Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop your current medications. However, if you are taking FDA-approved weight loss medications, you cannot participate in the trial.
Is the Diabetes Prevention Program (DPP) a promising treatment for prediabetes?Yes, the Diabetes Prevention Program (DPP) is a promising treatment for prediabetes. It is an effective lifestyle change program that can reduce the risk of developing type 2 diabetes by 58% over three years. It has been supported by major health organizations like the American Medical Association and the Centers for Disease Control and Prevention. The program has been adapted for different settings, including mobile and telehealth, making it accessible to more people.23456
What safety data exists for the Diabetes Prevention Program for prediabetes?The Diabetes Prevention Program (DPP) is a well-established, evidence-based lifestyle intervention aimed at reducing the incidence of type 2 diabetes in individuals with prediabetes. It has been evaluated in a large, multicenter, randomized clinical trial, which assessed both the safety and efficacy of the interventions. The program is associated with a significant reduction in diabetes incidence, and its implementation has been supported by major health organizations like the CDC and the American Medical Association. However, specific safety data details are not provided in the abstracts reviewed.12346
What data supports the idea that Diabetes Prevention Program for Prediabetes is an effective treatment?The available research shows that the Diabetes Prevention Program (DPP) is an effective treatment for reducing the risk of developing type 2 diabetes. One study highlights that the DPP is associated with a 58% reduction in the incidence of diabetes over three years. This significant decrease demonstrates the program's effectiveness in preventing the progression from prediabetes to diabetes. Additionally, the program has been supported by major health organizations like the American Medical Association and the Centers for Disease Control and Prevention, further indicating its credibility and effectiveness.23456
Eligibility Criteria
This trial is for English or Spanish-speaking men and women aged 65 and older with prediabetes, under NYU Langone Health's care. Participants must have a BMI of 30 or more, be able to travel for in-person evaluations, have access to a phone, and not have taken part in the Diabetes Prevention Program before.Inclusion Criteria
I have been diagnosed with pre-diabetes based on recent tests.
I can travel to NYU Langone for check-ups.
Exclusion Criteria
I cannot communicate well due to severe hearing loss or speech issues.
I have been diagnosed with active psychosis or cognitive issues.
I have diabetes or my kidneys are failing.
I have severe vision problems that prevent me from completing certain tasks.
I am currently taking weight loss medication approved by the FDA.
Treatment Details
The study compares two versions of the Diabetes Prevention Program (DPP): one delivered in person and another tailored for older adults via telehealth. It aims to see which method is more effective at preventing diabetes among seniors.
2Treatment groups
Active Control
Group I: In-person Diabetes Prevention Program (DPP)Active Control1 Intervention
Participants randomized to the in-person DPP intervention for 12 months
Group II: DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)Active Control1 Intervention
Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months.
DPP is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Diabetes Prevention Program for:
- Prediabetes prevention
- Type 2 diabetes prevention
🇪🇺 Approved in European Union as National Diabetes Prevention Program for:
- Prediabetes prevention
- Type 2 diabetes prevention
🇨🇦 Approved in Canada as CDC Diabetes Prevention Program for:
- Prediabetes prevention
- Type 2 diabetes prevention
Find a clinic near you
Research locations nearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
The Diabetes Prevention Program: baseline characteristics of the randomized cohort. The Diabetes Prevention Program Research Group. [2022]The Diabetes Prevention Program (DPP) is a 27-center randomized clinical trial designed to evaluate the safety and efficacy of interventions that may delay or prevent development of diabetes in people at increased risk for type 2 diabetes.
Strategies to identify adults at high risk for type 2 diabetes: the Diabetes Prevention Program. [2021]The Diabetes Prevention Program (DPP) was a large, multicenter, randomized clinical trial testing interventions to prevent or delay type 2 diabetes. A major challenge was to identify eligible high-risk adults, defined by DPP as having both impaired glucose tolerance (IGT) (2-h glucose 140-199 mg/dl) and elevated fasting plasma glucose (EFG) (95-125 mg/dl).
Implementation findings from a hybrid III implementation-effectiveness trial of the Diabetes Prevention Program (DPP) in the Veterans Health Administration (VHA). [2022]The Diabetes Prevention Program (DPP) is an effective lifestyle intervention to reduce incidence of type 2 diabetes. However, there are gaps in knowledge about how to implement DPP. The aim of this study was to evaluate implementation of DPP via assessment of a clinical demonstration in the Veterans Health Administration (VHA).
Practical Tips for Implementing the Diabetes Prevention Program in Clinical Practice. [2019]The Diabetes Prevention Program (DPP) is an evidence-based lifestyle change program for prediabetes that is associated with a 58% reduction in 3-year diabetes incidence, and it has been supported by the American Medical Association and the Centers for Disease Control and Prevention. However, 9 in 10 patients are unaware they have the condition.
BRInging the Diabetes prevention program to GEriatric populations (BRIDGE): a feasibility study. [2022]The purpose of this 6-week intervention was to test the feasibility and acceptability of implementing a telehealth-adapted Diabetes Prevention Program (DPP) at a senior center.
Mobile Delivery of the Diabetes Prevention Program in People With Prediabetes: Randomized Controlled Trial. [2022]The Centers for Disease Control and Prevention (CDC) diabetes prevention program (DPP) has formed the foundation for Type 2 Diabetes Mellitus (T2DM) prevention efforts and lifestyle change modifications in multiple care settings. To our knowledge, no randomized controlled trial has verified the efficacy of a fully mobile version of CDC's diabetes prevention program (DPP).