8:43 AM
Study NCT ID:
NCT03039569
Status:
COMPLETED
Last Update Posted:
2019-06-19
First Post:
2017-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wchai2@unl.edu', 'phone': '402-472-7822', 'title': 'Weiwen Chai', 'organization': 'University of Nebraska-Lincoln'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '1\\) The non-randomized, quasi-experimental study design; 2) Using self-report measures'}}, 'adverseEventsModule': {'timeFrame': '3 month', 'eventGroups': [{'id': 'EG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Self-Care Activities: Healthy Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.23', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '4.67', 'spread': '0.40', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '4.61', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '4.60', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Three months', 'description': 'An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)', 'unitOfMeasure': 'days/week (min: 0 days; Max: 7 days)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'PRIMARY', 'title': 'Diabetes Self-care Activity: Exercise', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.13', 'spread': '0.62', 'groupId': 'OG000'}, {'value': '4.91', 'spread': '0.66', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '4.48', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '4.25', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Three months', 'description': 'Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)', 'unitOfMeasure': 'days/week (min: 0 days; Max: 7 days)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'PRIMARY', 'title': 'Self-care Activity: Blood Glucose Testing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.09', 'spread': '0.64', 'groupId': 'OG000'}, {'value': '5.93', 'spread': '0.69', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '5.27', 'spread': '0.68', 'groupId': 'OG000'}, {'value': '5.63', 'spread': '0.70', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'three months', 'description': 'Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)', 'unitOfMeasure': 'days/ week (min: 0 days; max: 7 days))', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'PRIMARY', 'title': 'Self-care Activity: Medication Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.75', 'spread': '0.22', 'groupId': 'OG000'}, {'value': '5.83', 'spread': '0.23', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '5.73', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '5.67', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'three months', 'description': 'Self-report survey question (days over the last seven days)', 'unitOfMeasure': 'day/week (min: 0 days; max 7 days)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'PRIMARY', 'title': 'Self-care Activity: Foot Care', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.17', 'spread': '0.41', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '0.45', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '4.89', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '4.18', 'spread': '0.45', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'three months', 'description': 'Average of four self-report survey questions of the category (days over the last seven days)', 'unitOfMeasure': 'day/week (min: 0 days; max 7 days)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'PRIMARY', 'title': 'Eat >= 5 Servings Fruit and Vegetables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).\n\nText messaging: The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise"). The control group will not receive text messages'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Three months', 'description': 'Self report survey question (days/week)', 'unitOfMeasure': 'day/week (min: 0 days; max 7 days)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'SECONDARY', 'title': 'Self-report Hemoglobin A1C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '7.9', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '8.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '7.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '8.0', 'spread': '0.3', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Three months', 'description': 'Self-report hemoglobin for diabetes status', 'unitOfMeasure': 'percentage of glycated HB in blood', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'SECONDARY', 'title': 'Frequency of Concern of CVD Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'Never/rare concern', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Sometimes concern', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'title': 'Always concern', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Not answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'title': 'Never/rare concern', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}, {'title': 'Sometimes concern', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Always concern', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Not answer', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Three months', 'description': "Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Chi-square'}, {'type': 'SECONDARY', 'title': 'Total Carbohydrate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '126', 'spread': '10', 'groupId': 'OG000'}, {'value': '111', 'spread': '10', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '102', 'spread': '11', 'groupId': 'OG000'}, {'value': '100', 'spread': '11', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'One month', 'description': 'A self-report food frequency questionnaire over the past month', 'unitOfMeasure': 'gram/day', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'SECONDARY', 'title': 'Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2112', 'spread': '1451', 'groupId': 'OG000'}, {'value': '1042', 'spread': '1430', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'measurements': [{'value': '3163', 'spread': '1555', 'groupId': 'OG000'}, {'value': '405', 'spread': '1532', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Three months', 'description': 'A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity', 'unitOfMeasure': 'MET minutes/week', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Treatment effects were evaluated by assessing the differences in the outcome variables from baseline to the 12-week follow-up between participants in the intervention group and the control group using Proc Glimmix procedure.'}, {'type': 'SECONDARY', 'title': 'Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'No or low concern', 'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}, {'title': 'Somewhat concern', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}, {'title': 'Highly concern', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Not answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'title': 'No or low concern', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Somewhat concern', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Highly concern', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Not answer', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Three months', 'description': 'Self report survey question', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Chi-square'}, {'type': 'SECONDARY', 'title': 'Degree of Concern of CVD Event in Lifetime', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Text Messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).'}, {'id': 'OG001', 'title': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': 'No concern/low concern', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Somewhat concern', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'highly concern', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': 'Not answer', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'post-intervention', 'categories': [{'title': 'No concern/low concern', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'Somewhat concern', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}, {'title': 'highly concern', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Not answer', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Three months', 'description': 'Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Chi-square'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Text Messaging', 'description': 'Participants received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).\n\nText messaging: The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise"). The control group did not receive text messages'}, {'id': 'FG001', 'title': 'Control', 'description': 'Participants did not receive text message intervention. This is the measurement-only group'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '39'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Text Messaging', 'description': 'Intervention group received three text messages per week for 12 weeks'}, {'id': 'BG001', 'title': 'Control', 'description': 'Control group did not receive text messages'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '58.8', 'spread': '10.6', 'groupId': 'BG000'}, {'value': '55.7', 'spread': '12.2', 'groupId': 'BG001'}, {'value': '56.9', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'White', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-01', 'size': 350280, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-02-07T17:04', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-07', 'studyFirstSubmitDate': '2017-01-24', 'resultsFirstSubmitDate': '2018-08-27', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-02-22', 'studyFirstPostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Care Activities: Healthy Eating', 'timeFrame': 'Three months', 'description': 'An average of summary scores of the four self-report heathy eating related items in the category (days/over the last 7 days)'}, {'measure': 'Diabetes Self-care Activity: Exercise', 'timeFrame': 'Three months', 'description': 'Average of two self-report survey questions related to exercise in the category (days/over the last 7 days)'}, {'measure': 'Self-care Activity: Blood Glucose Testing', 'timeFrame': 'three months', 'description': 'Average of two self-report survey question items related to blood glucose testing in the category (days over the last seven days)'}, {'measure': 'Self-care Activity: Medication Adherence', 'timeFrame': 'three months', 'description': 'Self-report survey question (days over the last seven days)'}, {'measure': 'Self-care Activity: Foot Care', 'timeFrame': 'three months', 'description': 'Average of four self-report survey questions of the category (days over the last seven days)'}, {'measure': 'Eat >= 5 Servings Fruit and Vegetables', 'timeFrame': 'Three months', 'description': 'Self report survey question (days/week)'}], 'secondaryOutcomes': [{'measure': 'Self-report Hemoglobin A1C', 'timeFrame': 'Three months', 'description': 'Self-report hemoglobin for diabetes status'}, {'measure': 'Frequency of Concern of CVD Event', 'timeFrame': 'Three months', 'description': "Self-report question to measure a patient's cardiovascular disease awareness: Frequency of concern of CVD event"}, {'measure': 'Total Carbohydrate', 'timeFrame': 'One month', 'description': 'A self-report food frequency questionnaire over the past month'}, {'measure': 'Metabolic Equivalent (MET) Minutes Per Week for Moderate/Vigorous Physical Activity', 'timeFrame': 'Three months', 'description': 'A Self-report physical activity measure over the past month. The activities were converted to metabolic equivalent (MET: a measure of exercise intensity based on oxygen consumption) minutes per week for moderate/vigorous physical activity'}, {'measure': 'Awareness of Cardiovascular Disease (CVD): Degree of Concern of CVD Event in Next 5 Years', 'timeFrame': 'Three months', 'description': 'Self report survey question'}, {'measure': 'Degree of Concern of CVD Event in Lifetime', 'timeFrame': 'Three months', 'description': 'Self-report survey question on Cardiovascular disease (CVD) awareness: degree of concern of CVD event in lifetime'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type 2 diabetes patients', 'Diabetes self-management', 'Cardiovascular diseases awareness', 'Home food environment', 'Text message'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '20067953', 'type': 'BACKGROUND', 'citation': 'Cowie CC, Rust KF, Byrd-Holt DD, Gregg EW, Ford ES, Geiss LS, Bainbridge KE, Fradkin JE. Prevalence of diabetes and high risk for diabetes using A1C criteria in the U.S. population in 1988-2006. Diabetes Care. 2010 Mar;33(3):562-8. doi: 10.2337/dc09-1524. Epub 2010 Jan 12.'}, {'pmid': '11794490', 'type': 'BACKGROUND', 'citation': 'American Diabetes Association Task Force for Writing Nutrition Principles and Recommendations for the Management of Diabetes and Related Complications. American Diabetes Association position statement: evidence-based nutrition principles and recommendations for the treatment and prevention of diabetes and related complications. J Am Diet Assoc. 2002 Jan;102(1):109-18. doi: 10.1016/s0002-8223(02)90031-3.'}, {'pmid': '10895844', 'type': 'BACKGROUND', 'citation': 'Toobert DJ, Hampson SE, Glasgow RE. The summary of diabetes self-care activities measure: results from 7 studies and a revised scale. Diabetes Care. 2000 Jul;23(7):943-50. doi: 10.2337/diacare.23.7.943.'}, {'pmid': '23497632', 'type': 'BACKGROUND', 'citation': 'Goodarzi M, Ebrahimzadeh I, Rabi A, Saedipoor B, Jafarabadi MA. Impact of distance education via mobile phone text messaging on knowledge, attitude, practice and self efficacy of patients with type 2 diabetes mellitus in Iran. J Diabetes Metab Disord. 2012 Aug 31;11(1):10. doi: 10.1186/2251-6581-11-10.'}, {'pmid': '31212683', 'type': 'DERIVED', 'citation': 'Nepper MJ, McAtee JR, Wheeler L, Chai W. Mobile Phone Text Message Intervention on Diabetes Self-Care Activities, Cardiovascular Disease Risk Awareness, and Food Choices among Type 2 Diabetes Patients. Nutrients. 2019 Jun 11;11(6):1314. doi: 10.3390/nu11061314.'}]}, 'descriptionModule': {'briefSummary': 'In this project the investigators examined the impact of diabetes self-management education using text messaging on increasing awareness of CVD risk perception, dietary intake, physical activity, and diabetes self-management among adults with type 2 diabetes using a quasi experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or older). The recruited adult type 2 diabetes patients were assigned into the intervention group (40 participants) and control group (39 participants). The intervention group received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages were derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise") Text messages were positive and motivating and included a link to a specific AADE7 handout that allows participants to open and retrieve the specific AADE7 handout. The control group did not receive text messages. The participants (both intervention and control group) completed surveys at baseline (before study begins) and at the conclusion of the study (at three month of the intervention) about their dietary and lifestyle habits, diabetes self-care management activities, and awareness of cardiovascular diseases. We collected also collect patient\'s self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three month of the intervention).', 'detailedDescription': 'Type 2 diabetes and its complications have become an important public health problem, affecting nearly 350 million adults worldwide. However, successfully managing type 2 diabetes through proper nutrition and healthy lifestyles remains challenging for many diabetes patients. In this proposed project the investigators examined the impact of diabetes self-management education using text messaging on increasing awareness of CVD risk perception, dietary intake, physical activity, and diabetes self-management, and quality of life among adults with type 2 diabetes among adults with Type 2 diabetes using a quasi experimental design. The study sample included 79 adult type 2 diabetes patients (30 years or older). Inclusion criteria for the study sample of adult type II diabetes patients were: adults ages 30 or older, English speaking, and Hemoglobin A1C levels \\> 6.5%.\n\nAdult type 2 diabetes patients were recruited from the Center for Diabetes \\& Nutritional Health, an outpatient diabetes clinic of Methodist Hospital in Omaha with the assistance of Certified Diabetes Educators and Registered Dietitians. Diagnosis of type 2 diabetes were based on patient self-report and verified by the Co-Primary Investigator (who is Certified Diabetes educator and registered dietitian at the Methodist Hospital. The recruited adult type 2 diabetes patients were assigned into the intervention group (40 participants) and control group (39 participants). The intervention group received 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks). The messages consisted of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages were derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise") Text messages were positive and motivating and included a link to a specific AADE7 handout that allows participants to open and retrieve the specific AADE7 handout. Text messages were sent by the project investigators to the participants in the intervention group via a free computer-based text messaging service. The computer was password protected and can only be accessed by the investigators. Participant\'s phone numbers used for text message intervention were kept private. Only investigators and research assistant know the participant\'s cell phone numbers used for text message intervention and each participant\'s cell number was not shared with anyone else including other study participants. Text messages were sent by the project investigators or research assistant to the patients and were one-way text messages, meaning that patient did not need to reply to the text messages. If a patient had a medical concern about his/her diabetes, he/she was advised not to send a text message to the investigator, but to contact his/her physician or call 911 instead. The control group did not receive text messages. The participants (both intervention and control group) completed surveys at baseline (before study begins) and at the conclusion of the study (at three month of the intervention) about their dietary and lifestyle habits, diabetes self-care management, awareness of cardiovascular diseases and home food environment. The investigators also collected patient\'s self-report Hemoglobin A1C values at baseline and at the conclusion of the study (at three month of the intervention).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Self-report adult type 2 diabetes patients\n* Adults ages 30 or older\n* English speaking\n* Self-report Hemoglobin A1C \\> 6.5%\n* Have a cell phone able to receive text messages\n\nExclusion Criteria:\n\n* Individuals without Type 2 diabetes\n* Less than 30 years of age\n* Self-report Hemoglobin A1C less than 6.5%\n* Does not have a cell phone to receive text messages\n* Individuals who don't speak and understand English"}, 'identificationModule': {'nctId': 'NCT03039569', 'briefTitle': 'Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska Lincoln'}, 'officialTitle': 'Assessing Home Food Environment and Diabetes Self-management Among Adult Type 2 Diabetes Patients', 'orgStudyIdInfo': {'id': '16200'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Text messaging', 'description': 'Participants will receive 3 messages weekly consisting of nutrition education and diabetes self-management information and skills for 3 months (12 weeks).', 'interventionNames': ['Behavioral: Text messaging']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants will not receive text message intervention. This is the measurement-only group'}], 'interventions': [{'name': 'Text messaging', 'type': 'BEHAVIORAL', 'description': 'The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts ("Reducing Risks", "Monitoring", "Healthy Coping", "Problem Solving", "Taking Medication", "Healthy Eating", and "Exercise"). The control group will not receive text messages', 'armGroupLabels': ['Text messaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68583-0806', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska-Lincoln (with Methodist Hospital System)', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}], 'overallOfficials': [{'name': 'Weiwen Chai, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska Lincoln'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska Lincoln', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}