Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health (NCT06065098) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
United States812 participantsStarted 2023-09-28
Plain-language summary
Cardiovascular disease (CVD) is the leading cause of death in the US general population. Although CVD mortality rates declined for both Black and White populations during the past two decades, they are still higher in Black adults than White adults. There are also persistent disparities in CVD risk factors with higher prevalence of obesity, hypertension, and diabetes in Black compared to White populations. In addition, CVD and risk factors are more prevalent in the residents of Louisiana compared to the US general population. The Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health (CHERISH) study will use a church-based community health worker (CHW)-led multifaceted intervention to address racial inequities in CVD risk factors in predominantly Black communities in New Orleans, Louisiana. The primary aim of the CHERISH study is to compare the impact of two implementation strategies - a CHW-led multifaceted strategy and a group-based education strategy - for delivering interventions recommended by the 2019 American College of Cardiology (ACC)/American Heart Association (AHA) Guideline on the Primary Prevention of Cardiovascular Disease on implementation and clinical effectiveness outcomes in predominantly Black church community members over 18 months.
Who can participate
Age range
40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men or women aged ≥40 years
* Community members associated with the participating churches (church members and their families and friends)
* Individuals with three or more CVD risk factors (out of seven):
* Current smoker
* Overweight or obese (BMI ≥25 kg/m2)
* Insufficient physical activity (\<150 minutes/week moderate intensity or \<75 minutes/week vigorous intensity)
* Healthy diet score of \<4 components
* Total cholesterol ≥200 mg/dL
* Blood pressure ≥130/80 mmHg
* Fasting plasma glucose ≥100 mg/dL
* Willing and able to participate in the intervention
Exclusion Criteria:
* No prior hospitalization in the last 3 months for chronic heart failure or heart attack.
* No current diagnosis of cancer requiring chemotherapy or radiation therapy
* No stage-5 chronic kidney disease requiring chronic dialysis, or transplant.
* Not pregnant or planning to become pregnant in the next 18 months.
* No plans to move out of the New Orleans metropolitan area during the next year.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score