Heart FailurePhase 3MUTTON-HFNCT07922863
MUTTON-HF Pilot Expansion
A Phase 3 study testing Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and Recipes in people with Heart Failure, run by University of Pennsylvania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and Recipes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 16 Jan 2027to Jan 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- On hospice, not living at home, unable to provide consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and Recipes
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and RecipesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Culturally and Medically Tailored Meals | Experimental | Culturally and Medically Tailored Meals-receive 14 meals weekly for 12 weeks. Receives: Other: Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and Recipes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility
Percentage of meals received by the patients
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study start16 Jan 2027 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Health Service (IHS), Rockefeller Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07922863
- Sponsor's protocol ID
- 11012026
- Acronym
- MUTTON-HF
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is owned by tribes.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Centering Rural Tribal Communities to Advance Health and Food Sovereignty: Health, Economic, and Ecological Impacts of an Indigenous Culturally and Medically Tailored Meal Program
- ClinicalTrials.gov ID
- NCT07922863
- Acronym / sponsor ID
- MUTTON-HF / 11012026
- Conditions
- Heart Failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Indian Health Service (IHS), Rockefeller Foundation
- Study start
- 16 Jan 2027 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Culturally and Medically Tailored Meals | Experimental | Other: Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and RecipesCulturally and Medically Tailored Meals-receive 14 meals weekly for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- On hospice, not living at home, unable to provide consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and RecipesCulturally 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. | Other | Culturally and Medically Tailored Meals |
Primary outcome
Feasibility
Time frame: 90 days
Percentage of meals received by the patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No. Data is owned by tribes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Culturally and Medically Tailored Meals Incorporating Traditional Indigenous Foods and Recipes in people with Heart Failure, run by University of Pennsylvania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Eberly, MD, MPH (15054592927, leberly89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.