NCT07101289NARecruiting

Eat Well Heart Failure

Duke University

Start Date

10/22/2025

Completion Date

12/1/2027

Summary

The purpose of this parallel pragmatic randomized controlled trial (RCT) is to evaluate the impact of Eat Well (an evidence-based 'Food is Medicine' produce prescription program) with varying levels of behavioral support on health outcomes and care utilization patterns of Duke Health patients diagnosed with congestive heart failure (CHF). Objectives of this three arm trial include testing the effectiveness of Eat Well alone with minimal behavioral support and Eat Well with intensified behavioral support based on an evidence based approach to improve CHF patients' health outcomes, estimating health care cost savings between the intervention and control arms, and identifying barriers, facilitators, and potential strategies to enhance Eat Well effectiveness and implementation.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * Age 18 or older * Diagnosis of CHF regardless of ejection fraction AND * Hospitalization or ED visit within the past 12 months AND * At risk of food insecurity as defined by one of the following: screened positive for financial instability (medium risk and up) or food insecurity in the past 12 months minimum OR a Medicaid or dual eligible enrollee * English as preferred language * Valid email address (for virtual health coaching intervention) * NC mailing address Exclusion Criteria: * History of dialysis or end stage renal disease OR * History of LVAD or heart transplant.

Interventions

BEHAVIORAL

Personal health planning and nutritional coaching

OTHER

Prescription Produce

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Conditions

Congestive Heart Failure Chronic

Locations

Duke Health

Durham, North Carolina 27701

United States