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Meals on wheels for heart health: VA tests Low-Sodium diet to keep vets out of hospital

NCT ID NCT05996328

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 5 times

Summary

This study tests whether providing home-delivered low-sodium meals and short-term dietary counseling helps older veterans with heart failure recover better after a hospital stay. About 1,400 veterans aged 60 and older will be randomly assigned to receive either the meals plus counseling or standard dietary education alone. The main goal is to see if the intervention increases days alive and out of the hospital and improves quality of life.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Home-delivered low-sodium meals and dietary counseling
What this could lead to
If it works, this could provide a simple, practical way to improve recovery and reduce hospital readmissions for older heart failure patients.
What could go wrong
This is a large trial but still early in testing a behavioral intervention. Results may not apply to all heart failure patients, and dietary changes can be hard to maintain long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Veterans enrolled in a VHA facility * Hospitalized ( 24 hours) with new HF or worsening chronic HF * Dentition, swallowing function, etc. sufficient to safely consume food and liquid of standard composition and texture (i.e., no pureed food, no thickened liquids needed) * Able and willing to provide informed consent and perform study activities Exclusion Criteria: * Food allergies or intolerances that cannot be accommodated by study diet * On dialysis or estimated glomerular filtration rate \<30 at randomization * Serum potassium (non-hemolyzed) \>6.0 mmol/L during index hospitalization * Heart transplant or active transplant listing * Left ventricular assist device present or anticipated \<6 months * Malignancy or other non-cardiac condition limiting life expectancy to \<12 months * Planned admission to a skilled nursing facility following hospital discharge, or discharge to other location/situation where Veteran does not have control over diet * Lack of space to store food for a week or equipment to prepare food * Severe cognitive impairment (SLUMS score \<20, or \<19 if less than high school education completed) * Severe food insecurity (5 or 6 points on the USDA 6-item Food Insecurity Screen) * Body mass index \>50 kg/m2 * Other medical, psychiatric, behavioral, or logistical condition which, in the clinical judgement of the site investigator, makes it unlikely the patient can effectively participate in or complete the study

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    16 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Atlanta VA Medical and Rehab Center, Decatur, GA

    RECRUITING

    Decatur, Georgia, 30033-4004, United States

  • Birmingham VA Medical Center, Birmingham, AL

    RECRUITING

    Birmingham, Alabama, 35233-1927, United States

  • Michael E. DeBakey VA Medical Center, Houston, TX

    RECRUITING

    Houston, Texas, 77030-4211, United States

  • Minneapolis VA Health Care System, Minneapolis, MN

    RECRUITING

    Minneapolis, Minnesota, 55417-2309, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    RECRUITING

    Gainesville, Florida, 32608-1135, United States

  • Richmond VA Medical Center, Richmond, VA

    RECRUITING

    Richmond, Virginia, 23249-0001, United States

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    RECRUITING

    Ann Arbor, Michigan, 48105-2303, United States

  • VA Greater Los Angeles Healthcare System, West Los Angeles, CA

    RECRUITING

    West Los Angeles, California, 90073-1003, United States

  • VA Long Beach Healthcare System, Long Beach, CA

    RECRUITING

    Long Beach, California, 90822, United States

  • VA NY Harbor Healthcare System, New York, NY

    RECRUITING

    New York, New York, 10010-5011, United States

  • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

    RECRUITING

    Dallas, Texas, 75216-7167, United States

  • VA Palo Alto Health Care System, Palo Alto, CA

    RECRUITING

    Palo Alto, California, 94304-1207, United States

  • VA Portland Health Care System, Portland, OR

    RECRUITING

    Portland, Oregon, 97207-2964, United States

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    RECRUITING

    Salt Lake City, Utah, 84148-0001, United States

  • Washington DC VA Medical Center, Washington, DC

    RECRUITING

    Washington D.C., District of Columbia, 20422-0001, United States

  • William S. Middleton Memorial Veterans Hospital, Madison, WI

    RECRUITING

    Madison, Wisconsin, 53705-2254, United States

More trials for these conditions

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