BRIDGE: BRInging the Diabetes Prevention Program to GEriatric Populations
Study Details
Study Description
Brief Summary
Over 24 million Americans are over 65 years and have prediabetes. Prediabetes can be addressed using a public health approach: among the 20% of participants in the Diabetes Prevention Program (DPP) who were ages 60 and over, the diet and physical activity intervention conferred a 71% risk reduction of diabetes after an average follow-up of 3 years. The population of older adults is projected to more than double from 52.5 million in 2019 to ~100 million by 2060, and if projections hold, about half (48.3%) will have prediabetes. The proposed hybrid effectiveness implementation type 1 design will compare a DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) to an in person DPP tailored for older adults (DPP arm) using a randomized, controlled trial design (n=230). The preliminary data suggests DPP-TOAT is a feasible and acceptable way to deliver the DPP to older adults, and this will be the first study to compare the effectiveness and implementation of two strategies (telehealth versus in-person) to deliver a tailored DPP for the unique needs of the growing population of older adults.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Eligible patients will be recruited through electronic health records (Epic and MyChart) and randomized to the 12-month DPP-TOAT or the in-person DPP program. Primary effectiveness outcome will be 6-month weight loss and implementation outcome will be attendance. A pragmatic approach will be used in order to inform future studies conducted in community-based and rural settings. Findings will inform best practices in the delivery of an evidence-based intervention that could reach the 30+ million adults aged 65 and over with prediabetes.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: In-person Diabetes Prevention Program (DPP) Participants randomized to the in-person DPP intervention for 12 months |
Other: In-Person Diabetes Prevention Program (DPP)
Diabetes Prevention Program (DPP) is composed of 16 60-minute weekly sessions followed by six 60-minute monthly support sessions over 12 months in person approved by the Centers for Disease Control and Prevention (CDC)
|
| Active Comparator: DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months. |
Other: DPP Tailored for Older Adults and delivered via Telehealth
Diabetes Prevention Program (DPP) Tailored for Older Adults and delivered via Telehealth (DPP-TOAT) will be composed of 16 60-minute weekly sessions followed by six 60-minute monthly support sessions
|
Outcome Measures
Primary Outcome Measures
- Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP [Baseline visit, 6 months visit, 12 month visit]
In-person outcome assessment visits at the New York University Langone research clinic to measure weight at baseline, 6, and 12 months among all randomized participants
- Changes in HbA1c in participants in DPP-TOAT is similar to those in In-Person DPP [Baseline visit, 6 months visit, 12 month visit]
In-person outcome assessment visits at New York University Langone research clinic to measure glycemia at baseline, 6, and 12 months among all randomized participants
Secondary Outcome Measures
- Adherence to the DPP-TOAT is greater than the in-person DPP [Baseline visit, 6 months visit, 12 month visit]
This will be measured by the number of group sessions completed by each participant.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Men and women aged 65 years and older
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Diagnosis of pre-diabetes (A1c between 5.7-6.4%, fasting glucose between 100-125 mg/dL, or oral glucose tolerance test between 140-199 mg/dL within past 12 months)
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BMI of greater than or equal to 30
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English or Spanish-speaking
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Under the care of a Primary care provider (PCP) in the NYU Langone Health system
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Able to travel to NYU Langone for in-person evaluations
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Access to a telephone
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Informed consent
Exclusion Criteria:
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Prevalent diabetes or end-stage renal disease
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Prior participation in the Diabetes Prevention Program
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A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD) -10 codes
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Taking FDA-approved weight loss medications
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PCP stating that patient should not participate
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Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
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Severe visual impairment that precludes completion of assessments and/or intervention
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | NYU Langone Health | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
- Principal Investigator: Jeannette Beasley, MD, NYU Langone Health
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 21-01039
- 1R01DK127916-01A1