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Active, Not Recruiting

NCT Number: NCT05166785

BRInging the Diabetes Prevention Program to GEriatric Populations

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pre Diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Health

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPP Tailored for Older Adults and delivered via Telehealth

Other

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

In-Person Diabetes Prevention Program (DPP)

Other

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)

Primary outcomes

  1. 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

  2. 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

  1. Adherence to the DPP-TOAT is greater than the in-person DPP

    Time frame: Baseline visit, 6 months visit, 12 month visit

    This will be measured by the number of group sessions completed by each participant.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Acronym: BRIDGE

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Dec 22, 2021
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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