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

Inclusion Criteria3

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 Criteria6

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)

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.