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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-12
SponsorKatelyn Fox

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

recent diagnosis of T1DM (<6 months)

Trial design

Treatments tested in this trial

  • Produce prescription
  • Medically tailored meal kits
  • Nutrition Coaching

Treatment groups

12 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Katelyn Fox

Lead sponsor

The Miriam Hospital

Sponsor institution