MUTTON-HF Pilot Expansion (MUTTON-HF)

November 2, 2026 updated by: University of Pennsylvania

Centering Rural Tribal Communities to Advance Health and Food Sovereignty: Health, Economic, and Ecological Impacts of an Indigenous Culturally and Medically Tailored Meal Program

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with heart failure with a primary care physician at one of the IHS study sites and ER visit or hospitalization within the last 12 months

Exclusion Criteria:

  • On hospice, not living at home, unable to provide consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Culturally and Medically Tailored Meals

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 90 days

Percentage of meals received by the patients
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Collaborators

Rockefeller Foundation
Indian Health Service (IHS)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 16, 2027

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

November 2, 2026

First Submitted That Met QC Criteria

November 2, 2026

First Posted (Actual)

November 6, 2026

Study Record Updates

Last Update Posted (Actual)

November 6, 2026

Last Update Submitted That Met QC Criteria

November 2, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11012026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is owned by tribes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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