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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Adults aged 18 years or older - Prediabetes confirmed by blood test result within 12 months of enrollment, previous diagnosis of gestational diabetes mellitus (GDM), or positive screening for prediabetes based on the Prediabetes Risk Test - BMI of 25 kg/m² or greater (23 kg/m² or greater for Asian Americans) Who Should NOT Join This Trial: - Age younger than 18 years - BMI less than 25 kg/m² (less than 23 kg/m² for Asian Americans) - No current diagnosis of prediabetes or gestational diabetes mellitus - Prior diagnosis of type 1 or type 2 diabetes - Pregnancy at the time of enrollment - Development of a medical condition that, in the PI's judgment, could be exacerbated by the study interventions (e.g., eating disorder, severe sleep disorder) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Adults aged 18 years or older * Prediabetes confirmed by blood test result within 12 months of enrollment, previous diagnosis of gestational diabetes mellitus (GDM), or positive screening for prediabetes based on the Prediabetes Risk Test * BMI of 25 kg/m² or greater (23 kg/m² or greater for Asian Americans) Exclusion Criteria: * Age younger than 18 years * BMI less than 25 kg/m² (less than 23 kg/m² for Asian Americans) * No current diagnosis of prediabetes or gestational diabetes mellitus * Prior diagnosis of type 1 or type 2 diabetes * Pregnancy at the time of enrollment * Development of a medical condition that, in the PI's judgment, could be exacerbated by the study interventions (e.g., eating disorder, severe sleep disorder)

Treatments Being Tested

BEHAVIORAL

National 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.

BEHAVIORAL

Sleep 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.

BEHAVIORAL

Time-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.

Locations (1)

Nutrition Clinic, University of Delaware
Newark, Delaware, United States