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NCT Number: NCT07101289

Eat Well Heart Failure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Health

Durham, North Carolina, 27701, United States

Location status: Recruiting

Location contact

Stephen Greene, MD

CONTACT

[email protected]

860-484-9403

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Other names: Eat Well

Primary outcomes

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

    Time frame: 12 months

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

Secondary outcomes

  1. All cause hospitalizations

    Time frame: 12 months

    The total number of admissions to a hospital for any reason

  2. All cause ED visits

    Time frame: 12 months

    The total number of visits to the Emergency Department for any reason

  3. Outpatient utilization

    Time frame: 12 months

    The number of outpatient visits

  4. Change in Blood pressure

    Time frame: 12 months

    Change in Blood Pressure from baseline to visit closest to end of study assessed by both systolic and diastolic blood pressure

  5. Change in Body Mass Index

    Time frame: 12 months

    Change in Body Mass Index from baseline to visit closest to end of study

  6. Heart Failure Specific Hospitalization

    Time frame: 12 months

    Hospitalization related to heart failure.

  7. Heart Failure specific Emergency Department use

    Time frame: 12 months

    Visits to the emergency department related to heart failure

  8. Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12)

    Time frame: Baseline, 6 months, and 12 months

    The Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12) is a validated, self-administered health status measure for patients with heart failure. It is designed to quantify the patient's perception of their health status related to heart failure over the past two weeks.

    Scoring Range: Each domain score and the overall/clinical summary scores are transformed to a standardized range of 0 to 100.

    Interpretation: Higher scores indicate better health status and outcomes, while lower scores indicate worse health status and more severe limitations.

    0-24: Very poor to poor health 25-49: Poor to fair health 50-74: Fair to good health 75-100: Good to excellent health

  9. USDA 6-item Food Security Survey Module (FSSM)

    Time frame: Baseline, 6 months, and 12 months

    The USDA 6-item Food Security Survey Module (FSSM) is a short form of the larger 18-item survey, designed to efficiently assess and categorize a household's food security status. The scale is based on the number of affirmative (food-insecure) responses, with a raw score range of 0 to 6. A higher score indicates a worse outcome (greater food insecurity/less food security), while a lower score indicates a better outcome (higher food security).

  10. Dietary Screener Questionnaire (DSQ)

    Time frame: Baseline, 6 months, and 12 months.

    The 10-item DSQ assesses the frequency of fruit and vegetable intake. Higher scores on beneficial foods (like fruits and vegetables) mean a better outcome (healthier diet). Higher scores on less healthy items (like added sugars or red/processed meat) would mean a worse outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Cierra Buckman, MHS

CONTACT

[email protected]

843-269-5657

Connor Drake, PhD

CONTACT

[email protected]

919-724-2129

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Reinvestment Partners
  • ZealCare

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 3, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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