Medically Used Tailored Traditional Food to Optimize Nutrition in Heart Failure

NCT ID: NCT06549699

Last Updated: 2025-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-12
• Study Completion Date: 2025-12-01

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.

Conditions

Heart Failure

Keywords

Indigenous; Navajo; Traditional Foods; Nutrition security; food is medicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Meal delivery program

Patients will receive 2 meals daily (14 meals weekly) of medically-tailored meals incorporating traditional Navajo foods, followed by a cooking class at the end of the meal program (meals provided for 60 days).

Group Type: ACTIVE_COMPARATOR

Medically Tailored Meal Program with Traditional Navajo Foods

Intervention Type: OTHER

Patients will receive medically-tailored meals incorporating local traditional Navajo foods

Usual Care

Patients will receive usual care

Group Type: PLACEBO_COMPARATOR

Usual Care

Intervention Type: OTHER

Usual care plus healthy recipes provided

Interventions

Medically Tailored Meal Program with Traditional Navajo Foods

Patients will receive medically-tailored meals incorporating local traditional Navajo foods

Intervention Type: OTHER

Usual Care

Usual care plus healthy recipes provided

Intervention Type: OTHER

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) or ER visit 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indian Health Service (IHS)

FED

Sponsor Role: collaborator

American Heart Association

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lauren Eberly, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indian Health Service (IHS)

Locations

Gallup Indian Medical Center

Gallup, New Mexico, United States

Tohatchi Health Clinic

Tohatchi, New Mexico, United States

Countries

United States

Related Links

https://www.muttonhf.com/

Study Website

Other Identifiers

08072024

Identifier Type: -

Identifier Source: org_study_id