Food Is Medicine for Patients With Heart Failure

January 22, 2026 updated by: Cheryl A. Anderson, MPH, PhD, University of California, San Diego
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."

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study will look at the effects of providing medically tailored meals (MTMs) to people with heart disease for twelve weeks. Sixty adults with heart failure will be recruited from the San Diego and San Francisco Bay Area of California. They will be randomly assigned to two groups: 1) a group that receives 15 "medically tailored meals" plus snacks each week for 12 weeks, 2) a group that receives 14 "medically tailored meals" each week for 12 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". Many other secondary outcomes will be assessed including both qualitative factors (e.g., satisfaction, preferences, adherence) and quantitative clinically measures (e.g., blood cholesterol, blood pressure, weight).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 15 Medically Tailored Meals (MTM) + snacks
Participants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.
Other: 15 Medically Tailored Meals (MTM) per week
15 heart-healthy medically tailored meals delivered to participants each week. Meals include breakfast, lunch, dinner, and snack to consume Monday-Friday.
Experimental: 14 Medically Tailored Meals (MTM)
Participants will receive 14 medically tailored meals (MTM) per week for 12 weeks.
Other: 14 Medically Tailored Meals (MTM) per week
14 heart-healthy medically tailored meals delivered to participants each week. Meals include lunch and dinner to consume Monday-Sunday.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI)
Time Frame: Baseline and Week 12
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant satisfaction with delivery of medically tailored meals for individuals with heart failure
Time Frame: Week 4 and Week 12
Participant satisfaction will be assessed using a study-specific self-administered questionnaire that uses a 5-point Likert scale. Participants will be asked to rate their experiences with multiple aspects of the provided study meals (including taste, variety, quality, cultural appropriateness, amount of food, visual appeal, and delivery) from "poor" to "excellent".
Week 4 and Week 12
Dietary adherence to meal assignment using daily food diaries and 24-hour dietary recalls
Time Frame: Baseline and Weeks 4, 6, 8, and 12
Participants' qualitative daily food diaries and quantitative dietary analyses based on interviewer-assisted dietary recalls using Nutrition Data System for Research (NDSR) software will be combined to determine the proportion of provided meals that participants consumed.
Baseline and Weeks 4, 6, 8, and 12
Change in reported access to healthy foods as assessed by the Food Consumption Score (FCS)
Time Frame: Baseline, Week 12, and Week 24
The Food Consumption Score aggregates household-level data on the diversity and frequency of food groups consumed over the previous seven days, which is then weighted according to the relative nutritional value of the consumed food groups. The Food Consumption Score scale ranges from 0-112, with higher scores indicating better food consumption status.
Baseline, Week 12, and Week 24
Change in reported food security as assessed by the Food Insecurity Experience Scale (FIES)
Time Frame: Baseline, Week 12, Week 24
The Food Insecurity Experience Scale (FIES) consists of eight questions regarding people's access to adequate food during the last 30 days. The raw score scale ranges from 0-8, with a higher score indicating more food insecurity experiences. Scale items are analyzed together as a scale, not be reported in terms of percent of positive responses to individual questions. The classifications of food insecurity severity based on responses may be described as mild, moderate, and severe food insecurity.
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
Time Frame: Baseline, Week 12, Week 24
The 6-item survey collects information about whether participants had access to and were able to afford enough food in the last 30 days. The survey allows for stratification of participants into one of four food security categories based on their responses - high food security, marginal food security, low food security, and very low food security. The raw score scale ranges from 0 - 6, with a higher score indicating lower food security.
Baseline, Week 12, Week 24
Change in mean blood pressure
Time Frame: Baseline and Week 12
Mean blood pressure will be calculated based on 3 consecutive readings in the research clinic during each in-person study visit.
Baseline and Week 12
Change in blood lipid levels
Time Frame: Baseline and Week 12
Baseline and Week 12
Change in Hemoglobin A1C (HbA1C) levels
Time Frame: Baseline and Week 12
Baseline and Week 12
Change in weight
Time Frame: Baseline and Week 12
Weight will be measured by study personnel at each in-person study visit.
Baseline and Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Diego

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Stanford University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cheryl Anderson, PhD, MPH, MS, UC San Diego
  • Principal Investigator: Christopher Gardner, PhD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 1, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 6, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 26, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24RPGFIM1198191

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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