NCT07450118 · University of Delaware
Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans
What this study is about
This nested pilot randomly assigned 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.
View original scientific description
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.
Interventions
BEHAVIORAL
National Diabetes Prevention Program (DPP)
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.
BEHAVIORAL
Sleep Health Digital Application
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.
BEHAVIORAL
Time-Restricted Eating (TRE)
A self-guided intervention targeting eating window. Participants receive educational materials and a brief orientation session at randomization to support implementation and adherence.
Primary outcome measures
Percent weight loss
Time frame: Baseline 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Newark, Delaware
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2026 · Source of record for eligibility and locations