<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/NCT01686178</url>
  </required_header>
  <id_info>
    <org_study_id>1U01CA154240-05</org_study_id>
    <nct_id>NCT01686178</nct_id>
  </id_info>
  <brief_title>Countering Young Adult Tobacco Marketing in Bars</brief_title>
  <official_title>Countering Young Adult Tobacco Marketing in Bars</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of the study is to implement and evaluate interventions to decrease smoking among&#xD;
      young adults attending bars and nightclubs. It is believed that the proportion of young adult&#xD;
      current smokers during and after the intervention will be significantly less than the&#xD;
      proportion of young adult smokers before the intervention in each of the study cities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">July 2, 2017</completion_date>
  <primary_completion_date type="Actual">July 2, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-Reported Tobacco Smoking in past 30 days</measure>
    <time_frame>Between baseline and follow-up at 1,2, &amp; 3 years post-baseline</time_frame>
    <description>The main outcome measure for this analysis will be the proportion of current smoking, defined as self-reported smoking on one or more of the past 30 days.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17422</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Anti-smoking social marketing campaign</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In prior research, a high risk subpopulation of young adults was identified in San Diego, CA: the &quot;hipster&quot; subculture. We developed a yearlong pilot social branding intervention to decrease smoking among this group, using social events and social leaders to promote a strong nonsmoking lifestyle. The intervention rationale is based on utilizing industry market research tools to define the target audience and directly countering tobacco industry lifestyle marketing strategies. We now propose to extend this intervention to three other cities (tailoring the intervention to a high-risk subpopulation of young adults in each city) and evaluate it in a multicenter quasi-experimental controlled trial.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Survey research data will be collected in control cities with the same schedule as data collection in the cities where the intervention is taking place.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Anti-smoking social marketing campaign</intervention_name>
    <description>We will utilize industry market research tools to define the target audience (segment of community with high smoking prevalence and high social influence) and directly counter tobacco industry lifestyle marketing strategies through local promotion of a smokefree brand and branded bar and club events.</description>
    <arm_group_label>Anti-smoking social marketing campaign</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants are healthy volunteers 18-26 years old currently living in San Diego,&#xD;
             Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, or Los&#xD;
             Angeles who attend bars or nightclubs&#xD;
&#xD;
          -  Able to read, speak, and understand English&#xD;
&#xD;
          -  NOTE: PARTICIPANTS CAN ONLY TAKE PART IN THE STUDY BY ENCOUNTERING STUDY SURVEY TEAMS&#xD;
             OUT AT BARS OR NIGHTCLUBS IN ONE OF THE STUDY CITIES LISTED ABOVE. PARTICIPANTS CANNOT&#xD;
             SIGN UP FOR THE STUDY BY CALLING OR EMAILING.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Out of age range (18-26 years old)&#xD;
&#xD;
          -  Not living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area,&#xD;
             Nashville, Tucson, Los Angeles or New York City, or currently attending college&#xD;
             outside of the target cities.&#xD;
&#xD;
          -  Unable to read, speak, or understand English.&#xD;
&#xD;
          -  Unwillingness or inability to participate or give informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Pamela M Ling, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Ling PM, Glantz SA. Using tobacco-industry marketing research to design more effective tobacco-control campaigns. JAMA. 2002 Jun 12;287(22):2983-9. doi: 10.1001/jama.287.22.2983.</citation>
    <PMID>12052128</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2012</study_first_posted>
  <last_update_submitted>October 16, 2017</last_update_submitted>
  <last_update_submitted_qc>October 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smoking</keyword>
  <keyword>Smoking Cessation</keyword>
  <keyword>Tobacco Use Cessation</keyword>
  <keyword>Social Networks</keyword>
  <keyword>Social Control, Informal</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/NCT01686178
org study id: 1U01CA154240-05
nct id: NCT01686178
lead sponsor: 
collaborator: 
has dmc: No
The goal of the study is to implement and evaluate interventions to decrease smoking among
      young adults attending bars and nightclubs. It is believed that the proportion of young adult
      current smokers during and after the intervention will be significantly less than the
      proportion of young adult smokers before the intervention in each of the study cities.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Self-Reported Tobacco Smoking in past 30 days
time frame: Between baseline and follow-up at 1,2, & 3 years post-baseline
description: The main outcome measure for this analysis will be the proportion of current smoking, defined as self-reported smoking on one or more of the past 30 days.
arm group label: Anti-smoking social marketing campaign
arm group type: Experimental
description: In prior research, a high risk subpopulation of young adults was identified in San Diego, CA: the "hipster" subculture. We developed a yearlong pilot social branding intervention to decrease smoking among this group, using social events and social leaders to promote a strong nonsmoking lifestyle. The intervention rationale is based on utilizing industry market research tools to define the target audience and directly countering tobacco industry lifestyle marketing strategies. We now propose to extend this intervention to three other cities (tailoring the intervention to a high-risk subpopulation of young adults in each city) and evaluate it in a multicenter quasi-experimental controlled trial.
arm group label: Control
arm group type: No Intervention
description: Survey research data will be collected in control cities with the same schedule as data collection in the cities where the intervention is taking place.
intervention type: Behavioral
intervention name: Anti-smoking social marketing campaign
description: We will utilize industry market research tools to define the target audience (segment of community with high smoking prevalence and high social influence) and directly counter tobacco industry lifestyle marketing strategies through local promotion of a smokefree brand and branded bar and club events.
arm group label: Anti-smoking social marketing campaign
criteria: 
gender: All
minimum age: 18 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Pamela M Ling, MD, MPH
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
citation: Ling PM, Glantz SA. Using tobacco-industry marketing research to design more effective tobacco-control campaigns. JAMA. 2002 Jun 12;287(22):2983-9. doi: 10.1001/jama.287.22.2983.
PMID: 12052128
responsible party type: Sponsor