<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02235896</url>
  </required_header>
  <id_info>
    <org_study_id>14-004122</org_study_id>
    <nct_id>NCT02235896</nct_id>
  </id_info>
  <brief_title>Reducing CVD Risk in African Americans Faith Communities</brief_title>
  <acronym>FAITH!</acronym>
  <official_title>Cardiovascular Disease Prevention Among African-Americans by FAITH! (Fostering African-American Improvement in Total Health)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The ultimate goal of our partnership with local African-American churches is to implement an&#xD;
      effective, multi-component intervention to increase awareness of the critical importance of&#xD;
      healthy lifestyle in the prevention of cardiovascular disease (CVD). We will utilize the&#xD;
      American Heart Association (AHA) prevention strategy, &amp;quot;Life's Simple 7&amp;quot; to address&#xD;
      the major risk factors for CVD: diet, smoking, physical inactivity, hypertension, diabetes,&#xD;
      cholesterol and obesity in order to improve overall cardiovascular health. Our main strategy&#xD;
      consists of a community-based participatory research approach that involves focus groups to&#xD;
      assess participant knowledge and beliefs about CVD risk factors prior to program initiation.&#xD;
      We will also determine participant dietary and exercise practices, knowledge and perceptions&#xD;
      related to healthy lifestyle and chronic diseases, demographic/health status information,&#xD;
      health care utilization, biometrics (weight, blood pressure, blood tests for glucose and&#xD;
      cholesterol, etc.) and attitudes about medical research at baseline, program completion and&#xD;
      6-month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Church goers will undergo, baseline assessment of knowledge attitudes and behavior survey as&#xD;
      it relates to CVD risk and anthropomorphic measurements. A 3 month experiential educational&#xD;
      program will be provided at 2 locations. At 6 months after baseline a followup measure will&#xD;
      be obtained&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2015</completion_date>
  <primary_completion_date type="Actual">August 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge, attitudes about CVD and CVD risk</measure>
    <time_frame>1 year</time_frame>
    <description>Change from baseline in knowledge and attitudes about CVD and CVD risk as measured by survey</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Behavior change</measure>
    <time_frame>1 year</time_frame>
    <description>Self reported diet composition, physical activity, smoking and stress</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CVD Risk factors</measure>
    <time_frame>1 year</time_frame>
    <description>weight, lipids, blood glucose, BMI, Blood Pressure, % body fat, waist circumference</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitudes about participation in Research</measure>
    <time_frame>1 year</time_frame>
    <description>Knowledge and attitudes about medical research participation assessed by survey</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">37</enrollment>
  <condition>Cardiovascular Disease Risk Factors</condition>
  <arm_group>
    <arm_group_label>Education/Behavior Modification</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Education/Behavior modification program</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Education/Behavior Modification</intervention_name>
    <description>Education, lifestyle counseling, experiential cooking, exercise classes.</description>
    <arm_group_label>Education/Behavior Modification</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion:&#xD;
&#xD;
          -  Age &gt;18 yrs,&#xD;
&#xD;
          -  able to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sharonne Hayes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>December 30, 2015</last_update_submitted>
  <last_update_submitted_qc>December 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 31, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Sharonne Hayes</investigator_full_name>
    <investigator_title>Professor of Medicine, Cardiovascular Diseases</investigator_title>
  </responsible_party>
  <keyword>risk factors, African American, lipids, blood pressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02235896
org study id: 14-004122
nct id: NCT02235896
lead sponsor: 
has dmc: No
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, &quot;Life's Simple 7&quot; 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.
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
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Knowledge, attitudes about CVD and CVD risk
time frame: 1 year
description: Change from baseline in knowledge and attitudes about CVD and CVD risk as measured by survey
measure: Behavior change
time frame: 1 year
description: Self reported diet composition, physical activity, smoking and stress
measure: CVD Risk factors
time frame: 1 year
description: weight, lipids, blood glucose, BMI, Blood Pressure, % body fat, waist circumference
measure: Attitudes about participation in Research
time frame: 1 year
description: Knowledge and attitudes about medical research participation assessed by survey
arm group label: Education/Behavior Modification
arm group type: Other
description: Education/Behavior modification program
intervention type: Behavioral
intervention name: Education/Behavior Modification
description: Education, lifestyle counseling, experiential cooking, exercise classes.
arm group label: Education/Behavior Modification
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sharonne Hayes, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Sharonne Hayes
investigator title: Professor of Medicine, Cardiovascular Diseases
mesh term: Cardiovascular Diseases