[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588819":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":53,"interventions":73,"overallOfficials":82,"centralContacts":44,"locations":87,"responsibleParty":101,"collaborators":103,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":44,"maxAge":116,"enrollmentInfo":117,"targetDuration":44,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":130,"whyStopped":44,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":21,"otherOutcomes":44},[9,13,17],{"measure":10,"description":11,"timeFrame":12},"30-day urgent reutilization","Validated measure of unplanned readmission\u002FED\u002Furgent care use via electronic health record (EHR)","30 days post-discharge",{"measure":14,"description":15,"timeFrame":16},"Hunger during hospitalization","USDA Six-Item Short Form of the Food Security Survey Module, adapted to measure hunger in hospital. Families with lower scores are less likely to experience food insecurity. The family's level of food insecurity increases with the score.\n\n* Raw score 0-1-High food security\n* Raw score 2-4-Low food security\n* Raw score 5-6-Very low food security","Within 36 hours before discharge",{"measure":18,"description":19,"timeFrame":20},"Post-discharge hunger and food insecurity","USDA Six-Item Short Form of the Food Security Survey Module. Families with lower scores are less likely to experience food insecurity. The family's level of food insecurity increases with the score.\n\n* Raw score 0-1-High food security\n* Raw score 2-4-Low food security\n* Raw score 5-6-Very low food security","14 Days post-discharge",[22,26,29,32,35,38,41],{"measure":23,"description":24,"timeFrame":25},"30-day unplanned readmission","Validated measure of unplanned readmission","30 Days post-discharge",{"measure":27,"description":28,"timeFrame":25},"30-day Emergency department utilization","Emergency department utilization",{"measure":30,"description":31,"timeFrame":20},"Understanding of discharge instructions Confidence in care at home","Pediatric Transition Experience Measure (P-TEM)-Transition Preparation Domain",{"measure":33,"description":34,"timeFrame":20},"Return to normal routine","Family designed measure that assesses a family's return to normal routines",{"measure":36,"description":37,"timeFrame":20},"Post-Discharge coping","Post-Discharge Difficulty Coping Scale is measured at 14-day post-discharge phone call. Post-Discharge Coping Difficulty Scale uses an 11-point scaling format (0-10) with total scores ranging from 0 to 100. Higher scores represent greater coping difficulty.",{"measure":39,"description":40,"timeFrame":16},"Out of pocket expenses","Expenses paid by the family during the hospitalization",{"measure":42,"description":43,"timeFrame":20},"Ability to pay for medications","Family-reported measure regarding difficulty paying for medications",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":6,"observationalModel":44,"timePerspective":44,"maskingInfo":48},"RANDOMIZED","FACTORIAL",{"masking":49,"maskingDescription":44,"whoMasked":50},"DOUBLE",[51,52],"INVESTIGATOR","OUTCOMES_ASSESSOR",[54,58,65,69],{"label":55,"type":56,"description":57,"interventionNames":44},"Standard Care","NO_INTERVENTION","No post-discharge food support offered; no in-hospital food support offered; social work consults available per standard of care",{"label":59,"type":60,"description":61,"interventionNames":62},"Both In-Hosptial and Post-Discharge","ACTIVE_COMPARATOR","The study team will provide two meals to up to two parents per day (for a maximum of four meals per day) in the hospital. The study team will provide families with a grocery gift card and frozen meals at the time of discharge.",[63,64],"Other: In-hospital food support intervention","Other: Post-discharge food support intervention",{"label":66,"type":60,"description":67,"interventionNames":68},"Post-Discharge No In-Hospital","The study team will provide families with a grocery gift card and frozen meals at the time of discharge. No in-hospital food support offered; social work consults available per standard of care.",[64],{"label":70,"type":60,"description":71,"interventionNames":72},"In-Hospital No Post-Discharge","The study team will provide two meals to up to two parents per day (for a maximum of four meals per day) in the hospital. No post-discharge food support offered; social work consults available per standard of care.",[63],[74,78],{"type":6,"name":75,"description":76,"armGroupLabels":77,"otherNames":44},"In-hospital food support intervention","The in-hospital food support intervention will provide two meals for up to two parents per day.",[59,70],{"type":6,"name":79,"description":80,"armGroupLabels":81,"otherNames":44},"Post-discharge food support intervention","The post-discharge intervention will provide families with grocery gift cards and frozen meals at the time of discharge.",[59,66],[83],{"name":84,"affiliation":85,"role":86},"Kathy Auger","katherine.auger@cchmc.org","PRINCIPAL_INVESTIGATOR",[88],{"facility":89,"status":44,"city":90,"state":91,"zip":92,"country":93,"countryCode":94,"cosmosGeoPoint":95,"geoPoint":100,"contacts":44},"Cincinnati Children's Hospital Medical Center","Cincinnati","Ohio","45229","United States","US",{"type":96,"coordinates":97},"Point",[98,99],-84.51439,39.12711,{"lat":99,"lon":98},{"type":102,"investigatorFullName":44,"investigatorTitle":44,"investigatorAffiliation":44,"oldNameTitle":44,"oldOrganization":44},"SPONSOR",[104],{"name":105,"class":106},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH","100588819","food-based-support-for-hospitalized-children-and-their-families-100588819",false,"NCT06946355","Food-based Support for Hospitalized Children and Their Families","Food-based Randomized Trial for Enhancing Support of Hospitalized Children and Their Families","FRESH","Inclusion Criteria:\n\n* Patients must be currently admitted to a hospital unit where the study is active\n* All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible\n\nExclusion Criteria:\n\n* Patients admitted for end-of-life care, patients who will be discharged to a location other than home, patients who live independently, and patients in county custody.","ALL","21 Years",{"count":118,"type":119},9119,"ESTIMATED","INTERVENTIONAL",[122],"NA","The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of government or self-pay insurances will provide benefits. The main questions it aims to answer are:\n\n* Determine the effect of implementing an in-hospital food support intervention for low-income parents on reutilization and family-centered outcomes.\n* Among families with baseline food insecurity, determine the effectiveness of a post-discharge food support intervention and as-needed social work referral on reutilization and family-centered outcomes.\n\nResearchers will compare the in-hospital food support intervention and will be rolled out to sequential hospital units. In addition, the post-discharge food support intervention will be compared to standard discharge.\n\nSome participants will:\n\n* Receive in-hospital meal cards or standard care during hospitalization\n* Receive post-discharge food support intervention or standard discharge\n* Complete a 14-day post discharge follow-up survey",[125],"Food Insecurity",[127,128,129],"Pediatric","Hospitalization","Food Intake","ENROLLING_BY_INVITATION","2026-10-06",{"date":133,"type":134},"2026-10-09","ACTUAL",{"date":136,"type":134},"2025-05-27",{"date":138,"type":119},"2029-12-31",{"name":5,"class":6},1]