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Nutritional Therapy

Medically Tailored Meals for Heart Failure (MUTTON-HF Trial)

N/A

Waitlist Available

Led By Lauren Eberly, MD, MPH

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hospitalization (any-cause) within the last 12 months

Age greater than or equal to 18 years

Must not have

Hospice care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Summary

"This trial will provide heart failure patients with either specially prepared meals containing traditional Navajo foods or their usual care for 60 days."

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves food-based interventions, side effects may be minimal but could include potential food allergies or intolerances to new ingredients introduced through the Navajo traditional foods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 18 years old or older.

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I have been diagnosed with heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently receiving hospice care.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 180 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~180 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 180 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hospitalization or Emergency Department Visit

Secondary study objectives

Biomarker Data

ER visit for Heart Failure

ER visits

+4 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Meal delivery programActive Control1 Intervention

Patients will receive 2 meals daily (21 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 30 days for phase I pilot feasibility and 60 days for phase II)

Group II: Usual CarePlacebo Group1 Intervention

Patients will receive usual care plus the recipes of the meals received by intervention group

0 / 4Eligibility criteria met