Actively Recruiting
Eat Well Produce Prescription for Duke Health Patients With Congestive Heart Failure
Led by Duke University · Updated on 2025-11-12
900
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
D
Duke University
Lead Sponsor
R
Reinvestment Partners
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the Eat Well program, a prescription produce initiative, for Duke Health patients diagnosed with congestive heart failure (CHF). This randomized controlled trial aims to compare the effects of Eat Well alone with minimal behavioral support and Eat Well combined with intensified behavioral support on health outcomes, healthcare usage, and cost savings over 12 months. The study also seeks to identify factors that influence the program's effectiveness and implementation. Participants are assigned to one of three groups: usual care with educational materials, Eat Well with a $100 monthly produce benefit card and low behavioral support provided by Reinvestment Partners, or Eat Well with the produce benefit card plus high behavioral support offered by both Reinvestment Partners and ZealCare. The program provides a reloadable debit card for purchasing fruits, vegetables, and legumes, and behavioral support includes virtual coaching for chronic conditions. During the 12-month study period, participants will be monitored for emergency department visits, hospitalizations, and mortality rates. Secondary assessments include blood pressure, body mass index, heart failure-specific hospital use, quality of life questionnaires, food security surveys, and dietary intake questionnaires. The study tracks healthcare usage and health outcomes while providing ongoing support and follow-up to understand the program's overall impact on CHF patients.
CONDITIONS
Brief Title
Eat Well Heart Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 or older
- Diagnosis of congestive heart failure regardless of ejection fraction
- Hospitalization or emergency department visit within the past 12 months
- At risk of food insecurity or Medicaid/dual eligible enrollment
- English as preferred language
- Valid email address for virtual coaching
- North Carolina mailing address
You will not qualify if you...
- History of dialysis or end stage renal disease
- History of left ventricular assist device (LVAD) or heart transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants receive the Prescription Produce benefit card to purchase fruits, vegetables, and legumes, along with behavioral support through virtual coaching programs tailored to their assigned group.
Visits at baseline, 6 months, and 12 months for questionnaires and assessments
Trial Site Locations
Total: 1 location
1
Duke Health
Durham, North Carolina, United States, 27701
Actively Recruiting
Research Team
C
Connor Drake, PhD
C
Cierra Buckman, MHS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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