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Heart FailureNCT06540118

Food Is Medicine for Patients With Heart Failure

A study testing 15 Medically Tailored Meals (MTM) per week and 14 Medically Tailored Meals (MTM) per week in people with Heart Failure and Heart Failure，Congestive, run by University of California, San Diego at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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." Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
15 Medically Tailored Meals (MTM) per week and 14 Medically Tailored Meals (MTM) per week
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
2 sitesUnited States
Study dates
17 Oct 2024to 28 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of California San Diego

    La Jolla, California, 92093

  • Stanford University

    Stanford, California, 94305

Other trials in United States

About this study

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."

Read the 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).

Being tested
15 Medically Tailored Meals (MTM) per week, 14 Medically Tailored Meals (MTM) per week
Medical subject headings
Heart Failure, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 15 Medically Tailored Meals (MTM) per weekOther

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

  • 14 Medically Tailored Meals (MTM) per weekOther

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

Study groups in NCT06540118
Study groupRoleWhat they receive
15 Medically Tailored Meals (MTM) + snacksExperimentalParticipants will receive 15 medically tailored meals (MTM) per week, plus snacks, for 12 weeks.
Receives: Other: 15 Medically Tailored Meals (MTM) per week
14 Medically Tailored Meals (MTM)ExperimentalParticipants will receive 14 medically tailored meals (MTM) per week for 12 weeks.
Receives: Other: 14 Medically Tailored Meals (MTM) per week

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline and Week 12

Secondary outcomes (9)

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

    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".

    Measured: Week 4 and Week 12

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

    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.

    Measured: Baseline and Weeks 4, 6, 8, and 12

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

    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.

    Measured: Baseline, Week 12, and Week 24

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

    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.

    Measured: Baseline, Week 12, Week 24

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

    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.

    Measured: Baseline, Week 12, Week 24

  6. Change in mean blood pressure

    Mean blood pressure will be calculated based on 3 consecutive readings in the research clinic during each in-person study visit.

    Measured: Baseline and Week 12

  7. Change in blood lipid levels

    Measured: Baseline and Week 12

  8. Change in Hemoglobin A1C (HbA1C) levels

    Measured: Baseline and Week 12

  9. Change in weight

    Weight will be measured by study personnel at each in-person study visit.

    Measured: Baseline and Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start17 Oct 2024
  3. Primary completion28 Jul 2025
  4. Study completion28 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06540118
Sponsor's protocol ID
24RPGFIM1198191
Status last verified
Jan 2026
First submitted
24 Jul 2024
Last updated
26 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing 15 Medically Tailored Meals (MTM) per week and 14 Medically Tailored Meals (MTM) per week in people with Heart Failure and Heart Failure，Congestive, run by University of California, San Diego at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in diet quality at Week 12, as determined by the Healthy Eating Index (HEI) (time frame: Baseline and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06540118.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.

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Food Is Medicine for Patients With Heart Failure | AzTrials