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Behavioural Intervention

Diabetes Prevention Program for Prediabetes (BRIDGE Trial)

N/A
Recruiting
Led By Jeannette Beasley, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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)
Able to travel to NYU Langone for in-person evaluations
Must not have
Inability to communicate due to severe, uncorrectable hearing loss or speech disorder
A documented current history of active psychosis or other cognitive issues via International Classification of Diseases (ICD) -10 codes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline visit, 6 months visit, 12 month visit
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a diabetes prevention program tailored for older adults and delivered via Telehealth is more effective and easier to implement than the same program delivered in person.

Who is the study for?
This trial is for English or Spanish-speaking men and women aged 65 and older with prediabetes, under NYU Langone Health's care. Participants must have a BMI of 30 or more, be able to travel for in-person evaluations, have access to a phone, and not have taken part in the Diabetes Prevention Program before.
What is being tested?
The study compares two versions of the Diabetes Prevention Program (DPP): one delivered in person and another tailored for older adults via telehealth. It aims to see which method is more effective at preventing diabetes among seniors.
What are the potential side effects?
Since this trial involves lifestyle interventions like diet changes and physical activity rather than medication, side effects may include muscle soreness from exercise or dietary adjustments discomfort but are generally minimal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with pre-diabetes based on recent tests.
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I can travel to NYU Langone for check-ups.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot communicate well due to severe hearing loss or speech issues.
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I have been diagnosed with active psychosis or cognitive issues.
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I have diabetes or my kidneys are failing.
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I have severe vision problems that prevent me from completing certain tasks.
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I am currently taking weight loss medication approved by the FDA.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline visit, 6 months visit, 12 month visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline visit, 6 months visit, 12 month visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Changes in HbA1c in participants in DPP-TOAT is similar to those in In-Person DPP
Changes in weight in participants in DPP-TOAT is similar to those in In-Person DPP
Secondary study objectives
Adherence to the DPP-TOAT is greater than the in-person DPP

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Active Control
Group I: In-person Diabetes Prevention Program (DPP)Active Control1 Intervention
Participants randomized to the in-person DPP intervention for 12 months
Group II: DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)Active Control1 Intervention
Participants randomized to the DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm) intervention for 12 months.

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,443 Previous Clinical Trials
4,330,897 Total Patients Enrolled
NYU Langone HealthLead Sponsor
1,408 Previous Clinical Trials
855,513 Total Patients Enrolled
Jeannette Beasley, MDPrincipal InvestigatorNYU Langone Health
1 Previous Clinical Trials
16 Total Patients Enrolled

Media Library

DPP (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05166785 — N/A
Prediabetes Research Study Groups: In-person Diabetes Prevention Program (DPP), DPP program Tailored for Older Adults and delivered via Telehealth (DPP-TOAT arm)
Prediabetes Clinical Trial 2023: DPP Highlights & Side Effects. Trial Name: NCT05166785 — N/A
DPP (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05166785 — N/A
~93 spots leftby May 2026
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