RecruitingNot ApplicableNCT07101289

Eat Well Heart Failure

Eat Well Produce Prescription for Duke Health Patients With Congestive Heart Failure


Sponsor

Duke University

Enrollment

900 participants

Start Date

Oct 22, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria8

  • 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 Criteria2

  • History of dialysis or end stage renal disease OR
  • History of LVAD or heart transplant.

Interventions

BEHAVIORALPersonal health planning and nutritional coaching

Behavioral support will be offed by ZealCare, an evidence-based, virtual coaching behavioral support program for patients with chronic conditions.

OTHERPrescription Produce

Eat Well is a prescription produce program that provides a reloadable, restricted use debit card to participants to purchase fresh, frozen, or canned fruits, vegetables, and legumes at grocery stores.


Locations(1)

Duke Health

Durham, North Carolina, United States

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NCT07101289


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