Pediatric Food is Medicine Study (NCT07770490)
🩺 Plain-English Summary (8th-Grade Level)
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: * What food prescription program is used most completely and consistently by food insecure families with children aged 2-6? * How do the programs being tested impact the amount of fruits and vegetables children eat and the household's food and nutrition security status? Researchers 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. Participants will: * Receive 1 of 3 food prescription programs for 24 weeks (6 months) * 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). * 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. * 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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (6 items).
Location: University at Buffalo — Buffalo, New York
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- families with severe food allergies
- parents who report their child aged 2-6 is diagnosed with Avoidant/Restrictive Food Intake Disorder (ARFID), Pediatric Feeding Disorder (PFD), or dysphagia
- parents who report their child aged 2-6 is diagnosed with any conditions they feel would limit their child's eating/feeding to the point they are unable to participate in this study
- individuals who do not speak English or Spanish fluently
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University at Buffalo — Buffalo, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.