Eat Well Heart Failure
NCT07101289 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 900
Last updated 2025-11-12
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.
Conditions
- Congestive Heart Failure Chronic
Interventions
- BEHAVIORAL
-
Personal 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.
- OTHER
-
Prescription 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.
Sponsors & Collaborators
-
Reinvestment Partners
collaborator UNKNOWN -
ZealCare
collaborator UNKNOWN - lead OTHER
Principal Investigators
-
Connor Drake, PhD · Duke Health
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-10-22
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- United States
Study Locations
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