Food supplementation for patients with heart failure
Examining the Impact of Medically Tailored Meals vs Produce Supplements Delivered Conditionally vs Not on Health Engagement and Health Outcomes Among Patients With Heart Failure
NA · University of Texas Southwestern Medical Center · NCT06115369
This study tests if providing healthy meals or fresh produce to people recently hospitalized for heart failure can help them feel better compared to those who just get money for food.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center (other) |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06115369 on ClinicalTrials.gov |
What this trial studies
This study investigates whether providing healthy food, specifically medically-tailored meals or fresh produce boxes, can improve outcomes for patients recently hospitalized for heart failure. It employs a 2x2 factorial randomized control trial design to assess the effectiveness of these food interventions compared to a control group receiving monetary supplements. Additionally, the study examines if conditional food delivery, based on patient engagement with follow-up visits and medication adherence, yields better health outcomes than unconditional delivery. The aim is to address food insecurity and promote healthier eating habits among this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years who have recently been hospitalized for acute decompensated heart failure.
Not a fit: Patients with severe comorbidities, those requiring specialized care facilities, or individuals unable to receive food shipments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved health outcomes and reduced hospital readmissions for patients with heart failure.
How similar studies have performed: Previous studies have indicated that food supplementation can positively impact health outcomes, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults over 18 years age with a recent hospitalization for acute decompensated HF Exclusion Criteria: * Baseline hyperkalemia with K \> 5.5 mEq/L or history of hyperkalemia requiring hospitalization for urgent treatment, * Receipt of a heart transplant or left ventricular assist device, * Use of inotropic therapy at hospital discharge, * Discharge to a skilled nursing facility or long-term care facility that provides prepared patient meals, comorbidity with expected survival \< 6 months, and * Inability to provide an address to receive produce shipments (including unhoused individuals or individuals residing in temporary housing shelters). * Pregnancy
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Ambarish Pandey — UT Southwestern
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Heart Failure, Produce, Medically Tailored Meals, Patient Participation