MUTTON-HF: Rationale and Design of a Study of an Indigenous Food is Medicine Intervention

Top Things to Know

This study tests Food Is Medicine as clinical care, not just access support.

Community-designed, culturally grounded interventions strengthen internal validity and relevance.

An open-label design, broad inclusion criteria, and tailored delivery infrastructure improve generalizability to real-world Indigenous and rural settings.

Summary of Conclusion/Findings

This paper describes the rationale and design of MUTTON-HF, a pragmatic, open-label randomized controlled trial testing an Indigenous Food Is Medicine intervention for Diné (Navajo) patients with heart failure at two Indian Health Service sites. The study will randomize 204 patients with recent heart failure hospitalization or emergency department use to receive either 8 weeks of culturally and medically tailored meals incorporating traditional Diné foods or usual dietary advice. The primary outcome is the proportion of participants with any hospitalization or emergency room visit within 90 days, with secondary outcomes spanning heart failure–specific utilization, quality of life (Kansas City Cardiomyopathy Questionnaire), food security, diet quality, Indigenous nourishment, financial strain, and cardiometabolic biomarkers. The design leverages community-based participatory methods, local and Indigenous food sourcing, and tailored distribution strategies to address rural infrastructure barriers such as lack of electricity or home delivery access. Key strengths include real-world pragmatism, culturally grounded outcome measures, and integration of implementation and qualitative analyses alongside clinical endpoints. Limitations acknowledged by the authors include lack of blinding, short intervention duration, and inability to isolate the effects of cultural tailoring versus healthy food provision alone.