[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599980":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":32,"responsibleParty":46,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":19,"eligibilityCriteria":56,"healthyVolunteers":53,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":19,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":70,"overallStatus":34,"whyStopped":19,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"University of California, San Francisco","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Children with MASLD and food insecurity","EXPERIMENTAL","This group will receive $80 of fruit\u002Fvegetable vouchers per month x 6 months; parents\u002F guardians will participate in a semi-structured interview at the end of the study",[13],"Other: Fruit\u002Fvegetable vouchers",[15],{"type":6,"name":16,"description":17,"armGroupLabels":18,"otherNames":19},"Fruit\u002Fvegetable vouchers","The intervention is $80 of fruit\u002Fvegetable vouchers (EatSF Veggies4Vouchers) per month x 6 months",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Sarah L Maxwell, MD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Milagro Escobar","CONTACT","4155197863","milagro.escobar@ucsf.edu",{"name":22,"role":27,"phone":28,"phoneExt":19,"email":31},"sarah.maxwell@ucsf.edu",[33],{"facility":5,"status":34,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":19},"RECRUITING","San Francisco","California","94158","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-122.41942,37.77493,{"lat":44,"lon":43},{"type":47,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[49],{"name":50,"class":6},"American Gastroenterological Association","100599980","food-insecurity-and-masld-a-fruit-and-vegetable-intervention-study-100599980",false,"NCT07091539","Food Insecurity and MASLD: A Fruit and Vegetable Intervention Study","Inclusion Criteria:\n\n* The study population for all study aims consists of children and adolescents receiving care at the liver and WATCH clinics.\n\nInclusion criteria include:\n\n* family living in California;\n* a parent\u002Fguardian who speaks Spanish or English,\n* child is between the ages of 6 to \\\u003C18 years;\n* child has elevated BMI greater than or equal to 85% for age and sex\n* child has ALT value greater than 26 for boys and 22 for girls on two occasions within the last year; OR one elevated ALT value and imaging confirming steatosis\n* family does not intend to move out of California for the next year;\n* family is not already receiving EatSF Fruit and Vegetable Vouchers;\n* family is not participating in any other dietary education programs besides that offered by the liver\u002F WATCH clinics\n\nExclusion Criteria:\n\n* child has an underlying condition or medication causing their weight gain (i.e., hypothyroidism, Prader-Willi syndrome, antipsychotic medications) or a known liver condition other than MASLD\u002FMASH causing their elevated liver numbers;\n* child is on a weight loss medication (including: Qsymia or GLP-1 receptor agonists),\n* both of which are assessed as part of routine clinical care.","ALL","6 Years","17 Years",{"count":61,"type":62},48,"ESTIMATED","INTERVENTIONAL",[65],"NA","This proposal addresses a critical gap in the understanding of the impact of household food insecurity (FI) on pediatric metabolic dysfunction-associated steatotic liver disease (MASLD) severity. Evidence from adult studies links household FI to MASLD and liver fibrosis, and prior research of the PI has shown that exposure to household FI in early childhood was associated with a nearly fourfold increased odds of pediatric MASLD in middle childhood. Possible mechanisms linking household FI to pediatric MASLD include lower intake of fruits and vegetables, higher intake of caloric dense nutrient-poor foods (e.g., sugar-sweetened beverages), and less diversity of foods. Given consensus recommendations for the management of MASLD focus on lifestyle modification, i.e., diet and exercise to achieve weight loss, this proposal seeks to assess whether a clinic-based fruit\u002Fvegetable voucher intervention program (EatSF) could potentially improve clinical outcomes for children\u002Fadolescents with MASLD and household FI. Study participants include children\u002Fadolescents with household FI and MASLD who are receiving care at UCSF's liver clinic and Weight Management for Teen and Child Health (WATCH) Clinic, a pediatric subspecialty clinic. The study seeks to identify barriers and facilitators to fruit\u002Fvegetable voucher redemption, and assess changes in dietary intake, MASLD severity, and other cardiometabolic health factors in children participating in the pilot intervention. Study findings will form the basis of an R01 application to conduct a fully powered randomized controlled trial of the intervention.",[68,69],"MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease","Food Insecurity Among Children",[71,72,73],"MASLD","Food insecurity","pediatrics","2025-08-29",{"date":76,"type":77},"2025-09-02","ACTUAL",{"date":79,"type":77},"2025-07-30",{"date":81,"type":62},"2027-08",{"name":5,"class":6},1]