Recruiting

Food Is Medicine

Sponsor:

State University of New York at Buffalo

Code:

NCT07770490

Conditions

Food Insecurity

Fruit and Vegetable Consumption in Children

Produce Prescription Program Utilization

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Delivered Produce Prescription

Delivered Healthy Meal Kit

Standard of Care Mobile Market Voucher

Study Details

Brief 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

Study ID

NCT07770490

Start date

Jul 23, 2026

Status verified date

Aug, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • parent or primary caregiver of a child aged 2-6
  • child must receive Medicaid benefits
  • child must receive pediatric care at one of the study's 3 pediatric practice partners
  • 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).
  • participant must be responsible for at least 50% of the household food shopping
  • participant must be able to store and prepare food in their home

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

Study Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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).

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).

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.

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. ]
  • Child Fruit and Vegetable Consumption [ Time Frame: Completed at 3 timepoints: once after enrollment but prior to intervention start (baseline), once 6 months from baseline and 1-2 weeks prior to intervention end at 24 weeks, and once 12 months from baseline. ]

Central Contacts and Locations

Central contacts

Lucia Leone, PhD

716-829-6953lucialeo@buffalo.edu

Locations

University at Buffalo

Recruiting

Buffalo, New York, United States, 14214-8001

Contacts

Anne Lally Mathiebe, PhD

716-829-5436annelall@buffalo.edu

More Information

Sponsor

State University of New York at Buffalo

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

Keywords

  • Food Is Medicine
  • Produce Prescription

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by State University of New York at Buffalo on 2026-08-18.