NCT07911969Toborzás még nem indult
Comparative Feasibility and Effectiveness of Medically Tailored Meals Approaches for Pediatric End-Stage Kidney Disease
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. nov. 3.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 30 (tervezett)
- Első benyújtás
- 2026. okt. 16.
- Kezdés
- 2026. nov.
- Elsődleges befejezés
- 2027. dec.
- Fő szponzor
- Baylor College of Medicine
- Betegségek
- Krónikus vesebetegség
- NCT-szám
- NCT07911969
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 30
- 2026. nov. és az elsődleges befejezés (2027. dec.) között
- Nincs megadott helyszín, ország nélkül
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- 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;
Más betegség
- Children with significant co-morbidities including active malignancies and organ transplantation;
Egyéb
- 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.).
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 10 év – 17 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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