BRInging the Diabetes Prevention Program to GEriatric Populations

Pre Diabetes Clinical Trial

— BRIDGE  

Official title:

BRInging the Diabetes Prevention Program to GEriatric Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05166785
• Other study ID #: 21-01039
• Secondary ID: 1R01DK127916-01A
• Status: Recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: November 2026

Study information

• Verified date: October 2023
• Source: NYU Langone Health
• Contact: Taj Adams
• Phone: 646-501-4681
• Email: Bridgestudy[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: November 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Pre Diabetes
• Prediabetic State

Intervention

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
• 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)

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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