Medically Utilized Tailored Traditional Meals to Optimize Nutrition in Heart Failure Pilot Trial

Brief Summary

Detailed Description

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 controlled trial to compare the implementation of our medically and culturally tailored meal delivery program compared to usual care. For phase I, we will conduct a one-arm pilot trial of the MUTTON-HF intervention to determine 1) feasibility of the intervention and outcome assessment and 2) acceptability of the intervention and 3) fidelity of the intervention. We will enroll 20 patients to receive medically tailored meals (14 meals weekly) for 30 days to inform the phase II comparativeness effectiveness trial. Phase I outcomes will include implementation outcomes such as feasibility and acceptability of the intervention including the various delivery mechanisms and meals as measured by quantitative (i.e. % meals delivered and % meals received by patient) and qualitative methods, of outcome assessment including surveys and laboratory evaluation (% with completed outcome assessment), and fidelity of intervention as measured by quantitative (% meals consumed). We will additionally measure feasibility and acceptability of supporting local food systems by measuring % meals with locally sourced produce and meat, and % sourced from Navajo farmers and ranchers specifically. We will also explore implementation outcomes with community partners including farmers, growers, ranchers, food pantry.

Primary Outcomes

Secondary Outcomes

• Cultural Connectedness Scale-California(Baseline, 30 Days)
• Kansas City Cardiomyopathy Questionnaire (KCCQ-12)(Baseline, 30 Days)
• USDA Adult Food Security: Six Item short Form survey(Baseline, 30 Days)
• Hospitalization or Emergency Department Visit(90 Days)
• Laboratory Biomarker Data(Baseline, 30 Days)
• Weight/Body Mass Index(Baseline, 30 Days)
• Emergency Room Visits(90 Days)
• ER visits or hospitalizations(180 days)
• ER visit for Heart Failure(90 Days)
• Heart Failure Hospitalizations(90 days)
• Feasibility: Percentage of meals delivered successfully to the Gallup Food Pantry(30 days)
• Feasibility of Intervention: Delivery/Pick-Up(30 days)
• Acceptability of the Intervention (AIM) Measure(30 days)
• Net Promoter Score(30 days)
• Fidelity: Consumption(30 days)
• Acceptability: Taste(30 days)
• Qualitative measures of feasibility and acceptability(30 days)
• Feasibility of Supporting Local Food Systems(30 days)
• Feasibility: Local Food Sourcing(30 days)
• Feasibility of Outcome Assessment(30 days)
• Fidelity of Intervention(30 days)
• Adoption of Intervention(30 days)
• Diet Quality(Baseline and 30 days)
• Physical Activity(Baseline and 30 days)
• General Health Status(Baseline and 30 days)
• KCCW12-PL Physical Limitation Score(30 days)
• KCCQ12-PL Physical Limitation Score(30 days)
• KCCQ12-SF Symptom Frequency Score(30 Days)
• KCCQ-QL(30 Days)
• KCCQ-SL Social Limitation Score(30 days)