Eat Well Heart Failure

NCT07101289 | Recruiting

• 1 other identifier: PRO00117602
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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

Keywords

prescription produce; behavioral support

Outcome Measures

Primary Outcomes (1)

• Composite of incidence rates of ED visits, hospitalizations, and all-cause mortality at 12 months

  The primary outcome of interest will be a composite endpoint of: ED visits, hospitalizations, and all-cause mortality at 12 months.

  12 months

Secondary Outcomes (10)

• All cause hospitalizations

  12 months

• All cause ED visits

  12 months

• Outpatient utilization

  12 months

• Change in Blood pressure

  12 months

• Change in Body Mass Index

  12 months

Study Arms (3)

Usual Care

NO INTERVENTION

Patients will continue to receive their usual care as well as educational materials

Prescription Produce program with low behavioral support

ACTIVE COMPARATOR

Patients will receive the Eat Well Prescription Produce benefit card ($100/month for 12 months) with low behavioral support provided by Reinvestment Partners

Other: Prescription Produce

Prescription Produce program with high behavioral support

ACTIVE COMPARATOR

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

Behavioral: Personal health planning and nutritional coaching; Other: Prescription Produce

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 program with high behavioral support

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.

Also known as: Eat Well

Prescription Produce program with high behavioral support; Prescription Produce program with low behavioral support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Duke University: lead
• Reinvestment Partners: collaborator
• ZealCare: collaborator

Study Sites (1)

Duke Health

Durham, North Carolina, 27701, United States

RECRUITING

Study Officials

• Connor Drake, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Connor Drake, PhD

CONTACT

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

Cierra Buckman, MHS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will conduct a 3-arm parallel pragmatic randomized controlled trial (RCT) to evaluate the impact of the Eat Well Produce Prescription program ($100 per month on eligible produce for 12 months) and PHP (an evidence based behavioral intervention that features virtual health coaching and peer support) on health outcomes and care utilization patterns, compared with a control group of non-participants. The investigators will use an equal allocation strategy to randomly assign Duke Health CHF patients to one of three conditions: (i) standard of care; (ii) receiving Eat Well alone; (iii) receiving Eat Well with the PHP virtual group visit health coaching program). For intervention arms, the active intervention period will be 12 months. The investigators will also examine whether program participation outcomes vary by social risk (Medicaid eligibility and the randomization stratification criteria).

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 3, 2025
• Study Start: October 22, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)