Church-based Health Intervention for Cardiovascular Disease

(CHERISH Trial)

Overseen By Katherine T Mills, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Recent heart failure, Cancer, Dialysis, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

1050 Participants Needed

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 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.

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. ^{1 2 3 4 5}

Is 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. ^{1 3 4 6 7}

How 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. ^{1 4 8 9 10}

Eligibility 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.

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.

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

Treatment Details

Interventions

• Evidence-based interventions recommended by the 2019 ACC/AHA Guideline on the Primary Prevention of CVD

Trial Overview 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.

Participant Groups

Group I: Group-based Education Strategy Experimental Treatment 1 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 Treatment 1 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

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Findings from Research

A systematic review of 81 studies involving 17,275 participants found that church-based interventions significantly reduce cardiovascular disease (CVD) risk factors, including body weight, waist circumference, and systolic blood pressure.

The most effective interventions focused on increasing physical activity and improving diet, often incorporating cultural tailoring and spiritual components, which can help address health disparities in high-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. Maroney, K., Laurent, J., Alvarado, F., et al.[2023]

A cardiovascular prevention program targeting high-risk women (n = 1,052) significantly improved knowledge and awareness of heart disease and its risk factors, but did not achieve the primary goals of reducing obesity or increasing physical activity.

Participants showed a 10% increase in controlling hypertension and significant reductions in mean blood pressure, indicating some positive health outcomes despite not meeting all primary objectives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of national community organization cardiovascular prevention programs for high-risk women. Villablanca, AC., Arline, S., Lewis, J., et al.[2021]

This study involved 221 mid-life and older African Americans and aimed to reduce cardiovascular disease (CVD) risk through a church-based health intervention, highlighting the importance of community engagement in health programs.

The research found that while treatment and comparison groups had similar background characteristics and health behaviors, they differed in certain clinical factors, suggesting that targeted interventions may be necessary to address specific health disparities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing cardiovascular disease risk in mid-life and older African Americans: a church-based longitudinal intervention project at baseline. Ralston, PA., Lemacks, JL., Wickrama, KK., et al.[2022]

A faith-based cardiovascular disease (CVD) risk-reduction intervention in rural Illinois showed that participants who engaged in both the Heart Smart for Women (HSFW) program and the Heart Smart Maintenance (HSM) had significantly higher vegetable and combined fruit/vegetable consumption after one year compared to those who only participated in HSM.

Despite improvements in dietary habits, the study found no significant changes in physical activity levels among participants, highlighting the ongoing challenge of maintaining CVD risk-reduction behaviors in rural populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Faith-placed Cardiovascular Health Promotion Intervention for Rural Adults. Zimmermann, K., Carnahan, LR., Khare, MM., et al.[2022]

A 5-week non-dairy vegetarian nutrition intervention involving 53 volunteers from an urban African American community led to significant reductions in key cardiovascular risk markers, including a 43% decrease in serum insulin and a 14% reduction in low-density lipoprotein cholesterol (LDL).

The intervention resulted in a 19.4% decrease in the 10-year atherosclerotic cardiovascular disease (ASCVD) risk, highlighting the potential of dietary changes to improve heart health and reduce racial disparities in cardiovascular events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutrition Intervention for Reduction of Cardiovascular Risk in African Americans Using the 2019 American College of Cardiology/American Heart Association Primary Prevention Guidelines. Williams, KA., Fughhi, I., Fugar, S., et al.[2022]

The study analyzed 833 patients and found that the ACC/AHA guidelines recommend statin treatment for nearly half (49.5%) of the participants, significantly more than the ESC guidelines, which suggest treatment for only 23.1%.

The ACC/AHA guidelines indicate a higher recommendation for statin use in men (62.6%) compared to women (40.4%), while the ESC guidelines show much lower recommendations for both genders (12% for women and 38.4% for men), highlighting a substantial difference in primary prevention strategies between the two guidelines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Yılmaz, M., Atar, İ., Hasırcı, S., et al.[2019]

Cardiovascular disease rates in the U.S. increased in 2015 after years of decline, highlighting the urgent need for effective primary prevention strategies.

The review introduces a simplified ABCDE approach to help clinicians implement primary prevention measures against atherosclerotic cardiovascular disease, addressing key risk factors like obesity, smoking, and unhealthy lifestyles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

THE ABCDE'S OF PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE. Blumenthal, RS., Alfaddagh, A.[2022]

Collaborations between health agencies and black churches have been effective in addressing cardiovascular health disparities in the African-American community, particularly in high-risk areas like the stroke belt.

Key strategies for successful health programs include engaging pastors, promoting healthier meal options at church events, and incorporating scriptural references in health materials, which can enhance community participation and improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partnering with the black church: recipe for promoting heart health in the stroke belt. Butler-Ajibade, P., Booth, W., Burwell, C.[2022]

The Health for Hearts United (HHU) dissemination trial successfully engaged 100% of participating churches, leading to significant improvements in health behaviors among health leaders, including increased fruit and vegetable intake and decreased fat consumption and body mass index.

Outreach participants showed a significant increase in cardiovascular disease awareness, indicating that the HHU model may effectively reduce CVD risk in African American communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dissemination trial for Health for Hearts United: Model development, preliminary outcomes and lessons learned. Ralston, PA., Young-Clark, I., Wickrama, KAS., et al.[2023]

The HeartSmarts program effectively utilized faith-based institutions to educate African-Americans about cardiovascular disease, integrating health education with biblical scripture to enhance engagement.

Out of 199 participants, 137 provided positive feedback, indicating that the program was well accepted and successful in delivering important CVD health messages within their communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"It's Like Backing up Science with Scripture": Lessons Learned from the Implementation of HeartSmarts, a Faith-Based Cardiovascular Disease Health Education Program. Tettey, NS., Duran, PA., Andersen, HS., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Outcomes of national community organization cardiovascular prevention programs for high-risk women. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Reducing cardiovascular disease risk in mid-life and older African Americans: a church-based longitudinal intervention project at baseline. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of a Faith-placed Cardiovascular Health Promotion Intervention for Rural Adults. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Nutrition Intervention for Reduction of Cardiovascular Risk in African Americans Using the 2019 American College of Cardiology/American Heart Association Primary Prevention Guidelines. [2022]

6. Turkey pubmed.ncbi.nlm.nih.gov

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]

7. United States pubmed.ncbi.nlm.nih.gov

THE ABCDE'S OF PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Partnering with the black church: recipe for promoting heart health in the stroke belt. [2022]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Dissemination trial for Health for Hearts United: Model development, preliminary outcomes and lessons learned. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

"It's Like Backing up Science with Scripture": Lessons Learned from the Implementation of HeartSmarts, a Faith-Based Cardiovascular Disease Health Education Program. [2022]