[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659060":3},{"organization":4,"outcomesModule":7,"designInfo":55,"detailedDescription":54,"studyPopulation":54,"armGroups":61,"interventions":70,"overallOfficials":54,"centralContacts":76,"locations":54,"responsibleParty":82,"collaborators":86,"id":90,"slug":91,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":92,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":54,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":54,"overallStatus":110,"whyStopped":54,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":54},{"fullName":5,"class":6},"Baylor College of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":27,"otherOutcomes":54},[9,13,17,21,24],{"measure":10,"description":11,"timeFrame":12},"Intervention Acceptability: Acceptability of Intervention Measure","Acceptability of Intervention Measure (scores range from 4-20 with higher scores indicating higher acceptability of the intervention)","Immediately Post-Intervention",{"measure":14,"description":15,"timeFrame":16},"Study Enrollment Rate","Enrollment rate calculated from data obtained from recruitment logs","Pre-Randomization",{"measure":18,"description":19,"timeFrame":20},"Study Attrition Rate","Study attrition will be calculated from study logs","6 months",{"measure":22,"description":23,"timeFrame":20},"Family behavioral intervention sessions completed by families","Percentage of sessions completed by families will be determined from study logs",{"measure":25,"description":26,"timeFrame":20},"Food redemptions completed per family","Percentage of food redemptions completed by families will be determined from study logs",[28,32,36,39,42,45,48,51],{"measure":29,"description":30,"timeFrame":31},"Hemoglobin A1C","Hemoglobin A1C from medical record","Change from baseline at 6 months",{"measure":33,"description":34,"timeFrame":35},"Change in Food Security: USDA Household Food Security Questionnaire","USDA Household Food Security Questionnaire (scores range from 0-100 with higher scores indicating greater food insecurity)","Change from baseline to 6 months",{"measure":37,"description":38,"timeFrame":31},"Change in Nutrition Security: Center for Nutrition and Health Impact's Nutrition Secruity Module","Center for Nutrition and Health Impact's Nutrition Secruity Module (scores range from 0-4 with higher scores indicating a greater degree of houshold nutrition security)",{"measure":40,"description":41,"timeFrame":31},"Change in Diabetes Distress: Problem Areas in Diabetes Scale","Problem Areas in Diabetes Scale (scores range from 0-72 with higher scores indicating less emotional burden)",{"measure":43,"description":44,"timeFrame":31},"Change in Fear of Hypoglycemia: Hypoglycemia Fear Survey","Hypoglycemia Fear Survey (scores range from 0 to 104 with higher scores indicating a higher levels of fear of hypoglycemia)",{"measure":46,"description":47,"timeFrame":31},"Change in Diabetes Self-Management: The Diabetes Self-Management Questionnaire)","The Diabetes Self-Management Questionnaire (scores range from 0-36 with higher scores indicating higher levels of adherence to diabetes management behaviors)",{"measure":49,"description":50,"timeFrame":31},"Change in Diabetes Self-Efficacy: Self-Efficacy for Diabetes Management Questionnaire)","Self-Efficacy for Diabetes Management Questionnaire (Scores range from 8-40 with higher scores indicating higher self-efficacy)",{"measure":52,"description":53,"timeFrame":31},"Change in Dietary Intake: Automated Self-Administered 24-hour Dietary Assessment Tool","Automated Self-Administered 24-hour Dietary Assessment Tool: Macronutrient Intake",null,{"allocation":56,"interventionModel":57,"interventionModelDescription":54,"primaryPurpose":58,"observationalModel":54,"timePerspective":54,"maskingInfo":59},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":60,"maskingDescription":54,"whoMasked":54},"NONE",[62,67],{"label":63,"type":64,"description":54,"interventionNames":65},"Intervention","EXPERIMENTAL",[66],"Behavioral: Healthy Eating Program",{"label":68,"type":69,"description":54,"interventionNames":54},"Standard diabetes care","NO_INTERVENTION",[71],{"type":72,"name":73,"description":74,"armGroupLabels":75,"otherNames":54},"BEHAVIORAL","Healthy Eating Program","Children with T1D and their parent will participate in 9 virtual behavioral intervention sessions and will receive access to redeem food twice per month through a community-based Food Rx program during the 6-month intervention period.",[63],[77],{"name":78,"role":79,"phone":80,"phoneExt":54,"email":81},"Ashley Butler, PhD","CONTACT","832-822-4899","ambutler@bcm.edu",{"type":83,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":54,"oldOrganization":54},"PRINCIPAL_INVESTIGATOR","Ashley Butler","Associate Professor- Pediatrics-Psychology",[87],{"name":88,"class":89},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100659060","food-prescription-among-youth-with-type-1-diabetes-100659060",false,"NCT07860229","Food Prescription Among Youth With Type 1 Diabetes","A Pilot and Feasibility Evaluation of Food Prescription Among Youth With Type 1 Diabetes","NOURISH","Inclusion Criteria:\n\n1. Clinic-integrated Hunger Vital Sign™ screener questionnaire indicating food insecurity\n2. Ages 10-15 years\n3. T1D as defined by the American Diabetes Association criteria\n4. T1D disease duration \\>1 year\n5. Having a positive food insecurity screen documented in the EPIC medical record within the past 12 months\n6. Fluent in English or Spanish\n7. Not planning to leave the geographic area during the study\n\nExclusion Criteria:\n\n1. Physical\u002Fmental disease or condition that may conflict with study protocol\n2. Celiac Disease","ALL","10 Years","15 Years",{"count":102,"type":103},45,"ESTIMATED","INTERVENTIONAL",[106],"NA","The purpose of this study is to assess the feasibility and preliminary outcomes of a healthy eating program that consists of Food Rx combined with an evidence-based healthy eating family behavioral intervention refined for delivery by CHWs for families of youth with type 1 diabetes (ages 10-15 years) from food insecure households. The healthy eating program (Food Rx + healthy eating family behavioral intervention) will be evaluated in a randomized pilot trial where families will be randomized 1:1 (intervention: standard diabetes care).",[109],"Type 1 Diabetes (T1D)","NOT_YET_RECRUITING","2026-09-30",{"date":113,"type":114},"2026-10-06","ACTUAL",{"date":116,"type":103},"2026-10",{"date":118,"type":103},"2028-03",{"name":5,"class":6}]