[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605425":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":39,"responsibleParty":60,"collaborators":63,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":14,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":12,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":12,"overallStatus":84,"whyStopped":12,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Parkland Health and Hospital System","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","NO_INTERVENTION","The Usual Care control group reflects current clinical practices given to patients. This includes having access to routine wrap around services such as consultation with a dietitian and nutrition education materials. Providers provide references to applicable wrap around services; however, it is ultimately up to the patient to decide to utilize the resources.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"FAME","EXPERIMENTAL","The FAME intervention will be evaluated with a pragmatic randomized clinical trial. FAME will use a community health worker food navigator embedded in clinical settings to provide education and linkage to a community-based food hub that provides access to community driven food resources.",[18],"Behavioral: Food Navigation",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"BEHAVIORAL","Food Navigation","For those randomized to the FAME Intervention, it will begin with a Community Health Worker (CHW) Food Navigator consultation. The role of the Food Navigators is as follows:\n\n1. Identify the top dietary and food needs of the participant and their family. The Food Navigator will perform a needs assessment to define food access, kitchen resources\u002Fcapacity, and other social determinants of health.\n2. Set realistic, participant and family-driven nutrition goals. The Food Navigator will utilize Motivational Interviewing (MI), an evidence-based method of counseling that promotes motivation for change.\n3. Provide nutrition resources and referrals.\n4. Support children and families for up to 12 months.",[14],[26],{"name":27,"affiliation":28,"role":29},"Jaclyn Albin, MD","Parkland Health","PRINCIPAL_INVESTIGATOR",[31,36],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"Farra Kahalnik, MPH, MSSW","CONTACT","972-742-8052","Farra.Kahalnik@UTSouthwestern.edu",{"name":37,"role":33,"phone":12,"phoneExt":12,"email":38},"Meera Patel, PhD","Meera.Patel@UTSouthwestern.edu",[40],{"facility":41,"status":12,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Parkland Health & Hospital System","Dallas","Texas","75390","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-96.80667,32.78306,{"lat":51,"lon":50},[54,58],{"name":55,"role":33,"phone":56,"phoneExt":12,"email":57},"Kristin Alvarez","469-419-1816","kristin.alvarez@phhs.org",{"name":59,"role":29,"phone":12,"phoneExt":12,"email":12},"Jaclyn Albin",{"type":29,"investigatorFullName":59,"investigatorTitle":61,"investigatorAffiliation":62,"oldNameTitle":12,"oldOrganization":12},"Associate Professor","University of Texas Southwestern Medical Center",[64],{"name":62,"class":6},"100605425","food-as-medicine-study-100605425",false,"NCT07162350","Food as Medicine Study","Food as Medicine (FAME): An Innovative Approach to Improve Health and Nutrition Security Among High-Risk Children and Families in South Dallas","Eligibility Criteria:\n\nInclusion criteria for the participant include:\n\n1. Between the ages of 8-15 years,\n2. Have risk factors of chronic disease based on elevated BMI (\\>25; 85th percentile),\n3. Be seen at one of the selected Parkland COPC clinics,\n4. Have not completed a dietitian visit within the last 12 months,\n5. Both the participant and caregiver must be fluent in English or Spanish (read, write, and speak) and be willing to participate in the study over a 12-month duration.\n\nExclusion criteria for the participant include presence of any of the following:\n\n1. Autism with feeding difficulties\n2. Intellectual disability\n3. Cushing Disease\n4. Severe feeding difficulties for over 2 years\n5. Dietary restrictions (medically prescribed)\n6. Severe food allergy\n7. Severe psychiatric disorders\n8. Non-alcoholic fatty liver disease\n9. Non-alcoholic steatohepatitis\n10. Metabolic-associated fatty liver disease\n11. Metabolic-associated steatohepatitis\n12. Type 1 Diabetes\n13. Antipsychotics\n14. GLP1 Medication Prescribed\n15. Bariatric Surgery\n16. Pregnancy","ALL","8 Years","15 Years",{"count":76,"type":77},250,"ESTIMATED","INTERVENTIONAL",[80],"NA","The Food as Medicine (FAME) intervention aims to improve dietary quality in lower income, primarily ethnic minority youth through food navigation that bridges clinical care and community food resources. This study will evaluate the FAME intervention on dietary quality, food behaviors, health outcomes, and cost-effectiveness, using a pragmatic randomized clinical trial design in 250 at risk youth (8-15 years of age) and their caregiver(s) as compared to Usual Care through the following aims:\n\nAim 1: To evaluate the impact of the FAME intervention on child and caregiver(s) dietary quality at 6 and 12 months as compared to Usual Care. Hypothesis: FAME participants will have increased dietary quality as measured by ASA-24\u002FDQI.\n\nAim 2: To assess the intervention's impact on food behaviors, food insecurity, healthy food sourcing, knowledge, self-efficacy, health outcomes and cost-effectiveness at 6 and 12 months as compared to Usual Care.\n\nAim 3: Evaluate implementation outcomes including dose, satisfaction, and individual interviews and focus groups with youth, parents, physicians, clinic staff, community partners, and CHWs.",[83],"Chronic Diseases in Children","NOT_YET_RECRUITING","2026-04-02",{"date":87,"type":88},"2026-04-06","ACTUAL",{"date":90,"type":77},"2026-05",{"date":92,"type":77},"2028-06-30",{"name":5,"class":6},1]