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

ConditionPrediabetes

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Delaware

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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.
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.

Treatment groups

40 Participants

are divided into 2 treatment groups

Group A: Standard Diabetes Prevention Program (DPP Control)Active comparator 1 intervention

Group B: Enhanced Diabetes Prevention Program (DPP++)Experimental treatment 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline to 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Delaware

Lead sponsor

Source ClinicalTrials.gov

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