xml: <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/NCT05996029</url>
    </required_header>
    <id_info>
      <org_study_id>K4011</org_study_id>
      <nct_id>NCT05996029</nct_id>
    </id_info>
    <brief_title>A Joint Real-World Study of Digital Smoking Cessation Interventions</brief_title>
    <official_title>A Joint Real-World Study of Digital Smoking Cessation Interventions</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Run Shaw Hospital, Zhejiang University School of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Hangzhou Medisol Technology Co.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking Union Medical College Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        According to the &quot;China Smoking Health Hazard Report 2020&quot;, the total number of smokers in&#xD;
        China is estimated to be 350 million, of which 180 million are already addicted. In addition,&#xD;
        more than 700 million nonsmokers are exposed to secondhand smoke and become passive smoking&#xD;
        victims, among which the family is one of the main places of secondhand smoke exposure, and&#xD;
        mothers and children are the most affected group.&#xD;
  &#xD;
        Passive smoking is a risk factor for spontaneous abortion in pregnant women and an important&#xD;
        risk factor for the occurrence of gestational hypertension syndrome and pregnancy&#xD;
        complications, and it also affects embryonic development with adverse pregnancy outcomes such&#xD;
        as miscarriage, stillbirth, intrauterine growth retardation, preterm birth, immune&#xD;
        deficiency, birth defects, and mental retardation.&#xD;
  &#xD;
        Helping smokers quit is the fundamental solution to reducing secondhand smoke exposure. The&#xD;
        accessibility and effectiveness of traditional offline smoking cessation intervention&#xD;
        services do not meet the needs of society. With the development of mobile communication&#xD;
        technology, digital cessation such as SMS cessation, WeChat cessation, and APP cessation have&#xD;
        emerged, which combine clinical cessation guidelines with software technology and present&#xD;
        rich product features and interactive design, providing a new solution to expand the&#xD;
        accessibility of clinical cessation interventions and address the problem of secondhand smoke&#xD;
        exposure.We hope to explore the impact of different digital cessation tools and their&#xD;
        combinations on reducing smoking prevalence and maternal tobacco exposure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This project is a two-arm, practical-utility randomized controlled trial.The study was&#xD;
        designed to enroll 2214 quitters, and maternal cessation of enrollment after completion of&#xD;
        the quitter enrollment.After self-reported exposure to secondhand smoke has been tested with&#xD;
        a free cotinine urine test and the pregnant woman has signed an informed consent, she invites&#xD;
        the smoker who is causing her secondhand smoke to quit, which may include her husband,&#xD;
        family, friends, colleagues, neighbors, etc., or the pregnant woman herself.&#xD;
  &#xD;
        Invited smokers will choose a quit day within two weeks of enrollment, use a cognitive&#xD;
        behavioral therapy-based cessation package and online coaching from medical staff, as well as&#xD;
        additional digital cessation tools, and receive a 12-week follow-up (smoking/quit status).&#xD;
        Enrolled pregnant women will receive general education on maternal and child health&#xD;
        management and the dangers of tobacco, and will be encouraged to provide psychological&#xD;
        support and encouragement to invited quitters in the mini-program (provided both parties&#xD;
        volunteer). The pregnant women will receive a 16-week follow-up (secondhand smoke exposure).&#xD;
  &#xD;
        At the end of the study, all pregnant women and those who self-report successful cessation&#xD;
        will receive a free cotinine test as an objective test of cessation effectiveness.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-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>Biologically validated subject withdrawal rate</measure>
      <time_frame>through study completion, an average of 4 months</time_frame>
      <description>Urine cotinine concentrations was determined using a cotinine test kit (colloidal gold) at the end of follow-up.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Biologically validated maternal environmental tobacco exposure rate</measure>
      <time_frame>through study completion, an average of 4 months</time_frame>
      <description>Urine cotinine concentration was determined using a cotinine test kit (colloidal gold method) at the end of enrollment and follow-up to determine the exposure of second-hand smoke.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Engagement and adherence to digital smoking cessation interventions</measure>
      <time_frame>through study completion, an average of 4 months</time_frame>
      <description>Actual enrollment and enrollment of invited participants in the digital cessation population.&#xD;
  Proportion of subjects in the intervention group who completed a digital cessation intervention session.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Self-reported abstinence rates for subjects at weeks 1, 2, 3, 4, 8, and 12 after quitting date</measure>
      <time_frame>through study completion, an average of 4 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in maternal and smoking cessation subjects' respective psychological scale assessments at baseline and at the end of follow-up</measure>
      <time_frame>through study completion, an average of 4 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">2214</enrollment>
    <condition>Tobacco Smoke Pollution</condition>
    <condition>Passive Smoking</condition>
    <condition>Secondhand Smoking</condition>
    <arm_group>
      <arm_group_label>Intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Intensive intervention package &quot;Quit with Love&quot; (1 month)&#xD;
  Cognitive-behavioral (CBT) smoking cessation intervention&#xD;
  ACT cessation intervention with positive thinking&#xD;
  Online group smoking cessation intervention through live streaming&#xD;
  &quot;Quit Assistant&quot; intelligent support platform (3 months)&#xD;
  Quit smoking punch card toolkit&#xD;
  Machine learning algorithm-driven cessation assistance practice service</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Reduced functionality of the Love Quit applet Only a simple smoking punch card support function, mainly used to assist subjects to quit smoking on their own and collect follow-up information</description>
    </arm_group>
    <intervention>
      <intervention_type>Combination Product</intervention_type>
      <intervention_name>Digital Smoking Cessation</intervention_name>
      <description>The core technology of the study is a smoking cessation assistance practice service driven by a machine learning algorithm. The small programs used by the intervention group in this study included smoking cessation service packages based on cognitive behavioral therapy and online guidance from medical staff on staff, and more digital smoking cessation tools.</description>
      <arm_group_label>Intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Pregnant women's inclusion criteria A. Adult females during gestation and within 42&#xD;
               days after delivery B. I do not smoke, but I self-reported secondhand smoke exposure&#xD;
               problems&#xD;
  &#xD;
            2. Inclusion criteria for smoking quitters A. Adults over the age of 18 who smoke every&#xD;
               day; B. I have a clear intention to quit smoking;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Maternal maternal exclusion criteria A. I am a smoker (pregnant women who are willing&#xD;
               to quit smoking can join the smoking cessation group) B. Self-report had no risk of&#xD;
               secondhand smoke exposure&#xD;
  &#xD;
            2. Exclusion criteria for smoking quitters A. Receiving other smoking cessation&#xD;
               interventions; B. having a severe mental illness or psychological disorder C. No smart&#xD;
               phone or not skilled to use WeChat mini program&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Department of ob gyn, Peking Union Medical College Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>July 31, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05996029
  org study id: K4011
  nct id: NCT05996029
  lead sponsor: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  According to the "China Smoking Health Hazard Report 2020", the total number of smokers in
        China is estimated to be 350 million, of which 180 million are already addicted. In addition,
        more than 700 million nonsmokers are exposed to secondhand smoke and become passive smoking
        victims, among which the family is one of the main places of secondhand smoke exposure, and
        mothers and children are the most affected group.
  
        Passive smoking is a risk factor for spontaneous abortion in pregnant women and an important
        risk factor for the occurrence of gestational hypertension syndrome and pregnancy
        complications, and it also affects embryonic development with adverse pregnancy outcomes such
        as miscarriage, stillbirth, intrauterine growth retardation, preterm birth, immune
        deficiency, birth defects, and mental retardation.
  
        Helping smokers quit is the fundamental solution to reducing secondhand smoke exposure. The
        accessibility and effectiveness of traditional offline smoking cessation intervention
        services do not meet the needs of society. With the development of mobile communication
        technology, digital cessation such as SMS cessation, WeChat cessation, and APP cessation have
        emerged, which combine clinical cessation guidelines with software technology and present
        rich product features and interactive design, providing a new solution to expand the
        accessibility of clinical cessation interventions and address the problem of secondhand smoke
        exposure.We hope to explore the impact of different digital cessation tools and their
        combinations on reducing smoking prevalence and maternal tobacco exposure.
  This project is a two-arm, practical-utility randomized controlled trial.The study was
        designed to enroll 2214 quitters, and maternal cessation of enrollment after completion of
        the quitter enrollment.After self-reported exposure to secondhand smoke has been tested with
        a free cotinine urine test and the pregnant woman has signed an informed consent, she invites
        the smoker who is causing her secondhand smoke to quit, which may include her husband,
        family, friends, colleagues, neighbors, etc., or the pregnant woman herself.
  
        Invited smokers will choose a quit day within two weeks of enrollment, use a cognitive
        behavioral therapy-based cessation package and online coaching from medical staff, as well as
        additional digital cessation tools, and receive a 12-week follow-up (smoking/quit status).
        Enrolled pregnant women will receive general education on maternal and child health
        management and the dangers of tobacco, and will be encouraged to provide psychological
        support and encouragement to invited quitters in the mini-program (provided both parties
        volunteer). The pregnant women will receive a 16-week follow-up (secondhand smoke exposure).
  
        At the end of the study, all pregnant women and those who self-report successful cessation
        will receive a free cotinine test as an objective test of cessation effectiveness.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: Single (Outcomes Assessor)
  measure: Biologically validated subject withdrawal rate
  time frame: through study completion, an average of 4 months
  description: Urine cotinine concentrations was determined using a cotinine test kit (colloidal gold) at the end of follow-up.
  measure: Biologically validated maternal environmental tobacco exposure rate
  time frame: through study completion, an average of 4 months
  description: Urine cotinine concentration was determined using a cotinine test kit (colloidal gold method) at the end of enrollment and follow-up to determine the exposure of second-hand smoke.
  measure: Engagement and adherence to digital smoking cessation interventions
  time frame: through study completion, an average of 4 months
  description: Actual enrollment and enrollment of invited participants in the digital cessation population.
  Proportion of subjects in the intervention group who completed a digital cessation intervention session.
  measure: Self-reported abstinence rates for subjects at weeks 1, 2, 3, 4, 8, and 12 after quitting date
  time frame: through study completion, an average of 4 months
  measure: Changes in maternal and smoking cessation subjects' respective psychological scale assessments at baseline and at the end of follow-up
  time frame: through study completion, an average of 4 months
  arm group label: Intervention group
  arm group type: Experimental
  description: Intensive intervention package "Quit with Love" (1 month)
  Cognitive-behavioral (CBT) smoking cessation intervention
  ACT cessation intervention with positive thinking
  Online group smoking cessation intervention through live streaming
  "Quit Assistant" intelligent support platform (3 months)
  Quit smoking punch card toolkit
  Machine learning algorithm-driven cessation assistance practice service
  arm group label: control group
  arm group type: No Intervention
  description: Reduced functionality of the Love Quit applet Only a simple smoking punch card support function, mainly used to assist subjects to quit smoking on their own and collect follow-up information
  intervention type: Combination Product
  intervention name: Digital Smoking Cessation
  description: The core technology of the study is a smoking cessation assistance practice service driven by a machine learning algorithm. The small programs used by the intervention group in this study included smoking cessation service packages based on cognitive behavioral therapy and online guidance from medical staff on staff, and more digital smoking cessation tools.
  arm group label: Intervention group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No