Church-based Health Intervention for Cardiovascular Disease
(CHERISH Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Tulane University
Disqualifiers: Recent heart failure, Cancer, Dialysis, Pregnancy, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of this trial?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 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 Black community members over 18 months.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of this treatment for cardiovascular disease?
Research shows that church-based health programs can help reduce risk factors for heart disease, like high blood pressure and unhealthy weight, especially in communities with a high burden of these conditions. These programs often involve education and lifestyle changes, which have been effective in improving heart health.
12345Is the church-based health intervention for cardiovascular disease safe for humans?
Church-based health programs have been used to reduce risk factors for cardiovascular disease, such as high blood pressure and unhealthy lifestyle habits, and are generally considered safe for humans.
13467How is the church-based health intervention for cardiovascular disease unique compared to other treatments?
This treatment is unique because it uses church-based programs to deliver health interventions, integrating faith and community support to improve cardiovascular health, especially in high-risk groups like African Americans and rural populations. It combines evidence-based health strategies with spiritual and community elements, which can enhance engagement and effectiveness.
148910Eligibility Criteria
The CHERISH study is for Black or African American adults aged 40 and over who are connected to participating churches in New Orleans. They must have at least four of these risk factors: smoking, obesity, low physical activity, poor diet, high cholesterol, high blood pressure, or elevated blood sugar. Those with recent severe health issues like cancer treatment or heart failure aren't eligible.Inclusion Criteria
Criterion: People from the participating churches and their families and friends.
You have four or more of these health risk factors: smoking, being overweight, not getting enough exercise, not eating a healthy diet, high cholesterol, high blood pressure, or high blood sugar.
I am a Black or African American person aged 40 or older.
+1 more
Exclusion Criteria
I haven't been hospitalized for heart failure or a heart attack in the last 3 months.
I do not have advanced kidney disease requiring dialysis or a transplant.
I do not need chemotherapy or radiation for any cancer right now.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Implementation
Participants receive a CHW-led multifaceted intervention or a group-based education strategy to address CVD risk factors
18 months
Regular visits at 6, 12, and 18 months
Follow-up
Participants are monitored for sustainability of the intervention and maintenance of cardiovascular health metrics
6 months post-intervention
1 visit (in-person) at 24 months
Participant Groups
This trial tests two strategies to improve cardiovascular health in the Black community using guidelines from the ACC/AHA. One strategy involves a community health worker leading various interventions; the other uses group education. The study will last 18 months and measure how well each method works.
2Treatment groups
Experimental Treatment
Group I: Group-based Education StrategyExperimental Treatment1 Intervention
Group-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP.
Group II: Community health worker-led implementation strategy:Experimental Treatment1 Intervention
Individual coaching sessions; healthcare navigation; healthcare at community settings; church-based nutrition education and exercise programs; and self-monitoring of BP.
Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD is already approved in United States for the following indications:
🇺🇸 Approved in United States as 2019 ACC/AHA Guideline on the Primary Prevention of CVD interventions for:
- Primary prevention of cardiovascular disease
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Tulane UniversityNew Orleans, LA
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Who Is Running the Clinical Trial?
Tulane UniversityLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. [2023]Church-based interventions have been shown to reduce cardiovascular disease (CVD) risk factors and could reduce health disparities in groups with a high burden of CVD. We aim to conduct a systematic review and meta-analysis to determine the effectiveness of church-based interventions for CVD risk factor improvement and to examine the types of interventions that are effective.
Outcomes of national community organization cardiovascular prevention programs for high-risk women. [2021]The purpose of this study was to reduce cardiovascular disease (CVD) risk in women by implementing a cardiovascular prevention health promotion program in faith- and community-based sites. The primary outcomes were reducing obesity and increasing physical activity. A longitudinal cohort of high-risk (age > 40, ethnic minority) women (n = 1,052) was enrolled at 32 sites across the USA. The pre- or post-educational intervention consisted of eight biweekly counseling sessions conducted over 4 months each addressing one of six of the major CVD risk factors (smoking, diabetes, hypertension, cholesterol, obesity, and physical inactivity) as well as signs and symptoms of a heart attack and stroke; plus 4-6 maintenance sessions over three additional months. A multifaceted approach delivered by lay and medically trained personnel involving medical screenings, health behavior counseling, risk behavior modification, and stage of change were determined at baseline and end of counseling or maintenance. Following list-wise deletion, data were analyzed on 423 women who completed all follow-up time-points. Overall, significant improvement was attained in most of 28 secondary outcomes but not in the primary outcomes. Knowledge and awareness of heart disease as the leading killer or women, all of the signs and symptoms of a heart attack, calling 911, and CVD risk factors increased significantly (p
Reducing cardiovascular disease risk in mid-life and older African Americans: a church-based longitudinal intervention project at baseline. [2022]African Americans (AAs) experience higher age-adjusted morbidity and mortality than Whites for cardiovascular disease (CVD). Church-based health programs can reduce risk factors for CVD, including elevated blood pressure [BP], excess body weight, sedentary lifestyle and diet. Yet few studies have incorporated older adults and longitudinal designs.
Effectiveness of a Faith-placed Cardiovascular Health Promotion Intervention for Rural Adults. [2022]Cardiovascular disease (CVD) is the leading cause of mortality in the US. Further, rural US adults experience disproportionately high CVD prevalence and mortality compared to non-rural. Cardiovascular risk-reduction interventions for rural adults have shown short-term effectiveness, but long-term maintenance of outcomes remains a challenge. Faith organizations offer promise as collaborative partners for translating evidence-based interventions to reduce CVD.
Nutrition Intervention for Reduction of Cardiovascular Risk in African Americans Using the 2019 American College of Cardiology/American Heart Association Primary Prevention Guidelines. [2022]The 2019 American College of Cardiology/American Heart Association (ACC/AHA) Prevention Guidelines emphasize reduction in dietary sodium, cholesterol, refined carbohydrates, saturated fat and sweetened beverages. We hypothesized that implementing this dietary pattern could reduce cardiovascular risk in a cohort of volunteers in an urban African American (AA) community church, during a 5-week ACC/AHA-styled nutrition intervention, assessed by measuring risk markers and adherence, called HEART-LENS (Helping Everyone Assess Risk Today Lenten Nutrition Study).
Comparison of application of 2013 ACC/AHA guideline and 2011 European Society of Cardiology guideline for the management of dyslipidemias for primary prevention in a Turkish cohort. [2019]Atherosclerotic cardiovascular disease is a major global cause of death. The common approach in primary prevention of cardiovascular disease is to identify patients at high risk for cardiovascular disease. This article analyzes and compares the application of 2013 American College of Cardiology/American Heart Association (ACC/AHA) guideline and the 2011 European Society of Cardiology (ESC) guideline for the management of dyslipidemias for primary prevention in Turkish population.
THE ABCDE'S OF PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE. [2022]The growing burden of obesity, smoking, elevated cholesterol, diabetes, hypertension, sedentary lifestyle, and unhealthy dietary habits fuels cardiovascular disease. In 2015, the rates of cardiovascular disease in the United States rose for the first time after decades of steady decline. To combat this rising trend, there is a great need to emphasize primary cardiovascular prevention. In this review, we provide a summary of the current primary prevention recommendations using a simplified ABCDE approach. The aim is to help clinicians utilize an easy-to-use, structured approach to primary atherosclerotic cardiovascular disease prevention.
Partnering with the black church: recipe for promoting heart health in the stroke belt. [2022]Health disparities related to cardiovascular disease (e.g., heart disease, high blood pressure, diabetes, and stroke) have remained higher in the African-American community than in other populations. African Americans living in the stroke belt are at an even higher risk for these conditions. Recently, increasing numbers of health agencies and researchers have successfully partnered with the black church to respond to the troubling statistics regarding these health disparities. Because the black church has a long history of being in the forefront of addressing critical social, economic, political, and health issues of African Americans, it is clear they are the principal gatekeepers in reversing these negative health trends. Working with churches to reduce cardiovascular disease is not a new concept. Hypertension screening programs were established at churches approximately 30 years ago. This article shares findings of elements to improve relations between community agencies and pastors, explores the strengths and challenges of working with churches, examines the role of the pastors in establishing successful programs, and identifies model programs. This article will identify key factors that are essential to cardiovascular health programs that purport to reach high-risk populations for cardiovascular disease with life saving environmental policies and behavior change strategies. Suggestions are provided for working with pastors, churches, and church resources to maximize the desired outcomes of future health promotion interventions. Examples of strategies include serving healthier choices during church meals; the inclusion of relevant scriptural citations in promotional materials; the implementation of instruction, training, and exercise programs; and, the provision of tangible compensation to the churches and congregants facilitating the health initiatives.
Dissemination trial for Health for Hearts United: Model development, preliminary outcomes and lessons learned. [2023]Cardiovascular disease CVD), the leading cause of death in the U.S., is a particular problem for African Americans (AAs). Church-based health interventions are effective in reducing CVD risk, yet few have been successfully disseminated. This paper describes the model development, preliminary health outcomes, and lessons learned from the Health for Hearts United (HHU) dissemination trial which evolved from the longitudinal Reducing CVD Risk Study in a two-county area in North Florida. Community-based participatory research approaches and the socio-ecological model guided the study.
"It's Like Backing up Science with Scripture": Lessons Learned from the Implementation of HeartSmarts, a Faith-Based Cardiovascular Disease Health Education Program. [2022]African-Americans are disproportionately impacted by cardiovascular disease (CVD). Faith-based institutions provide a non-traditional route for health education targeted at African-Americans. This paper describes HeartSmarts, a faith-based CVD education program. Evidence-based literature was used to develop a curriculum, which was tailored by integrating biblical scripture representing aspects of health behaviors. Eighteen church peer-educators were recruited to participate in a 12-week training. They then disseminated the faith-based curriculum to members of their congregations. There were 199 participants of which 137 provided feedback via open-ended surveys indicating that HeartSmarts was well accepted and effective for disseminating CVD health messages while engaging spirituality.