Pediatric Food is Medicine Study
17 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Intervencionista
Inscripción (Estimado)
225
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Lucia Leone, PhD
- Número de teléfono: 716-829-6953
- Correo electrónico: lucialeo@buffalo.edu
Ubicaciones de estudio
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New York
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Buffalo, New York, Estados Unidos, 14214-8001
- Reclutamiento
- University at Buffalo
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Contacto:
- Anne Lally Mathiebe, PhD
- Número de teléfono: 716-829-5436
- Correo electrónico: annelall@buffalo.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Delivered Produce Prescription
Participants randomly assigned to receive the Delivered Produce Prescription intervention.
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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).
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Experimental: Delivered Healthy Meal Kit
Participants randomly assigned to receive the Delivered Healthy Meal Kit intervention.
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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).
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Comparador activo: Standard of Care Mobile Market Voucher
Participants randomly assigned to receive the Standard of Care Mobile Market Voucher intervention.
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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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Produce Prescription Program Redemption
Periodo de tiempo: From intervention start to one week after the end of the intervention period of 24 weeks.
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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).
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From intervention start to one week after the end of the intervention period of 24 weeks.
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Child Fruit and Vegetable Consumption
Periodo de tiempo: 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.
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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.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Produce Prescription Program Enrollment
Periodo de tiempo: Collected during study recruitment process.
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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.
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Collected during study recruitment process.
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Produce Prescription Program Usage
Periodo de tiempo: From intervention start to one week after the end of the intervention period of 24 weeks.
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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.
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From intervention start to one week after the end of the intervention period of 24 weeks.
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Household Food Security
Periodo de tiempo: 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.
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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).
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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.
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Household Nutrition Security
Periodo de tiempo: 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.
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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.
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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.
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de julio de 2026
Finalización primaria (Estimado)
31 de diciembre de 2029
Finalización del estudio (Estimado)
31 de diciembre de 2029
Fechas de registro del estudio
Enviado por primera vez
12 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de agosto de 2026
Publicado por primera vez (Actual)
18 de agosto de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- R01MD020348 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Descripción del plan IPD
Utilization Data (Participant Level):
- Behavioral data that is observable by the research team (i.e., enrollment data) will be shared in aggregate for each study arm.
- Self-report utilization data will be summarized at the participant level and integrated into the participant-level data set.
Parent-Reported Data (Baseline, 6 and 12 months):
- 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.
- 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.
Marco de tiempo para compartir 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.
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .