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BRInging the Diabetes Prevention Program to GEriatric Populations

NCT ID: NCT05166785

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-05

Study Completion Date

2026-11-30

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.

Conditions

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Pre Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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In-person Diabetes Prevention Program (DPP)

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

Group Type ACTIVE_COMPARATOR

In-Person Diabetes Prevention Program (DPP)

Intervention Type 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)

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.

Group Type ACTIVE_COMPARATOR

DPP Tailored for Older Adults and delivered via Telehealth

Intervention Type 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

Interventions

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DPP 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

Intervention Type OTHER

In-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)

Intervention Type OTHER

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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

NIH

Sponsor Role collaborator

NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jeannette M Beasley, PhD, RDN

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Joshua Chodosh, MD, MHS

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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21-01039

Identifier Type: -

Identifier Source: org_study_id

1R01DK127916-01A1

Identifier Type: NIH

Identifier Source: secondary_id

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