Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT03524404
Status:
COMPLETED
Last Update Posted:
2021-11-16
First Post:
2018-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BRInging the Diabetes Prevention Program to GEriatric Populations - PILOT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-08', 'studyFirstSubmitDate': '2018-05-02', 'studyFirstSubmitQcDate': '2018-05-02', 'lastUpdatePostDateStruct': {'date': '2021-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Program engagement', 'timeFrame': '8 Weeks', 'description': 'calculated by subtracting attending study visits from those enrolled'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes']}, 'referencesModule': {'references': [{'pmid': '31741744', 'type': 'DERIVED', 'citation': 'Beasley JM, Kirshner L, Wylie-Rosett J, Sevick MA, DeLuca L, Chodosh J. BRInging the Diabetes prevention program to GEriatric populations (BRIDGE): a feasibility study. Pilot Feasibility Stud. 2019 Nov 11;5:129. doi: 10.1186/s40814-019-0513-7. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this pilot study is to test the feasibility of implementing a telehealth adaption of the Diabetes Prevention Program (DPP) intervention among 30 NYC senior center members. The intervention will be conducted through 6 weekly webinars with a certified DPP coach. Participants will receive a binder and physical activity tracker to complete self-monitoring of diet and physical activity. The primary outcome is feasibility and acceptability of the intervention measured by workshop attendance and focus group feedback. Secondary outcomes include changes in diet, physical activity, and weight.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women age ≥ 60 years\n* Diabetes Risk Score \\>=5\n\nExclusion Criteria:\n\n* Decisional incapacity to consent'}, 'identificationModule': {'nctId': 'NCT03524404', 'acronym': 'BRIDGE', 'briefTitle': 'BRInging the Diabetes Prevention Program to GEriatric Populations - PILOT', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'BRInging the Diabetes Prevention Program to GEriatric Populations(BRIDGE): a Pilot Study to Test the Usability and Effectiveness of a Telehealth Adaption of the Diabetes Prevention Program (DPP) in a Community of Older Adults', 'orgStudyIdInfo': {'id': '18-00229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diabetes Prevention Program (DPP)', 'description': 'Live stream the first six sessions of the Diabetes Prevention Program (DPP) curriculum to Senior Planet on a weekly basis, The webinars will be about 1 hour long, led by a certified DPP educator, and live-streamed to the senior center. Participants will have weekly weigh-ins and meet with a research assistant led focus group following two out of the six sessions to discuss program acceptability.', 'interventionNames': ['Behavioral: 6 Week Intervention']}], 'interventions': [{'name': '6 Week Intervention', 'type': 'BEHAVIORAL', 'description': 'Weekly interactive webinars based on the DPP curriculum at senior center.', 'armGroupLabels': ['Diabetes Prevention Program (DPP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Jeannette Beasley, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jeannette.Beasley@nyumc.org'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}