Status:
COMPLETED
Medically Used Tailored Traditional Food to Optimize Nutrition in Heart Failure
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Indian Health Service (IHS)
American Heart Association
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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).
Detailed Description
The American Indian and Alaska Native population has experienced significant cardiovascular health disparities compared with other racial and ethnic groups in the U.S. \[1\] Heart failure, in particul...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age \>=18 years
- ICD I50\* diagnosis
- Clinical encounter in last 12 months
- Primary care physician at the two IHS sites
- Hospitalization (any-cause) or ER visit within last 12 months
- Exclusion Criteria
- Hospice care
- Living in acute rehabilitation or skilled nursing facility
- Living outside the Gallup Service Unit (outside 50-mile catchment area)
Exclusion
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2025
Estimated Enrollment :
206 Patients enrolled
Trial Details
Trial ID
NCT06549699
Start Date
May 12 2025
End Date
December 1 2025
Last Update
December 29 2025
Active Locations (2)
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1
Gallup Indian Medical Center
Gallup, New Mexico, United States, 87301
2
Tohatchi Health Clinic
Tohatchi, New Mexico, United States, 87325