Eat Well Program for Heart Failure

Overseen By Connor Drake, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Dialysis, End stage renal, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a program called Eat Well, which provides a monthly food benefit card, can help individuals with congestive heart failure (CHF) improve their health. It will test two levels of support: one with more assistance and guidance and one with less, comparing these to usual care. Suitable participants have been diagnosed with CHF, recently visited the hospital or emergency room, and are experiencing food insecurity (difficulty accessing enough healthy food). The trial will also examine how this program might reduce healthcare costs and identify factors that aid or hinder its success.

As an unphased trial, this study offers a unique opportunity to contribute to understanding how nutritional support can enhance health outcomes for CHF patients.

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's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that programs like Eat Well, which offer free or discounted fruits and vegetables, are safe for people. Studies have found that these programs can improve heart health by encouraging more fruit and vegetable consumption. For instance, one study discovered that participants had lower blood pressure and blood sugar levels. This suggests that the Eat Well program is generally safe and could enhance health without causing harm. Another review of similar programs found they helped people eat more fruits and vegetables and improved food security, ensuring reliable access to enough food. No reports of serious negative effects have emerged from these programs. Therefore, joining the Eat Well program could be a safe way to help manage heart failure. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Eat Well Program for heart failure because it explores how dietary support can directly improve heart health. Unlike traditional treatments that focus on medications and lifestyle advice, this program provides a tangible benefit: a $100 monthly card for fresh produce. The trial investigates the impact of high versus low behavioral support, offering insights into how different levels of guidance can drive healthier eating habits. By potentially enhancing heart failure management through nutrition, this approach opens up new possibilities for patient care.

What evidence suggests that the Eat Well program could be effective for heart failure?

This trial will compare different levels of support within the Eat Well program for heart failure patients. Research has shown that the Eat Well program, which provides prescriptions for fruits and vegetables, can improve heart and metabolic health by encouraging increased produce consumption. The program also addresses food insecurity, which can hinder healthy eating. Studies have found that participants not only enjoy better health but may also experience reduced healthcare costs. Specifically, research with veterans demonstrated health improvements and a decreased need for medical services. The program focuses on boosting heart health, which is crucial for those with heart failure. Overall, the Eat Well program could effectively improve diet and health outcomes. ^{1 2 6 7 8}

Who Is on the Research Team?

Connor Drake, PhD

Principal Investigator

Duke Health

Are You a Good Fit for This Trial?

This trial is for Duke Health patients with congestive heart failure. It's designed to see if a program called Eat Well, which includes prescription produce and health planning, can improve their health and reduce healthcare costs.

Inclusion Criteria

At risk of food insecurity as defined by screening positive for financial instability (medium risk and up) or food insecurity in the past 12 months minimum OR being a Medicaid or dual eligible enrollee

I prefer to communicate in English.

I have been diagnosed with congestive heart failure.

Exclusion Criteria

History of LVAD or heart transplant

I have had dialysis or have end-stage kidney disease.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Eat Well Prescription produce benefit card with varying levels of behavioral support for 12 months

12 months

Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Eat Well

Trial Overview The study tests the 'Eat Well' program's effectiveness in managing heart failure. Participants are randomly assigned to receive either the standard Eat Well program or an enhanced version with extra behavioral support, compared to a control group.

How Is the Trial Designed?

Group I: Prescription Produce program with high behavioral support Active Control 2 Interventions

Patients will receive the Eat Well Prescription produce benefit card ($100/month for 12 months) with high behavioral support provided by Reinvestment Partners and ZealCare

Group II: Prescription Produce program with low behavioral support Active Control 1 Intervention

Patients will receive the Eat Well Prescription Produce benefit card ($100/month for 12 months) with low behavioral support provided by Reinvestment Partners

Group III: Usual Care Active Control 1 Intervention

Patients will continue to receive their usual care as well as educational materials

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

ZealCare

Collaborator

Reinvestment Partners

Collaborator

Trials

1

Recruited

30+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07101289

Study Details | NCT07101289 | Eat Well Heart Failure Objectives of this three arm trial include testing the effectiveness of Eat Well alone with minimal behavioral support and Eat Well with intensified behavioral ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCOUTCOMES.122.009520

Impact of Produce Prescriptions on Diet, Food Security ... Produce prescriptions may improve cardiometabolic health by increasing fruit and vegetable (F&V) consumption and food insecurity.

3. hsrd.research.va.gov hsrd.research.va.gov/news/research_news/food-insecurity-091025.cfm

HSR Supports Partnership to Fight Veteran Food Insecurity Drake and his team are examining participating Veterans' health outcomes and healthcare utilization as well as changes in their well-being and ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714424002386?via%3Dihub

Addressing cost barriers to healthy eating with Eat Well, a ... We seek to test the effect of a prescription produce program, 'Eat Well' on cardiometabolic health and healthcare utilization. We will also assess the ...

5. caper-lime-s2a3.squarespace.com caper-lime-s2a3.squarespace.com/s/Eat-Well-Research-Brief_Final.pdf

EAT WELL RESEARCH FINDINGS Reinvestment Partners produce prescription program on health outcomes and healthcare utilization for veterans. Research Partner: Durham VA Health Care System.

6. news-medical.net news-medical.net/news/20251110/Healthy-meal-deliveries-boost-quality-of-life-for-people-with-heart-failure.aspx

Healthy meal deliveries boost quality of life for people with ... This randomized trial included 150 adults who were enrolled within two weeks of being discharged from the hospital for acute heart failure.

7. jneb.org jneb.org/article/S1499-4046(24)00387-7/fulltext

Examining Food Security, Fruit and Vegetable Intake ... The objective of this study was to conduct a systematic review to examine the impact of PPR programs on food security, fruit and vegetable (FV) intake, and/or ...

8. health.harvard.edu health.harvard.edu/blog/produce-prescriptions-may-promote-better-heart-health-202310182983

Produce prescriptions may promote better heart health Free or discounted fresh fruits and vegetables were linked to lowered blood pressure and blood sugar in people living in low-income communities.