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

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.

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 (<65 versus ≥65 years), and left ventricular ejection fraction (<50% versus ≥50%). Study subjects will receive either culturally and medically tailored meals that incorporate traditional Diné recipes and foods or usual dietary advice for 8 weeks. Data analysts will be blinded to group assignment until study completion.

The primary efficacy end point is the proportion of patients with a hospitalization or emergency room visit (all-cause) within 90 days. Secondary outcomes will include hospitalizations or emergency room visits for heart failure specifically; Kansas City Cardiomyopathy Questionnaire scores for health-related quality of life; measures of food insecurity; Indigenous nourishment; diet quality; financial strain; and clinical biomarkers from study enrollment to 8 weeks.

Community-based interventions that leverage the protective assets of Indigenous communities are needed to improve cardiovascular health among Native populations. This pragmatic randomized controlled trial will target a rural tribal population and be the first to evaluate the efficacy of an Indigenous food is medicine intervention to improve Indigenous cardiovascular health outcomes for patients with heart failure.

URL: https://www.clinicaltrials.gov; Unique identifier: NCT06549699.