Traditional Navajo Foods for Heart Failure

(Mutton-HF Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Hospice, Acute rehab, Skilled nursing

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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 30 days (14 meals weekly).

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Medically Tailored Meal Program with Traditional Navajo Foods for heart failure?

The research highlights that traditional Navajo foods are infrequently consumed, and there is a need to improve the intake of essential nutrients in the Navajo diet. Programs like the Navajo Fruit and Vegetable Prescription Program have shown positive impacts on health outcomes by increasing access to healthy traditional foods, suggesting that a similar approach could benefit heart failure patients by improving their overall diet quality. ^{1 2 3 4 5}

How does the Medically Tailored Meal Program with Traditional Navajo Foods differ from other treatments for heart failure?

This treatment is unique because it incorporates traditional Navajo foods into a medically tailored meal program, focusing on culturally relevant dietary changes to manage heart failure, unlike standard treatments that may not consider cultural dietary preferences. ^{1 2 3 5 6}

Research Team

Lauren Eberly, MD, MPH

Principal Investigator

Indian Health Service (IHS)

Eligibility Criteria

This trial is for adults over 18 with heart failure who've seen a doctor or been hospitalized in the last year. They must live within 50 miles of the Gallup Service Unit and not be in hospice care or living in acute rehab/skilled nursing facilities.

Inclusion Criteria

Clinical encounter in the last 12 months

Primary care physician at the two IHS sites

I have been hospitalized for any reason in the past year.

Exclusion Criteria

Living in acute rehabilitation or skilled nursing facility

Living outside the Gallup Service Unit (outside 50-mile catchment area)

I am not currently receiving hospice care.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored meals incorporating traditional Navajo foods, 14 meals weekly for 30 days

4 weeks

Weekly meal delivery

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveys and laboratory evaluations

4 weeks

2 visits (in-person)

Extension

Optional continuation of monitoring for long-term outcomes such as hospitalizations and ER visits

90 days

Treatment Details

Interventions

• Medically Tailored Meal Program with Traditional Navajo Foods

Trial Overview The study tests if special meals that follow DASH/SRD guidelines and include traditional Navajo foods can help people with heart failure. Participants will get these home-delivered meals for a month, while others will continue their usual diet.

Participant Groups

Group I: Meal delivery program Experimental Treatment 1 Intervention

Patients will receive 2 meals daily (14 meals weekly) of medically-tailored meals incorporating traditional Navajo foods, followed by a cooking class at the end of the meal program (meals provided for 4 weeks)

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Indian Health Service

Collaborator

Trials

4

Recruited

3,100+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Indian Health Service (IHS)

Collaborator

Trials

6

Recruited

3,300+

References

1. United States pubmed.ncbi.nlm.nih.gov

Contemporary diet and body weight of Navajo women receiving food assistance: an ethnographic and nutritional investigation. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Dietary intake and development of a quantitative FFQ for a nutritional intervention to reduce the risk of chronic disease in the Navajo Nation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Intake of nutrients and food sources of nutrients among the Navajo: findings from the Navajo Health and Nutrition Survey. [2018]

4. England pubmed.ncbi.nlm.nih.gov

Cooking for Health: a healthy food budgeting, purchasing, and cooking skills randomized controlled trial to improve diet among American Indians with type 2 diabetes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Impact of a Fruit and Vegetable Prescription Program on Health Outcomes and Behaviors in Young Navajo Children. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Nutritional composition of commonly consumed traditional Apache foods in Arizona. [2015]