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Pediatric Food is Medicine Study

17 de agosto de 2026 atualizado por: Lucia Leone, State University of New York at Buffalo

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

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

225

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • New York
      • Buffalo, New York, Estados Unidos, 14214-8001
        • Recrutamento
        • University at Buffalo
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Delivered Produce Prescription
Participants randomly assigned to receive the Delivered Produce Prescription intervention.
Outro: 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).
Experimental: Delivered Healthy Meal Kit
Participants randomly assigned to receive the Delivered Healthy Meal Kit intervention.
Outro: 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).
Comparador Ativo: Standard of Care Mobile Market Voucher
Participants randomly assigned to receive the Standard of Care Mobile Market Voucher intervention.
Outro: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Produce Prescription Program Redemption
Prazo: From intervention start to one week after the end of the intervention period of 24 weeks.
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
Prazo: 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.
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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Produce Prescription Program Enrollment
Prazo: Collected during study recruitment process.
Program enrollment will be measured as the percentage of patients eligible and referred that decide to enroll in each arm. Those who choose not to enroll will be asked to provide more information on why they do not want to enroll. This will help us understand what aspects of the programs appeal to or dissuade initial enrollment.
Collected during study recruitment process.
Produce Prescription Program Usage
Prazo: From intervention start to one week after the end of the intervention period of 24 weeks.
Usage will be self-reported via a periodic text message survey sent to participants. Surveys will ask participants approximately what percentage of the produce that they received was used by someone in their household: all (coded as 100%), most (coded as 75%), about half (coded as 50%), some (coded as 25%) and none (coded as 0%). Answers from all completed surveys over 6 months will be averaged to get a percent usage for each family.
From intervention start to one week after the end of the intervention period of 24 weeks.
Household Food Security
Prazo: 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 Food is assessed with the USDA Household Food Security Survey Module and The USDA scoring system sums affirmative response to create a 0-10 scale and then categorizes respondents as high food security (0), marginal food security (1-2), low food security (3-5) and very low food security (6-10).
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
Prazo: 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 is assessed with the The Nutrition Security, Healthfulness Choice, and Dietary Choice Measure, which assesses the ability to obtain foods that meet nutritional/health needs and diet preferences, without resource limitation or worry.
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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

State University of New York at Buffalo

Colaboradores

National Institute on Minority Health and Health Disparities (NIMHD)

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

23 de julho de 2026

Conclusão Primária (Estimado)

31 de dezembro de 2029

Conclusão do estudo (Estimado)

31 de dezembro de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

12 de agosto de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de agosto de 2026

Primeira postagem (Real)

18 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de agosto de 2026

Última verificação

1 de agosto de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • R01MD020348 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

  1. Utilization Data (Participant Level):

    1. Behavioral data that is observable by the research team (i.e., enrollment data) will be shared in aggregate for each study arm.
    2. Self-report utilization data will be summarized at the participant level and integrated into the participant-level data set.

  2. Parent-Reported Data (Baseline, 6 and 12 months):

    1. Self-report survey data from consented participants includes participant demographics, psychosocial measures, parent fruit and vegetable intake, household food and nutrition security outcomes and intervention acceptability and usage data. All data will be de-identified prior sharing. Participant IDs will allow for matching with other data sources to create a participant-level data set.
    2. ASA24 diet recall data reported for a reference child by the enrolled parent will be integrated into the participant-level data set as fruit and vegetable and calorie-related data. All other data available in aggregate upon request.

Prazo de Compartilhamento de IPD

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.

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • ANALYTIC_CODE

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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