A Phase 3 interventional study of Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and Recipes in Heart Failure, sponsored by University of Pennsylvania. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by University of Pennsylvania · Phase 3, Interventional, and Treatment
The goal of this study is to learn whether a meal program for people with heart failure works well when it is brought to new American Indian and Alaska Native communities, and how it affects patients, their households and local Native food systems. The program provides meals that are both medically tailored and culturally tailored, made with traditional foods from local Native producers. In an earlier randomized trial in Navajo Nation (MUTTON-HF), this program reduced hospitalizations and improved quality of life.
The study will examine whether the program can be successfully implemented at new Indian Health Service and Tribal sites and whether patients and community partners find it acceptable. It will also look at whether taking part improves patients' and caregivers' food security, financial strain, ability to work and other measures of economic stability, and whether the program strengthens local Native food systems by directing purchasing to Native farmers and ranchers and creating jobs.
About 100 adults with heart failure will take part at up to three Indian Health Service or Tribal health facilities. Participants will receive 14 frozen meals each week for 12 weeks, picked up or delivered locally, and will complete surveys when they enroll and again at 3 months. Some will be invited to an interview about their experience. Caregivers, participating farmers and ranchers, and program staff will also be asked to complete surveys and interviews, and health care use will be collected from medical records.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 100 is above the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
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Exclusion Criteria:
Culturally and Medically Tailored Meals-receive 14 meals weekly for 12 weeks.
Other: Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and Recipes
Culturally and Medically Tailored Meals Incorporating Locally Sourced Indigenous Foods and Recipes. Patients receive 14 meals weekly x 12 weeks. Meals adhere to AHA DASH guidelines and AHA Heart Check Nutrition Requirements.
Feasibility
Percentage of meals received by the patients
Time frame: 90 days
No study locations are listed for this record.
Plan to share: No — Data is owned by tribes.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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