<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/NCT01699321</url>
  </required_header>
  <id_info>
    <org_study_id>10-1903</org_study_id>
    <secondary_id>1U54CA156733</secondary_id>
    <nct_id>NCT01699321</nct_id>
  </id_info>
  <brief_title>FITShop: Promoting Physical Activity in Black Barbershops</brief_title>
  <acronym>FITShop</acronym>
  <official_title>Promoting Physical Activity in Black Barbershops</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>North Carolina Central University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Physical activity has been proven to reduce the risk of cancer. The North Carolina FITShop&#xD;
      research study will test the effectiveness of a program aimed at increasing physical activity&#xD;
      among African American men. Approximately 14 barbershops and 560 shop customers within&#xD;
      Orange, Durham, Chatham, Alamance, and Wake counties will be enrolled into this research&#xD;
      study. If FITShop is effective, we will share our results throughout North Carolina and&#xD;
      nationally.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Black men suffer disproportionately higher rates of nearly all disease categories, including&#xD;
      cancer --the leading cause of death in North Carolina. An estimated 50% of cancer is&#xD;
      preventable with lifestyle modifications such as increasing physical activity (PA),&#xD;
      eliminating tobacco use/exposure and maintaining a healthy weight. Evidence suggests that&#xD;
      physical activity can reduce risk to several types of cancer. Innovative ways to reach Black&#xD;
      men with effective health promotion interventions are needed. Barbershops represent one place&#xD;
      where Black men can be reached, but have not been utilized as settings for intervening to&#xD;
      promote physical activity. An experienced, interdisciplinary, partnership between community&#xD;
      members (barbershop owners, barbers and their customers) and researchers from UNC Chapel&#xD;
      Hill/Lineberger Comprehensive Cancer Center and the Gillings School of Global Public Health,&#xD;
      and North Carolina Central University are conducting a two-phase outreach study to bridge&#xD;
      this gap. Phase 1 is a series of inter-related formative research studies (in-depth&#xD;
      interviews with barbers/owners; observations in shops; focus groups with customers) leading&#xD;
      to the development of a theory and evidence-guided, multi-level physical activity&#xD;
      intervention (FITShop) designed to increase PA among Black men in barbershops. Using Phase 1&#xD;
      results, Phase 2 is a two-arm, group randomized, initial efficacy trial of the FITShop&#xD;
      intervention in 14 Black barbershops with 40 customers per shop (n=560 total). Customers in&#xD;
      Arm 1 (7 shops, 280 customers) will receive the FITShop intervention which includes barber&#xD;
      training, PA contest in the shop, use of pedometers, community connections and personal&#xD;
      feedback plus recommendations for PA. Customers in Arm 2 (7 shops, 280 customers) will&#xD;
      receive a Financial Empowerment (FE) attention-control intervention that mimics exposure&#xD;
      amount without influencing the primary outcome. Consistent with community-based participatory&#xD;
      research principles, an Advisory Board will guide all aspects of the study planning,&#xD;
      development, implementation and analysis of results. The primary outcome (physical activity)&#xD;
      will be measured via accelerometer using a 7-day protocol and with self-report questionnaires&#xD;
      at baseline and 6 months using a previously tested protocol with Black men recruited from&#xD;
      barbershops. All primary/secondary outcomes will be measured on all customers at an&#xD;
      assessment event/via questionnaire prior to randomization (and at 6 mo) using standardized,&#xD;
      previously tested protocols. Process evaluation will assess dose of intervention delivered,&#xD;
      received, fidelity, as well as reach, adoption and representativeness at the customer, barber&#xD;
      and barbershop levels. Since barbershops are located in all communities, if effective, this&#xD;
      intervention has promise for dissemination &amp; sustainability.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2014</completion_date>
  <primary_completion_date type="Actual">September 2013</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in physical activity measures</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Minutes of physical activity will be self-reported along with physical activity status, self-efficacy, barriers, etc. Accelerometers will be given at baseline and the 6 month follow-up.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in smoking status</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Self-reported smoking status (y/n)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in weight/BMI</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Participants weight will be measured at baseline and 6 months. Their BMI will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in waist circumference</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Participant's waist circumference will be measured at baseline and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in resting heart rate</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Participant's resting heart rate will be measured at baseline and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood pressure</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Participant's blood pressure will be measured at baseline and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in aerobic fitness level</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in psycho-social variables</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Participant's will self-report psycho-social variables at baseline and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in barber-customer interactions</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Research team will conduct shop observations at baseline and 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in barbershop characteristics</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">628</enrollment>
  <condition>Physical Activity</condition>
  <arm_group>
    <arm_group_label>Your Move (physical activity)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Your Move intervention is a multi-level, theory and evidence-based intervention that will include the following components: monthly handbills with community resources, newsletters, contests (shop and customer level), tailored health feedback report, and monthly phone calls from the research team.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Your Money (financial empowerment)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The Your Money program is an attention control intervention. Owners and barbers will receive 3 workshops that focus on financial health. Customers will receive monthly handbills and newsletters about different financial health topics.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Your Move (physical activity)</intervention_name>
    <description>Materials that are provided will aim to increase a participant's minutes of physical activity.</description>
    <arm_group_label>Your Move (physical activity)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Your Money (financial empowerment)</intervention_name>
    <description>Materials that are provided to participants will direct them to resources for financial health.</description>
    <arm_group_label>Your Money (financial empowerment)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18+ years of age&#xD;
&#xD;
          -  African American&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Regular customer of the barbershop&#xD;
&#xD;
        Exclusion Criteria:&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>Laura A Linnan, ScD, CHES</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Carolina Central University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27707</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>June 15, 2015</last_update_submitted>
  <last_update_submitted_qc>June 15, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 16, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>physical activity</keyword>
  <keyword>barbershop</keyword>
  <keyword>cancer prevention</keyword>
  <keyword>exercise</keyword>
  <keyword>men's health</keyword>
  <keyword>African American men</keyword>
  <!-- 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/NCT01699321
org study id: 10-1903
secondary id: 1U54CA156733
nct id: NCT01699321
lead sponsor: 
collaborator: 
has dmc: Yes
Physical activity has been proven to reduce the risk of cancer. The North Carolina FITShop
      research study will test the effectiveness of a program aimed at increasing physical activity
      among African American men. Approximately 14 barbershops and 560 shop customers within
      Orange, Durham, Chatham, Alamance, and Wake counties will be enrolled into this research
      study. If FITShop is effective, we will share our results throughout North Carolina and
      nationally.
Black men suffer disproportionately higher rates of nearly all disease categories, including
      cancer --the leading cause of death in North Carolina. An estimated 50% of cancer is
      preventable with lifestyle modifications such as increasing physical activity (PA),
      eliminating tobacco use/exposure and maintaining a healthy weight. Evidence suggests that
      physical activity can reduce risk to several types of cancer. Innovative ways to reach Black
      men with effective health promotion interventions are needed. Barbershops represent one place
      where Black men can be reached, but have not been utilized as settings for intervening to
      promote physical activity. An experienced, interdisciplinary, partnership between community
      members (barbershop owners, barbers and their customers) and researchers from UNC Chapel
      Hill/Lineberger Comprehensive Cancer Center and the Gillings School of Global Public Health,
      and North Carolina Central University are conducting a two-phase outreach study to bridge
      this gap. Phase 1 is a series of inter-related formative research studies (in-depth
      interviews with barbers/owners; observations in shops; focus groups with customers) leading
      to the development of a theory and evidence-guided, multi-level physical activity
      intervention (FITShop) designed to increase PA among Black men in barbershops. Using Phase 1
      results, Phase 2 is a two-arm, group randomized, initial efficacy trial of the FITShop
      intervention in 14 Black barbershops with 40 customers per shop (n=560 total). Customers in
      Arm 1 (7 shops, 280 customers) will receive the FITShop intervention which includes barber
      training, PA contest in the shop, use of pedometers, community connections and personal
      feedback plus recommendations for PA. Customers in Arm 2 (7 shops, 280 customers) will
      receive a Financial Empowerment (FE) attention-control intervention that mimics exposure
      amount without influencing the primary outcome. Consistent with community-based participatory
      research principles, an Advisory Board will guide all aspects of the study planning,
      development, implementation and analysis of results. The primary outcome (physical activity)
      will be measured via accelerometer using a 7-day protocol and with self-report questionnaires
      at baseline and 6 months using a previously tested protocol with Black men recruited from
      barbershops. All primary/secondary outcomes will be measured on all customers at an
      assessment event/via questionnaire prior to randomization (and at 6 mo) using standardized,
      previously tested protocols. Process evaluation will assess dose of intervention delivered,
      received, fidelity, as well as reach, adoption and representativeness at the customer, barber
      and barbershop levels. Since barbershops are located in all communities, if effective, this
      intervention has promise for dissemination & sustainability.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in physical activity measures
time frame: Baseline and 6 months
description: Minutes of physical activity will be self-reported along with physical activity status, self-efficacy, barriers, etc. Accelerometers will be given at baseline and the 6 month follow-up.
measure: Change in smoking status
time frame: Baseline and 6 months
description: Self-reported smoking status (y/n)
measure: Change in weight/BMI
time frame: Baseline and 6 months
description: Participants weight will be measured at baseline and 6 months. Their BMI will be calculated
measure: Change in waist circumference
time frame: Baseline and 6 months
description: Participant's waist circumference will be measured at baseline and 6 months.
measure: Change in resting heart rate
time frame: Baseline and 6 months
description: Participant's resting heart rate will be measured at baseline and 6 months.
measure: Change in blood pressure
time frame: Baseline and 6 months
description: Participant's blood pressure will be measured at baseline and 6 months.
measure: Change in aerobic fitness level
time frame: Baseline and 6 months
description: Participant's aerobic fitness level will be measured using a step test at baseline and 6 months.
measure: Change in psycho-social variables
time frame: Baseline and 6 months
description: Participant's will self-report psycho-social variables at baseline and 6 months.
measure: Change in barber-customer interactions
time frame: Baseline and 6 months
description: Research team will conduct shop observations at baseline and 6 months.
measure: Change in barbershop characteristics
time frame: Baseline and 6 months
description: Barbershop characteristics will be reported through environmental scans of the shop and informational interviews with the owners and barbers.
arm group label: Your Move (physical activity)
arm group type: Experimental
description: The Your Move intervention is a multi-level, theory and evidence-based intervention that will include the following components: monthly handbills with community resources, newsletters, contests (shop and customer level), tailored health feedback report, and monthly phone calls from the research team.
arm group label: Your Money (financial empowerment)
arm group type: Other
description: The Your Money program is an attention control intervention. Owners and barbers will receive 3 workshops that focus on financial health. Customers will receive monthly handbills and newsletters about different financial health topics.
intervention type: Behavioral
intervention name: Your Move (physical activity)
description: Materials that are provided will aim to increase a participant's minutes of physical activity.
arm group label: Your Move (physical activity)
intervention type: Other
intervention name: Your Money (financial empowerment)
description: Materials that are provided to participants will direct them to resources for financial health.
arm group label: Your Money (financial empowerment)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Laura A Linnan, ScD, CHES
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
facility: 
country: United States
responsible party type: Sponsor