Healthy Food Provision for Heart Failure

(FOOD-HF Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Disqualifiers: Hyperkalemia, Heart transplant, Inotropic therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The current study proposes to investigate if the provision of healthy food can improve outcomes following discharge after HF hospitalization. To investigate this in an efficient and pragmatic manner, a 2x2 factorial randomized control trial design will be utilized to simultaneously investigate two separate, important food-related questions: * Does the provision of 90 days of either medically-tailored meals or fresh produce boxes improve 90-day patient outcomes among those with HF relative to a control group not receiving food supplements and instead receiving an equivalent monetary supplement? * Does receipt of the supplement in a conditional fashion, where the supplement is continued only if the participant attends follow-up visits or fills prescribed medications at the pharmacy, have more impact than providing unconditional supplementation?

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on providing healthy food to improve heart failure outcomes.

What data supports the effectiveness of this treatment for heart failure?

Research suggests that providing medically tailored meals and focusing on overall nutritional status, such as using fresh produce and reducing sodium intake, can improve health outcomes for heart failure patients. These approaches align with trends in nutrition guidelines and have shown promise in studies like the GOURMET study. ^{1 2 3 4 5}

Is it safe to use healthy food options for heart failure patients?

Research suggests that using fresh products and avoiding processed foods is generally safe and can lead to a healthier diet for heart failure patients. Medically tailored meals and nutritional therapy have been studied and are considered safe, especially for those who are food-insecure, as they can improve dietary outcomes without reported safety concerns. ^{1 2 3 5 6}

How does the 'Healthy Food Provision for Heart Failure' treatment differ from other treatments for heart failure?

This treatment is unique because it focuses on providing fresh produce and medically tailored meals to improve heart health, rather than relying solely on medication. It emphasizes a holistic approach by addressing overall nutritional status and using fresh, unprocessed foods to reduce sodium intake, which aligns with current trends in nutrition guidelines for heart failure management. ^{2 5 6 7 8}

Research Team

Ambarish Pandey, MD

Principal Investigator

UT Southwestern

Eligibility Criteria

This trial is for adults over 18 who were recently hospitalized for heart failure. They must not have severe potassium issues, a heart transplant, or be on certain heart medications at discharge. People in long-term care facilities, those with short life expectancies, without a stable address, or pregnant women can't join.

Exclusion Criteria

You have had a heart transplant or have a left ventricular assist device.

Inability to provide an address to receive produce shipments (including unhoused individuals or individuals residing in temporary housing shelters)

Pregnancy

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either medically tailored meals or fresh produce boxes for 90 days

12 weeks

Weekly deliveries

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Conditional Engagement

Food supplements are provided conditionally based on attending follow-up visits and filling prescriptions

12 weeks

Treatment Details

Interventions

• Control
• Fresh Produce
• Medically Tailored Meals

Trial Overview The study tests if providing medically tailored meals or fresh produce boxes for 90 days after hospital discharge helps patients with heart failure more than just giving financial support. It also looks at whether tying the food supplement to attending follow-up visits or medication adherence makes a difference.

Participant Groups

Group I: Medically Tailored Meals Experimental Treatment 2 Interventions

Season Health, our food intervention partner, will provide participants with weekly deliveries of twice daily prepared medically tailored meals (MTM). Study participants will be able to select choices for these from a large selection of health options. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.

Group II: Fresh Produce Experimental Treatment 2 Interventions

We will work with Season Health, our food intervention partner to provide participants with weekly deliveries of a large box full of fresh produce and pantry staples. The study participants will be able to select choices for these from a large selection of health options. The study team will work with Season Health to create customizations to allow for the incorporation of patient dietary preferences. Study team members will assist patients in setting up their Season Health accounts.

Group III: Control arm Active Control 1 Intervention

This control arm will receive dietary education only.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

American Heart Association

Collaborator

Trials

352

Recruited

6,196,000+

Findings from Research

The study evaluated the effects of home-delivered, medically tailored meals on food-insecure patients after hospitalization for congestive heart failure, involving 39 participants compared to a matched cohort of 117 patients.

While participants showed a slight reduction in body mass index and an increase in blood pressure, these changes were not statistically significant; however, there was a trend suggesting that the intervention may improve dietary habits and potentially reduce blood pressure over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of medically tailored meals and nutrition therapy on biometric and dietary outcomes among food-insecure patients with congestive heart failure: a matched cohort study. Belak, L., Owens, C., Smith, M., et al.[2022]

Current evidence on sodium restriction in heart failure is limited, but the ongoing Sodium-HF study aims to provide more definitive results, highlighting the need for high-quality research in lifestyle management.

The GOURMET study showed promising results by integrating sodium restriction with a broader nutritional approach, emphasizing the importance of overall dietary quality and support in improving health outcomes for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sodium restriction in heart failure: where are the data?] Navis, GJ.[2020]

Optimal nutritional intake is crucial for managing heart failure, yet there are currently no established guidelines for clinicians to ensure patients receive adequate nutrition.

The article reviews existing information and provides initial recommendations for essential nutrients, including micronutrients, protein, and omega-3 fatty acids, highlighting their potential role in improving health outcomes for heart failure patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional recommendations for patients with heart failure. Lennie, TA.[2019]

A 21-day study involving 80 male patients with coronary artery disease showed that a diet with 20% energy from lipids significantly reduced total cholesterol, LDL cholesterol, and triglycerides compared to a control diet with 30% energy from lipids.

The implementation of an 'antiatherogenic catering' approach, combined with an educational program, effectively lowered nutritional risk factors in CAD patients without the need for individual counseling, suggesting a practical method for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An organizational model to translate nutritional recommendations into routine clinical practice in secondary prevention of coronary artery disease. Aquilani, R., Boni, S., Verdirosi, S., et al.[2013]

Specific diets, like the Mediterranean and plant-based diets, along with intravenous iron supplementation for iron deficiency, have shown promise in improving cardiovascular health for patients with heart failure.

Individualized nutritional therapy is recommended to address the risk of malnutrition in heart failure patients, highlighting the need for targeted screening and interdisciplinary collaboration among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nutrition in Case of Heart Failure]. Mueller, M., Siegenthaler, J., Fäh, D., et al.[2022]

The MULTIFIT system, which involves physician supervision and nurse mediation for heart failure management, led to a significant 38% reduction in daily dietary sodium intake and increased medication adherence, resulting in improved patient outcomes over an average follow-up of 138 days.

Patients using the MULTIFIT system experienced a dramatic 87% reduction in hospitalization rates for heart failure and a 67% decrease in emergency room visits, demonstrating its effectiveness in managing heart failure and reducing healthcare resource utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization. West, JA., Miller, NH., Parker, KM., et al.[2019]

In a study of 45 older heart failure patients, many did not meet their energy intake needs, with 64% consuming less than the estimated average requirements, which could impact their overall health and management of heart failure.

A significant portion of patients had high sodium intake (82% exceeding 2 mg daily) and potassium intake (18% above 3500 mg daily), indicating potential dietary risks that may need to be addressed in their treatment plans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining the nutritional status and dietary intake of older heart failure patients. Price, RJ., Witham, MD., McMurdo, ME.[2017]

In a study of 240 heart failure patients, being married was linked to better adherence to healthy food choices (green food group), suggesting social support may play a role in dietary habits.

Conversely, being overweight was associated with lower adherence to healthier food options (blue food group), while patients with diabetes showed higher consumption of unhealthy ultra-processed foods (red food group), indicating that certain health conditions can negatively impact dietary choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BALANCE Dietary Index in Patients with Heart Failure, and Its Adherence in Sergipe, Brazil. Costa, JO., Aidar, FJ., Barbosa, JS., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The impact of medically tailored meals and nutrition therapy on biometric and dietary outcomes among food-insecure patients with congestive heart failure: a matched cohort study. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Sodium restriction in heart failure: where are the data?] [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Nutritional recommendations for patients with heart failure. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

An organizational model to translate nutritional recommendations into routine clinical practice in secondary prevention of coronary artery disease. [2013]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Nutrition in Case of Heart Failure]. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A comprehensive management system for heart failure improves clinical outcomes and reduces medical resource utilization. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Defining the nutritional status and dietary intake of older heart failure patients. [2017]

8. Switzerland pubmed.ncbi.nlm.nih.gov

BALANCE Dietary Index in Patients with Heart Failure, and Its Adherence in Sergipe, Brazil. [2022]