Recruiting

Eat Well

Sponsor:

Duke University

Code:

NCT07101289

Conditions

Congestive Heart Failure Chronic

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Personal health planning and nutritional coaching

Prescription Produce

Study Details

Brief 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

Study ID

NCT07101289

Start date

Oct 22, 2025

Status verified date

Nov, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

900 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

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.

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Connor Drake, PhD

919-724-2129connor.drake@duke.edu

Cierra Buckman, MHS

843-269-5657cierra.buckman@duke.edu

Locations

Duke Health

Recruiting

Durham, North Carolina, United States, 27701

Contacts

Stephen Greene, MD

860-484-9403stephen.greene@duke.edu

More Information

Sponsor

Duke University

Last update posted

Nov 12, 2025

Last verified

Nov, 2025

Keywords

  • prescription produce
  • behavioral support

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-11-12.