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Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
Sponsor: Baylor College of Medicine
Summary
End-Stage Kidney Disease (ESKD) in children is a severe and irreversible condition that significantly impacts their growth, development, and overall quality of life. Children with ESKD often face numerous physical, emotional, and social challenges, including the need for life-saving dialysis or kidney transplantation. Despite advancements in clinical management, dietary adherence remains a critical component in managing ESKD and improving health outcomes. This study will compare two approaches to providing medically tailored meals (MTMs) for children with ESKD. A total of 30 children and their parents or caregivers will be randomly assigned to one of two groups: (1) a culinary medicine program that teaches families how to plan, shop for, and prepare kidney-friendly meals at home, or (2) a program that provides pre-prepared, kidney-friendly meals delivered to their homes. The study will assess how practical and acceptable each approach is for families and examine its potential effects on children's health and dietary habits. Researchers will evaluate participation, satisfaction, and study completion rates. They will also examine changes in children's blood potassium and phosphorus levels, blood pressure, fluid balance, diet quality, and health-related quality of life. In addition, the study will explore whether the culinary medicine program improves parents' nutrition knowledge, confidence in preparing healthy meals, meal planning, grocery shopping, cooking skills, and availability of healthy foods at home. Researchers will also compare the costs of the two approaches, including food, educational materials, and staff time, to estimate the cost per child. The findings will help determine whether these approaches are practical for families and provide information to guide future studies and programs to improve nutrition and health among children with ESKD.
Key Details
Gender
All
Age Range
10 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2026-11
Completion Date
2027-12
Last Updated
2026-11-03
Healthy Volunteers
No
Conditions
Interventions
Culinary Medicine Intervention
The intervention includes 12 weekly, 2-3 hour sessions (in-person or virtual based on participant preference and logistics). While some sessions may take place in home to facilitate hands-on cooking instruction and skill-building, others may be conducted virtually. Virtual sessions will be designed to replicate hands-on instruction guiding participants in real-time using video conferencing tools, offering step-by-step guidance, observing technique, and providing feedback throughout the cooking process. Sessions will focus on patient-centered communication, culinary skills, meal preparation for children with ESKD, self-efficacy building, and feedback. Each family will receive a cooking kit and groceries tailored to dietary needs.
Pre-prepared MTMs
During the 12-week intervention, children in this arm will receive weekly delivery of 14 fully prepared, refrigerated and/or frozen meals (7 lunches, 7 dinners). They will also receive educational materials and resources to help align family meals with the child's dietary requirements, making it easier to manage meal preparation. HFB will also work with the participants to address any barriers related to delivery schedules.