Clinical trial NCT06675331: Mutton Heart Failure Food is Medicine Pilot
Official title: Medically Utilized Tailored Traditional Meals to Optimize Nutrition in Heart Failure Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: indigenous
food is medicine
Traditional Foods
Nutrition Security
Navajo
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Indian Health Service (IHS)
name: Brigham and Women's Hospital
name: American Heart Association
First posted: 2024-11-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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 30 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. 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.

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