Clinical Trial

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

Not Yet Recruiting
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Record status
This record was last updated May 15, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT07590817
Lead Sponsor Katelyn Fox
Conditions Type 1 Diabetes (T1D), Food Insecurity
Enrollment 12 participants
Start Date 2026-05-30
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-05-15