Food Is Medicine for Patients With Heart Failure

NCT06540118 | Completed

• 1 other identifier: 24RPGFIM1198191
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. The primary outcome of the study is the quality of the diet being consumed in week 12 of the study, as determined by the "Healthy Eating Index."

Conditions

Heart Failure; Heart Failure，Congestive; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)

  HEI will be used to determine diet quality based on dietary recall data collected via Nutrition Data System for Research (NDSR) software. HEI scores range from 0 to 100. An ideal overall HEI score of 100 reflects that the set of foods aligns with key dietary recommendations and dietary patterns published in the Dietary Guidelines for Americans.

  Baseline and Week 12

Secondary Outcomes (9)

• Participant satisfaction with delivery of medically tailored meals for individuals with heart failure

  Week 4 and Week 12

• Dietary adherence to meal assignment using daily food diaries and 24-hour dietary recalls

  Baseline and Weeks 4, 6, 8, and 12

• Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS)

  Baseline, Week 12, and Week 24

• Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES)

  Baseline, Week 12, Week 24

• Change in reported food security as assessed by the Short Form of the U.S. Adult Food Security Survey Module

  Baseline, Week 12, Week 24

Study Arms (2)

15 Medically Tailored Meals (MTM) + snacks

EXPERIMENTAL

Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.

Other: 15 Medically Tailored Meals (MTM) per week

14 Medically Tailored Meals (MTM)

EXPERIMENTAL

Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.

Other: 14 Medically Tailored Meals (MTM) per week

Interventions

14 Medically Tailored Meals (MTM) per week OTHER

14 heart-healthy medically tailored meals delivered to participants each week. Meals include lunch and dinner to consume Monday-Sunday.

14 Medically Tailored Meals (MTM)

15 Medically Tailored Meals (MTM) per week OTHER

15 heart-healthy medically tailored meals delivered to participants each week. Meals include breakfast, lunch, dinner, and snack to consume Monday-Friday.

15 Medically Tailored Meals (MTM) + snacks

Eligibility Criteria

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

You may qualify if:

• Willingness to comply with all study procedures and availability for the duration of the study
• Living in San Diego or the Bay Area of California
• Reported congestive heart failure (CHF) diagnosis
• Current diet can be improved
• Willing to eat all meals provided by the study

You may not qualify if:

• Diagnosed with end-stage heart failure
• Diagnosed with diabetes (type 1 or uncontrolled type 2)
• Currently taking insulin and/or meglitinides medications
• Currently taking Glucagon-Like Peptide-1 (GLP-1) Agonists medications and not stable on a maximum maintenance dose for a minimum of 1 month
• Hemoglobin A1c (HbA1c) results \>8 %
• Life expectancy of \<1 year
• Pregnancy or lactation
• Known severe allergic reactions and/or food intolerances that would interfere with the ability to eat study-provided meals, including foods that are prepared in a facility that works with the allergen
• Current smoker or tobacco use within the past year
• Planning to leave San Diego or the Bay Area during the course of the study
• Unable to communicate reasonably well either orally or through written material in English
• Those who, in the opinion of the investigators, cannot reliably complete the study protocol

Sponsors & Collaborators

• University of California, San Diego: lead
• Stanford University: collaborator

Study Sites (2)

University of California San Diego

La Jolla, California, 92093, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Heart Failure; Heart Diseases

Interventions

myotubularin

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

• Cheryl Anderson, PhD, MPH, MS

  UC San Diego

  PRINCIPAL INVESTIGATOR

• Christopher Gardner, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: By the nature of the dietary intervention, it is impossible to blind participants to study arm assignment. However, research staff collecting outcome data, apart from dietary adherence data, will remain blinded to participants' assigned study arm throughout data collection. Additionally, the statistician(s) analyzing data for efficacy of the intervention will use a dataset with study arm masked in order to remain blinded to the assigned intervention for the final analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Dean

Study Record Dates

• First Submitted: July 24, 2024
• First Posted: August 6, 2024
• Study Start: October 17, 2024
• Primary Completion: July 28, 2025
• Study Completion: July 28, 2025
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)