Feasibility of an Indigenous Food Is Medicine Program for Patients With Heart Failure in Rural Navajo Nation: The MUTTON-HF Nonrandomized Clinical Trial.

Importance: The ongoing consequences of settler colonialism produce adverse structural drivers, particularly nutrition insecurity, that contribute to cardiovascular health disparities among Indigenous populations. There is increased focus in Native communities to reclaim traditional precontact foods to improve health. Therefore, a locally sourced, Indigenous, medically tailored meal delivery program-MUTTON-HF (Medically Utilized Tailored Traditional Foods to Optimize Nutrition in Heart Failure)-was developed to improve health outcomes. Objective: To determine implementation outcomes, including feasibility and acceptability, as well as to explore preintervention vs postintervention health measures of a medically tailored meal program incorporating traditional foods and recipes for patients with heart failure in rural Navajo Nation. Design, Setting, and Participants: The single-arm pilot nonrandomized clinical trial was conducted from October 7, 2024, to February 3, 2025, to evaluate implementation and health outcomes of the MUTTON-HF program. Participants included adults (≥18 years) with a diagnosis of heart failure who were receiving care at one of 2 Indian Health Service sites in rural Navajo Nation. Intervention: Patients received 14 culturally and medically tailored meals weekly (2 meals daily) for 4 weeks. Main Outcomes and Measures: The primary outcomes were intervention feasibility and acceptability, assessed with surveys, qualitative interviews, and programmatic data at 30 days. Intervention feasibility was determined by evaluating the number and percentage of meal boxes successfully received by each patient. Acceptability was assessed using the Acceptability of Intervention Measure (AIM) (score range, 4-20), patient program ratings (range, 1-10), and the Net Promoter Score. Secondary outcomes, which were assessed via surveys and medical record review, included intervention adoption and fidelity, feasibility for community partners (including farmers and ranchers, using the Feasibility of Intervention Measure [score range, 4-20]), and preintervention vs postintervention health measures (eg, clinical biomarkers, food insecurity [based on the US Department of Agriculture 6-item Short-Form Food Security Survey Module], 12-item Kansas City Cardiomyopathy Questionnaire [KCCQ] scores, and Cultural Connectedness Scale [CCS] scores). Results: This study enrolled 20 American Indian patients (mean [SD] age, 58.2 [11.7] years; 13 were male [65.0%]) residing in communities exceeding a 136-km radius in Arizona and New Mexico. Patients had a mean (SD) left ventricular ejection fraction of 40.0% (16.0%). Of the 80 weekly meal boxes, 72 (90.0%) were successfully received by patients. The mean (SD) AIM score was 16.9 (3.1), the mean (SD) patient program rating was 8.6 (1.6), and the Net Promoter Score was 45.0%. Most patients (17 [85.0%]) reported they were likely to change their diet to be healthier moving forward. Mean (SD) Feasibility of Intervention Measure scores were 19.8 (0.5) for community farmers and ranchers and 20 (0) for community partners. Significant preintervention to postintervention improvements were observed for food security (the number of patients who were food secure increased from 8 [40.0%] to 17 [85.0%]), KCCQ physical limitation (mean [SD], from 59.6 [31.3] to 82.7 [21.9]) and social limitation (mean [SD], from 74.6 [24.1] to 83.8 [25.0]) scores, CCS Traditions subscore (mean [SD], from 7.2 [2.9] to 7.9 [3.0]), and weight change among patients with obesity (mean [SD], -2.3 [3.3] kg). Conclusions and Relevance: In this nonrandomized clinical trial, the MUTTON-HF intervention incorporating Indigenous recipes and locally sourced Native food was feasible and acceptable for patients with heart failure in rural Navajo Nation. These findings will inform a future randomized clinical trial to evaluate the effectiveness of this intervention to advance Indigenous cardiovascular health and food sovereignty. Trial Registration: ClinicalTrials.gov Identifier: NCT06675331.