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Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes

12 de mayo de 2026 actualizado por: Katelyn Fox

Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes

Study Design: This two-arm parallel trial will randomize 12 families to receive 6-weeks of medically tailored meals or produce prescriptions. Both groups will receive nutrition coaching, weekly during the intervention. The hypothesis is that both interventions to have a positive impact on food security and fruit and vegetable intake. However, medically tailored meals also reduce the logistic barriers of planning, preparing, and calculating the carbohydrate content of nutritionally balanced meals essential for DM management. Therefore, the medically tailored meal intervention will result in greater improvements in the co-primary outcomes of diet quality and glucose stability after the intervention.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

12

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.

Ubicaciones de estudio

  • Estados Unidos
    • Rhode Island
      • Providence, Rhode Island, Estados Unidos, 02903
        • Hasbro Children's Hospital
        • Contacto:
          • Katelyn Fox, PhD
          • Número de teléfono: 401-793-8251 4017870821
          • Correo electrónico: katelyn_fox@brown.edu
        • Contacto:
          • Rivkah Cohen
        • Sub-Investigador:
          • Lisa Swartz Topor, MD

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

  • Niño

Acepta Voluntarios Saludables

No

Descripción

Inclusion Criteria:

  • Families of school-age children (ages 5-12 years) with T1DM and food insecurity
  • fluent in English or Spanish.
  • child uses a continuous glucose monitor (CGM)
  • willing to provide consent for the research team to access CGM data

Exclusion Criteria:

  • recent diagnosis of T1DM (<6 months)

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: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Medically tailored meal kits + nutrition coaching
Medically Tailored Meals: Each family in this arm will receive medically tailored meal kits (3 semi-prepared meals and recipes per week x 6 weeks).Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Conductual: Medically tailored meal kits
Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.
Conductual: Nutrition Coaching
Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Comparador activo: Produce prescription + nutrition coaching

Produce prescriptions: Each family in this arm will receive weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size). Boxes will also include recipes and examples of how to incorporate the produce into family meals

Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Conductual: Nutrition Coaching
Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Conductual: Produce prescription
Produce prescriptions: Weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Feasibility
Periodo de tiempo: baseline, pre-intervention and immediately after the intervention
Feasibility will be assessed using the following criteria: Recruitment of >50% of families screened eligible, retention of > 65% of randomized families at follow-up, >50% adherence to coaching protocol, and >50% preparation of the prescribed meals.
baseline, pre-intervention and immediately after the intervention
Acceptability
Periodo de tiempo: immediately after the intervention
Acceptability will be assessed using the following criteria: caregiver report of target child consuming prepared foods more than half of the time, and a net promotor score >20.
immediately after the intervention

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Diet quality
Periodo de tiempo: baseline, pre-intervention and immediately after the intervention
The 24-hour dietary recalls will be collected by masked assessors using Nutrition Data System for Research (NDSR), a computer-based software application that facilitates the collection of recalls in a standardized fashion, using a multiple-pass interview approach to improve participant recall.51 Healthy Eating Index (HEI-2020) will be calculated using the NCI per person algorithm.HEI-2020 is scored on a scale from 0-100 with higher scores reflecting better diet quality.
baseline, pre-intervention and immediately after the intervention
Change in Glucose Stability
Periodo de tiempo: baseline, pre-intervention and immediately after the intervention
Glucose stability will be assessed using time in range (TIR), using CGM data. We will calculate TIR as the percent of time an individual spends in a target BG range (% of readings with-in 70-180 mg/dL). TIR is a strong indicator of DM management and future CVD risk.
baseline, pre-intervention and immediately after the intervention
Change in Food Security
Periodo de tiempo: baseline, pre-intervention and immediately after the intervention
United States Department of Agriculture Food Security Survey Module (USDA FSSM) 18-Item. This survey is score on a scale of 0-18 with higher scores indicating higher food insecurity. Categorically For households with one or more children a Raw score zero= High food security, Raw score 1-2=Marginal food security, Raw score 3-7=Low food security, Raw score 8-18=Very low food security
baseline, pre-intervention and immediately after the intervention

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Engagement
Periodo de tiempo: through study completion, an average of 6 weeks
Redemption rate and adherence rate.
through study completion, an average of 6 weeks
Percent adherence to the study protocol
Periodo de tiempo: through study completion, an average of 6 weeks
adherence to the nutrition coaching protocol
through study completion, an average of 6 weeks
Cost
Periodo de tiempo: through study completion, an average of 6 weeks
cost per participant
through study completion, an average of 6 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Katelyn Fox

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 (Estimado)

30 de mayo de 2026

Finalización primaria (Estimado)

30 de junio de 2026

Finalización del estudio (Estimado)

30 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

30 de septiembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

12 de mayo de 2026

Publicado por primera vez (Actual)

15 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 25FIMPG1492233

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Data to be generated during this study include surveys, interviews, 24-hour dietary recalls, participant height, weight, blood pressure, and continuous glucose monitor readings. Once the data collection for this study has concluded, all direct respondent identifiers (e.g., names and addresses) will be removed from the data and a key maintained in a separate and separately stored and encrypted file for future contact purposes. To ensure participant consent for data sharing, IRB paperwork and informed consent documents will include language describing plans for data management and sharing of data, describing the motivation for sharing, and explaining that personal identifying information will be removed. Study respondents will be asked to consent to data collection and de-identified data sharing with the wider research community via deposit in the openICPSR repository.

Marco de tiempo para compartir IPD

06/26/2026

Criterios de acceso compartido de IPD

Researchers through the openICPSR repository.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • 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. .

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