Pilot of Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes (NCT07590817)
Food Is Medicine Interventions to Reduce Cardiovascular Disease Risk in Children With Food Insecurity and Diabetes
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Hasbro Children's Hospital — Providence, Rhode Island
Age range: 5 Years to 12 Years
🧪 Interventions in This Study
- Produce prescription (BEHAVIORAL)
- Medically tailored meal kits (BEHAVIORAL)
- Nutrition Coaching (BEHAVIORAL)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Hasbro Children's Hospital — Providence, Rhode Island
📞 Contact the Study Coordinator
Phone: (401) 787-0821
Email: katelyn_fox@brown.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.