Clinical trial NCT06549699: Medically Used Tailored Traditional Food to Optimize Nutrition in Heart Failure
Official title: MUTTON-HF (Medically Used Tailored Traditional Food to Optimize Nutrition) in Heart Failure)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Heart Failure
Keywords: Indigenous
Navajo
Traditional Foods
Nutrition security
food is medicine
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Indian Health Service (IHS)
name: American Heart Association
name: Brigham and Women's Hospital
First posted: 2024-08-12
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.\[4\]\[5\] 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.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* ICD I50\* diagnosis
* Clinical encounter in last 12 months
* Primary care physician at the two IHS sites
* Hospitalization (any-cause) within last 12 months

Exclusion Criteria

* Hospice care
* Living in acute rehabilitation or skilled nursing facility
* Living outside the Gallup Service Unit (outside 50-mile catchment area)

Primary outcomes:
measure: Hospitalization or Emergency Department Visit
timeFrame: 90 days
Secondary outcomes:
measure: Cultural Connectedness Scale-California
timeFrame: 60 days
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-12)
timeFrame: 60 days
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Quality of Life Subset
timeFrame: 60 days
measure: Food Security
timeFrame: 60 days
measure: Biomarker Data
timeFrame: 60 days
measure: Weight
timeFrame: 60 days
measure: ER visits
timeFrame: 90 days
measure: Hospitalizations
timeFrame: 90 days
measure: ER visit for Heart Failure
timeFrame: 90 days
measure: Heart Failure hospitalization
timeFrame: 90 days
measure: Diet Quality
timeFrame: 60 Days, 90 days
measure: Financial Stress
timeFrame: 60 Days
measure: Intervention characteristics: Partnership
timeFrame: 60 Days
measure: Implementation Outcomes: Feasibility
timeFrame: 60 Days
measure: Implementation Outcomes: Fidelity
timeFrame: 60 Days
measure: Implementation Outcomes: Acceptability
timeFrame: 60 Days
measure: Implementation Outcomes: Fidelity, acceptability, feasibility, adoption
timeFrame: 60 Days
measure: Physical Activity
timeFrame: 60 Days
measure: General Health Status
timeFrame: 60 Days
measure: KCCQ12-PL Physical Limitation Score
timeFrame: 60 Days
measure: KCCQ12-SF Symptom Frequency Score
timeFrame: 60 Days
measure: KCCQ-SL Social Limitation Score
timeFrame: 60 Days
measure: Indigenous Nourishment Scale
timeFrame: Baseline, 60 days
measure: Height
timeFrame: 60 days
measure: urine albumin:creatinine
timeFrame: 60 days
Other outcomes:
Locations:
city: Gallup
country: United States
facility: Gallup Indian Medical Center
state: New Mexico
city: Tohatchi
country: United States
facility: Tohatchi Health Clinic
state: New Mexico
Study officials:
affiliation: Indian Health Service (IHS)
name: Lauren Eberly, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: