Traditional Navajo Foods for Heart Failure

(Mutton-HF Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Hospice, Acute rehab, Skilled nursing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if meals including traditional Navajo foods can improve symptoms in people with heart failure. Participants will receive 14 home-delivered, specially prepared meals each week for 30 days. These meals adhere to heart-healthy dietary guidelines as part of a Medically Tailored Meal Program with Traditional Navajo Foods. The trial seeks participants diagnosed with heart failure, hospitalized in the past year, and with a primary care doctor at one of the specific health sites. As an unphased trial, it offers a unique opportunity to explore the potential health benefits of traditional Navajo foods for heart failure patients.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this meal delivery program is safe for heart failure patients?

Research shows that the Medically Tailored Meal Program with Traditional Navajo Foods is generally safe for participants. This program uses the DASH diet, known for its heart health benefits. The DASH diet has proven safe and effective for many with heart issues.

The trial is in the "Not Applicable" phase, indicating that detailed safety data specific to this program might not yet be available. However, the focus on traditional, culturally-tailored foods emphasizes natural, wholesome ingredients, which are usually well-tolerated.

Overall, while specific safety data for this exact program might not be available yet, similar past studies consider the diet and use of traditional foods safe. ^{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 takes a unique approach by using diet as a therapeutic tool. Unlike standard treatments, which often rely on medications like beta-blockers and ACE inhibitors, this program incorporates culturally significant Navajo foods to potentially improve heart health. This approach not only provides nutrition but also engages patients in culturally relevant practices, which can enhance adherence and overall well-being. Additionally, the program includes cooking classes, empowering patients to continue healthy eating habits beyond the trial.

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

Research shows that meal programs designed for medical needs can help people with heart failure. Studies have found that diets like the DASH diet, which reduces salt and includes more fruits and vegetables, can improve heart health. In this trial, participants will receive a medically tailored meal program incorporating traditional Navajo foods, adding a cultural touch that may help Navajo patients adhere to the diet and enhance its effectiveness. Early results suggest that easy access to healthy foods through these meal programs can improve quality of life and lead to better heart health. This method combines good nutrition with respect for cultural traditions to support heart health meaningfully. ^{1 2 3 6 7}

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 adults over 18 with heart failure who've seen a doctor or been hospitalized in the last year. They must live within 50 miles of the Gallup Service Unit and not be in hospice care or living in acute rehab/skilled nursing facilities.

Inclusion Criteria

Clinical encounter in the last 12 months

Primary care physician at the two IHS sites

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

Exclusion Criteria

Living in acute rehabilitation or skilled nursing facility

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

I am not currently receiving hospice care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored meals incorporating traditional Navajo foods, 14 meals weekly for 30 days

4 weeks

Weekly meal delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and laboratory evaluations

4 weeks

2 visits (in-person)

Extension

Optional continuation of monitoring for long-term outcomes such as hospitalizations and ER visits

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Meal Program with Traditional Navajo Foods

Trial Overview The study tests if special meals that follow DASH/SRD guidelines and include traditional Navajo foods can help people with heart failure. Participants will get these home-delivered meals for a month, while others will continue their usual diet.

How Is the Trial Designed?

Group I: Meal delivery program Experimental Treatment 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 4 weeks)

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Indian Health Service

Collaborator

Trials

4

Recruited

3,100+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Indian Health Service (IHS)

Collaborator

Trials

6

Recruited

3,300+

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. 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 ...

3. 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 ...

4. newsroom.heart.org newsroom.heart.org/news/access-to-healthy-foods-linked-to-improved-quality-of-life-for-adults-with-heart-failure

Access to healthy foods linked to improved quality of life for ... This randomized trial included 150 adults who were enrolled within two weeks of being discharged from the hospital for acute heart failure.

5. 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 ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCULATIONAHA.124.073166?doi=10.1161/CIRCULATIONAHA.124.073166

Centering Diné (Navajo) Voices: Barriers, Facilitators, and ... 43. Medically utilized tailored traditional meals to optimize nutrition in heart failure (Mutton-HF). ClinicalTrials.gov identifier ...

7. 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 ...