[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100634116":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":39,"centralContacts":48,"locations":54,"responsibleParty":73,"collaborators":26,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":26,"eligibilityCriteria":82,"healthyVolunteers":78,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":26,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":97,"overallStatus":101,"whyStopped":26,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Massachusetts, Worcester","OTHER",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Community Servings","EXPERIMENTAL","The treatment group will receive six months of medically-tailored meals for pediatric Type I Diabetes through Community Servings non-profit organization in addition to standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Participants will have a six-month follow-up period following completion of the medically tailored meals programming. Subjects will complete the PedsQL quality of life surveys, program-specific surveys on medically-tailored meals with Community Servings, and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and\u002For registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study.",[13,14,15,16],"Other: Community Servings","Other: PedsQL Survey","Other: Nutrition Counseling","Other: SDOH Survey",{"label":18,"type":19,"description":20,"interventionNames":21},"Standard of Care Pediatric Type I Diabetes","ACTIVE_COMPARATOR","The control group will receive twelve months of standard-of-care treatment from UMass Pediatric Endocrinology and nutrition counseling. Subjects will complete the PedsQL quality of life surveys and social drivers of health risk surveys while participating in the study. Subjects will attend all clinically indicated appointments with their endocrinologist and\u002For registered dietician on a quarterly basis with no additional appointments for research purposes. Demographics, health information, and continuous glucose monitoring (CGM) data (if the participant uses a CGM device) will be collected throughout the duration of the study. If the subject completes all study procedures, they will have the option to access six months of Community Servings medically-tailored meals provided by the research institution upon completion of the study.",[14,15,16],[23,27,31,35],{"type":6,"name":9,"description":24,"armGroupLabels":25,"otherNames":26},"Participants randomized to the intervention group will receive the Community Servings medically-tailored meal plan for the first 6 months after enrollment. The Community Servings plan will provide 10 medically-tailored meals per week, delivered to the participant residence on the day of the week preferred by the participant. Following enrollment, participants will meet with a Community Servings team member to review dietary restrictions. The meals were designed by Registered Dieticians for children and adolescents with Type 1 Diabetes and will be prepared and distributed by the Community Servings team. Participants in the intervention arm will also be asked to complete a survey on the utility of the Community Servings intervention at the conclusion of the program, 6 months after initial enrollment. The survey and responses will be housed in the REDCap.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"PedsQL Survey","All participants or their parents will complete a baseline quality of life assessment appropriate for their age group and again at 3 months, 6 months, and at end of follow-up at 12 months. The PedsQL Measurement Model is a modular approach to measuring health-related quality of life (HRQOL) in healthy children and adolescents and those with acute and chronic health conditions. This model integrates multidimensional physical, emotional, social, and school functioning scales and reports total, physical health, and psychological health summary scores. This survey can be completed in person with research staff, over the phone with research staff, or remotely via a link distributed from the REDCap database. Responses will be stored in the REDCap database.",[9,18],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Nutrition Counseling","Participants will recieve standare-of-care nutrition counseling from a registered dietician with the UMass Pediatric Endocrinology clinic to receive education and review dietary and nutrition recommendations personalized to the patient and management of Type I diabetes.",[9,18],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":26},"SDOH Survey","All participants or their parents will complete a baseline social driver of health (SDOH) survey at the time of enrollment and again at 3 months, 6 months, and at end of follow-up at 12 months. The SDOH survey is provided for all patients at UMass and evaluates the risk for food, housing, utility, and transportation concerns. This survey can be completed in person with research staff, over the phone with research staff, or remotely via a link distributed from the REDCap database. Responses will be stored in the REDCap database.",[9,18],[40,44,46],{"name":41,"affiliation":42,"role":43},"Lawrence Rhein, MD, MPH","UMass Chan Medical School","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":42,"role":43},"Arvin Garg, MD, MPH",{"name":47,"affiliation":42,"role":43},"Leslie Soyka, MD",[49],{"name":50,"role":51,"phone":52,"phoneExt":26,"email":53},"Madeline E French, BS, MBE","CONTACT","5088870106","madeline.french2@umassmed.edu",[55],{"facility":56,"status":26,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"UMass Memorial Children's Medical Center","Worcester","Massachusetts","01655","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-71.80229,42.26259,{"lat":66,"lon":65},[69,70,71,72],{"name":50,"role":51,"phone":52,"phoneExt":26,"email":53},{"name":41,"role":43,"phone":26,"phoneExt":26,"email":26},{"name":45,"role":43,"phone":26,"phoneExt":26,"email":26},{"name":47,"role":43,"phone":26,"phoneExt":26,"email":26},{"type":43,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Lawrence Rhein","Neonatologist and Pediatric Pulmonologist; Chair, Department of Pediatrics and Associate Professor, UMass Chan Medical School","100634116","food-is-medicine-in-pediatric-patients-with-diabetes-100634116",false,"NCT07535502","Food is Medicine in Pediatric Patients With Diabetes","The Effect of a Novel Food is Medicine Program on Outcomes in Pediatric Patients With Diabetes: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Current patients of the UMMMC Pediatric Endocrinology Clinic\n* Children and Adolescents less than or equal to 17 years of age at the time of enrollment\n* Diagnosed with Type 1 Diabetes at least 3 months ago\n* Public (MassHealth or Medicaid) Health Insurance\n\nExclusion Criteria:\n\n* Celiac disease or severe gluten allergy\n* Congenital, genetic, or chronic comorbidities\n* DCF Custody\n* Pregnant women\n* Prisoners\n* Non-English speaking subjects","ALL","5 Years","17 Years",{"count":87,"type":88},50,"ESTIMATED","INTERVENTIONAL",[91],"NA","The objective of this randomized controlled trial is to evaluate the effect of novel Food is Medicine Programming in the form of medically tailored pre-packaged meals for pediatric patients with Type 1 Diabetes. The provision of medically-tailored meals to children and adolescents with diabetes that have potential food security or access concerns in addition to nutrition counseling will improve clinical outcomes, decrease healthcare utilization, and improve health-related quality of life (HRQOL). Consulting with a Registered Dietician is the established multidisciplinary standard of care for pediatric patients with diabetes at UMass. Community Servings provides a medically-tailored pre-packaged meal plan designed for pediatric patients with Type 1 Diabetes. The addition of Community Servings to the current standard of care in pediatric patients with potential food security or access concerns will further improve clinical, decrease healthcare utilization, and improve HRQOL outcomes in pediatric patients with Type 1 Diabetes.",[94,95,96],"Type I Diabetes","Pediatrics","Food Insecurity",[98,94,95,96,99,100],"Food is Medicine","Continuous Glucose Monitoring","Medically-tailored Meals","NOT_YET_RECRUITING","2026-04-14",{"date":104,"type":105},"2026-04-17","ACTUAL",{"date":107,"type":88},"2026-05-20",{"date":109,"type":88},"2029-12-31",{"name":5,"class":6},1]