Comparative feasibility and effectiveness of medically tailored meals approaches for pediatric end stage kidney disease

PROJECT SUMMARY/ABSTRACT End-Stage Kidney Disease (ESKD) in children is a challenging medical condition affecting growth, development, and quality of life. Nearly 10,000 children in the US rely on dialysis or kidney transplants. ESKD patients face a restrictive diet, impacting nutrition and overall health. Nutritional inadequacy in ESKD affects electrolyte balance, fluid status, blood pressure, and growth, especially in children. Medically tailored meals (MTMs) are a potential solution, delivered directly to homes or through dietitian-led culinary medicine (CM) education for caregivers. Balancing convenience and education poses feasibility challenges for both approaches. The Texas Children’s Hospital (TCH) serves a majority of urban, Hispanic, and African American pediatric ESKD patients. A proof-of-concept trial at TCH aims to compare CM-based MTMs and pre-prepared MTMs for ESKD pediatric patients. The trial involves 30 parent-child dyads, with data collected through Electronic Medical Records, surveys, and food recalls. Specific aims include: Aim 1 - Conduct formative research with key stakeholders (parents/caregivers [henceforth referred to as parents] of ESKD pediatric patients, dietitians, social workers, pediatric nephrologists) to obtain perspectives on managing ESKD specific dietary needs, pre-prepared MTMs, integrating CM with nutrition education and culturally-appropriate implementation strategies; and Aim 2 - Assess feasibility, acceptability, and preliminary impact with parent/child dyads (n=30). Hypotheses focus on the feasibility and acceptability of both interventions, with secondary hypotheses exploring the impact on parents’ behaviors and children’s diet quality. Exploratory hypotheses examine metabolic profiles. The study also aims to determine the budget impact of both interventions. The study aligns with PAS-20-86 Small R01s for Clinical Trials, addressing NIDDK's mission to gather preliminary data on feasibility, effectiveness, and cost-effectiveness of MTM approaches for ESKD pediatric patients. The significance of the study lies in its potential effectiveness, scalability, and sustainability for larger trials.