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.
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 likely to reside in high-priority communities. Moreover, comorbid conditions such as hypertension remain inadequately addressed. Sleep health improvements and time-restricted eating (TRE) are two promising, evidence-based strategies shown to enhance metabolic and cardiovascular outcomes. Despite recommendations from national guidelines for diabetes prevention and management to include sleep health, their widespread implementation is limited by the lack of an effective delivery platform. Expanding the DPP to include these interventions (creating the "DPP++"; DPP + sleep health + TRE) could provide a scalable solution to enhance efficacy and improve access to diabetes prevention across all communities. This 12-month Clinical and Translational Research (CTR) pilot study will evaluate the clinical efficacy of DPP++ compared to the standard DPP among adults at risk for T2D already enrolled in DPP cohorts administered by the University of Delaware Nutrition Clinic. Focused community-engagement efforts that are overseen by the study steering committee will target traditionally overlooked populations to enroll in these cohorts. Between months 1-3 of the standard DPP, participants will be invited to join a nested randomized controlled trial. In month 4, consenting participants will be randomized to either the standard DPP (control) or DPP++. Aim 1 of this study will compare the efficacy of DPP++ vs. standard DPP on metabolic health at 6 and 12 months. Aim 2 will assess DPP++ vs. standard DPP differences in cardiovascular health and quality of life. Completing this pilot will also support the capacity for integrating the sleep health and TRE intervention components into clinical practice.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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.
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.
Nutrition Clinic, University of Delaware
Newark, Delaware, United States
RECRUITINGPercent weight loss
Percent weight loss from baseline, calculated from body weight measured at baseline and the primary endpoint (month 6). Between-group differences in percent weight loss will be compared between the experimental DPP++ and control DPP arms.
Time frame: Baseline to 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
A self-guided intervention targeting eating window. Participants receive educational materials and a brief orientation session at randomization to support implementation and adherence.