CSP #2025 - Geriatric OUt-of-hospital Randomized MEal Trial in Heart Failure: Veterans Affairs (GOURMET-VA) (GOURMET-VA)

August 11, 2026 updated by: VA Office of Research and Development
The purpose of this multi-center clinical trial is to study the efficacy and safety of providing nutritional support added to the study-defined standard of care which consists of standardized dietary education and a single dietary counseling session shortly after discharge, versus study-defined standard of care alone.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • 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 Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-1927
        • Recruiting
        • Birmingham VA Medical Center, Birmingham, AL
        • Contact:
    • California
      • Long Beach, California, United States, 90822
        • Recruiting
        • VA Long Beach Healthcare System, Long Beach, CA
        • Contact:
      • Palo Alto, California, United States, 94304-1207
        • Recruiting
        • VA Palo Alto Health Care System, Palo Alto, CA
        • Contact:
      • West Los Angeles, California, United States, 90073-1003
        • Recruiting
        • VA Greater Los Angeles Healthcare System, West Los Angeles, CA
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20422-0001
        • Recruiting
        • Washington DC VA Medical Center, Washington, DC
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32608-1135
        • Recruiting
        • North Florida/South Georgia Veterans Health System, Gainesville, FL
        • Contact:
    • Georgia
      • Decatur, Georgia, United States, 30033-4004
        • Recruiting
        • Atlanta VA Medical and Rehab Center, Decatur, GA
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48105-2303
        • Recruiting
        • VA Ann Arbor Healthcare System, Ann Arbor, MI
        • Contact:
        • Study Chair:
          • Scott L. Hummel, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55417-2309
        • Recruiting
        • Minneapolis VA Health Care System, Minneapolis, MN
        • Contact:
    • New York
      • New York, New York, United States, 10010-5011
        • Recruiting
        • VA NY Harbor Healthcare System, New York, NY
        • Contact:
    • Oregon
      • Portland, Oregon, United States, 97207-2964
        • Recruiting
        • VA Portland Health Care System, Portland, OR
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75216-7167
        • Recruiting
        • VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX
        • Contact:
      • Houston, Texas, United States, 77030-4211
        • Recruiting
        • Michael E. DeBakey VA Medical Center, Houston, TX
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84148-0001
        • Recruiting
        • VA Salt Lake City Health Care System, Salt Lake City, UT
        • Contact:
    • Virginia
      • Richmond, Virginia, United States, 23249-0001
        • Recruiting
        • Richmond VA Medical Center, Richmond, VA
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53705-2254
        • Recruiting
        • William S. Middleton Memorial Veterans Hospital, Madison, WI
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Study-defined standard of care
Other: Study -defined standard of care
Study-defined standard of care consists of standardized dietary education and a single dietary counseling session shortly after discharge
Experimental: Home-delivered meals and short-term dietary counseling
Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus three additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.
Other: Home-delivered meals and short-term dietary counseling
Home-delivered, low-sodium, nutritionally robust meals for 6 weeks plus three additional remotely delivered dietary counseling sessions in addition to the study-defined standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of pairwise comparisons with wins of Clinical Benefit, evaluated a hierarchical composite of days alive out of hospital and =5-point difference in the change of health-related quality of life
Time Frame: within 6 weeks post-index hospital discharge

All patients randomized to intervention are compared to all patients randomized to placebo within strata. In each comparison with any two patients, a patient will win by achieving a superior clinical outcome which is determined by sequentially assessing the following criteria with evaluation halted when distinct advantage for either patient is shown:

  1. Days alive out of hospital at 6 weeks: shorter days is worse; tied, if same days alive out of hospital. Move to evaluation of 2 if tied.
  2. Change of The Kansas City Cardiomyopathy Questionnaire Clinical Summary (KCCQ-CS) at 6 weeks from baseline: the threshold for the difference is greater or equal to 5 for a win; tied, if difference is less than 5.

The KCCQ-CS ranges from 0 to 100, where a higher score reflects a better outcome.
within 6 weeks post-index hospital discharge

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DAOH at 6 months post-discharge
Time Frame: 6 months post-discharge
This outcome was selected to determine whether home-delivered meals, augmented by enhanced dietary counseling, during a high-risk period have durable effects on readmission burden.
6 months post-discharge

Collaborators and Investigators

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

Sponsor

VA Office of Research and Development

Investigators

  • Study Chair: Scott L. Hummel, MD, VA Ann Arbor Healthcare System, Ann Arbor, MI

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)

July 24, 2026

Primary Completion (Estimated)

June 29, 2029

Study Completion (Estimated)

October 31, 2030

Study Registration Dates

First Submitted

August 9, 2023

First Submitted That Met QC Criteria

August 9, 2023

First Posted (Actual)

August 18, 2023

Study Record Updates

Last Update Posted (Actual)

August 14, 2026

Last Update Submitted That Met QC Criteria

August 11, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Digital data underlying primary scientific publications from this study will be held as part of a data sharing resource maintained by the Cooperative Studies Program (VA-CSP). These data may be available to the public and other VA and non-VA researchers under certain conditions and consistent with the informed consent and CSP policy which prioritize protecting subjects' privacy and confidentiality to the fullest extent possible

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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