Mutton Heart Failure Food is Medicine Pilot

NCT06675331 | Completed DMC

• 1 other identifier: 10072024
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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 30 days (14 meals weekly).

Conditions

Heart Failure

Keywords

indigenous; food is medicine; Traditional Foods; Nutrition Security; Navajo

Outcome Measures

Primary Outcomes (1)

• Feasibility: Percentage of meals successfully received by the patient

  Proportions of meals that were successfully picked up or received by the patient. We have determined that \>70% would count as success/feasibility of the intervention.

  30 days

Secondary Outcomes (30)

• Cultural Connectedness Scale-California

  Baseline, 30 Days

• Kansas City Cardiomyopathy Questionnaire (KCCQ-12)

  Baseline, 30 Days

• USDA Adult Food Security: Six Item short Form survey

  Baseline, 30 Days

• Hospitalization or Emergency Department Visit

  90 Days

• Laboratory Biomarker Data

  Baseline, 30 Days

Other Outcomes (1)

• Medication and Medical Therapy Adherence

  30 days

Study Arms (1)

Meal delivery program

EXPERIMENTAL

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)

Other: Medically Tailored Meal Program with Traditional Navajo Foods

Interventions

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) 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

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

Study Sites (1)

Tohatchi Health Clinic

Tohatchi, New Mexico, 87325, United States

Location

Related Links

• Trial 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 5, 2024
• Study Start: October 7, 2024
• Primary Completion: February 7, 2025
• Study Completion: May 1, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)