Image

BRInging the Diabetes Prevention Program to GEriatric Populations

BRInging the Diabetes Prevention Program to GEriatric Populations

Not Recruiting
65 years and older
All
Phase N/A

Powered by AI

Overview

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.

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.

Eligibility

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

Study details
    Pre Diabetes

NCT05166785

NYU Langone Health

12 December 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.