BRInging the Diabetes Prevention Program to GEriatric Populations

Study Overview
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Brief Summary
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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
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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.

Official Title
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BRInging the Diabetes Prevention Program to GEriatric Populations

Conditions
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Pre Diabetes

Intervention / Treatment
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* Other: DPP Tailored for Older Adults and delivered via Telehealth
* Other: In-Person Diabetes Prevention Program (DPP)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: In-person Diabetes Prevention Program (DPP)<br>Participants randomized to the in-person DPP intervention for 12 months | Other: In-Person Diabetes Prevention Program (DPP)<br>* 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)<br>|
| Active Comparator: DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)<br>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<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP | 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 | Baseline visit, 6 months visit, 12 month visit | 
| Changes in HbA1c in participants in DPP-TOAT is similar to those in In-Person DPP | 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 | Baseline visit, 6 months visit, 12 month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to the DPP-TOAT is greater than the in-person DPP | This will be measured by the number of group sessions completed by each participant. | Baseline visit, 6 months visit, 12 month visit |