Pediatric Food is Medicine Study

NCT07770490 | Recruiting

• 1 other identifier: R01MD020348
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

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

Keywords

Food Is Medicine; Produce Prescription

Outcome Measures

Primary Outcomes (2)

• Produce Prescription Program Redemption

  Redemption will be measured as the percentage of all 24 potential deliveries or mobile market visits that are confirmed via a periodic text message survey sent to participants asking if they received their produce prescription that week. Self-report redemption data can be confirmed using delivery software data (experimental delivery arms) and mobile market point-of-sale software (standard of care mobile market voucher arm).

  From intervention start to one week after the end of the intervention period of 24 weeks.

• Child Fruit and Vegetable Consumption

  Child Fruit and Vegetable Consumption will be calculated using data from one parent-reported dietary recall for the reference child at each timepoint (baseline, 6-months, and 12-months) completed using the ASA24. The ASA24 is an online self-administered 24-hour recall program developed by the National Cancer Institute (NCI). The ASA24 produces individual-level food group estimates based on USDA's MyPlate Equivalents Database. MyPyramid cup equivalents as calculated by the ASA24 will be used to determine cups of F\&V.

  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.

Secondary Outcomes (4)

• Produce Prescription Program Enrollment

  Collected during study recruitment process.

• Produce Prescription Program Usage

  From intervention start to one week after the end of the intervention period of 24 weeks.

• Household Food Security

  Completed at 3 timepoints: once at 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.

• Household Nutrition Security

  Completed at 3 timepoints: once at 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.

Study Arms (3)

Delivered Produce Prescription

EXPERIMENTAL

Participants randomly assigned to receive the Delivered Produce Prescription intervention.

Other: Delivered Produce Prescription

Delivered Healthy Meal Kit

EXPERIMENTAL

Participants randomly assigned to receive the Delivered Healthy Meal Kit intervention.

Other: Delivered Healthy Meal Kit

Standard of Care Mobile Market Voucher

ACTIVE COMPARATOR

Participants randomly assigned to receive the Standard of Care Mobile Market Voucher intervention.

Other: Standard of Care Mobile Market Voucher

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 Produce Prescription

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).

Delivered Healthy Meal Kit

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.

Standard of Care Mobile Market Voucher

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214-8001, United States

RECRUITING

Central Study Contacts

Lucia Leone, PhD

CONTACT

716-829-6953; lucialeo@buffalo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 12, 2026
• First Posted: August 18, 2026
• Study Start: July 23, 2026
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: All de-identified data will be shared prior to the end of the study or at the time of publication. Any data relating to the primary aims that is not published at the end of the study will be embargoed for up to 3 years.
• Access Criteria: De-identified data as described, along with data collection instruments, the statistical analysis plan, analytic code, and protocols will be shared in the freely available repository Open Science Framework.

Locations

US (1)