Recruiting

DPP++

Sponsor:

University of Delaware

Code:

NCT07450118

Conditions

Prediabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

National Diabetes Prevention Program (DPP)

Sleep Health Digital Application

Time-Restricted Eating (TRE)

Study Details

Brief 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.

Conditions

Prediabetes

Study ID

NCT07450118

Start date

May, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Standard Diabetes Prevention Program (DPP Control)

Participants continue with the standard 12-month National Diabetes Prevention Program (DPP) as delivered by the University of Delaware Nutrition Clinic. The DPP is a 26-session, group-based lifestyle intervention focusing on healthy eating, increased physical activity, and behavior change strategies, with a primary goal of achieving 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.

experimental: Enhanced Diabetes Prevention Program (DPP++)

Participants receive the standard 12-month DPP plus two additional evidence-based components delivered in months 5-6: (1) a sleep health digital application delivering self-guided behavioral strategies to improve sleep, and (2) a time-restricted eating intervention. Educational materials and a brief orientation session are provided at the time of randomization to support engagement with both added components.

Interventions

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.

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.

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.

Primary outcome measure

  • Percent weight loss [ Time Frame: Baseline to 6 months ]

Central Contacts and Locations

Central contacts

Freda Patterson, PhD

302-831-6588fredap@udel.edu

Locations

Nutrition Clinic, University of Delaware

Recruiting

Newark, Delaware, United States, 19713

More Information

Sponsor

University of Delaware

Last update posted

Mar 4, 2026

Last verified

Feb, 2026

Keywords

  • Prediabetes
  • Time Restricted Eating
  • Sleep Health
  • Cardiometabolic Health
  • Circadian Health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Delaware on 2026-03-04.