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

Starting soon · Not applicable

Conditions studied: Type 1 Diabetes (T1D), Food Insecurity

In brief

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.

Key facts

Study ID

NCT07590817

Run by

Katelyn Fox

People needed

12

Starts

2026-05-30

Expected to finish

2026-06-30

Last updated by the study team

2026-05-15

Who can join

Age: 5 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• recent diagnosis of T1DM (<6 months)

Where it is running

• Hasbro Children's Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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