Reducing CVD Risk in African Americans Faith Communities

Cardiovascular Disease Risk Factors Clinical Trial

— FAITH!  

Official title:

Cardiovascular Disease Prevention Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02235896
• Other study ID #: 14-004122
• Status: Completed
• Phase: N/A
• First received: September 5, 2014
• Last updated: December 30, 2015
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: December 2015
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The ultimate goal of our partnership with local African-American churches is to implement an effective, multi-component intervention to increase awareness of the critical importance of healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the American Heart Association (AHA) prevention strategy, "Life's Simple 7" to address the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes, cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy consists of a community-based participatory research approach that involves focus groups to assess participant knowledge and beliefs about CVD risk factors prior to program initiation. We will also determine participant dietary and exercise practices, knowledge and perceptions related to healthy lifestyle and chronic diseases, demographic/health status information, health care utilization, biometrics (weight, blood pressure, blood tests for glucose and cholesterol, etc.) and attitudes about medical research at baseline, program completion and 6-month follow-up.

Description:

Church goers will undergo, baseline assessment of knowledge attitudes and behavior survey as it relates to CVD risk and anthropomorphic measurements. A 3 month experiential educational program will be provided at 2 locations. At 6 months after baseline a followup measure will be obtained

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion:

• Age >18 yrs,

• able to consent

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease Risk Factors
• Cardiovascular Diseases

Intervention

Behavioral:
• Education/Behavior Modification
Education, lifestyle counseling, experiential cooking, exercise classes.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge, attitudes about CVD and CVD risk	Change from baseline in knowledge and attitudes about CVD and CVD risk as measured by survey	1 year	No
Primary	Behavior change	Self reported diet composition, physical activity, smoking and stress	1 year	No
Secondary	CVD Risk factors	weight, lipids, blood glucose, BMI, Blood Pressure, % body fat, waist circumference	1 year	No
Secondary	Attitudes about participation in Research	Knowledge and attitudes about medical research participation assessed by survey	1 year	No