Pediatric Food is Medicine Study

Part of paid clinical trials in Buffalo, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT07770490
Status
Recruiting
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Conditions

  • Food Insecurity
  • Fruit and Vegetable Consumption in Children
  • Produce Prescription Program Utilization

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Delivered Produce Prescription — OTHER
    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).
  • Delivered Healthy Meal Kit — OTHER
    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).
  • Standard of Care Mobile Market Voucher — OTHER
    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.

Study Details

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.

Key Dates

First listed
Aug 18, 2026
Start date
Jul 23, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Delivered Produce Prescription
    Participants randomly assigned to receive the Delivered Produce Prescription intervention.
  • Experimental: Delivered Healthy Meal Kit
    Participants randomly assigned to receive the Delivered Healthy Meal Kit intervention.
  • Active Comparator: Standard of Care Mobile Market Voucher
    Participants randomly assigned to receive the Standard of Care Mobile Market Voucher intervention.

Primary Outcome Measure

Produce Prescription Program Redemption [ Time Frame: From intervention start to one week after the end of the intervention period of 24 weeks. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University at BuffaloBuffaloNew York14214-8001
Anne Lally Mathiebe, PhD
[email protected]
716-829-5436

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By research site
University at Buffalo· Buffalo, NY

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