An Indigenous Food Is Medicine Intervention: The MUTTON-HF Randomized Clinical Trial

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Abstract

IMPORTANCE: Nutrition insecurity is a major driver of poor cardiovascular health in Indigenous communities. Medically tailored meals that reclaim traditional foods may improve heart failure outcomes and quality of life. Community-based participatory methods were used to design Medically Utilized Tailored Traditional Foods to Optimize Nutrition in Heart Failure (MUTTON-HF), a culturally and medically tailored meal program incorporating traditional Navajo foods and recipes. OBJECTIVE: To determine the efficacy of a culturally and medically tailored meal program on the incidence of hospitalizations and emergency department visits. DESIGN, SETTING, AND PARTICIPANTS: This pragmatic, open-label randomized clinical trial was conducted from May to November 2025 at 2 Indian Health Service sites in rural Navajo Nation. Eligible patients were adults with heart failure who were receiving care at the study sites and had a hospitalization or emergency department visit during the last 12 months. All patients were followed for 12 weeks for outcomes, death, and adverse events. The data were analyzed from December 2025 to February 2026. INTERVENTION: Patients were randomized in a 1:1 ratio to 8 weeks of a culturally and medically tailored meal program or usual dietary advice. MAIN OUTCOMES AND MEASURES: The primary end point was the proportion of patients with an all-cause hospitalization or emergency department visit within 90 days. Secondary outcomes included hospitalizations or emergency department visits separately, and for heart failure specifically, and change in Kansas City Cardiomyopathy Questionnaire scores, food insecurity, financial strain, blood pressure, and weight from enrollment to 8 weeks. RESULTS: A total of 206 patients (mean [SD] age, 65.8 [14.2] years; 87 female individuals [42%] and 119 male individuals [58%]; 203 American Indian individuals [99%], 2 American Indian or Alaskan Native and White individuals [0.97%], and 1 White individual [0.03%]; ejection fraction, 48%) were randomized. The primary outcome was significantly less frequent in the intervention arm (43 [40.6%] vs 57 [57.0%]; relative risk, 0.72; 95% CI, 0.54-0.96; P = .02), which was driven mainly by reduced hospitalizations (13 [12.3%] vs 26 [26.0%]). There was a lower incidence of heart failure hospitalizations specifically (4 [3.8%] vs 13 [13.0%]). The Kansas City Cardiomyopathy Questionnaire score and food security measures had significantly greater increases in the intervention arm while measures of financial strain, weight, and blood pressure significantly decreased in the intervention arm. Adverse events were uncommon. CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, an Indigenous Food is Medicine intervention reduced the incidence of hospitalization and emergency department visits among patients with heart failure. Community-based interventions that leverage protective assets of Native communities are needed to advance Indigenous health. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06549699.

Abstract as published, via PubMed.