Medically Tailored Meals for Heart Failure

(MUTTON-HF Trial)

Enrolling by invitation at 1 trial location

Overseen By Lauren Eberly, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Hospice, Rehabilitation, Nursing facility, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether meals tailored to heart health, incorporating traditional Navajo foods, can improve outcomes for people with heart failure. Participants will receive home-delivered meals designed to support heart health for 60 days and might also attend a cooking class. The goal is to determine if these meals make a difference compared to usual care. The trial seeks individuals diagnosed with heart failure who have been hospitalized for any reason within the last year.

As an unphased trial, this study offers a unique opportunity to explore culturally tailored dietary interventions that could enhance heart health.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Medically Tailored Meal Program with Traditional Navajo Foods is safe for heart failure patients?

A previous study found that a meal program specifically designed for health needs significantly lowered blood pressure and improved heart health in 101 participants with mild to moderate heart issues. These meals included traditional Navajo foods. Research has shown that direct dietary support, such as tailored meals, can benefit heart health.

No reports of serious side effects have emerged from these meal programs, suggesting participants tolerate them well. This trial uses food as the treatment, differing from drug-based treatments, which usually carry a higher risk of side effects. Instead, these meals are crafted to support heart health and include culturally relevant foods, potentially making them easier for participants to adapt to and enjoy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Medically Tailored Meal Program with Traditional Navajo Foods for heart failure because it uniquely combines nutrition and cultural heritage to improve health outcomes. Unlike standard treatments, which often involve medication and lifestyle changes, this approach provides patients with two daily meals that are specifically tailored to their medical needs, incorporating traditional Navajo foods. This culturally relevant dietary intervention not only addresses nutritional requirements but also fosters community engagement and cultural connection, potentially enhancing adherence and overall effectiveness.

What evidence suggests that the Medically Tailored Meal Program with Traditional Navajo Foods could be effective for heart failure?

Research has shown that specially designed meal programs can improve heart health. In this trial, participants in one arm will receive a Medically Tailored Meal Program incorporating traditional Navajo foods, which may further benefit heart health, especially in rural Navajo areas. Direct dietary support of this kind has been linked to better management of heart failure. Overall, evidence suggests that these meals can help people with heart failure. ^{1 2 3 4 5}

Who Is on the Research Team?

Lauren Eberly, MD, MPH

Principal Investigator

Indian Health Service (IHS)

Are You a Good Fit for This Trial?

This trial is for individuals with heart failure who are interested in exploring the effects of a special diet. Participants will receive meals that comply with dietary recommendations and include traditional Navajo foods, delivered to their homes.

Inclusion Criteria

Clinical encounter in the last 12 months

I have been hospitalized for any reason in the past year.

I have been diagnosed with heart failure.

Exclusion Criteria

Living in acute rehabilitation or skilled nursing facility

Living outside the Gallup Service Unit (outside 50-mile catchment area)

I am currently receiving hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase I Pilot Feasibility Study

Implementation and evaluation of the feasibility and acceptability of the meal delivery program

60 days

Phase II Randomized Control Trial

Comparative effectiveness trial of the meal delivery program versus usual care

60 days

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and interviews to assess dietary changes and program impact

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Meal Program with Traditional Navajo Foods

Trial Overview The study is testing whether a medically tailored meal program can improve health outcomes compared to usual care. Half of the participants will get these specialized meals for 60 days, while the other half will continue with their regular eating habits.

How Is the Trial Designed?

Group I: Meal delivery program Active Control 1 Intervention

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 II: Usual Care Placebo Group 1 Intervention

Patients will receive usual care

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Indian Health Service

Collaborator

Trials

4

Recruited

3,100+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Indian Health Service (IHS)

Collaborator

Trials

6

Recruited

3,300+

Published Research Related to This Trial

Heart failure (HF) patients often face complex challenges due to deranged physiology and malnutrition, making effective nutritional strategies crucial for their care.

The DASH (Dietary Approaches to Stop Hypertension) diet may be particularly beneficial for HF patients, as it aligns with the need for a dietary program that supports both nutritional needs and HF management goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. Rifai, L., Silver, MA.[2019]

Participants in a medically-tailored meal program for individuals with type 2 diabetes reported high satisfaction and noted improvements in their quality of life and diabetes management, highlighting the program's effectiveness.

The study emphasized the importance of culturally appropriate meals and suggested that combining these meal programs with diabetes education could enhance their impact on managing diabetes and reducing stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I was able to eat what I am supposed to eat"-- patient reflections on a medically-tailored meal intervention: a qualitative analysis. Berkowitz, SA., Shahid, NN., Terranova, J., et al.[2020]

A comprehensive meal program (CCNW) significantly lowered blood pressure and improved cardiovascular risk factors in 101 participants with mild-to-moderate hypertension, showing greater benefits than a self-selected diet.

The CCNW plan led to better outcomes in cholesterol, LDL levels, HbA1c, and overall nutrient intake, while also enhancing compliance and quality of life, highlighting the importance of a complete dietary approach over focusing on individual nutrients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive nutrition plan improves cardiovascular risk factors in essential hypertension. McCarron, DA., Oparil, S., Resnick, LM., et al.[2019]

This study will evaluate the efficacy of a Medically Tailored Meals (MTM) program for individuals with type 2 diabetes and hyperglycemia, involving 212 participants over 26 weeks, to see if it can improve their blood sugar levels and overall health.

The trial aims to provide valuable data on the clinical outcomes of MTM, which could support its large-scale implementation in healthcare systems to help manage chronic conditions like diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia. Law, KK., Coyle, DH., Neal, B., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06675331

NCT06675331 | Mutton Heart Failure Food is Medicine Pilot There is increasing evidence that direct dietary support, such as produce prescription or provision of medically tailored meals may improve cardiovascular ...

2. withpower.com withpower.com/trial/phase-heart-failure-9-2024-0928e

Medically Tailored Meals for Heart Failure (MUTTON-HF Trial) What data supports the effectiveness of the Medically Tailored Meal Program with Traditional Navajo Foods treatment for heart failure? The DASH diet, which ...

3. sheep-turquoise-h6pl.squarespace.com sheep-turquoise-h6pl.squarespace.com/s/Mutton-Protocolv22RCT317withperprotocol.pdf

MUTTON-HF (Medically Utilized Tailored Traditional food to ... sourced culturally tailored meal delivery program to improve outcomes in heart failure in rural Navajo. Nation. This study includes two phases, with a phase ...

4. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073166

Centering Diné (Navajo) Voices: Barriers, Facilitators, and ... Medically utilized tailored traditional meals to optimize nutrition in heart failure (Mutton-HF). ClinicalTrials.gov identifier: NCT06549699 ...

5. ihs.gov ihs.gov/newsroom/ihs-updates/june-30-2025-ihs-updates-for-tribes-and-tribal-and-urban-indian-organizations/

June 30, 2025: IHS Updates for Tribes and Tribal and ... The team designed MUTTON-HF (Medically Utilized Tailored Traditional Food to Optimize Nutrition in Heart Failure), a medically tailored meal ...