[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644841":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":41,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":25,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":81,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"West Virginia University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Produce Gift Card to Usual Care","EXPERIMENTAL","Participants are randomized to receive the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for 5 months, followed by crossover to usual care for an additional 5 months.",[13,14],"Behavioral: Produce Gift Card and Dietary Education","Other: Usual Care",{"label":16,"type":10,"description":17,"interventionNames":18},"Usual Care to Produce Gift Card","Participants are randomized to receive usual care for 5 months, followed by crossover to the produce prescription intervention, consisting of fruit and vegetable vouchers and standardized dietary education, for an additional 5 months.",[13,14],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Produce Gift Card and Dietary Education","Participants receive $100 per month in Walmart gift cards restricted to the purchase of fruits and vegetables. Gift cards are provided monthly during the intervention period and usage is tracked using participant-specific access codes. Participants also receive standardized dietary education consistent with current clinical guidelines, delivered by study personnel during the intervention period only.",[9,16],null,{"type":6,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Usual Care","Participants receive standard clinical care for management of type 2 diabetes. No study-provided produce vouchers or study-provided dietary education are provided during this period.",[9,16],[31],{"name":32,"affiliation":33,"role":34},"George Sokos, DO, FACC","West Virginia University Heart and Vascular Institute","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},"Syed Ahmad, MD","CONTACT","304-598-4850","syed.ahmad@hsc.wvu.edu",[42],{"facility":33,"status":25,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Morgantown","West Virginia","26506","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-79.9559,39.62953,{"lat":52,"lon":51},[55,56],{"name":37,"role":38,"phone":39,"phoneExt":25,"email":40},{"name":32,"role":34,"phone":25,"phoneExt":25,"email":25},{"type":34,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"George Sokos","Professor of Medicine; Medical Director, Non-Invasive Cardiology, Advanced Heart Failure, Pulmonary Hypertension, Cardiac Transplant","100644841","cardiometabolic-impact-of-a-produce-prescription-program-in-patients-with-type-2-diabetes-and-food-insecurity-100644841",false,"NCT07674979","Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity","A Randomized Crossover Trial Evaluating the Cardiometabolic Impact of a Produce Prescription Program in Patients With Type 2 Diabetes and Food Insecurity","GARDEN-CARDIO","Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes mellitus\n* Most recent HbA1c \\>8% within the prior 6 months\n* Must have had a clinic visit within the past 6 months\n* Positive screening for food insecurity based on the USDA 6-item food security survey\n* Receiving care through WVU cardiometabolic, endocrinology, or primary care clinics\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* End-stage renal disease\n* Advanced heart failure\n* Severe cognitive impairment\n* Chronic pancreatitis\n* Pancreatic malignancy\n* Pregnancy at time of enrollment\n* Anticipated inability to utilize intervention vouchers (e.g., lack of access to Walmart)","ALL","18 Years",{"count":71,"type":72},88,"ESTIMATED","INTERVENTIONAL",[75],"NA","This study is testing whether providing monthly vouchers to buy fruits and vegetables can help improve blood sugar control in adults with type 2 diabetes. People receiving care at WVU clinics who recently had an HbA1c level above 8% will be invited to participate in the study. Those who are interested will speak with a study coordinator, be screened for eligibility, and, if eligible, will provide written consent to join the study. Participants will be randomly assigned to one of two groups. One group will receive $100 per month in produce-only grocery vouchers and standardized dietary education for 5 months, followed by 5 months of usual diabetes care. The second group will receive usual diabetes care first for 5 months, followed by 5 months of produce-only grocery vouchers and standardized dietary education. This crossover design allows all participants to experience both approaches during the study. Researchers will measure changes in blood sugar (HbA1c) as the main outcome. Other outcomes include blood pressure, cholesterol levels, body weight, diet quality, food security, anxiety symptoms, depressive symptoms, and physical activity. These will be assessed through lab tests, clinic measurements, and surveys at certain time points during the 10 month study period. The study team will also track how often participants use the vouchers and any challenges they face. The risks of participating are expected to be minimal and similar to routine diabetes care. The total study duration, including enrollment, participation, and analysis, is expected to be about 18 months.",[78],"Type 2 Diabetes",[80],"Food Insecurity","NOT_YET_RECRUITING","2026-06-24",{"date":84,"type":85},"2026-06-30","ACTUAL",{"date":87,"type":72},"2026-07",{"date":89,"type":72},"2027-06",{"name":5,"class":6},1]