Two approaches to lower type 2 diabetes risk in at-risk Delaware adults
Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
This pilot will test whether adding sleep health support and time-restricted eating to the Diabetes Prevention Program helps overweight or obese adults with prediabetes in Delaware improve weight, blood sugar, and heart health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Delaware Academic / other |
| Locations | 1 site (Newark, Delaware) |
| Trial ID | NCT07450118 on ClinicalTrials.gov |
What this trial studies
This 12-month randomized pilot enrolls 40 overweight or obese adults with prediabetes already participating in the National Diabetes Prevention Program and randomly assigns them to standard DPP or DPP augmented with a digital sleep-health app and time-restricted eating guidance (DPP++). The intervention arm receives sleep coaching via a digital application and a structured TRE schedule alongside standard DPP content, while the control arm receives standard DPP alone. Primary outcomes include weight loss, fasting glucose or HbA1c, blood pressure, and other cardiometabolic metrics, with secondary measures of feasibility and implementation in a Delaware clinical setting. The trial tests whether the combined behavioral additions produce greater metabolic and cardiovascular benefit and are deliverable at scale.
Who should consider this trial
Good fit: Adults aged 18 or older with confirmed prediabetes and BMI ≥25 kg/m² (≥23 kg/m² for Asian Americans) who can attend the University of Delaware clinic and participate in the 12-month DPP are ideal candidates.
Not a fit: People with existing type 1 or type 2 diabetes, pregnant individuals, those below the BMI thresholds, or individuals with eating disorders or severe sleep disorders that could be worsened by the interventions are unlikely to benefit.
Why it matters
Potential benefit: If successful, DPP++ could produce greater weight loss and improved glucose and blood pressure control than standard DPP, offering a scalable way to enhance diabetes prevention.
How similar studies have performed: Separate trials of time-restricted eating and sleep-improvement programs have shown metabolic and cardiovascular benefits, but combining these approaches within the DPP framework is relatively novel and under-tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Newark, Delaware
- Nutrition Clinic, University of Delaware — Newark, Delaware, United States (Recruiting)
Study contacts
- Study coordinator: Freda Patterson, PhD
- Email: fredap@udel.edu
- Phone: 302-831-6588
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.