<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/NCT03236025</url>
  </required_header>
  <id_info>
    <org_study_id>UW17-269</org_study_id>
    <nct_id>NCT03236025</nct_id>
  </id_info>
  <brief_title>A Video-led Smoking Cessation Intervention in Helping Male Smokers Whose Partners Got Pregnant to Quit Smoking</brief_title>
  <official_title>The Effectiveness of a Video-led Smoking Cessation Intervention in Helping Male Smokers in Mainland China Whose Partner Got Pregnant to Quit Smoking: A 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>Yes</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 aims to use a three arms randomized clinical trial study to evaluate the&#xD;
      effectiveness of a video-led intervention in helping male smokers whose partner got pregnant&#xD;
      in Mainland China to quit smoking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With a globally growing number of smokers, up to about half of men and one tenth of women are&#xD;
      becoming smokers and relatively few stopping, especially in Mainland China.&#xD;
&#xD;
      It has been proved that tobacco is responsible for even more deaths and diseases. Smokers&#xD;
      have two to three times mortality in middle age among otherwise similar persons who had never&#xD;
      smoked. According to the literature review, smoking has been confirmed to be an important&#xD;
      risk factor to most chronic diseases and cancer.&#xD;
&#xD;
      For the male smokers at their reproductive ages, who is preparing to have a baby, smoking may&#xD;
      negatively influence their reproductive capacity. Sufficient studies found that the quantity&#xD;
      and duration of smoking, especially the current smoking is positively associated with the&#xD;
      risk of erectile dysfunction. Smoking may increase the risk of a higher risk of developing&#xD;
      oligospermia, asthenozoospermia and teratozoospermia for man in the reproductive years, which&#xD;
      may lead to the inefficiency of fertilization and even give birth to abnormal fetus. Besides,&#xD;
      secondhand Smoking (SHS) exposure also have further and longer negative effects on their&#xD;
      female partner and their baby born in the future. The non-smoking population is much more&#xD;
      sensitive to the nicotine in the passive smoking than smokers. The SHS may increase the risk&#xD;
      of respiratory infections, ear problem, immediate adverse effects on cardiovascular system,&#xD;
      lung cancer and so on to adults. For the children, the passive smoking make children have a&#xD;
      higher chance to get severe asthma, slow lung growth. Hence, children and women live with&#xD;
      smokers may have a higher risk of premature death and disease. Besides, newborns whose&#xD;
      mothers were exposed to secondhand smoke showed significantly lower scores in the habituation&#xD;
      cluster and motor system cluster, as well as the delay of neurobehavioral development&#xD;
      regardless of socio-demographic, obstetric and pediatric factors. Conclusively, smoking has&#xD;
      direct and indirect negative effect to male smokers in reproductive ages themselves and their&#xD;
      family members.&#xD;
&#xD;
      Based on the official statistic figures in 2010, about one third of people in China were&#xD;
      current smokers, and the number of young smokers is increasing. While most current smokers&#xD;
      (83.9%) report having no intention to quit smoking (WHO, 2011). On average, between 60% and&#xD;
      70% of Chinese men continue to smoke into middle age, which is different with the western&#xD;
      countries. Hence, finding out a solution to decrease the married reproductive male smoking&#xD;
      rate is extremely crucial.&#xD;
&#xD;
      Overall awareness of the health hazards of tobacco has improved in the last 15 years in&#xD;
      China, but is still relatively poor. Even there were several patterns of propaganda and&#xD;
      education applied in China, the efficiency is not very satisfactory. Hence, an effective&#xD;
      education interventions that delivery the health hazards of tobacco to male smokers and&#xD;
      secondhand smoking to their wives and baby born in the future should be developed and&#xD;
      implemented for reproductive male smokers in China.&#xD;
&#xD;
      Different patterns of interventions, such as counselling, advertising, leaflets and so on&#xD;
      have been implemented, however the effect is not so well as we expected. Thus, a more&#xD;
      efficient intervention should be developed. As the high usage rate of smart phone,&#xD;
      interventions implemented by cellphone can be considered as a new approach. Watching video&#xD;
      has been proven to be significantly associated with prevalence abstinence. Video, combining&#xD;
      with the advantage of text, image, and tones, will take visual, auditory and reading&#xD;
      stimulation to the brain, consequently, enhance the delivery and memory of information for&#xD;
      people. Hence video is an efficient intervention medium for smoking cessation.&#xD;
&#xD;
      Given that, a video-led intervention will be applied to help male smokers whose partner got&#xD;
      pregnant in Mainland China to quit or reduce the cigarette smoking.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">March 31, 2019</completion_date>
  <primary_completion_date type="Actual">October 31, 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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Biochemically validated smoking abstinence at the 6-month follow-up</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>The biochemically validated smoking abstinence was confirmed by an exhaled carbon monoxide level &lt; 4 parts per million (p.p.m.)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported 7-day point prevalence quit rate</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>Subjects report that they had not smoked within the recent 7 days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The level of readiness to quit</measure>
    <time_frame>6-month follow-up</time_frame>
    <description>The readiness to quit is divided into pre-contemplation stage (attempt to quit more that 30 days later), contemplation stage (attempt to quit within 30 days but more than 7 days), preparation stage (attempt to quit within 7 days), and action stage (quitting)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">1023</enrollment>
  <condition>Smoking Cessation</condition>
  <arm_group>
    <arm_group_label>Experimental group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Video+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. The videos which presented the health effects of smoking, especially emphasizing the importance of smoking cessation on the fetal and pregnancy, will be sent in sequence through the smart phone to the participants in the experimental group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conditional control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Text-message+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. Text-message contains the same content with videos and will be sent in the same frequency with the videos through the smart phone to the participants in the Conditional control group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Participants in the control group will be given a one-sentence smoking cessation advice during the baseline assessment. A leaflet showed the information related to the smoking cessation will be allocated to them at the same time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Video+brief smoking cessation+pamphlet</intervention_name>
    <description>The videos presented the health effects of smoking, especially emphasizing the importance of smoking cessation on pregnant women, fetuses, and newborns.</description>
    <arm_group_label>Experimental group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Combination Product</intervention_type>
    <intervention_name>Text-message+brief smoking cessation+pamphlet</intervention_name>
    <description>The text -message contains the same content with the videos</description>
    <arm_group_label>Conditional control group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>brief smoking cessation+pamphlet</intervention_name>
    <description>The pamphlet showed the general information related to the smoking cessation, the brief smoking cessation only contains a sentence like &quot;You'd better quit smoking.&quot;</description>
    <arm_group_label>Placebo control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  male resident aged 18 or above;&#xD;
&#xD;
          -  smoking at least one cigarette per day averagely during the past 1 months and&#xD;
             validated by exhaled CO test (≥ 4ppm);&#xD;
&#xD;
          -  have a pregnant partner whose embryo had been confirmed to not have any significant&#xD;
             deformity;&#xD;
&#xD;
          -  able to communicate in Mandarin (including reading Chinese);&#xD;
&#xD;
          -  have a smart phone for intervention and follow-up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  smokers who meet the above criteria but are currently involved in other smoking&#xD;
             cessation programs or the pilot study;&#xD;
&#xD;
          -  mentally or physically unfit for communication;&#xD;
      </textblock>
    </criteria>
    <gender>Male</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>William Ho Cheung LI, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The University of Hong Kong</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 8, 2020</last_update_submitted>
  <last_update_submitted_qc>January 8, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>smoking cessation</keyword>
  <keyword>video</keyword>
  <keyword>male smoker</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/NCT03236025
org study id: UW17-269
nct id: NCT03236025
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to use a three arms randomized clinical trial study to evaluate the
      effectiveness of a video-led intervention in helping male smokers whose partner got pregnant
      in Mainland China to quit smoking.
With a globally growing number of smokers, up to about half of men and one tenth of women are
      becoming smokers and relatively few stopping, especially in Mainland China.

      It has been proved that tobacco is responsible for even more deaths and diseases. Smokers
      have two to three times mortality in middle age among otherwise similar persons who had never
      smoked. According to the literature review, smoking has been confirmed to be an important
      risk factor to most chronic diseases and cancer.

      For the male smokers at their reproductive ages, who is preparing to have a baby, smoking may
      negatively influence their reproductive capacity. Sufficient studies found that the quantity
      and duration of smoking, especially the current smoking is positively associated with the
      risk of erectile dysfunction. Smoking may increase the risk of a higher risk of developing
      oligospermia, asthenozoospermia and teratozoospermia for man in the reproductive years, which
      may lead to the inefficiency of fertilization and even give birth to abnormal fetus. Besides,
      secondhand Smoking (SHS) exposure also have further and longer negative effects on their
      female partner and their baby born in the future. The non-smoking population is much more
      sensitive to the nicotine in the passive smoking than smokers. The SHS may increase the risk
      of respiratory infections, ear problem, immediate adverse effects on cardiovascular system,
      lung cancer and so on to adults. For the children, the passive smoking make children have a
      higher chance to get severe asthma, slow lung growth. Hence, children and women live with
      smokers may have a higher risk of premature death and disease. Besides, newborns whose
      mothers were exposed to secondhand smoke showed significantly lower scores in the habituation
      cluster and motor system cluster, as well as the delay of neurobehavioral development
      regardless of socio-demographic, obstetric and pediatric factors. Conclusively, smoking has
      direct and indirect negative effect to male smokers in reproductive ages themselves and their
      family members.

      Based on the official statistic figures in 2010, about one third of people in China were
      current smokers, and the number of young smokers is increasing. While most current smokers
      (83.9%) report having no intention to quit smoking (WHO, 2011). On average, between 60% and
      70% of Chinese men continue to smoke into middle age, which is different with the western
      countries. Hence, finding out a solution to decrease the married reproductive male smoking
      rate is extremely crucial.

      Overall awareness of the health hazards of tobacco has improved in the last 15 years in
      China, but is still relatively poor. Even there were several patterns of propaganda and
      education applied in China, the efficiency is not very satisfactory. Hence, an effective
      education interventions that delivery the health hazards of tobacco to male smokers and
      secondhand smoking to their wives and baby born in the future should be developed and
      implemented for reproductive male smokers in China.

      Different patterns of interventions, such as counselling, advertising, leaflets and so on
      have been implemented, however the effect is not so well as we expected. Thus, a more
      efficient intervention should be developed. As the high usage rate of smart phone,
      interventions implemented by cellphone can be considered as a new approach. Watching video
      has been proven to be significantly associated with prevalence abstinence. Video, combining
      with the advantage of text, image, and tones, will take visual, auditory and reading
      stimulation to the brain, consequently, enhance the delivery and memory of information for
      people. Hence video is an efficient intervention medium for smoking cessation.

      Given that, a video-led intervention will be applied to help male smokers whose partner got
      pregnant in Mainland China to quit or reduce the cigarette smoking.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Biochemically validated smoking abstinence at the 6-month follow-up
time frame: 6-month follow-up
description: The biochemically validated smoking abstinence was confirmed by an exhaled carbon monoxide level < 4 parts per million (p.p.m.)
measure: Self-reported 7-day point prevalence quit rate
time frame: 6-month follow-up
description: Subjects report that they had not smoked within the recent 7 days.
measure: The level of readiness to quit
time frame: 6-month follow-up
description: The readiness to quit is divided into pre-contemplation stage (attempt to quit more that 30 days later), contemplation stage (attempt to quit within 30 days but more than 7 days), preparation stage (attempt to quit within 7 days), and action stage (quitting)
arm group label: Experimental group
arm group type: Experimental
description: Video+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. The videos which presented the health effects of smoking, especially emphasizing the importance of smoking cessation on the fetal and pregnancy, will be sent in sequence through the smart phone to the participants in the experimental group.
arm group label: Conditional control group
arm group type: Active Comparator
description: Text-message+one-sentence smoking cessation advice +general smoking cessation leaflet will be allocated to the participants in the experimental group. Text-message contains the same content with videos and will be sent in the same frequency with the videos through the smart phone to the participants in the Conditional control group.
arm group label: Placebo control group
arm group type: Placebo Comparator
description: Participants in the control group will be given a one-sentence smoking cessation advice during the baseline assessment. A leaflet showed the information related to the smoking cessation will be allocated to them at the same time.
intervention type: Combination Product
intervention name: Video+brief smoking cessation+pamphlet
description: The videos presented the health effects of smoking, especially emphasizing the importance of smoking cessation on pregnant women, fetuses, and newborns.
arm group label: Experimental group
intervention type: Combination Product
intervention name: Text-message+brief smoking cessation+pamphlet
description: The text -message contains the same content with the videos
arm group label: Conditional control group
intervention type: Other
intervention name: brief smoking cessation+pamphlet
description: The pamphlet showed the general information related to the smoking cessation, the brief smoking cessation only contains a sentence like "You'd better quit smoking."
arm group label: Placebo control group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: William Ho Cheung LI, PhD
role: Principal Investigator
affiliation: The University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Sponsor
sharing ipd: No