Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
Recruiting · NCT07450118 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Delaware
View the official record on ClinicalTrials.gov →Interventions studied
National Diabetes Prevention Program (DPP)Sleep Health Digital ApplicationTime-Restricted Eating (TRE)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed across 1 US state.
- Nutrition Clinic, University of Delaware - Newark, Delaware, United States