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
Sponsors and collaborators
Katelyn Fox
Lead sponsor
The Miriam Hospital
Sponsor institution