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Life sciences · Phase 3 Trial
ClinicalTrials.gov · November 6, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 3 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
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Registry record from ClinicalTrials.gov (NCT07922863). This is a study registration, not published results. Lead sponsor: University of Pennsylvania. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Heart Failure. Interventions: OTHER: Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and Recipes. Primary outcome measures: Feasibility , 90 days. Brief summary: 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.