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

BACKGROUND: Nutrition insecurity is a major driver of poor cardiovascular health in Indigenous communities. Medically tailored meals may improve heart failure outcomes and quality of life. There is growing momentum among Indigenous communities to reclaim traditional precontact foods to improve cardiovascular health. In this context, utilizing community-based-participatory methods, we designed MUTTON-HF (Medically Utilized Tailored Traditional Foods to Optimize Nutrition in Heart Failure)-an Indigenous culturally and medically tailored meals program that locally sources Native produce and meat and incorporates traditional Diné (Navajo) foods and recipes. METHODS: The MUTTON-HF trial is a 2-center, pragmatic, open-label randomized controlled trial to determine the efficacy and safety of MUTTON-HF among Diné patients with heart failure and hospitalization, or emergency room visit in the last 12 months. Two hundred and four subjects at 2 Indian Health Service sites will be randomized in a 1:1 stratified fashion by sex, age (