BRInging the Diabetes Prevention Program to GEriatric Populations (BRIDGE)

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.

Study Overview

• Status: Recruiting
• Conditions: Pre Diabetes
• Intervention / Treatment: Other: In-Person Diabetes Prevention Program (DPP); Other: DPP Tailored for Older Adults and delivered via Telehealth

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.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Taj Adams; Phone Number: 646-501-4681; Email: Bridgestudy@nyulangone.org
• Study Contact Backup: Name: Jeannette Beasley, PhD, RDN; Email: Jeannette.Beasley@nyulangone.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Health
      • Contact: Taj Adams; Phone Number: 646-501-4681; Email: Bridgestudy@nyulangone.org
      • Principal Investigator: Jeannette M Beasley, PhD, RDN
      • Principal Investigator: Joshua Chodosh, MD, MHS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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); 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)
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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline visit, 6 months visit, 12 month visit

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Jeannette M Beasley, PhD, RDN, NYU Langone Health; Principal Investigator: Joshua Chodosh, MD, MHS, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: December 8, 2021
• First Submitted That Met QC Criteria: December 8, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 27, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 21-01039; 1R01DK127916-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No