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Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
Sponsor: Katelyn Fox
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.
Official title: Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
Key Details
Gender
All
Age Range
5 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
12
Start Date
2026-05-30
Completion Date
2026-06-30
Last Updated
2026-05-15
Healthy Volunteers
No
Conditions
Interventions
Produce prescription
Produce prescriptions: Weekly boxes of fresh produce. Similar to the USDA's TEFAP (The Emergency Food Assistance Program), boxes include 10-12 lbs of fresh fruits and vegetables per month (adjustable based on family size).
Medically tailored meal kits
Medically Tailored Meals: Families will receive 3 semi-prepared medically tailored meal kits and recipes per week x 6 weeks.
Nutrition Coaching
Nutrition Coaching: Nutrition coaches will provide families with weekly phone check-ins using brief motivational interviewing and applied problem solving. During the first half of the intervention (weeks 1-3), coaches will assess barriers to preparing and consuming the prescribed foods (meal kits or produce), with the goal of improving diet quality. The second half of the intervention (weeks 4-6) will focus on building self-efficacy, skills, and resources required to plan and prepare meals on a budget and strategies to increase fruit and vegetable intake.
Locations (1)
Hasbro Children's Hospital
Providence, Rhode Island, United States