<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/NCT01730196</url>
  </required_header>
  <id_info>
    <org_study_id>R18DK082401</org_study_id>
    <nct_id>NCT01730196</nct_id>
  </id_info>
  <brief_title>Lifestyle Change to Prevent Diabetes Via African-American Churches</brief_title>
  <official_title>Fit Body and Soul: A Lifestyle Intervention for Diabetes Prevention Conducted Through African American Churches</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Augusta University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Augusta University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of&#xD;
      the GLB program compared with a health education intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2009</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight change</measure>
    <time_frame>12-weeks post intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fasting plasma glucose</measure>
    <time_frame>12 week post intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>physical activity level</measure>
    <time_frame>12 week post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life measures</measure>
    <time_frame>12 week post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost-effectiveness</measure>
    <time_frame>12 week post-intervetnion</time_frame>
    <description>Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemoglobin A1C</measure>
    <time_frame>12 week intervention</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>waist circumference</measure>
    <time_frame>12 weeks post-intervention</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">604</enrollment>
  <condition>Diabetes</condition>
  <condition>Weight Loss</condition>
  <arm_group>
    <arm_group_label>Fit Body and Soul</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Faith-based adaptation of the Group Life Style Program</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wellness education</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A health education program developed from the list of topics provided by the Centers for Disease Control and Prevention (CDC) Guide to Community Prevention Services</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Fit Body and Soul</intervention_name>
    <arm_group_label>Fit Body and Soul</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Wellness Education</intervention_name>
    <arm_group_label>Wellness education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Self-described African American&#xD;
&#xD;
          -  BMI ≥25kg/m2&#xD;
&#xD;
          -  Planning to remain within the community for 1 year&#xD;
&#xD;
          -  Non-diabetic&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Fasting plasma glucose ≥ 126 mg/dl following at least an 8-hr fast or A1C≥7.0%&#xD;
&#xD;
          -  HIV/AIDS&#xD;
&#xD;
          -  Active tuberculosis&#xD;
&#xD;
          -  Cancer requiring treatment in past 5 years except for cancers that have been cured or&#xD;
             in the opinion of the researchers has a good prognosis&#xD;
&#xD;
          -  Stroke within the past 6 months&#xD;
&#xD;
          -  Cirrhosis of the liver&#xD;
&#xD;
          -  Currently pregnant or planning pregnancy within the study period&#xD;
&#xD;
          -  Gastric weight-loss surgery&#xD;
&#xD;
          -  Weight loss &gt; 10% in past three months for any reason other than childbirth&#xD;
&#xD;
          -  Anti-diabetic medications&#xD;
&#xD;
          -  Prescription weight- loss medications&#xD;
&#xD;
          -  Anti-neoplastic agents&#xD;
&#xD;
          -  Anti-psychotic agents that have gluco-corticoid effect&#xD;
&#xD;
          -  Oral corticosteroid use &gt;6 weeks&#xD;
&#xD;
          -  Unwilling or unable to give informed consent&#xD;
&#xD;
          -  Unable to communicate with the church team or research group&#xD;
&#xD;
          -  Participation in another research study that would interfere with FBAS&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>64 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard W Sattin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Augusta University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Georgia Health Sciences University</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30912</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>April 8, 2014</last_update_submitted>
  <last_update_submitted_qc>April 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 9, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Augusta University</investigator_affiliation>
    <investigator_full_name>Richard Sattin</investigator_full_name>
    <investigator_title>Professor and Research Director, Department of Emergency Medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Weight Loss</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/NCT01730196
org study id: R18DK082401
nct id: NCT01730196
lead sponsor: 
has dmc: Yes
Fit Body and Soul is single-blinded, cluster- randomized trial of a faith-based adaptation of
      the GLB program compared with a health education intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Investigator)
measure: Weight change
time frame: 12-weeks post intervention
measure: Fasting plasma glucose
time frame: 12 week post intervention
measure: physical activity level
time frame: 12 week post-intervention
measure: quality of life measures
time frame: 12 week post-intervention
measure: cost-effectiveness
time frame: 12 week post-intervetnion
description: Health Related Quality of Life (HRQoL) which will be assessed using the EQ-5D and the SF-12v2®
measure: hemoglobin A1C
time frame: 12 week intervention
measure: waist circumference
time frame: 12 weeks post-intervention
arm group label: Fit Body and Soul
arm group type: Experimental
description: Faith-based adaptation of the Group Life Style Program
arm group label: Wellness education
arm group type: Active Comparator
description: A health education program developed from the list of topics provided by the Centers for Disease Control and Prevention (CDC) Guide to Community Prevention Services
intervention type: Behavioral
intervention name: Fit Body and Soul
arm group label: Fit Body and Soul
intervention type: Behavioral
intervention name: Wellness Education
arm group label: Wellness education
criteria: 
gender: All
minimum age: 20 Years
maximum age: 64 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Richard W Sattin, MD
role: Principal Investigator
affiliation: Augusta University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Augusta University
investigator full name: Richard Sattin
investigator title: Professor and Research Director, Department of Emergency Medicine
mesh term: Diabetes Mellitus
mesh term: Weight Loss