RecruitingNot ApplicableNCT07450118

Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans

Sponsor

University of Delaware

Enrollment

40 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Prediabetes

Summary

This nested pilot Randomized Clinical Trial will determine whether the Diabetes Prevention Program (DPP) enhanced with evidence-based sleep health and time restricted eating interventions ("DPP++") is more effective than the DPP alone for improving metabolic and cardiovascular metrics in 40 overweight/obese adults with prediabetes.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This pilot trial is comparing two approaches to reduce the risk of developing Type 2 diabetes in adults in Delaware who already have prediabetes. The study is testing whether a structured diabetes prevention program, possibly combined with another intervention, is effective in this specific population. **You may be eligible if:** - You are 18 years of age or older - You have prediabetes confirmed by a blood test within the past 12 months, a previous diagnosis of gestational diabetes, or a positive result on a prediabetes risk screening test - Your body mass index (BMI) is 25 kg/m² or higher (23 kg/m² or higher if you are Asian American) **You may NOT be eligible if:** - You have already been diagnosed with Type 1 or Type 2 diabetes - You are currently pregnant - Your BMI is below the threshold for your ethnic group - You have a medical condition that could be made worse by the study interventions (such as a severe eating disorder or serious sleep disorder) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNational Diabetes Prevention Program (DPP)

A 12-month, 26-session group-based lifestyle intervention delivered by trained lifestyle coaches focusing on healthy eating, physical activity, stress management, and behavior change strategies. The primary goal is to achieve 5-7% weight loss and 150 minutes of moderate-to-vigorous physical activity per week. Sessions are delivered weekly in months 1-4, bi-weekly in months 5-6, and monthly in months 7-12.

BEHAVIORALSleep Health Digital Application

A self-guided digital sleep health program delivering evidence-based behavioral strategies to improve sleep duration, timing, and quality. Participants have access to the application during months 5-12 of the study.

BEHAVIORALTime-Restricted Eating (TRE)

A self-guided intervention targeting eating window. Participants receive educational materials and a brief orientation session at randomization to support implementation and adherence.