Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
University of Delaware
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.
Description
Prediabetes affects over one-third of Delaware residents, placing more than 70% at risk of developing type 2 diabetes (T2D) within a decade if left untreated. This public health burden disproportionately impacts diverse population segments, including racial/ethnic minority groups and those with lower income and education; groups who are less likely to benefit from current prevention strategies. The 12-month National Diabetes Prevention Program (DPP) is the first-line intervention to prevent T2D, but only 35% of participants achieve the recommended ≥5% weight loss, with non-responders more like…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 enroll…
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.
Location
- Nutrition Clinic, University of DelawareNewark, Delaware