Pediatric Food is Medicine Study

Comparative Effectiveness of Food Prescription Programs for Food Insecure Families With Young Children

Overview

Key facts that identify this study and show where it stands today.

ClinicalTrials.gov ID: NCT07770490
Lead Sponsor: State University of New York at BuffaloOTHER
Overall Status: Recruiting
Study Type: Interventional
Phase: Not Applicable
Enrollment: 225Estimated
Last Update Posted: Aug 18, 2026Actual
Start Date: Jul 23, 2026Actual
Primary Completion Date: Dec 31, 2029Estimated
Completion Date: Dec 31, 2029Estimated

Description

What the study is about and why it is being run, in the researchers' own words.

Official Title: Comparative Effectiveness of Food Prescription Programs for Food Insecure Families With Young Children
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

The medical conditions and diseases this study investigates.

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

Interventions

The treatments and procedures being evaluated in this study.

Delivered Produce Prescription
Delivered Healthy Meal Kit
Standard of Care Mobile Market Voucher

Participation

Who can join this study and the criteria used to decide.

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Eligibility Criteria: 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

Design

How the study is designed and how its participant groups are organized.

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Single

Contacts

The people to reach with questions about this study or how to join it.

Lucia Leone, PhDContact

lucialeo@buffalo.edu716-829-6953

Locations

Where the study is run and whether each site is currently recruiting.

University at BuffaloRecruiting

Buffalo, New York 14214-8001, United States

Collaborators

The organizations and people involved in this study.

Lead Sponsor: State University of New York at BuffaloOTHER
Collaborators

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Other registered studies that closely resemble this one.

Detailed Description

In the U.S., 17.3% of families with children report food insecurity with even higher rates among lower-income families. Given the impacts of food insecurity on diet and health, a growing trend of "Food is Medicine" seeks to address health disparities through the integration of food and nutrition security initiatives into healthcare systems. The Food is Medicine (FIM) framework prioritizes nutrition security-access to high quality foods that promote well-being-to address health and healthcare-related outcomes across different populations. Several state Medicaid programs have begun funding FIM interventions, including food prescription programs (i.e., medically tailored groceries, produce prescriptions). Food prescriptions have the potential to manage and prevent diet-related health conditions, reduce healthcare utilization, and reduce food insecurity, however, poor usage threatens their effectiveness with prescription redemption rates as low as 9-18% in the literature. There is a need for rigorous research on usage and acceptability of food prescription interventions as a tool to reach the youngest populations at risk for food and nutrition insecurity. While food prescriptions may originate with a healthcare provider and be paid for by health insurance, the execution of these programs lies with community-based organizations and food retailers. This research addresses the urgent need for community organizations to understand how to increase utilization of food prescription programs among families with small children. The study employs a community-engaged approach to develop and test two innovative food prescription interventions among 225 Medicaid families with children (ages 2-6) who have screened positive for food insecurity at local pediatric clinics. This population has been chosen to match eligibility for a recently passed Medicaid food prescription program in New York state. Each family will be randomized to one of three study arms and provided a food prescription, focusing on fresh produce, weekly for 26 weeks. The usual care control arm will receive a mobile market-based produce prescription, and the two intervention arms will receive either a customizable box of fresh produce or a choice of meal kits (produce box with recipes and all the complementary ingredients to make 3 healthy meals with the produce), both delivered to their home. The research team will work with community partners who normally deliver FIM programs so that findings can be immediately applicable to FIM practitioners. Outcomes will focus on program utilization (enrollment, redemption, and food usage) for Aim 1 and fruit and vegetable consumption, diet quality, food and nutrition security and cooking self-efficacy for Aim 2. Aim 3 will qualitatively examine program implementation, secondary program impacts, and cost effectiveness. Together these aims will help understand how to address low utilization rates of food prescription programs with the goal of reducing food insecurity among families with young children.