CClinicalTrials.gg
CompletedNCT05166785BRIDGEUpdated Sep 23, 2026

BRInging the Diabetes Prevention Program to GEriatric Populations

An interventional study of DPP Tailored for Older Adults and delivered via Telehealth and In-Person Diabetes Prevention Program (DPP) in Pre Diabetes, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Pre Diabetes

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In context

Glucose Intolerance

778 studies on the registry are indexed under Glucose Intolerance; 129 are open to participants now.

This study's enrollment of 238 is above the median of 60 across 645 interventional studies indexed under Glucose Intolerance.

Browse Glucose Intolerance studies →

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
238 participants (actual)

Study arms

  • Active comparator
    In-person Diabetes Prevention Program (DPP)

    Participants randomized to the in-person DPP intervention for 12 months

    Other: In-Person Diabetes Prevention Program (DPP)

  • Active comparator
    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.

    Other: DPP Tailored for Older Adults and delivered via Telehealth

Interventions

  • OtherDPP Tailored for Older Adults and delivered via Telehealth

    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

  • OtherIn-Person Diabetes Prevention Program (DPP)

    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)

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What researchers measure

Primary outcomes

  1. 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

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

  2. 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

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

Secondary outcomes

  1. 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.

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

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Study locations

1 site
  • NYU Langone Health
    New York, New York 10016, United States
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References and documents

Study documents

  • Informed consent form · Dec 2, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Data collected from this study include anthropometric and blood draw data that will be uploaded to the participants' electronic medical record and questionnaire data that will only be used for study-related purposes.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05166785
Lead sponsor
NYU Langone Health
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Sponsor
First posted
Dec 22, 2021
Start date
Oct 5, 2022
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026
Last update
Sep 23, 2026

Study contacts

Jeannette M Beasley, PhD, RDN
principal investigator · NYU Langone Health
Joshua Chodosh, MD, MHS
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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