Medically Used Tailored Traditional Food to Optimize Nutrition in Heart Failure

NCT06549699 | Completed DMC

• 1 other identifier: 08072024
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 2

Brief Summary

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 60 days (14 meals weekly).

Conditions

Heart Failure

Keywords

Indigenous; Navajo; Traditional Foods; Nutrition security; food is medicine

Outcome Measures

Primary Outcomes (1)

• Hospitalization or Emergency Department Visit

  Hospitalization or Visit to Emergency Department (All-cause)

  90 days

Secondary Outcomes (25)

• Cultural Connectedness Scale-California

  60 days

• Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  60 days

• Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Quality of Life Subset

  60 days

• Food Security

  60 days

• Biomarker Data

  60 days

Study Arms (2)

Meal delivery program

ACTIVE COMPARATOR

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 60 days).

Other: Medically Tailored Meal Program with Traditional Navajo Foods

Usual Care

PLACEBO COMPARATOR

Patients will receive usual care

Other: Usual Care

Interventions

Usual Care OTHER

Usual care plus healthy recipes provided

Usual Care

Medically Tailored Meal Program with Traditional Navajo Foods OTHER

Patients will receive medically-tailored meals incorporating local traditional Navajo foods

Meal delivery program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>=18 years
• ICD I50\* diagnosis
• Clinical encounter in last 12 months
• Primary care physician at the two IHS sites
• Hospitalization (any-cause) or ER visit within last 12 months

You may not qualify if:

• Hospice care
• Living in acute rehabilitation or skilled nursing facility
• Living outside the Gallup Service Unit (outside 50-mile catchment area)

Sponsors & Collaborators

• American Heart Association: collaborator
• Brigham and Women's Hospital: collaborator
• University of Pennsylvania: lead
• Indian Health Service (IHS): collaborator

Study Sites (2)

Gallup Indian Medical Center

Gallup, New Mexico, 87301, United States

Location

Tohatchi Health Clinic

Tohatchi, New Mexico, 87325, United States

Location

Related Publications (1)

• Eberly LA, George C, Sandman S, Bex D, Jones K, Yazzie A, Gray L, Morgan L, Tennison A, Williams C, Chandra M, Wickre R, Wickre B, Bolas M, Welbel R, Ignace D, Feliciano B, Damon-Mallette D, Lindsey E, Mora P, Merino M, Schisterman EF, Shin SS. MUTTON-HF: Rationale and Design of a Study of an Indigenous Food is Medicine Intervention. Circ Heart Fail. 2026 Mar 2:e014013. doi: 10.1161/CIRCHEARTFAILURE.125.014013. Online ahead of print.

  PMID: 41766529 DERIVED

Related Links

• Study Website

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Lauren Eberly, MD, MPH

  Indian Health Service (IHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 12, 2024
• Study Start: May 12, 2025
• Primary Completion: November 11, 2025
• Study Completion: December 1, 2025
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)