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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 belowSelect...
I have been hospitalized for any reason in the past year.
Select...
I have been diagnosed with heart failure.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
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
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
Cultural Connectedness Scale-California
ER visit for HF
ER visits
+7 moreOther study objectives
Implementation Outcomes
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)
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalOTHER
1,666 Previous Clinical Trials
11,840,215 Total Patients Enrolled
46 Trials studying Heart Failure
104,358 Patients Enrolled for Heart Failure
University of PennsylvaniaLead Sponsor
2,079 Previous Clinical Trials
42,721,380 Total Patients Enrolled
47 Trials studying Heart Failure
10,996 Patients Enrolled for Heart Failure
Indian Health ServiceUNKNOWN
3 Previous Clinical Trials
3,086 Total Patients Enrolled
2 Trials studying Heart Failure
307 Patients Enrolled for Heart Failure
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