Enhanced DPP for Prediabetes

Overseen By Freda Patterson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Delaware

Disqualifiers: Type 1 diabetes, Type 2 diabetes, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 12 months

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I am 18 years old 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)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-3 months

Randomization

Participants are randomized to either the standard DPP or DPP++

1 month

Treatment

Participants receive either the standard DPP or the enhanced DPP++ with additional sleep health and time-restricted eating interventions

12 months

Weekly sessions in months 1-4, bi-weekly in months 5-6, monthly in months 7-12

Follow-up

Participants are monitored for metabolic and cardiovascular health outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

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

How Is the Trial Designed?

Group I: Enhanced Diabetes Prevention Program (DPP++) Experimental Treatment 3 Interventions

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.

Group II: Standard Diabetes Prevention Program (DPP Control) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Delaware

Lead Sponsor

Trials

167

Recruited

25,700+