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Comparing Two Treatments to Reduce Type 2 Diabetes Risk

This study is testing two different approaches to help people with prediabetes reduce their risk of developing type 2 diabetes. One approach is the National Diabetes Prevention Program (DPP), which is a group-based program focusing on healthy eating and physical activity. The other approach, called "DPP++," combines the DPP with a digital sleep health program and guidance on time-restricted eating (eating only during certain hours of the day). The study aims to see if DPP++ is more effective than DPP alone in improving health measures like weight. You might be able to join if you are 18 or older, have prediabetes confirmed by a blood test or a history of gestational diabetes, and have a BMI of 25 or greater (23 or greater for Asian Americans). The study plans to enroll 40 participants, and its current status is unclear.

Study design
This is a pilot randomized clinical trial comparing two behavioral interventions. It plans to enroll 40 participants.
What's involved
Participants will engage in a 12-month, 26-session group-based lifestyle intervention. Some will also use a digital sleep health application during months 5-12 and receive educational materials for time-restricted eating.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, percent weight loss, is measured at 6 months.

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NCT07450118

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

Recruiting
NAAges 18+InterventionalTreatment
University of Delaware
~40 participants
Updated 2026-03-04 on ClinicalTrials.gov
What's tested:National Diabetes Prevention Program (DPP)Sleep Health Digital ApplicationTime-Restricted Eating (TRE)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent weight loss
Measured over Baseline to 6 months

Conditions

Prediabetes

Explore related trials

Prediabetes

Where it's being run

1 sites across 1 states
Delaware1

Who to contact

Freda Patterson, PhD
[email protected]
302-831-6588
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Percent weight lossBaseline to 6 months

    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.