NCT07911969Not yet recruiting
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
Source: ClinicalTrials.gov · Last updated 3 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 16 Oct 2026
- Start date
- 1 Nov 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Baylor College of Medicine
- Diseases
- Chronic kidney disease
- NCT number
- NCT07911969
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Nov 2026 to the primary completion date, 31 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Children who have been receiving chronic dialysis for less than 3 months;
- Children scheduled to receive a living donor kidney transplant in 3 months or less;
Other illness
- Children with significant co-morbidities including active malignancies and organ transplantation;
Other
- Children with severe developmental delay that could affect the ability to communicate;
- those who are tube-fed or receive their nutrition predominantly tube or intravenous means;
- Children in foster-care;
- Children or family participating in any other food is medicine initiative (food/produce prescription, MTMs, etc.).
Who the study is looking for
- Pediatric patients aged between 10 and 17 years receiving chronic outpatient dialysis- hemodialysis or peritoneal dialysis at Texas Children's Hospital;
- Patients have been receiving chronic outpatient dialysis for at least 3 months to ensure a stable dialysis prescription and dry weight assessment;
- Patients who receive more than 80% of their feeds by mouth and can provide feedback on the taste;
- Ability of the parent to speak and read in English or Spanish.
Age in the registry: 10 years to 17 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.