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Eat Well Heart Failure

NCT ID: NCT07101289

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-22

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Congestive Heart Failure Chronic

Keywords

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prescription produce behavioral support

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Usual Care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type ACTIVE_COMPARATOR

Prescription Produce

Intervention Type 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.

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

Group Type ACTIVE_COMPARATOR

Personal health planning and nutritional coaching

Intervention Type BEHAVIORAL

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

Prescription Produce

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Other Intervention Names

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Eat Well

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reinvestment Partners

UNKNOWN

Sponsor Role collaborator

ZealCare

UNKNOWN

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Connor Drake, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Duke Health

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Connor Drake, PhD

Role: CONTACT

Phone: 919-724-2129

Email: [email protected]

Cierra Buckman, MHS

Role: CONTACT

Phone: 843-269-5657

Email: [email protected]

Facility Contacts

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Stephen Greene, MD

Role: primary

Other Identifiers

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PRO00117602

Identifier Type: -

Identifier Source: org_study_id