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Eat Well Produce Prescription for Duke Health Patients With Congestive Heart Failure

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
North Carolina
Duke Health
RECRUITING
Durham
Contact Information
Primary
Connor Drake, PhD
connor.drake@duke.edu
919-724-2129
Backup
Cierra Buckman, MHS
cierra.buckman@duke.edu
843-269-5657
Time Frame
Start Date: 2025-10-22
Estimated Completion Date: 2027-12
Participants
Target number of participants: 900
Treatments
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
Related Therapeutic Areas
Sponsors
Collaborators: Reinvestment Partners, ZealCare
Leads: Duke University

This content was sourced from clinicaltrials.gov