BRInging the Diabetes Prevention Program to GEriatric Populations

NCT05166785 | Active Not Recruiting DMC

• 2 other identifiers: 21-010391R01DK127916-01A1
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre Diabetes

Outcome Measures

Primary Outcomes (2)

• 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

  Baseline visit, 6 months visit, 12 month visit

• 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

  Baseline visit, 6 months visit, 12 month visit

Secondary Outcomes (1)

• Adherence to the DPP-TOAT is greater than the in-person DPP

  Baseline visit, 6 months visit, 12 month visit

Study Arms (2)

In-person Diabetes Prevention Program (DPP)

ACTIVE COMPARATOR

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

Other: In-Person Diabetes Prevention Program (DPP)

DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)

ACTIVE COMPARATOR

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

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

DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)

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)

In-person Diabetes Prevention Program (DPP)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Aging

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Growth and Development; Physiological Phenomena

Study Officials

• Jeannette M Beasley, PhD, RDN

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

• Joshua Chodosh, MD, MHS

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: December 22, 2021
• Study Start: October 5, 2022
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)