Mutton Heart Failure Food is Medicine Pilot (Mutton-HF)

Medically Utilized Tailored Traditional Meals to Optimize Nutrition in Heart Failure Pilot 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).

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Other: Medically Tailored Meal Program with Traditional Navajo Foods

Detailed Description

The American Indian and Alaska Native population has experienced significant cardiovascular health disparities compared with other racial and ethnic groups in the U.S. [1] Heart failure, in particular, causes significant morbidity and mortality in Navajo Nation. For many Navajo patients, similar to other American Indian populations, food insecurity is a major driver of health disparities. [2][3] In fact, qualitative data from our heart failure patient advisory committee have found that 89% of patients with heart failure believe nutrition insecurity is a major barrier to optimal health. Dietary factors are believed to be an important cause of hospitalizations in patients with heart failure and cardiovascular outcomes. There is increasing evidence that direct dietary support, such as produce prescription or provision of medically tailored meals may improve cardiovascular outcomes and disease-specific quality of life. Furthermore, there has been an increased focus in Indigenous communities to reclaim traditional indigenous foods to improve health. However, more evidence of the benefit of traditional Indigenous foods for cardiovascular health is needed.

We, therefore, in discussion with community members and tribal partners at two Indian Health Service (IHS) sites in Navajo Nation, will implement and evaluate the effectiveness of a medically and Native-sourced culturally tailored meal delivery program to improve outcomes in heart failure in rural Navajo Nation. This study will include two phases, with a phase I pilot feasibility study, followed by phase II-a comparativeness effectiveness randomized controlled trial to compare the implementation of our medically and culturally tailored meal delivery program compared to usual care. For phase I, we will conduct a one-arm pilot trial of the MUTTON-HF intervention to determine 1) feasibility of the intervention and outcome assessment and 2) acceptability of the intervention and 3) fidelity of the intervention. We will enroll 20 patients to receive medically tailored meals (14 meals weekly) for 30 days to inform the phase II comparativeness effectiveness trial.

Phase I outcomes will include implementation outcomes such as feasibility and acceptability of the intervention including the various delivery mechanisms and meals as measured by quantitative (i.e. % meals delivered and % meals received by patient) and qualitative methods, of outcome assessment including surveys and laboratory evaluation (% with completed outcome assessment), and fidelity of intervention as measured by quantitative (% meals consumed). We will additionally measure feasibility and acceptability of supporting local food systems by measuring % meals with locally sourced produce and meat, and % sourced from Navajo farmers and ranchers specifically. We will also explore implementation outcomes with community partners including farmers, growers, ranchers, food pantry.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Tohatchi, New Mexico, United States, 87325
      • Tohatchi Health Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Meal delivery program; 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; Patients will receive medically-tailored meals incorporating local traditional Navajo foods

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
ER visits or hospitalizations	All cause	180 days
Hospitalization or Emergency Department Visit	Hospitalization or Visit to Emergency Department (All-cause)	90 Days
Kansas City Cardiomyopathy Questionnaire (KCCQ-12)	This is a validated score for evaluating quality of life and symptom measures in heart failure patients. Score ranges from 0-100, with 0 meaning very poor quality of life/symptoms and health status, 100 meaning excellent quality of life/symptom burden/health status.	Baseline, 30 Days
USDA Adult Food Security: Six Item short Form survey	The six-item short form of the survey module and the associated Six-Item Food Security Scale were developed by researchers at the National Center for Health Statistics in collaboration with Abt Associates Inc.	Baseline, 30 Days
Laboratory Biomarker Data	Albumin, prealbumin, creatinine, NT-proBNP, HbA1c, Total cholesterol, LDL-C, HDL-C, Triglycerides, CRP	Baseline, 30 Days
Weight/Body Mass Index	weight and BMI	Baseline, 30 Days
Cultural Connectedness Scale-California	The Cultural Connectedness Scale (CCS) was developed in Canada by First Nations/Indigenous persons for First Nations/Indigenous persons. The 29-item CCS consists of three sub-scales: identity, traditions, and spirituality. This scale ranges from 0-40, with 40 indicating higher levels of cultural connectiveness.	Baseline, 30 Days
Emergency Room Visits	ER visits: All cause	90 Days
ER visit for Heart Failure	ER visit for volume overload or HF symptoms	90 Days
Heart Failure Hospitalizations	Hospitalizations for heart failure specifically	90 days
Feasibility: Percentage of meals delivered successfully to the Gallup Food Pantry	Proportions of meals that were successfully delivered to the Gallup Food Pantry by our community partner and Native-run Kitchen	30 days
Feasibility of Intervention: Delivery/Pick-Up	We will survey patients post-intervention with question to assess feasibility: "I would rate getting the meals (either picking up or delivery): Very easy, Somewhat easy, Neither easy nor difficult, Somewhat difficult, Very difficult.	30 days
Acceptability of the Intervention (AIM) Measure	We will evaluate acceptability of the intervention among the patients through quantitative assessment using the validated acceptability of the intervention (AIM) measure	30 days
Net Promoter Score	We will also assess acceptability of the intervention through assess the Net Promoter Score (i.e. how likely is it that you would recommend this program to a community member?"), which is a scale 1 (highly unlikely) to 10 (highly likely).	30 days
Fidelity: Consumption	Patients will also rate meals from 1-5 and the amount of the meal they consumed (none [or only a few bites], less than half, about half, most, or all)	30 days
Acceptability: Taste	Patients will also be surveyed post-intervention the following questions to assess acceptability: How would you rate the meals overall, in terms of taste (excellent, good, average, below average, bad?"	30 days
Qualitative measures of feasibility and acceptability	We will also perform semi-structured interviews of patients to assess feasibility and acceptability through qualitative methods. Semi-structured interviews will be guided by the Consolidated Framework for Implementation Research (CFIR), and we will explore multiple constructs within each CFIR domain that are hypothesized by the study team and based on existing literature to be relevant to acceptability and feasibility of the program	30 days
Feasibility of Supporting Local Food Systems	We will assess feasibility among our community partners by assessing the validated feasibility of the intervention measure (FIM) among our food pantry partners.	30 days
Feasibility: Local Food Sourcing	We will also assess the % of meals that include locally sourced ingredients, % of meals sourced by Native suppliers/farmers (produce), % of meals soured by Native ranchers (meat)	30 days
Feasibility of Outcome Assessment	We will determine the proportion of patients that completes baseline, as well as post-implementation survey and laboratory data. We will consider ≥ 80% completion rates as a success.	30 days
Fidelity of Intervention	We will assess fidelity of the intervention by evaluating: We will have patients' complete food diaries for 3 days during week 1 and week 4 of the intervention.; % of meals consumed: Patients will also fill out meal cards weekly with percent consumed (None [or a few bites], ¼, ½, ¾, all [or nearly all]).§ We will stratify meals consumed by whether the meal used traditional Diné ingredients or not.; We will additionally survey participants post-intervention the following:In terms of leftovers, how much of the meals were not eaten and had to be thrown out? (all, most, about half, less than half, none).We will consider ≥ 70% meals consumed (at least ½ or more of the meal) or ≥70% indicating they ate "most" or more of the meals as a success	30 days
Adoption of Intervention	We will survey participants post-intervention the following using a Likert scale: How likely is it that this program will change your diet to be healthier moving forward? (very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely); How likely is it that you will add any of the meals or recipes from this program to your on-going diet in the future? (very likely, somewhat likely, neither likely nor unlikely, somewhat unlikely, very unlikely)	30 days
Diet Quality	We will assess diet quality using the 10-item DSQ [10] with an addition question to assess traditional Dine food intake (During the past month, how often did you eat traditional Diné foods (such as blue corn mush, steamed, roasted or dried corn, sumac berries, mutton, local varieties of squash or beans) at baseline and at the end of the intervention.	Baseline and 30 days
Physical Activity	We will evaluate how much physical activity/exercise patients are participating in weekly at baseline, and at 30 days by asking patients to estimate the number of minutes weekly that they are participating in formal exercise or physical activity.	Baseline and 30 days
General Health Status	We will evaluate patients' general health status using a single general health status question (would you say that in general your health is excellent, very good, good, fair, or poor) at baseline and post-intervention	Baseline and 30 days
KCCW12-PL Physical Limitation Score	Subsection of KCCQ-12 Summary	30 days
KCCQ12-PL Physical Limitation Score	Subsection of KCCQ12 looking at physical limitation	30 days
KCCQ12-SF Symptom Frequency Score	Subsection of KCCQ-12 looking at frequency of symptoms	30 Days
KCCQ-QL	Subsection of KCCQ-12 that looks at quality of life	30 Days
KCCQ-SL Social Limitation Score	Subsection of KCCQ-12 looking at social limitation	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication and Medical Therapy Adherence	Additional exploratory outcomes will prescription rates for all medication as well as guideline-directed medical therapy specifically (for heart failure with reduced ejection fraction this would include ACEi/ARB/ARNI, Beta-blocker, SGLT2 inhibitors, and mineralocorticoid receptor antagonist; for HFpEF this would include SGLT2 inhibitors).	30 days

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Brigham and Women's Hospital; American Heart Association; Indian Health Service (IHS)
• Investigators: Principal Investigator: Lauren Eberly, MD, MPH, Indian Health Service (IHS)

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2024
• Primary Completion (Actual): February 7, 2025
• Study Completion (Actual): May 1, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 4, 2024
• First Posted (Actual): November 5, 2024

Study Record Updates

• Last Update Posted (Estimated): May 20, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Navajo; Nutrition Security; indigenous; Traditional Foods; food is medicine
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Failure
• Other Study ID Numbers: 10072024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data is tribally owned data and is protected under Navajo Nation Human Research Review Board regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No