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Behavioural Intervention

Traditional Navajo Foods 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

ICD I50* diagnosis

Must not have

Hospice care

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 180 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will give people with heart failure either specially prepared meals delivered to their homes that follow a specific diet or their usual care for a month.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves dietary changes rather than medication, side effects may include digestive adjustments to new foods. However, no significant medical side effects are expected from the meal program.

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 have been diagnosed with heart failure.

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I am 18 years old or older.

Exclusion Criteria

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

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I am not 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

Feasibility: Percentage of meals successfully received by the patient

Secondary study objectives

Acceptability of the Intervention (AIM) Measure

Acceptability: Taste

Adoption of Intervention

+22 more

Other study objectives

Medication and Medical Therapy Adherence

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Meal delivery programExperimental Treatment1 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)

0 / 4Eligibility criteria met