Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-01-08 @ 2:55 AM
Study NCT ID:
NCT02160834
Status:
WITHDRAWN
Last Update Posted:
2015-03-24
First Post:
2014-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Sedentary Time in Obese Adults (Study 2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D057185', 'term': 'Sedentary Behavior'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'study not initiated', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-19', 'studyFirstSubmitDate': '2014-06-09', 'studyFirstSubmitQcDate': '2014-06-10', 'lastUpdatePostDateStruct': {'date': '2015-03-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in percentage of daily sedentary time from baseline to post-intervention.', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Change in percentage of daily sedentary time from baseline to follow-up', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Sedentary behavior', 'Physical activity', 'Obesity', 'Mobile health', 'Smartphone', 'Time spent sedentary'], 'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'Greater time spent in sedentary behaviors, independent of physical activity level, can increase risk of morbidity and mortality. Objective assessments indicate that bariatric surgery patients spend large amounts of time in sedentary behaviors. The present study is the first to test whether a mobile health (mHealth) approach that employs widely adopted smartphone technology to monitor and modify sedentary behaviors as they occur is a feasible and acceptable method of reducing sedentary time in these patients and other obese populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Bariatric surgery patients and other obese individuals will be considered\n* Body mass index \\>= 25 kg/m2\n\nExclusion Criteria:\n\n* Report being unable to engage in daily activities and walk continuously for \\>= 10 minutes without assistance\n* Are currently involved in a physical activity intervention.\n* Are unable to read or understand the study materials\n* Are currently taking medications that cause dizziness and/or feeling faint when sitting or standing.\n* Report any condition that in the opinion of investigators would preclude adherence to the intervention protocol including plans to relocate, history of substance abuse or other significant psychiatric problems, or terminal illness.'}, 'identificationModule': {'nctId': 'NCT02160834', 'acronym': 'B-MOBILE', 'briefTitle': 'Reducing Sedentary Time in Obese Adults (Study 2)', 'organization': {'class': 'OTHER', 'fullName': 'The Miriam Hospital'}, 'officialTitle': 'A Mobile Health Approach to Reducing Sedentary Time in Bariatric Surgery Patients', 'orgStudyIdInfo': {'id': '1R03KD095740-02'}, 'secondaryIdInfos': [{'id': 'R03DK095740', 'link': 'https://reporter.nih.gov/quickSearch/R03DK095740', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'B-MOBILE smartphone-based intervention (3-min break)', 'description': 'Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."', 'interventionNames': ['Behavioral: B-MOBILE Smartphone-Based Intervention (3-min break)']}, {'type': 'EXPERIMENTAL', 'label': 'B-MOBILE Smartphone-Based Intervention (6-min break)', 'description': 'Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."', 'interventionNames': ['Behavioral: B-MOBILE Smartphone-Based Intervention (6-min break)']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'B-MOBILE Smartphone-Based Intervention (3-min break)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."', 'armGroupLabels': ['B-MOBILE smartphone-based intervention (3-min break)']}, {'name': 'B-MOBILE Smartphone-Based Intervention (6-min break)', 'type': 'BEHAVIORAL', 'description': 'Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in "real time."', 'armGroupLabels': ['B-MOBILE Smartphone-Based Intervention (6-min break)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02903', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'The Weight Control and Diabetes Research Center', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Dale S Bond, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Miriam Hospital/Brown Alpert Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Miriam Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}