BRInging the Diabetes Prevention Program to GEriatric Populations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 238
- Locations
- 1
- Primary Endpoint
- Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP
Study Overview
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.
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Men and women aged 65 years and older
- •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)
- •BMI of greater than or equal to 30
- •English-speaking
- •Under the care of a Primary care provider (PCP) in the NYU Langone Health system
- •Able to travel to NYU Langone for in-person evaluations
- •Access to a telephone
- •Informed consent
Exclusion Criteria
- •Prevalent diabetes or end-stage renal disease
- •Prior participation in the Diabetes Prevention Program
- •A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD) -10 codes
- •Taking FDA-approved weight loss medications
- •PCP stating that patient should not participate
- •Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
- •Severe visual impairment that precludes completion of assessments and/or intervention
Arms & Interventions
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.
Intervention: DPP Tailored for Older Adults and delivered via Telehealth (Other)
In-person Diabetes Prevention Program (DPP)
Participants randomized to the in-person DPP intervention for 12 months
Intervention: In-Person Diabetes Prevention Program (DPP) (Other)
Outcomes
Primary Outcomes
Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP
Time Frame: 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
Time Frame: 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 Outcomes
- Adherence to the DPP-TOAT is greater than the in-person DPP(Baseline visit, 6 months visit, 12 month visit)