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

Who can join

Ages 18 and older · All sexes

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)

About the study

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.

What is being tested

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

Sponsor: University of Delaware · Participants: 40 · Started: 2026-05

Contact the study team

• Freda Patterson, PhD · Phone: 302-831-6588

Official record on ClinicalTrials.gov — NCT07450118

Locations in the U.S.

Conditions

• Prediabetes

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.