[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100652158":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":29,"centralContacts":36,"locations":42,"responsibleParty":62,"collaborators":66,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":29,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":78,"minAge":79,"maxAge":29,"enrollmentInfo":80,"targetDuration":29,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":45,"whyStopped":29,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"State University of New York at Buffalo","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Delivered Produce Prescription","EXPERIMENTAL","Participants randomly assigned to receive the Delivered Produce Prescription intervention.",[13],"Other: Delivered Produce Prescription",{"label":15,"type":10,"description":16,"interventionNames":17},"Delivered Healthy Meal Kit","Participants randomly assigned to receive the Delivered Healthy Meal Kit intervention.",[18],"Other: Delivered Healthy Meal Kit",{"label":20,"type":21,"description":22,"interventionNames":23},"Standard of Care Mobile Market Voucher","ACTIVE_COMPARATOR","Participants randomly assigned to receive the Standard of Care Mobile Market Voucher intervention.",[24],"Other: Standard of Care Mobile Market Voucher",[26,30,33],{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Participants will receive weekly home deliveries of fresh F\\&V over 6 months (24 weeks). After enrollment, participants will be assigned a default box based on their family size. Box contents will change weekly based on seasonal availability and if a participant does nothing, they will receive a default box, but if they choose, they could customize their order to receive any variety of F\\&Vs that they want (with the quantity staying consistent).",[9],null,{"type":6,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"Participants will receive 3 meal kits per week delivered to their home for 6 months (24 weeks). Meal kits include a recipe for a meal and all the ingredients needed to make it for the entire family. Recipes are reviewed by a dietician to align with dietary guidelines with a focus on kid-friendly options and seasonal produce. Meal kit recipes are paired with an instructional video from a local chef (sent via text or e-mail). At enrollment, participants will be assigned a default meal kit based on family size and diet (vegetarian or not). If they do nothing, participants will automatically receive the ingredients to make 3 default meals. If they choose, they can visit a webstore weekly and choose their meals from approximately 6 different weekly options. Meal options will repeat every 4 weeks to encourage repeated exposure to preferred F\\&Vs and recipes. Participants will receive essential ingredients to be used across recipes upfront (e.g., olive oil, flour, spice).",[15],{"type":6,"name":20,"description":34,"armGroupLabels":35,"otherNames":29},"Participants will receive a weekly credit to purchase produce from a mobile produce market at their clinic location (or any of 20+ mobile market locations in the region). The control arm is modeled after produce prescription programs already offered by our partners but augmented to match the prescription duration allowed by the NY Medicaid 1115 waiver (6 months). Massachusetts Avenue Project and UB Veggie Van will host weekly mobile markets at each of the three pediatric clinic locations. Similar to the Veggie Van model (see preliminary studies), participants who shop at the market will have the option to select a default box of produce based on family size or an equivalent number of individual items. The contents of the produce boxes will mirror the produce available in the intervention arms. Mobile market credits will automatically be added to accounts each week and will not carry-over.",[20],[37],{"name":38,"role":39,"phone":40,"phoneExt":29,"email":41},"Lucia Leone, PhD","CONTACT","716-829-6953","lucialeo@buffalo.edu",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"University at Buffalo","RECRUITING","Buffalo","New York","14214-8001","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-78.87837,42.88645,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":29,"email":61},"Anne Lally Mathiebe, PhD","716-829-5436","annelall@buffalo.edu",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"PRINCIPAL_INVESTIGATOR","Lucia Leone","Principal Investigator",[67],{"name":68,"class":69},"National Institute on Minority Health and Health Disparities (NIMHD)","NIH","100652158","pediatric-food-is-medicine-study-100652158",false,"NCT07770490","Pediatric Food is Medicine Study","Comparative Effectiveness of Food Prescription Programs for Food Insecure Families With Young Children","Inclusion Criteria:\n\n* parent or primary caregiver of a child aged 2-6\n* child must receive Medicaid benefits\n* child must receive pediatric care at one of the study's 3 pediatric practice partners\n* participant must screen positive for food insecurity using the two-item food security measures on NYS Medicaid Accountable Health Communities (AHC) Health-Related Social Needs Screening Tool): 1.) Within the past 12 months, you worried that your food would run out before you got money to buy more (Often true, Sometimes true, Never true), and 2.) Within the past 12 months, the food you bought just didn't last and you didn't have money to get more (Often true, Sometimes true, Never true).\n* participant must be responsible for at least 50% of the household food shopping\n* participant must be able to store and prepare food in their home\n\nExclusion Criteria:\n\n* families with severe food allergies\n* parents who report their child aged 2-6 is diagnosed with Avoidant\u002FRestrictive Food Intake Disorder (ARFID), Pediatric Feeding Disorder (PFD), or dysphagia\n* parents who report their child aged 2-6 is diagnosed with any conditions they feel would limit their child's eating\u002Ffeeding to the point they are unable to participate in this study\n* individuals who do not speak English or Spanish fluently\n* households receiving nutrition services through NYS Medicaid 1115 waiver or similar free programs providing produce prescriptions or meal kits will be excluded until these free nutrition services end as these services would be duplicative of the interventions offered through this study",true,"ALL","18 Years",{"count":81,"type":82},225,"ESTIMATED","INTERVENTIONAL",[85],"NA","The goal of this clinical trial is to learn how to increase the usage and acceptability of Food Is Medicine programs among families with young children experiencing food insecurity who receive Medicaid benefits. Food Is Medicine programs connect food and nutrition programs to the healthcare system to address health issues. Food Is Medicine programs include food prescription programs that are recommended to patients by healthcare providers. These programs are designed to increase the amount of fruit and vegetables people eat to improve their health. The program described here works with pediatric practices serving a high Medicaid population in Buffalo, NY to recruit families with children aged 2-6 who are experiencing food insecurity-not having reliable access to the food they need. The main questions it aims to answer are:\n\n* What food prescription program is used most completely and consistently by food insecure families with children aged 2-6?\n* How do the programs being tested impact the amount of fruits and vegetables children eat and the household's food and nutrition security status?\n\nResearchers will compare 2 experimental delivery Food Is Medicine programs, a meal kit program and a produce prescription program, to each other and a standard of care mobile market voucher program to understand which program works the best for families with young children.\n\nParticipants will:\n\n* Receive 1 of 3 food prescription programs for 24 weeks (6 months)\n* Complete a short survey at different times throughout the program reporting how much of the food in the food prescription their family ate and why they didn't eat it all (if applicable).\n* Complete a phone survey about their family, their eating and shopping habits, and other health questions before they start the program, at the end of the program, and 6 months after the program ended.\n* Complete an online diet recall survey recording what their child aged 2-6 ate for a 24-hour period before they start the program, at the end of the program, and 6 months after the program ended.",[88,89,90],"Food Insecurity","Fruit and Vegetable Consumption in Children","Produce Prescription Program Utilization",[92,93],"Food Is Medicine","Produce Prescription","2026-08-17",{"date":96,"type":97},"2026-08-18","ACTUAL",{"date":99,"type":97},"2026-07-23",{"date":101,"type":82},"2029-12-31",{"name":5,"class":6},1]