[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637719":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":36,"responsibleParty":62,"collaborators":27,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":27,"eligibilityCriteria":72,"healthyVolunteers":68,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":27,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":92,"whyStopped":27,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":102},{"fullName":5,"class":6},"The Miriam Hospital","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Medically tailored meal kits + nutrition coaching","EXPERIMENTAL","Medically Tailored Meals: Each family in this arm will receive medically tailored meal kits (3 semi-prepared meals and recipes per week x 6 weeks).Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.",[13,14],"Behavioral: Medically tailored meal kits","Behavioral: Nutrition Coaching",{"label":16,"type":17,"description":18,"interventionNames":19},"Produce prescription + nutrition coaching","ACTIVE_COMPARATOR","Produce prescriptions: Each family in this arm will receive weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size). Boxes will also include recipes and examples of how to incorporate the produce into family meals\n\nNutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.",[20,14],"Behavioral: Produce prescription",[22,28,32],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BEHAVIORAL","Produce prescription","Produce prescriptions: Weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size).",[16],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"Medically tailored meal kits","Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.",[9],{"type":23,"name":33,"description":34,"armGroupLabels":35,"otherNames":27},"Nutrition Coaching","Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.",[9,16],[37],{"facility":38,"status":27,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hasbro Children's Hospital","Providence","Rhode Island","02903","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-71.41283,41.82399,{"lat":48,"lon":47},[51,57,59],{"name":52,"role":53,"phone":54,"phoneExt":55,"email":56},"Katelyn Fox, PhD","CONTACT","4017870821","401-793-8251","katelyn_fox@brown.edu",{"name":58,"role":53,"phone":27,"phoneExt":27,"email":27},"Rivkah Cohen",{"name":60,"role":61,"phone":27,"phoneExt":27,"email":27},"Lisa Swartz Topor, MD","SUB_INVESTIGATOR",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"SPONSOR_INVESTIGATOR","Katelyn Fox","Research Scientist","100637719","pilot-of-food-is-medicine-interventions-to-reduce-cardiovascular-disease-risk-in-children-with-food-insecurity-and-diabetes-100637719",false,"NCT07590817","Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes","Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes","Inclusion Criteria:\n\n* Families of school-age children (ages 5-12 years) with T1DM and food insecurity\n* fluent in English or Spanish.\n* child uses a continuous glucose monitor (CGM)\n* willing to provide consent for the research team to access CGM data\n\nExclusion Criteria:\n\n* recent diagnosis of T1DM (\\\u003C6 months)","ALL","5 Years","12 Years",{"count":77,"type":78},12,"ESTIMATED","INTERVENTIONAL",[81],"NA","Study Design: This two-arm parallel trial will randomize 12 families to receive 6-weeks of medically tailored meals or produce prescriptions. Both groups will receive nutrition coaching, weekly during the intervention. The hypothesis is that both interventions to have a positive impact on food security and fruit and vegetable intake. However, medically tailored meals also reduce the logistic barriers of planning, preparing, and calculating the carbohydrate content of nutritionally balanced meals essential for DM management. Therefore, the medically tailored meal intervention will result in greater improvements in the co-primary outcomes of diet quality and glucose stability after the intervention.",[84,85],"Type 1 Diabetes (T1D)","Food Insecurity",[87,85,88,89,90,91],"Type 1 Diabetes","Food is Medicine","Medically Tailored Meals","Produce Prescriptions","Nutrition Education","NOT_YET_RECRUITING","2026-05-12",{"date":95,"type":96},"2026-05-15","ACTUAL",{"date":98,"type":78},"2026-05-30",{"date":100,"type":78},"2026-06-30",{"name":64,"class":6},1]