- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524404
BRInging the Diabetes Prevention Program to GEriatric Populations - PILOT (BRIDGE)
November 8, 2021 updated by: NYU Langone Health
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
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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New York, New York, United States, 10016
- New York University School of Medicine
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men and women age ≥ 60 years
- Diabetes Risk Score >=5
Exclusion Criteria:
- Decisional incapacity to consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Diabetes Prevention Program (DPP)
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.
|
Weekly interactive webinars based on the DPP curriculum at senior center.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Program engagement
Time Frame: 8 Weeks
|
calculated by subtracting attending study visits from those enrolled
|
8 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jeannette Beasley, MD, Jeannette.Beasley@nyumc.org
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 28, 2018
Primary Completion (Actual)
April 15, 2019
Study Completion (Actual)
April 15, 2019
Study Registration Dates
First Submitted
May 2, 2018
First Submitted That Met QC Criteria
May 2, 2018
First Posted (Actual)
May 14, 2018
Study Record Updates
Last Update Posted (Actual)
November 16, 2021
Last Update Submitted That Met QC Criteria
November 8, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-00229
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.