From Kitchen to Clinic: Study protocol for a family-centered, food-as-medicine approach using medically tailored meals and caregiver coaching in pediatric oncology care.
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BACKGROUND: Children undergoing cancer treatment are at high risk for malnutrition, poor diet quality, and early cardiometabolic risk due to treatment-related side effects, disrupted appetite, and household-level barriers to healthy eating. Caregivers play a central role in nutritional support during treatment but often experience substantial burden, time constraints, and nutrition insecurity. Food-as-medicine strategies, including medically tailored meals (MTMs), have shown promise in adult populations but remain underexplored in pediatric oncology, particularly during active treatment and within family-centered models. OBJECTIVE: The primary objective of this study is to evaluate the feasibility, acceptability, and adherence of From Kitchen to Clinic, a 12-week, family-centered food-as-medicine intervention that integrates MTM delivery with caregiver coaching for caregivers of children undergoing cancer treatment. Secondary objectives include collecting exploratory data on patient dietary intake, weight and lean body mass trajectories, treatment tolerance, household food and nutrition security, and caregiver burden and distress to inform a future definitive trial. METHODS: This prospective, single-arm feasibility study will enroll 60 caregiver-child dyads (N = 120) recruited from three outpatient pediatric oncology clinics at a large children's hospital. The 12-week intervention includes an intensive phase (weeks 1-8) with weekly MTM delivery and caregiver coaching, followed by a tapered phase (weeks 9-12) with reduced meal frequency and bi-weekly coaching. Feasibility outcomes include recruitment, retention, assessment completion, intervention adherence, and acceptability, evaluated against predefined progression criteria. Exploratory outcomes will be assessed at baseline and at 3, 6, and 12 months post-intervention using validated dietary, anthropometric, clinical, and caregiver-reported measures. TRIAL REGISTRATION: NCT07454902.