Congestive Heart Failure ChronicNCT07101289
Eat Well Heart Failure
A study testing Personal health planning and nutritional coaching and Prescription Produce in people with Congestive Heart Failure Chronic, run by Duke University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure Chronic
- What is being tested?
- Personal health planning and nutritional coaching and Prescription Produce
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- History of dialysis or end stage renal disease OR
- History of LVAD or heart transplant.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Health
Durham, North Carolina, 27701
Stephen Greene, MD, 860-484-9403, stephen.greene@duke.edu
About this study
Official title: Eat Well Produce Prescription for Duke Health Patients With Congestive 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.
- Conditions
- Congestive Heart Failure Chronic
- Being tested
- Personal health planning and nutritional coaching, Prescription Produce
- Keywords
- prescription produce, behavioral support
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personal health planning and nutritional coachingBehavioural
Behavioral support will be offed by ZealCare, an evidence-based, virtual coaching behavioral support program for patients with chronic conditions.
Prescription ProduceOther
Also called Eat Well
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Personal health planning and nutritional coaching; Other: Prescription Produce |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
All cause hospitalizations
The total number of admissions to a hospital for any reason
Measured: 12 months
All cause ED visits
The total number of visits to the Emergency Department for any reason
Measured: 12 months
Outpatient utilization
The number of outpatient visits
Measured: 12 months
Change in Blood pressure
Change in Blood Pressure from baseline to visit closest to end of study assessed by both systolic and diastolic blood pressure
Measured: 12 months
Change in Body Mass Index
Change in Body Mass Index from baseline to visit closest to end of study
Measured: 12 months
Heart Failure Specific Hospitalization
Hospitalization related to heart failure.
Measured: 12 months
Heart Failure specific Emergency Department use
Visits to the emergency department related to heart failure
Measured: 12 months
Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12)
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
Measured: Baseline, 6 months, and 12 months
USDA 6-item Food Security Survey Module (FSSM)
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).
Measured: Baseline, 6 months, and 12 months
Dietary Screener Questionnaire (DSQ)
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.
Measured: Baseline, 6 months, and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2025
- Study start22 Oct 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart Failure ChronicStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Reinvestment Partners, ZealCare
- Responsible party
- Sponsor
- Investigators
- Connor Drake, PhD, Principal investigator, Duke Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07101289
- Sponsor's protocol ID
- PRO00117602
- Status last verified
- Nov 2025
- First submitted
- 28 Jul 2025
- Last updated
- 12 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eat Well Produce Prescription for Duke Health Patients With Congestive Heart Failure
- ClinicalTrials.gov ID
- NCT07101289
- Acronym / sponsor ID
- PRO00117602
- Conditions
- Congestive Heart Failure Chronic
- Keywords
- prescription produce, behavioral support
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Reinvestment Partners, ZealCare
- Study start
- 22 Oct 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Prescription ProducePatients will receive the Eat Well Prescription Produce benefit card ($100/month for 12 months) with low behavioral support provided by Reinvestment Partners |
| Prescription Produce program with high behavioral support | Active comparator | Behavioral: Personal health planning and nutritional coaching, Other: Prescription ProducePatients will receive the Eat Well Prescription produce benefit card ($100/month for 12 months) with high behavioral support provided by Reinvestment Partners and ZealCare |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- History of dialysis or end stage renal disease OR
- History of LVAD or heart transplant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Personal health planning and nutritional coachingBehavioral support will be offed by ZealCare, an evidence-based, virtual coaching behavioral support program for patients with chronic conditions. | Behavioural | Prescription Produce program with high behavioral support |
| Prescription ProduceAlso: Eat WellEat 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 | Prescription Produce program with high behavioral support, Prescription Produce program with low behavioral support |
Primary outcome
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.
10 secondary outcomes
All cause hospitalizations
Time frame: 12 months
All cause ED visits
Time frame: 12 months
Outpatient utilization
Time frame: 12 months
Change in Blood pressure
Time frame: 12 months
Change in Body Mass Index
Time frame: 12 months
Heart Failure Specific Hospitalization
Time frame: 12 months
Heart Failure specific Emergency Department use
Time frame: 12 months
Kansas City Cardiomyopathy Questionnaire 12-item version (KCCQ-12)
Time frame: Baseline, 6 months, and 12 months
USDA 6-item Food Security Survey Module (FSSM)
Time frame: Baseline, 6 months, and 12 months
Dietary Screener Questionnaire (DSQ)
Time frame: Baseline, 6 months, and 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Connor Drake, PhD principal investigator
Duke Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personal health planning and nutritional coaching and Prescription Produce in people with Congestive Heart Failure Chronic, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Connor Drake, PhD (919-724-2129, connor.drake@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of incidence rates of ED visits, hospitalizations, and all-cause mortality at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2025.