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)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (2 locations)

    1

    Gallup Indian Medical Center

    Gallup, New Mexico, United States, 87301

    2

    Tohatchi Health Clinic

    Tohatchi, New Mexico, United States, 87325