<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/NCT03800966</url>
  </required_header>
  <id_info>
    <org_study_id>coshdrama201819</org_study_id>
    <nct_id>NCT03800966</nct_id>
  </id_info>
  <brief_title>A Brief Intervention Programme for TID</brief_title>
  <official_title>A Leaflet-based Programme for Tobacco Industry Denormalisation - a Brief Randomised Controlled Trial</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>
      The brief RCT will be conducted in the form of a questionnaire survey, with two kinds of&#xD;
      leaflets embedded in the same questionnaire. The RCT will be conducted in classrooms by&#xD;
      teachers who will be given two kinds of questionnaires (with leaflet embedded) used for&#xD;
      intervention and control groups. The questionnaires will be mixed in a way that two adjacent&#xD;
      questionnaires are always different. The intervention leaflets will contain information for&#xD;
      tobacco industry denormalisation. The control leaflets will contain information for tobacco&#xD;
      control policy in Hong Kong. The study aims to test the effect of a leaflet-based&#xD;
      intervention on primary school students' attitudes towards tobacco industry.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">March 25, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 2019</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attitudes towards tobacco industry in children</measure>
    <time_frame>1 month</time_frame>
    <description>Children will report their opinions towards 4 statements: 1); Tobacco companies are a trustworthy industry; 2) Tobacco industries use many tactics to resist tobacco control regulations; 3) Tobacco industries do everything they can to get young people to smoke; 4) Tobacco industries cheated the public for commercial gain. All the 4 questions have 5 options from definitely yes to definitely no. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry. A sum of scores from the 4 questions will be deemed as measurement of attitudes towards tobacco industry in primary school students.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intention to smoke cigarettes in children</measure>
    <time_frame>1 month</time_frame>
    <description>Two questions will be used to assess this outcome: 1) If one of your good friends offers you a cigarette, will you smoke it? 2) Do you think you will smoke cigarettes in the next 12 months? Response options are definitely not /probably not /not sure /probably yes /definitely yes. Those choosing options &quot;definitely not&quot; for all the two questions will be deemed having no intention to smoke cigarettes; other responses will be deemed having intention to smoke cigarettes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intention to use e-cigarettes in children</measure>
    <time_frame>1 month</time_frame>
    <description>Two questions will be used to assess this outcome: 1) If one of your good friends offers you an e-cigarette, will you use it? 2) Do you think you will use e-cigarettes in the next 12 months? Response options are definitely not /probably not /not sure /probably yes /definitely yes. Those choosing options &quot;definitely not&quot; for all the two questions will be deemed having no intention to use e-cigarettes; other responses will be deemed having intention to use e-cigarettes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tobacco control policy support in children</measure>
    <time_frame>1 month</time_frame>
    <description>Children will report their opinions towards 2 statements: 1) The Hong Kong government should enact a total ban on e-cigarettes promptly; 2) The Hong Kong government should prohibit the sale of all tobacco products by legislation. All the 2 questions have 5 options from definitely yes to definitely no. The options will be recoded into 4-0, with higher scores indicating stronger support towards the tobacco control policy in Hong Kong. A sum of scores from the 2 questions will be deemed as measurement of support for tobacco control policy in Hong Kong in primary school students.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Attitude towards smoking in children</measure>
    <time_frame>1 month</time_frame>
    <description>Children will report their opinions towards one statement: Smoking is personal choice, there is no right and wrong. The question has 5 options from definitely yes to definitely no. The options will be recoded into 4-0, with higher scores indicating more negative attitudes towards smoking. Score from that question will be deemed as measurement of attitude towards smoking in primary school students.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1069</enrollment>
  <condition>Attitudes Towards Tobacco Industry</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention leaflets will contain information on the TI's tactics to get young people to smoke.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The control leaflets will contain information on the tobacco control in Hong Kong.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Leaflet</intervention_name>
    <description>Leaflets for both groups will be printed in colour. Leaflet in each group contains 8 pictures and 8 statement, whose sequences will be scrambled. Primary school students need to do the matching, to ensure they read the statements.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Parents and children should all understand Chinese&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sai Yin Ho, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local primary 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 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>May 21, 2019</last_update_submitted>
  <last_update_submitted_qc>May 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2019</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>Principle investigator and associate professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03800966
org study id: coshdrama201819
nct id: NCT03800966
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The brief RCT will be conducted in the form of a questionnaire survey, with two kinds of
      leaflets embedded in the same questionnaire. The RCT will be conducted in classrooms by
      teachers who will be given two kinds of questionnaires (with leaflet embedded) used for
      intervention and control groups. The questionnaires will be mixed in a way that two adjacent
      questionnaires are always different. The intervention leaflets will contain information for
      tobacco industry denormalisation. The control leaflets will contain information for tobacco
      control policy in Hong Kong. The study aims to test the effect of a leaflet-based
      intervention on primary school students' attitudes towards tobacco industry.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: Attitudes towards tobacco industry in children
time frame: 1 month
description: Children will report their opinions towards 4 statements: 1); Tobacco companies are a trustworthy industry; 2) Tobacco industries use many tactics to resist tobacco control regulations; 3) Tobacco industries do everything they can to get young people to smoke; 4) Tobacco industries cheated the public for commercial gain. All the 4 questions have 5 options from definitely yes to definitely no. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry. A sum of scores from the 4 questions will be deemed as measurement of attitudes towards tobacco industry in primary school students.
measure: Intention to smoke cigarettes in children
time frame: 1 month
description: Two questions will be used to assess this outcome: 1) If one of your good friends offers you a cigarette, will you smoke it? 2) Do you think you will smoke cigarettes in the next 12 months? Response options are definitely not /probably not /not sure /probably yes /definitely yes. Those choosing options "definitely not" for all the two questions will be deemed having no intention to smoke cigarettes; other responses will be deemed having intention to smoke cigarettes.
measure: Intention to use e-cigarettes in children
time frame: 1 month
description: Two questions will be used to assess this outcome: 1) If one of your good friends offers you an e-cigarette, will you use it? 2) Do you think you will use e-cigarettes in the next 12 months? Response options are definitely not /probably not /not sure /probably yes /definitely yes. Those choosing options "definitely not" for all the two questions will be deemed having no intention to use e-cigarettes; other responses will be deemed having intention to use e-cigarettes.
measure: Tobacco control policy support in children
time frame: 1 month
description: Children will report their opinions towards 2 statements: 1) The Hong Kong government should enact a total ban on e-cigarettes promptly; 2) The Hong Kong government should prohibit the sale of all tobacco products by legislation. All the 2 questions have 5 options from definitely yes to definitely no. The options will be recoded into 4-0, with higher scores indicating stronger support towards the tobacco control policy in Hong Kong. A sum of scores from the 2 questions will be deemed as measurement of support for tobacco control policy in Hong Kong in primary school students.
measure: Attitude towards smoking in children
time frame: 1 month
description: Children will report their opinions towards one statement: Smoking is personal choice, there is no right and wrong. The question has 5 options from definitely yes to definitely no. The options will be recoded into 4-0, with higher scores indicating more negative attitudes towards smoking. Score from that question will be deemed as measurement of attitude towards smoking in primary school students.
arm group label: Intervention
arm group type: Experimental
description: The intervention leaflets will contain information on the TI's tactics to get young people to smoke.
arm group label: Control
arm group type: Placebo Comparator
description: The control leaflets will contain information on the tobacco control in Hong Kong.
intervention type: Other
intervention name: Leaflet
description: Leaflets for both groups will be printed in colour. Leaflet in each group contains 8 pictures and 8 statement, whose sequences will be scrambled. Primary school students need to do the matching, to ensure they read the statements.
arm group label: Control
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sai Yin Ho, PhD
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: Principle investigator and associate professor
sharing ipd: Undecided