<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/NCT01671553</url>
  </required_header>
  <id_info>
    <org_study_id>COSH-SmokefreeTeen</org_study_id>
    <nct_id>NCT01671553</nct_id>
  </id_info>
  <brief_title>Helping Smokers to Quit Via the Smoke-free Teen Contest 2011: A Randomized Controlled Trial</brief_title>
  <official_title>Helping Smokers to Quit Via the Smoke-free Teen Contest 2011: A Randomized 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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background The home is the primary source of SHS exposure. The scientific evidence shows that&#xD;
      there is no risk-free level of exposure to SHS that stop smoking is the sole way to&#xD;
      completely eliminate the risk of SHS exposure. Although research studies indicated that&#xD;
      smoking bans in restaurants, bars, and workplaces can significantly reduce the level of SHS&#xD;
      exposure, governments lack the authority to restrict smoking in homes. Therefore, parental&#xD;
      cessation is a more effective means to reduce the SHS exposure.&#xD;
&#xD;
      Aim The aims are (1) to promote smoking cessation in the community and (2) assess the effect&#xD;
      of different smoking cessation approaches through the Smoke-free Teen Contest. The specific&#xD;
      objectives of the study are to test the effectiveness of different smoking cessation&#xD;
      approaches on quit rate and change in smoking behaviours among smokers who are referred by&#xD;
      Hong Kong Council on Smoking and Health (COSH).&#xD;
&#xD;
      Methods The referred smokers were nominated by primary 1 to secondary 3 students who joined&#xD;
      the Smoke-free Teen Contest organized by COSH. Two domains of outcome will be assessed: (1)&#xD;
      the primary outcome is the self-reported 7-day point prevalence (pp) quit rate at 6 months&#xD;
      and (2)the secondary outcomes included (i) biochemical validated quit rate at 6 months and&#xD;
      (ii) rate of smoking reduction by at least of half and (iii) number of quit attempts at 6&#xD;
      months.&#xD;
&#xD;
      Procedure Smokers, who are referred by the Hong Kong Council on Smoking and Health (COSH),&#xD;
      were nominated by primary 1 to secondary 3 students joined Smoke-free Teen Contest organized&#xD;
      by COSH. Those smokers will be randomized into two groups (Intervention group and Control&#xD;
      group) using the clustered randomization method by school. After the clustered randomization,&#xD;
      the oral consent of eligible subjects were obtained to the study through telephone interview.&#xD;
      Intervention group will receive 1,2,3, 8-week and 6-month telephone follow-up after baseline,&#xD;
      while control group will only receive 6-month telephone follow-up after baseline. Those&#xD;
      participants who reported to have stopped smoking will be invited for biochemical validation&#xD;
      of smoking status at 6-month follow-up.&#xD;
&#xD;
      Hypothesis We hypothesize that the intensive telephone counselling plus NRT treatment will&#xD;
      lead to significant increases in rates of smoking cessation in the intervention groups than&#xD;
      the control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Smoking is the single most preventable cause of deaths in Hong Kong and the smoking&#xD;
      prevalence was about 11.8% (20.5% in males and 3.6% in females) in 2008. It was estimated&#xD;
      that smoking accounts for about one fifth of all deaths and kills about 5,700 people per&#xD;
      year. Smoking has been associated with serious damage to health at all ages, leading to&#xD;
      cancers, heart diseases, stroke, chronic lung diseases, and many other health problems. It&#xD;
      was estimated in 1998 that a total of US$688 million medical cost were attributed to&#xD;
      smoking-related diseases annually, with active smoking accounted for 77% and passive smoking&#xD;
      23% of the total cost. However, it is difficult for smokers to quit smoking without&#xD;
      assistance because smoking is addictive, and most smokers prefer to try and quit on their own&#xD;
      rather than seeking treatment, thus it is hard to reach those smokers who do not present&#xD;
      themselves for treatment. On the other hand, a previous study also indicated that high quit&#xD;
      rate (38%) could be achieved for those smokers who received a 6-week supply of free NRT plus&#xD;
      telephone counselling and self-help materials.&#xD;
&#xD;
      Consistent findings from previous studies demonstrated that social support appears to be one&#xD;
      of the strongest determinants of success at quitting smoking and remaining abstinent. Ward&#xD;
      and Klesges showed that social (family) support affects smoking outcome and may influence&#xD;
      readiness to quit. In a US study, family support was reported to be the most significant&#xD;
      predictor, compared to peer and significant-other support, on the experiential and behavioral&#xD;
      processes of change in a smoking cessation program for adult smokers. Similar results were&#xD;
      also found in a local study on the motivation to reduce smoking among smokers who are not&#xD;
      willing to quit. It is therefore imperative to involve a family member as the first point of&#xD;
      contact in the health care system regarding supporting their smoking family members in the&#xD;
      quitting process.&#xD;
&#xD;
      In Hong Kong, 33.6% of fathers and 2.6% of mothers smoke. Nevertheless, only 1.8% male&#xD;
      smokers had tried smoking cessation service and among those who had not tried any, 86.1%&#xD;
      reported that they would not try the service. Establishing rapport with schools and building&#xD;
      capacity in tobacco control in students could be a feasible way to engage smokers in tobacco&#xD;
      control advocacy. This could also help smokers who may not have access to services which&#xD;
      assists them in quitting smoking.&#xD;
&#xD;
      To fill those aforementioned gaps, in this proposed project, all primary school students and&#xD;
      junior forms of secondary school students are mobilized for the establishment of smoke-free&#xD;
      homes. They play an active role in advocating for a 'Smoke-free Environment' in their home by&#xD;
      nominating, encouraging and supporting their family members and relatives to quit smoking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2011</start_date>
  <completion_date type="Anticipated">October 2012</completion_date>
  <primary_completion_date type="Actual">July 2012</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The self-reported 7-day point prevalence (pp) quit rate at 6 months</measure>
    <time_frame>Six months</time_frame>
    <description>Whether the participant has quitted smoking in the past seven days at the time point of 6 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical validated quit rate at 6 months</measure>
    <time_frame>Six months</time_frame>
    <description>Test the cotinine level in the saliva provided by the participants&#xD;
Rate of smoking reduction by at least of half&#xD;
Number of quit attempts at 6 months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">269</enrollment>
  <condition>Comparative Effectiveness Research</condition>
  <arm_group>
    <arm_group_label>Counseling group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Study participants in the intervention group were received an intensive smoking cessation telephone counselling with 2-weeks free and 6-weeks discount nicotine replacement therapy (NRT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Study participants in the control group were not received any quitting assistance other than the self-help materials provided by Hong Kong Council on Smoking and Health (COSH).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Counseling group</intervention_name>
    <description>The content for the brief counseling group adopts a AWARD approach including asking the smoking habit, warning about the health risks associated with smoking, advising the smokers to quit, referring to specialized service, and repeating the above message. Additional telephone follow-up counseling at 1, 2, 3 and 8-week will be made to the participants in this group.</description>
    <arm_group_label>Counseling group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong residents aged 18 or above&#xD;
&#xD;
          -  Able to communicate in Cantonese&#xD;
&#xD;
          -  Intend to quit smoking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers who are psychologically or physically unable to communicate&#xD;
&#xD;
          -  Currently following other forms of smoking cessation programme&#xD;
&#xD;
          -  Have a previous history of allergy to NRT patch or gum&#xD;
      </textblock>
    </criteria>
    <gender>All</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>Sophia SC Chan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>HKU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sophia SC Chan, PhD</last_name>
    <phone>852-28192622</phone>
    <email>nssophia@hku.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong SAR</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sophia SC Chan, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>August 20, 2012</last_update_submitted>
  <last_update_submitted_qc>August 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 23, 2012</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>Prof. Sophia Siu-chee Chan</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01671553
org study id: COSH-SmokefreeTeen
nct id: NCT01671553
lead sponsor: 
has dmc: Yes
Background The home is the primary source of SHS exposure. The scientific evidence shows that
      there is no risk-free level of exposure to SHS that stop smoking is the sole way to
      completely eliminate the risk of SHS exposure. Although research studies indicated that
      smoking bans in restaurants, bars, and workplaces can significantly reduce the level of SHS
      exposure, governments lack the authority to restrict smoking in homes. Therefore, parental
      cessation is a more effective means to reduce the SHS exposure.

      Aim The aims are (1) to promote smoking cessation in the community and (2) assess the effect
      of different smoking cessation approaches through the Smoke-free Teen Contest. The specific
      objectives of the study are to test the effectiveness of different smoking cessation
      approaches on quit rate and change in smoking behaviours among smokers who are referred by
      Hong Kong Council on Smoking and Health (COSH).

      Methods The referred smokers were nominated by primary 1 to secondary 3 students who joined
      the Smoke-free Teen Contest organized by COSH. Two domains of outcome will be assessed: (1)
      the primary outcome is the self-reported 7-day point prevalence (pp) quit rate at 6 months
      and (2)the secondary outcomes included (i) biochemical validated quit rate at 6 months and
      (ii) rate of smoking reduction by at least of half and (iii) number of quit attempts at 6
      months.

      Procedure Smokers, who are referred by the Hong Kong Council on Smoking and Health (COSH),
      were nominated by primary 1 to secondary 3 students joined Smoke-free Teen Contest organized
      by COSH. Those smokers will be randomized into two groups (Intervention group and Control
      group) using the clustered randomization method by school. After the clustered randomization,
      the oral consent of eligible subjects were obtained to the study through telephone interview.
      Intervention group will receive 1,2,3, 8-week and 6-month telephone follow-up after baseline,
      while control group will only receive 6-month telephone follow-up after baseline. Those
      participants who reported to have stopped smoking will be invited for biochemical validation
      of smoking status at 6-month follow-up.

      Hypothesis We hypothesize that the intensive telephone counselling plus NRT treatment will
      lead to significant increases in rates of smoking cessation in the intervention groups than
      the control group.
Smoking is the single most preventable cause of deaths in Hong Kong and the smoking
      prevalence was about 11.8% (20.5% in males and 3.6% in females) in 2008. It was estimated
      that smoking accounts for about one fifth of all deaths and kills about 5,700 people per
      year. Smoking has been associated with serious damage to health at all ages, leading to
      cancers, heart diseases, stroke, chronic lung diseases, and many other health problems. It
      was estimated in 1998 that a total of US$688 million medical cost were attributed to
      smoking-related diseases annually, with active smoking accounted for 77% and passive smoking
      23% of the total cost. However, it is difficult for smokers to quit smoking without
      assistance because smoking is addictive, and most smokers prefer to try and quit on their own
      rather than seeking treatment, thus it is hard to reach those smokers who do not present
      themselves for treatment. On the other hand, a previous study also indicated that high quit
      rate (38%) could be achieved for those smokers who received a 6-week supply of free NRT plus
      telephone counselling and self-help materials.

      Consistent findings from previous studies demonstrated that social support appears to be one
      of the strongest determinants of success at quitting smoking and remaining abstinent. Ward
      and Klesges showed that social (family) support affects smoking outcome and may influence
      readiness to quit. In a US study, family support was reported to be the most significant
      predictor, compared to peer and significant-other support, on the experiential and behavioral
      processes of change in a smoking cessation program for adult smokers. Similar results were
      also found in a local study on the motivation to reduce smoking among smokers who are not
      willing to quit. It is therefore imperative to involve a family member as the first point of
      contact in the health care system regarding supporting their smoking family members in the
      quitting process.

      In Hong Kong, 33.6% of fathers and 2.6% of mothers smoke. Nevertheless, only 1.8% male
      smokers had tried smoking cessation service and among those who had not tried any, 86.1%
      reported that they would not try the service. Establishing rapport with schools and building
      capacity in tobacco control in students could be a feasible way to engage smokers in tobacco
      control advocacy. This could also help smokers who may not have access to services which
      assists them in quitting smoking.

      To fill those aforementioned gaps, in this proposed project, all primary school students and
      junior forms of secondary school students are mobilized for the establishment of smoke-free
      homes. They play an active role in advocating for a 'Smoke-free Environment' in their home by
      nominating, encouraging and supporting their family members and relatives to quit smoking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The self-reported 7-day point prevalence (pp) quit rate at 6 months
time frame: Six months
description: Whether the participant has quitted smoking in the past seven days at the time point of 6 months
measure: Biochemical validated quit rate at 6 months
time frame: Six months
description: Test the cotinine level in the saliva provided by the participants
Rate of smoking reduction by at least of half
Number of quit attempts at 6 months
arm group label: Counseling group
arm group type: Experimental
description: Study participants in the intervention group were received an intensive smoking cessation telephone counselling with 2-weeks free and 6-weeks discount nicotine replacement therapy (NRT).
arm group label: Control group
arm group type: No Intervention
description: Study participants in the control group were not received any quitting assistance other than the self-help materials provided by Hong Kong Council on Smoking and Health (COSH).
intervention type: Behavioral
intervention name: Counseling group
description: The content for the brief counseling group adopts a AWARD approach including asking the smoking habit, warning about the health risks associated with smoking, advising the smokers to quit, referring to specialized service, and repeating the above message. Additional telephone follow-up counseling at 1, 2, 3 and 8-week will be made to the participants in this group.
arm group label: Counseling group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sophia SC Chan, PhD
role: Principal Investigator
affiliation: HKU
last name: Sophia SC Chan, PhD
phone: 852-28192622
email: nssophia@hku.hk
facility: 
status: Recruiting
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The University of Hong Kong
investigator full name: Prof. Sophia Siu-chee Chan
investigator title: Professor