Church-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health
CHERISH
1 other identifier
interventional
806
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cardiovascular-diseases
Started Sep 2023
Typical duration for not_applicable cardiovascular-diseases
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2023
CompletedStudy Start
First participant enrolled
September 28, 2023
CompletedFirst Posted
Study publicly available on registry
October 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
September 3, 2025
August 1, 2025
3.9 years
August 21, 2023
August 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Difference in change in estimated atherosclerotic cardiovascular disease (ASCVD) risk score
The ACC/AHA ASCVD risk score will be calculated using the pooled population cohort equation based on age (years), total cholesterol (mg/dL), high-density lipoprotein (HDL)-cholesterol (mg/dL), antihypertensive medication use, systolic BP (mmHg), current smoking status, and diabetes status. The risk score ranges from 0% to 100%.
Measured from baseline to 18 months
Fidelity summary score
The fidelity summary score is composed of the following key implementation strategy components: proportion of assigned health education sessions attended in all participants, proportion of assigned discussion sessions attended in all participants, proportion of recommended minutes of physical activity completed in all participants, proportion of days per week that fruits/vegetables are eaten as recommended in all participants, proportion of recommended home BP monitoring completed in patients with hypertension, proportion of required provider visits attended in all patients, and proportion of antihypertensive, antidiabetic, and statin medications taken in patients with hypertension or diabetes, or those who are eligible for statin treatment, respectively.
Measured at 6, 12, and 18 months
Secondary Outcomes (22)
Difference in change in systolic blood pressure level
Measured from baseline to 18 months
Difference in change in diastolic blood pressure level
Measured from baseline to 18 months
Difference in change in total cholesterol level
Measured from baseline to 18 months
Difference in change in low-density lipoprotein (LDL) cholesterol level
Measured from baseline to 18 months
Difference in change in fasting glucose level
Measured from baseline to 18 months
- +17 more secondary outcomes
Other Outcomes (4)
Difference in proportion of those receiving statin treatment who are eligible
Measured from baseline to 18 months
Difference in proportion of those who cease smoking of those who are current smokers at baseline
Measured from baseline to 18 months
Difference in medication adherence
Measured from baseline to 18 months
- +1 more other outcomes
Study Arms (2)
Community health worker-led implementation strategy:
EXPERIMENTALIndividual coaching sessions; healthcare navigation; healthcare at community settings; church-based nutrition education and exercise programs; and self-monitoring of BP.
Group-based Education Strategy
EXPERIMENTALGroup-based education sessions; information on primary care physicians; and instruction on self-monitoring of BP.
Interventions
The recommended evidence-based interventions include therapeutic lifestyle change and medical treatment of hypertension, diabetes, and hypercholesterolemia.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tulane Universitylead
- National Institutes of Health (NIH)collaborator
Study Sites (1)
Tulane University
New Orleans, Louisiana, 70112, United States
Related Publications (3)
Maroney K, Laurent J, Alvarado F, Gabor A, Bell C, Ferdinand K, He J, Mills KT. Systematic review and meta-analysis of church-based interventions to improve cardiovascular disease risk factors. Am J Med Sci. 2023 Sep;366(3):199-208. doi: 10.1016/j.amjms.2023.05.010. Epub 2023 May 25.
PMID: 37244637BACKGROUNDHe J, Bundy JD, Geng S, Tian L, He H, Li X, Ferdinand KC, Anderson AH, Dorans KS, Vasan RS, Mills KT, Chen J. Social, Behavioral, and Metabolic Risk Factors and Racial Disparities in Cardiovascular Disease Mortality in U.S. Adults : An Observational Study. Ann Intern Med. 2023 Sep;176(9):1200-1208. doi: 10.7326/M23-0507. Epub 2023 Aug 15.
PMID: 37579311BACKGROUNDBundy JD, Mills KT, He H, LaVeist TA, Ferdinand KC, Chen J, He J. Social determinants of health and premature death among adults in the USA from 1999 to 2018: a national cohort study. Lancet Public Health. 2023 Jun;8(6):e422-e431. doi: 10.1016/S2468-2667(23)00081-6.
PMID: 37244672BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Clinical research coordinators and laboratory technicians who assess health-related outcomes will be blinded to intervention assignment. Study physicians who review serious adverse events and unanticipated problems will also be blinded to intervention assignment.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 21, 2023
First Posted
October 3, 2023
Study Start
September 28, 2023
Primary Completion (Estimated)
August 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- No later than three years after the end of the final participant follow-up or two years after the main paper of the trial has been published, whichever comes first
Our study data sharing plan will comply with all NIH policies for data sharing. Data sharing will be executed through the centralized NIH data repository and will be implemented in a timely manner. The study data, including data from baseline and follow-up visits, will be prepared for transmission to the NHLBI data repository - the Biologic Specimen and Data Repository Information Coordinating Center (BioLINCC). The datasets will be submitted to the NHLBI no later than three years after the end of the final participant follow-up or two years after the main paper of the trial has been published, whichever comes first. The NHLBI will review the submitted data prior to release. These data will be free of identifiers that allow identification of individual research participants either directly or through "deductive disclosure." In addition, we will offer, through our publicly accessible website, opportunities for outside investigators to collaborate with us using complete study data.