Pediatric Food is Medicine Study

Summary

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.

Conditions

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

Interventions

OTHER

Delivered Produce Prescription

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).

OTHER

Delivered Healthy Meal Kit

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).

OTHER

Standard of Care Mobile Market Voucher

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.

Sponsors & Collaborators

• National Institute on Minority Health and Health Disparities (NIMHD)

  collaborator NIH

• State University of New York at Buffalo

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2026-07-23

Primary Completion

2029-12-31

Completion

2029-12-31

Countries

• United States

Study Locations