<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/NCT03264144</url>
  </required_header>
  <id_info>
    <org_study_id>17629016</org_study_id>
    <nct_id>NCT03264144</nct_id>
  </id_info>
  <brief_title>Address Tobacco Use Among Adolescents in Hong Kong</brief_title>
  <official_title>Changing Social Norms Around Smoking: A Cluster Randomized Controlled Trial to Address Tobacco Use Among Adolescents in Hong Kong</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will examine the effectiveness of a social norms campaign in correcting smoking&#xD;
      misperceptions, reducing smoking susceptibility and changing smoking-related behaviours in&#xD;
      Hong Kong adolescents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study involves a behavioural intervention with social norms approaches to correct smoking&#xD;
      misperceptions, reduce smoking susceptibility and change smoking-related behaviours in Hong&#xD;
      Kong adolescents. A 2-arm stratified clustered randomised controlled trial (RCT) will be&#xD;
      conducted to evaluate the effectiveness of the intervention. A total of 18 secondary schools&#xD;
      will be randomly selected from the 5 regions in Hong Kong and invited to the RCT. The schools&#xD;
      will then be randomly allocated to intervention or control group in the ratio of 1:1.&#xD;
      Secondary 1 to 5 (US Grade 7 to 11) students will be invited. Students in both intervention&#xD;
      and control group will complete a baseline survey, and the intervention group will receive&#xD;
      the intervention after the baseline. Intervention materials includes posters and table tents&#xD;
      at school, flyers to students, and online banner on school website. The intervention adopts&#xD;
      social norms approaches, and will highlight the prevalence of adolescents who do not smoke&#xD;
      and have no intention to smoke. It will last for 2 months. Both intervention and control&#xD;
      groups will complete follow-up surveys at 3 and 9 months. The control group will receive the&#xD;
      intervention materials after the RCT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 13, 2017</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</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>Perceived adolescent smoking prevalence</measure>
    <time_frame>At the time of survey</time_frame>
    <description>Perceived prevalence of current smoking secondary school students in Hong Kong</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking susceptibility</measure>
    <time_frame>At the time of survey</time_frame>
    <description>Intention to smoke in the next 12 months, if good friends are smoking in front, and if a good friend offered a cigarette</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Smoking intensity</measure>
    <time_frame>Past 30 days</time_frame>
    <description>Number of smoking days in the past 30 days, average daily cigarette consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intention to quit</measure>
    <time_frame>At the time of survey</time_frame>
    <description>Intention to quit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quit attempts</measure>
    <time_frame>Past 3 months</time_frame>
    <description>Number of quit attempts</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12868</enrollment>
  <condition>Tobacco Use</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Students in the schools assigned to the intervention group will receive the intervention after the baseline survey. The intervention will be a social norms campaign involving posters, table tents, flyers and an online banner.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Students in the schools assigned to the control group will not receive anything during the randomised controlled trial. They will receive the intervention materials after the trial.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Social norms campaign</intervention_name>
    <description>Intervention messages will mainly highlight the prevalence of Hong Kong adolescents who do not smoke cigarettes and have no intention to smoke cigarettes. The messages will be conveyed to students through posters, table tents, flyers and an online banner. Posters will be posted at prominent places in schools, table tents will be placed in school canteens, flyers will be distributed to students, and the online banner will be placed at the school website. The intervention will last for 2 months.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Local secondary schools that cover grades 1-6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  International secondary schools&#xD;
&#xD;
          -  Special schools for adolescents with visual, hearing or other physical impairments or&#xD;
             disabilities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>20 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sai Yin Ho, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local secondary schools</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>May 1, 2018</last_update_submitted>
  <last_update_submitted_qc>May 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Dr. Daniel Sai-Yin Ho</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Social norms</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Smoking</keyword>
  <keyword>Randomised controlled trial</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03264144
org study id: 17629016
nct id: NCT03264144
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will examine the effectiveness of a social norms campaign in correcting smoking
      misperceptions, reducing smoking susceptibility and changing smoking-related behaviours in
      Hong Kong adolescents.
The study involves a behavioural intervention with social norms approaches to correct smoking
      misperceptions, reduce smoking susceptibility and change smoking-related behaviours in Hong
      Kong adolescents. A 2-arm stratified clustered randomised controlled trial (RCT) will be
      conducted to evaluate the effectiveness of the intervention. A total of 18 secondary schools
      will be randomly selected from the 5 regions in Hong Kong and invited to the RCT. The schools
      will then be randomly allocated to intervention or control group in the ratio of 1:1.
      Secondary 1 to 5 (US Grade 7 to 11) students will be invited. Students in both intervention
      and control group will complete a baseline survey, and the intervention group will receive
      the intervention after the baseline. Intervention materials includes posters and table tents
      at school, flyers to students, and online banner on school website. The intervention adopts
      social norms approaches, and will highlight the prevalence of adolescents who do not smoke
      and have no intention to smoke. It will last for 2 months. Both intervention and control
      groups will complete follow-up surveys at 3 and 9 months. The control group will receive the
      intervention materials after the RCT.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Perceived adolescent smoking prevalence
time frame: At the time of survey
description: Perceived prevalence of current smoking secondary school students in Hong Kong
measure: Smoking susceptibility
time frame: At the time of survey
description: Intention to smoke in the next 12 months, if good friends are smoking in front, and if a good friend offered a cigarette
measure: Smoking intensity
time frame: Past 30 days
description: Number of smoking days in the past 30 days, average daily cigarette consumption
measure: Intention to quit
time frame: At the time of survey
description: Intention to quit
measure: Quit attempts
time frame: Past 3 months
description: Number of quit attempts
arm group label: Intervention
arm group type: Experimental
description: Students in the schools assigned to the intervention group will receive the intervention after the baseline survey. The intervention will be a social norms campaign involving posters, table tents, flyers and an online banner.
arm group label: Control
arm group type: No Intervention
description: Students in the schools assigned to the control group will not receive anything during the randomised controlled trial. They will receive the intervention materials after the trial.
intervention type: Behavioral
intervention name: Social norms campaign
description: Intervention messages will mainly highlight the prevalence of Hong Kong adolescents who do not smoke cigarettes and have no intention to smoke cigarettes. The messages will be conveyed to students through posters, table tents, flyers and an online banner. Posters will be posted at prominent places in schools, table tents will be placed in school canteens, flyers will be distributed to students, and the online banner will be placed at the school website. The intervention will last for 2 months.
arm group label: Intervention
criteria: 
gender: All
minimum age: 11 Years
maximum age: 20 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sai Yin Ho, Dr
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. Daniel Sai-Yin Ho
investigator title: Associate Professor
sharing ipd: No