The American Indian and Alaska Native population has experienced significant cardiovascular health disparities compared with other racial and ethnic groups in the U.S. \[1\] Heart failure, in particular, causes significant morbidity and mortality in Navajo Nation. For many Navajo patients, similar to other American Indian populations, food insecurity is a major driver of health disparities. \[2\]\[3\] In fact, qualitative data from our heart failure patient advisory committee have found that 89% of patients with heart failure believe nutrition insecurity is a major barrier to optimal health. Dietary factors are believed to be an important cause of hospitalizations in patients with heart failure and cardiovascular outcomes. There is increasing evidence that direct dietary support, such as produce prescription or provision of medically tailored meals may improve cardiovascular outcomes and disease-specific quality of life. Furthermore, there has been an increased focus in Indigenous communities to reclaim traditional indigenous foods to improve health. However, more evidence of the benefit of traditional Indigenous foods for cardiovascular health is needed.

We, therefore, in discussion with community members and tribal partners at two Indian Health Service (IHS) sites in Navajo Nation, will implement and evaluate the effectiveness of a medically and Native-sourced culturally tailored meal delivery program to improve outcomes in heart failure in rural Navajo Nation. This study will include two phases, with a phase I pilot feasibility study, followed by phase II-a comparativeness effectiveness randomized control trial to compare the implementation of our medically and culturally tailored meal delivery program compared to usual care. This study describes the phase I feasibility study in which 20 patients will receive medically medically-tailored meals for 30 days with 14 meals weekly. Phase I outcomes will include implementation outcomes such as feasibility and acceptability to inform phase II. The primary outcome for Phase I will be the proportion of patients who have a hospitalization or ER visit for any cause within 90 days post implementation. Secondary outcomes will include: heart failure hospitalizations specifically, ER visits for volume overload specifically (ER visits for lower extremity edema, dyspnea, with clinical evaluation consistent with volume overload) within 90 days, Kansas City Cardiomyopathy Questionnaire clinical summary score at baseline and at 30 days; weight at baseline (and BMI) at 30 days, and the following lab parameters and biomarkers at baseline and at 30 days: albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP, and measures of food insecurity. We will also collect measures of Indigenous cultural connectiveness using the validated Cultural Connectedness Scale-California (CCS-CA) at baseline and at 30 days, as well as qualitative analyses of patients, farmers/ranchers, local food suppliers to assess implementation outcomes. This is a single arm feasibility pilot study and therefore, we will be comparing baseline to post-implementation (30 day) measures to assess for changes.