<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/NCT04416698</url>
  </required_header>
  <id_info>
    <org_study_id>other tobacco products</org_study_id>
    <nct_id>NCT04416698</nct_id>
  </id_info>
  <brief_title>Understanding Risk Perception, Behaviour, and Attitudes Related to Other New Tobacco Products Among Youth</brief_title>
  <official_title>Helping Youth to Quit Smoking by Understanding Their Risk Perception, Behaviour, and Attitudes Related to Electronic Cigarettes and Other New Tobacco Products</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>
      To understand the risk perception, behaviour, and attitudes related to electronic cigarettes&#xD;
      and other tobacco products among youth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase I Individual qualitative interviews will be conducted to understanding the needs and&#xD;
      concerns of youth smokers of e-cigarette or other new tobacco products, including their risk&#xD;
      perceptions, and the behaviour, attitudes, and experiences related to these products.&#xD;
&#xD;
      Phase II The findings from the interview in phase I will guide the development of a structure&#xD;
      questionnaire for a cross-sectional survey to further explore the behaviour, attitudes, and&#xD;
      experiences related to e-cigarette or other new tobacco products among youth.&#xD;
&#xD;
      The findings of this study have important implications for research and clinical practice.&#xD;
      Understanding how youth smokers perceive the risks of using e-cigarette and other new tobacco&#xD;
      products, and their behaviour, attitudes, experiences related to smoking to help them achieve&#xD;
      smoking abstinence. Moreover, the results of this study can understand the misconceptions&#xD;
      about e-cigarette and other new tobacco product among youth, increase their perception of the&#xD;
      risks of continued smoking and benefits of quitting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 5, 2020</start_date>
  <completion_date type="Anticipated">May 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Smoking behaviors in phase I</measure>
    <time_frame>Baseline</time_frame>
    <description>the behaviour, attitudes, and experiences related to electronic cigarettes and other new tobacco products among youth in individual qualitative interview (Phase I)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Smoking behaviors in phase II</measure>
    <time_frame>Baseline</time_frame>
    <description>the behaviour, attitudes, and experiences related to electronic cigarettes and other new tobacco products among youth in structured questionnaires (Phase II)</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">390</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Youth smokers</arm_group_label>
    <description>Participants of Youth Quitline</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Individual qualitative interview</intervention_name>
    <description>Individual interviews will be conducted to understanding the needs and concerns of youth smokers of e-cigarette or other new tobacco products, including their risk perceptions, and the behaviour, attitudes, and experiences related to these tobacco products.</description>
    <arm_group_label>Youth smokers</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>cross-sectional survey study</intervention_name>
    <description>structured questionnaire will be constructed for a cross-sectional survey to further explore the behaviour, attitudes, and experiences related to electronic cigarettes or other new tobacco products among youth.</description>
    <arm_group_label>Youth smokers</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Youth smokers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Youth smokers who contacted the Youth Quitline will be eligible to be included in this&#xD;
             study if they (1) are ethnic Chinese; (2) are aged ≤ 25 years; (3) are ever user of&#xD;
             e-cigarette or any new tobacco products; and (4) spoke Cantonese.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  psychologically or physically unable to communicate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>12 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ho Cheung William Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ho Cheung William Li, PhD</last_name>
    <phone>+85239176634</phone>
    <email>william3@hku.hk</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wei Xia, PhD</last_name>
    <phone>+85239176650</phone>
    <email>xiavive@hku.hk</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <state>Pokfulam</state>
        <country>Hong Kong</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ho Cheung William Li, PhD</last_name>
      <phone>+85239176634</phone>
      <email>william3@hku.hk</email>
    </contact>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 5, 2020</last_update_submitted>
  <last_update_submitted_qc>June 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2020</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. LI William Ho Cheung</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Youth smokers smoking cessation, tobacco products</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.</ipd_description>
    <ipd_time_frame>After the project is completed and the results of the project has been published.</ipd_time_frame>
    <ipd_access_criteria>Request could be sent to Principal Investigator (william3@hku.hk)</ipd_access_criteria>
  </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/NCT04416698
org study id: other tobacco products
nct id: NCT04416698
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To understand the risk perception, behaviour, and attitudes related to electronic cigarettes
      and other tobacco products among youth.
Phase I Individual qualitative interviews will be conducted to understanding the needs and
      concerns of youth smokers of e-cigarette or other new tobacco products, including their risk
      perceptions, and the behaviour, attitudes, and experiences related to these products.

      Phase II The findings from the interview in phase I will guide the development of a structure
      questionnaire for a cross-sectional survey to further explore the behaviour, attitudes, and
      experiences related to e-cigarette or other new tobacco products among youth.

      The findings of this study have important implications for research and clinical practice.
      Understanding how youth smokers perceive the risks of using e-cigarette and other new tobacco
      products, and their behaviour, attitudes, experiences related to smoking to help them achieve
      smoking abstinence. Moreover, the results of this study can understand the misconceptions
      about e-cigarette and other new tobacco product among youth, increase their perception of the
      risks of continued smoking and benefits of quitting.
observational model: Other
time perspective: Cross-Sectional
measure: Smoking behaviors in phase I
time frame: Baseline
description: the behaviour, attitudes, and experiences related to electronic cigarettes and other new tobacco products among youth in individual qualitative interview (Phase I)
measure: Smoking behaviors in phase II
time frame: Baseline
description: the behaviour, attitudes, and experiences related to electronic cigarettes and other new tobacco products among youth in structured questionnaires (Phase II)
arm group label: Youth smokers
description: Participants of Youth Quitline
intervention type: Behavioral
intervention name: Individual qualitative interview
description: Individual interviews will be conducted to understanding the needs and concerns of youth smokers of e-cigarette or other new tobacco products, including their risk perceptions, and the behaviour, attitudes, and experiences related to these tobacco products.
arm group label: Youth smokers
intervention type: Behavioral
intervention name: cross-sectional survey study
description: structured questionnaire will be constructed for a cross-sectional survey to further explore the behaviour, attitudes, and experiences related to electronic cigarettes or other new tobacco products among youth.
arm group label: Youth smokers
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: No
last name: Ho Cheung William Li, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Ho Cheung William Li, PhD
phone: +85239176634
email: william3@hku.hk
last name: Wei Xia, PhD
phone: +85239176650
email: xiavive@hku.hk
facility: 
status: Recruiting
contact: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Dr. LI William Ho Cheung
investigator title: Associate Professor
sharing ipd: Yes
ipd description: The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
ipd time frame: After the project is completed and the results of the project has been published.
ipd access criteria: Request could be sent to Principal Investigator (william3@hku.hk)