Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Reducing CVD Risk in African Americans Faith Communities (FAITH!)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02235896
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : December 31, 2015
Sponsor:
Information provided by (Responsible Party):
Sharonne Hayes, Mayo Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Disease Risk Factors Behavioral: Education/Behavior Modification Not Applicable

Detailed 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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Cardiovascular Disease Prevention Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health)
Study Start Date : September 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Education/Behavior Modification
Education/Behavior modification program
Behavioral: Education/Behavior Modification
Education, lifestyle counseling, experiential cooking, exercise classes.




Primary Outcome Measures :
  1. Knowledge, attitudes about CVD and CVD risk [ Time Frame: 1 year ]
    Change from baseline in knowledge and attitudes about CVD and CVD risk as measured by survey

  2. Behavior change [ Time Frame: 1 year ]
    Self reported diet composition, physical activity, smoking and stress


Secondary Outcome Measures :
  1. CVD Risk factors [ Time Frame: 1 year ]
    weight, lipids, blood glucose, BMI, Blood Pressure, % body fat, waist circumference

  2. Attitudes about participation in Research [ Time Frame: 1 year ]
    Knowledge and attitudes about medical research participation assessed by survey



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion:

  • Age >18 yrs,
  • able to consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02235896


Locations
Layout table for location information
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Layout table for investigator information
Principal Investigator: Sharonne Hayes, MD Mayo Clinic

Layout table for additonal information
Responsible Party: Sharonne Hayes, Professor of Medicine, Cardiovascular Diseases, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02235896     History of Changes
Other Study ID Numbers: 14-004122
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: December 31, 2015
Last Verified: December 2015

Keywords provided by Sharonne Hayes, Mayo Clinic:
risk factors, African American, lipids, blood pressure

Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases