Medically Tailored Meals for Heart Failure

(MUTTON-HF Trial)

Recruiting 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

204 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the effectiveness of the Medically Tailored Meal Program with Traditional Navajo Foods treatment for heart failure?

The DASH diet, which focuses on reducing salt and increasing nutrient-rich foods, has shown promise in managing heart failure, suggesting that a similar approach with traditional Navajo foods could be beneficial. Additionally, programs like the Navajo Fruit and Vegetable Prescription Program have improved health outcomes by increasing access to healthy foods, indicating potential positive effects for heart failure patients. ^{1 2 3 4 5}

How is the Medically Tailored Meal Program with Traditional Navajo Foods different from other treatments for heart failure?

This treatment is unique because it incorporates culturally relevant foods, specifically traditional Navajo foods, into the meal plan, which may enhance patient adherence and satisfaction compared to standard dietary approaches that do not consider cultural preferences. ^{3 6 7 8 9}

Research Team

Lauren Eberly, MD, MPH

Principal Investigator

Indian Health Service (IHS)

Eligibility Criteria

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

I am currently receiving hospice care.

Living in acute rehabilitation or skilled nursing facility

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Contemporary diet and body weight of Navajo women receiving food assistance: an ethnographic and nutritional investigation. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Dietary intake and development of a quantitative FFQ for a nutritional intervention to reduce the risk of chronic disease in the Navajo Nation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

A Review of the DASH Diet as an Optimal Dietary Plan for Symptomatic Heart Failure. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Impact of a Fruit and Vegetable Prescription Program on Health Outcomes and Behaviors in Young Navajo Children. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Mediterranean and DASH diet scores and mortality in women with heart failure: The Women's Health Initiative. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Cultural Relevancy of Culinary and Nutritional Medicine Interventions: A Scoping Review. [2022]

7. England 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. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Comprehensive nutrition plan improves cardiovascular risk factors in essential hypertension. [2019]

9. United States 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. [2023]