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

NCT07450118 | Recruiting

• 1 other identifier: 2355212
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent 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.

  Baseline to 6 months

Study Arms (2)

Standard Diabetes Prevention Program (DPP Control)

ACTIVE COMPARATOR

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.

Behavioral: National Diabetes Prevention Program (DPP)

Enhanced Diabetes Prevention Program (DPP++)

EXPERIMENTAL

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.

Behavioral: National Diabetes Prevention Program (DPP); Behavioral: Sleep Health Digital Application; Behavioral: Time-Restricted Eating (TRE)

Interventions

National Diabetes Prevention Program (DPP) BEHAVIORAL

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.

Enhanced Diabetes Prevention Program (DPP++); Standard Diabetes Prevention Program (DPP Control)

Sleep Health Digital Application BEHAVIORAL

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.

Enhanced Diabetes Prevention Program (DPP++)

Time-Restricted Eating (TRE) BEHAVIORAL

A self-guided intervention targeting eating window. Participants receive educational materials and a brief orientation session at randomization to support implementation and adherence.

Enhanced Diabetes Prevention Program (DPP++)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Delaware: lead

Study Sites (1)

Nutrition Clinic, University of Delaware

Newark, Delaware, 19713, United States

RECRUITING

MeSH Terms

Conditions

Prediabetic State; Intermittent Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Central Study Contacts

Freda Patterson, PhD

CONTACT

302-831-6588; fredap@udel.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Nested randomized controlled trial embedded within the University of Delaware Nutrition Clinic's accredited 12-month National Diabetes Prevention Program (DPP). Participants already enrolled in DPP cohorts are invited to join the nested RCT during months 1-3 of the standard DPP, with randomization occurring by month 4 using a stratified permuted block design stratified by sex. Consenting participants are randomized 1:1 to continue with the standard DPP (control) or the enhanced DPP++ (experimental), which adds a sleep health digital application and time-restricted eating components during months 5-6.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)