[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627552":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":36,"locations":42,"responsibleParty":57,"collaborators":27,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":27,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":27,"enrollmentInfo":69,"targetDuration":27,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":45,"whyStopped":27,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"University of Delaware","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard Diabetes Prevention Program (DPP Control)","ACTIVE_COMPARATOR","Participants continue with the standard 12-month National Diabetes Prevention Program (DPP) as delivered by the University of Delaware Nutrition Clinic. The DPP is a 26-session, group-based lifestyle intervention focusing on healthy eating, increased physical activity, and behavior change strategies, with a primary goal of achieving 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.",[13],"Behavioral: National Diabetes Prevention Program (DPP)",{"label":15,"type":16,"description":17,"interventionNames":18},"Enhanced Diabetes Prevention Program (DPP++)","EXPERIMENTAL","Participants receive the standard 12-month DPP plus two additional evidence-based components delivered in months 5-6: (1) a sleep health digital application delivering self-guided behavioral strategies to improve sleep, and (2) a time-restricted eating intervention. Educational materials and a brief orientation session are provided at the time of randomization to support engagement with both added components.",[13,19,20],"Behavioral: Sleep Health Digital Application","Behavioral: Time-Restricted Eating (TRE)",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"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.",[15,9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"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.",[15],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"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.",[15],[37],{"name":38,"role":39,"phone":40,"phoneExt":27,"email":41},"Freda Patterson, PhD","CONTACT","302-831-6588","fredap@udel.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":27},"Nutrition Clinic, University of Delaware","RECRUITING","Newark","Delaware","19713","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-75.74966,39.68372,{"lat":55,"lon":54},{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"PRINCIPAL_INVESTIGATOR","Freda Patterson","Professor","100627552","nested-pilot-study-comparing-two-treatments-to-reduce-type-2-diabetes-risk-in-at-risk-delawareans-100627552",false,"NCT07450118","Nested Pilot Study Comparing Two Treatments to Reduce Type 2 Diabetes Risk in At-Risk Delawareans","Inclusion Criteria:\n\n* Adults aged 18 years or older\n* 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\n* BMI of 25 kg\u002Fm² or greater (23 kg\u002Fm² or greater for Asian Americans)\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* BMI less than 25 kg\u002Fm² (less than 23 kg\u002Fm² for Asian Americans)\n* No current diagnosis of prediabetes or gestational diabetes mellitus\n* Prior diagnosis of type 1 or type 2 diabetes\n* Pregnancy at the time of enrollment\n* 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)","ALL","18 Years",{"count":70,"type":71},40,"ESTIMATED","INTERVENTIONAL",[74],"NA","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\u002Fobese adults with prediabetes.",[77],"Prediabetes",[77,79,80,81,82],"Time Restricted Eating","Sleep Health","Cardiometabolic Health","Circadian Health","2026-02-26",{"date":85,"type":86},"2026-03-04","ACTUAL",{"date":88,"type":71},"2026-05",{"date":90,"type":71},"2027-06",{"name":5,"class":6},1]