Eat Well Heart Failure

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT07101289
Status
Recruiting
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Conditions

  • Congestive Heart Failure Chronic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Personal health planning and nutritional coaching — BEHAVIORAL
    Behavioral support will be offed by ZealCare, an evidence-based, virtual coaching behavioral support program for patients with chronic conditions.
  • Prescription Produce — OTHER
    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.

Study Details

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.

Key Dates

Start date
Oct 22, 2025
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
900 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Usual Care
    Patients will continue to receive their usual care as well as educational materials
  • Active Comparator: Prescription Produce program with low behavioral support
    Patients will receive the Eat Well Prescription Produce benefit card ($100/month for 12 months) with low behavioral support provided by Reinvestment Partners
  • Active Comparator: Prescription Produce program with high behavioral support
    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

Primary Outcome Measure

Composite of incidence rates of ED visits, hospitalizations, and all-cause mortality at 12 months [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke HealthDurhamNorth Carolina27701
Stephen Greene, MD
[email protected]
860-484-9403

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