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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
5 Years to 12 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares 6 weeks of meals made for health needs with prescriptions for fruits and vegetables. It is for 12 families with children ages 5–12 who have type 1 diabetes and do not always have enough food. Both groups get weekly food coaching, and researchers will check diet quality and how steady blood sugar stays.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your family has a child ages 5–12 with type 1 diabetes and does not always have enough food.
  • Your family speaks English or Spanish fluently.
  • Your child uses a continuous glucose monitor (CGM), a device that tracks blood sugar.
  • You agree to let the research team access your child’s CGM data.

Who can't join

  • Your child was diagnosed with type 1 diabetes less than 6 months ago.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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)

Study sites (1)

RI