<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/NCT03021655</url>
  </required_header>
  <id_info>
    <org_study_id>YouthQuitline_RCT</org_study_id>
    <nct_id>NCT03021655</nct_id>
  </id_info>
  <brief_title>A Pilot Randomized Control Trial to Help Youth Smokers to Quit Smoking:</brief_title>
  <official_title>Effectiveness of Using Adventure-based Training and WhatsApp Group to Relieve Emotion and Pressure so as to Quit Smoking: A Pilot Randomized Control 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a 3-arm randomized controlled trial including: (1) Adventure-based training&#xD;
      intervention group, (2) WhatsApp intervention group and (3) Control group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression and stress are obstacles of youth smokers to quit smoking, youth smokers who have&#xD;
      positive thinking and less depression exhibited smoking abstinence at last. Adventure-based&#xD;
      training could enhance participants' self-efficacy, self-esteem and also improve mental&#xD;
      health of children and youth by doing physical activity. On the other hand, previous mobile&#xD;
      phone-based studies (e.g. short messaging services or Apps) showed that the mental health of&#xD;
      youth had been improved by providing instant response to the subjects when they felt&#xD;
      depressed. A paper published recently proved that WhatsApp group could prevent relapse among&#xD;
      the quitters. Thus, adventure-based training and social support in WhatsApp group would&#xD;
      predict to reduce depression and stress so as to quit smoking in youth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">November 2021</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Self-reported 7-day point prevalence</measure>
    <time_frame>6-month</time_frame>
    <description>The subjects will be asked whether they have smoked cigarette in the past 7 day at 6-month</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Biochemical validated quit rate</measure>
    <time_frame>6-month</time_frame>
    <description>Bio-chemical validated quit rate will be conducted if the subjects who reported they have been stop smoking for at least 7 days at 6-month. They will be invited to perform saliva cotinine test (using NicAlert strip) plus exhaled carbon monoxide text to validate the smoking status.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Depressive symptoms</measure>
    <time_frame>6-month</time_frame>
    <description>A 20-item scale (CESDC) will be used to assess the depressive symptoms of the subjects after 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Self-esteem</measure>
    <time_frame>6-month</time_frame>
    <description>A 10-item scale (RSES) will be used to assess the self-esteem level of the subjects after 6 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Quality of life</measure>
    <time_frame>6-month</time_frame>
    <description>A 11-item scale (SF-6D) will be used to assess the quality of life of the subjects after 6 months.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Adventure-based intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adventure-based intervention group included 1 day-camp and will be divided into 2 parts: (1) physical activity such as wall climbing, ropes course etc, (2) health education delivering about the relationship of self-efficacy, self-esteem, emotion and smoking abstinence. The training will be held before the 6-month follow-up. Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>WhatsApp intervention group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For WhatsApp intervention group, not more than 8 subjects with same gender will be assigned into a group. Messages about mood and stress management will be sent to the group per week and the group will last for 6 months. It aims to relieve their pressure and emotion by sharing their unhappy things with other subjects. Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>For the control group, the subjects will receive telephone counseling on quitting smoking at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Adventure-based intervention group</intervention_name>
    <description>One-day adventure-based training will be assigned to subjects and the activities include wall climbing, rope course and health talk on mood, pressure management and smoking cessation.</description>
    <arm_group_label>Adventure-based intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>WhatsApp intervention group</intervention_name>
    <description>A WhatsApp group will be opened for the subjects and we will send messages about mood and pressure management to them and encourage them to quit smoking. The subjects can share their unhappy things in the group.</description>
    <arm_group_label>WhatsApp intervention group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12-, 24-month and smoking cessation counselling will be delivered to the subjects.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hong Kong resident aged 25 or below&#xD;
&#xD;
          -  Able to communicate, read and write in Cantonese/ Chinese&#xD;
&#xD;
          -  Smoked in the past 30 days&#xD;
&#xD;
          -  Mobile can access internet&#xD;
&#xD;
          -  Would access internet through mobile or at home&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have difficulty to communicate via telephone&#xD;
&#xD;
          -  Ever used/using psychiatric drugs&#xD;
&#xD;
          -  Physically disabled&#xD;
&#xD;
          -  Having queries irrelevant to tobacco control&#xD;
&#xD;
          -  Undergoing other smoking cessation service&#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 Li, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ho-cheung Li, PhD</last_name>
    <phone>39176634</phone>
    <email>william3@hku.hk</email>
  </overall_contact>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>William Li, PhD</last_name>
      <phone>852-39176634</phone>
      <email>william3@hku.hk</email>
    </contact>
    <investigator>
      <last_name>Ho Cheung William Li, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 4, 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</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Adventure-based training</keyword>
  <keyword>WhatsApp</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/NCT03021655
org study id: YouthQuitline_RCT
nct id: NCT03021655
lead sponsor: 
has dmc: No
This study is a 3-arm randomized controlled trial including: (1) Adventure-based training
      intervention group, (2) WhatsApp intervention group and (3) Control group.
Depression and stress are obstacles of youth smokers to quit smoking, youth smokers who have
      positive thinking and less depression exhibited smoking abstinence at last. Adventure-based
      training could enhance participants' self-efficacy, self-esteem and also improve mental
      health of children and youth by doing physical activity. On the other hand, previous mobile
      phone-based studies (e.g. short messaging services or Apps) showed that the mental health of
      youth had been improved by providing instant response to the subjects when they felt
      depressed. A paper published recently proved that WhatsApp group could prevent relapse among
      the quitters. Thus, adventure-based training and social support in WhatsApp group would
      predict to reduce depression and stress so as to quit smoking in youth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Self-reported 7-day point prevalence
time frame: 6-month
description: The subjects will be asked whether they have smoked cigarette in the past 7 day at 6-month
measure: Biochemical validated quit rate
time frame: 6-month
description: Bio-chemical validated quit rate will be conducted if the subjects who reported they have been stop smoking for at least 7 days at 6-month. They will be invited to perform saliva cotinine test (using NicAlert strip) plus exhaled carbon monoxide text to validate the smoking status.
measure: Change in Depressive symptoms
time frame: 6-month
description: A 20-item scale (CESDC) will be used to assess the depressive symptoms of the subjects after 6 months.
measure: Change in Self-esteem
time frame: 6-month
description: A 10-item scale (RSES) will be used to assess the self-esteem level of the subjects after 6 months.
measure: Change in Quality of life
time frame: 6-month
description: A 11-item scale (SF-6D) will be used to assess the quality of life of the subjects after 6 months.
arm group label: Adventure-based intervention group
arm group type: Experimental
description: Adventure-based intervention group included 1 day-camp and will be divided into 2 parts: (1) physical activity such as wall climbing, ropes course etc, (2) health education delivering about the relationship of self-efficacy, self-esteem, emotion and smoking abstinence. The training will be held before the 6-month follow-up. Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.
arm group label: WhatsApp intervention group
arm group type: Experimental
description: For WhatsApp intervention group, not more than 8 subjects with same gender will be assigned into a group. Messages about mood and stress management will be sent to the group per week and the group will last for 6 months. It aims to relieve their pressure and emotion by sharing their unhappy things with other subjects. Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.
arm group label: Control group
arm group type: Other
description: For the control group, the subjects will receive telephone counseling on quitting smoking at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month.
intervention type: Behavioral
intervention name: Adventure-based intervention group
description: One-day adventure-based training will be assigned to subjects and the activities include wall climbing, rope course and health talk on mood, pressure management and smoking cessation.
arm group label: Adventure-based intervention group
intervention type: Behavioral
intervention name: WhatsApp intervention group
description: A WhatsApp group will be opened for the subjects and we will send messages about mood and pressure management to them and encourage them to quit smoking. The subjects can share their unhappy things in the group.
arm group label: WhatsApp intervention group
intervention type: Behavioral
intervention name: Control group
description: Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12-, 24-month and smoking cessation counselling will be delivered to the subjects.
arm group label: Control group
criteria: 
gender: All
minimum age: 12 Years
maximum age: 25 Years
healthy volunteers: No
last name: Ho-cheung Li, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
last name: Ho-cheung Li, PhD
phone: 39176634
email: william3@hku.hk
facility: 
status: Recruiting
contact: 
investigator: 
country: China
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: No