Study subjects with heart failure will receive either pre-prepared, home-delivered DASH/SRD-compliant meals incorporating local Navajo traditional foods or usual care for 60 days (14 meals weekly).
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.\[4\]\[5\] 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. The investigators, 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. Phase I outcomes will include implementation outcomes such as feasibility and acceptability to inform phase II. The primary outcome for the trial in Phase II 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 60 days; prescription adherence rates (% of filled prescriptions out of prescriptions made) for all medication as well as GDMT specifically at 60 days, weight at baseline (and BMI) at 60 days, and the following lab parameters and biomarkers at baseline and at 60 days: albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP, and measures of food insecurity. The investigators will also collect measures of Indigenous cultural connectiveness using the validated Cultural Connectedness Scale-California (CCS-CA) at baseline and at 60 days, as well as qualitative analyses of local food suppliers to evaluate how this program strengthens local food systems. The investigators will also evaluate food diaries and perform a survey at 90 days to evaluate for any sustainable change in diet and behavior post intervention. Semi-structured interviews will be performed of stakeholders including a subset of patients, primary care providers and food suppliers to assess implementation outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
206
Patients will receive medically-tailored meals incorporating local traditional Navajo foods
Usual care plus healthy recipes provided
Gallup Indian Medical Center
Gallup, New Mexico, United States
Tohatchi Health Clinic
Tohatchi, New Mexico, United States
Hospitalization or Emergency Department Visit
Hospitalization or Visit to Emergency Department (All-cause)
Time frame: 90 days
Cultural Connectedness Scale-California
The investigators will measure cultural connectedness utilizing a 6-question modified version of the validated Cultural Connectedness Scale-California (CCS-CA) at baseline and at 60 days. This is a validated score, developed by Indigenous scholars to measure cultural connectiveness in Indigenous populations, and has been shown to correlate with physical health and be a social determinant of health. This scale has previously been modified for use in Diné populations specifically by the investigators. The investigators will evaluate total score, as well as subcomponents of identity, traditions, and spirituality.
Time frame: 60 days
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
This is a validated score for evaluating quality of life and symptom measures in heart failure patients. Score ranges from 0-100, with 0 meaning very poor quality of life/symptoms and health status, 100 meaning excellent quality of life/symptom burden/health status.
Time frame: 60 days
Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Quality of Life Subset
Subset of this is a validated score for evaluating quality of life measures in heart failure patients. Score ranges from 0-100, with 0 meaning very poor quality of life/symptoms and health status, 100 meaning excellent quality of life/symptom burden/health status.
Time frame: 60 days
Food Security
The investigators will evaluate baseline and 60-day rates of food insecurity utilizing the USDA Adult Food Security: Six Item short Form survey (USDA FSSM 6-Item).\[12\] At the 60-day evaluation, the investigators will adapt the USDA FSSM 6-Item questionnaire to evaluate food insecurity within the last 2 (rather than 12 months).
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Time frame: 60 days
Biomarker Data
albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP
Time frame: 60 days
Weight
Weight (kilograms). Weight and height will be combined to report BMI in kg/m\^2
Time frame: 60 days
ER visits
All cause
Time frame: 90 days
Hospitalizations
All cause
Time frame: 90 days
ER visit for Heart Failure
ER visit for volume overload or HF symptoms
Time frame: 90 days
Heart Failure hospitalization
Time frame: 90 days
Diet Quality
The investigators will assess diet quality using the 10-item DSQ \[11\] with an addition question to assess traditional Diné food intake (During the past month, how often did the participant eat traditional Diné foods (such as blue corn mush, steamed, roasted or dried corn, sumac berries, mutton, local varieties of squash or beans) at baseline and at the end of the intervention.
Time frame: 60 Days, 90 days
Financial Stress
The investigators will measure Financial Stress Scale at baseline and at 60 days using two questions:\[16\] How worried was the participant over the last 2 months about paying for housing (rent, mortgage, etc.)? How worried was the participant over the last 2 months about paying monthly bills? § All questions will be answered on a 4-point scale, where 1 = "not worried at all", 2 = "not too worried", 3 = "moderately worried", and 4 = "very worried"
Time frame: 60 Days
Intervention characteristics: Partnership
The investigators will evaluate the following: * % of meals that include locally sourced ingredients * % of food supply sourced by Diné producers/suppliers/farmers * % of meals sourced by Native suppliers/farmers
Time frame: 60 Days
Implementation Outcomes: Feasibility
The investigators will evaluate the percentage of meals delivered successfully to the patient (or percentage of meals that were successfully picked up by the patient if picked up from the food pantry or other location).
Time frame: 60 Days
Implementation Outcomes: Fidelity
The investigators will assess baseline dietary patterns through 3-day food diaries during week 1 and week 8 after enrollment. The investigators will also survey participants on the % of meals consumed at 60 days. Additionally at 90 days, the investigators will perform a survey to evaluate dietary patterns post intervention and adoption of any of the recipes/behavioral changes.
Time frame: 60 Days
Implementation Outcomes: Acceptability
The investigators will evaluate patient satisfaction by evaluating the Net Promoter Score (i.e. how likely is it that the patient would recommend this program to a community member?") post-intervention.
Time frame: 60 Days
Qualitative Implementation Outcomes: Fidelity, acceptability, feasibility, adoption
The investigators will perform semi-structured interviews of non-patient stakeholders (i.e. farmers that supplied produce, livestock farmers, food pantry) to assess acceptability and feasibility of providing produce for the meals, as well as the degree to which the program contributed to strengthening the local food system. The investigators will also perform semi-structured interviews of primary care providers and a subset of patients. Semi-structured interviews will be guided by the Consolidated Framework for Implementation Research (CFIR), and the investigators will explore multiple constructs within each CFIR domain that are hypothesized by the study team and based on existing literature to be relevant to acceptability and feasibility of the program.
Time frame: 60 Days
Physical Activity
The investigators will evaluate how much physical activity/exercise patients are participating in weekly at baseline, and at 60 days by asking patients to estimate the number of minutes weekly that they are participating in formal exercise or physical activity.
Time frame: 60 Days
General Health Status
The investigators will evaluate patients' general health status using a single general health status question (would the patient that in general their health is excellent, very good, good, fair, or poor) at baseline and post-intervention
Time frame: 60 Days
KCCQ12-PL Physical Limitation Score
Subsection of KCCQ-12 Score
Time frame: 60 Days
KCCQ12-SF Symptom Frequency Score
Subsection of KCCQ12 Score
Time frame: 60 Days
KCCQ-SL Social Limitation Score
Subsection of KCCQ-12 Score
Time frame: 60 Days
Indigenous Nourishment Scale
The investigators will evaluate the Indigenous Nourishment Scale (Measure A), which is a scale developed through community-based methods in Indigenous communities to encompass multiple dimensions of nourishment. The investigators will assign score of 0-6 for each response (0 for never-6 for always), for a total score 0-54 (with 0 meaning low levels of nourishment and 54 high levels of nourishment.
Time frame: Baseline, 60 days
Height
Height (cm). Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 60 days
urine albumin:creatinine
Urine albumin:creatinine ratio
Time frame: 60 days