<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/NCT01722747</url>
  </required_header>
  <id_info>
    <org_study_id>R01CA120958</org_study_id>
    <nct_id>NCT01722747</nct_id>
  </id_info>
  <brief_title>Bihar School Teachers Study</brief_title>
  <acronym>BSTS</acronym>
  <official_title>Promoting Tobacco Control Among Teachers in India</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Harvard School of Public Health (HSPH)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Healis-Sekhsaria Institute for Public Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Carelon Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Minnesota</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>School of Preventive Oncology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Harvard School of Public Health (HSPH)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BRIEF SUMMARY: This study, which is closed to enrollment, is testing the efficacy of a&#xD;
      tobacco-control intervention geared towards school teachers in Bihar, India. This cluster&#xD;
      randomized trial aims to promote tobacco use cessation among teachers and increase tobacco&#xD;
      policy adoption in 72 Bihar schools. Teachers are the focus of the study because as role&#xD;
      models for youth and key opinion leaders related to community norms, they represent an&#xD;
      important group for tobacco control. Teachers in Bihar also have reported high rates of&#xD;
      tobacco use. According to the Global School Personnel Survey conducted in 2006, 39% of&#xD;
      teachers in the eastern region of India (which includes Bihar) use some form of tobacco,&#xD;
      compared to the national average of 29%. This study aims to reduce these numbers through&#xD;
      discussion groups with teachers, individual cessation counseling, educational materials, and&#xD;
      a tobacco policy workgroup in each intervention school. This study is a collaboration between&#xD;
      US researchers and researchers at the Healis-Sekhsaria Institute for Public Health, Mumbai&#xD;
      India.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>6-month abstinence from tobacco</measure>
    <time_frame>assessed 9-months post-intervention</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Adoption of a school tobacco policy</measure>
    <time_frame>9-month post-intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>short-term tobacco use cessation</measure>
    <time_frame>Average of 3 weeks post-intervention</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">945</enrollment>
  <condition>Tobacco Use Cessation</condition>
  <arm_group>
    <arm_group_label>Intervention Condition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed Intervention Control condition</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Receives abbreviated 3-month delayed intervention after final data collection time point</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)</intervention_name>
    <description>A 7-month intervention was conducted over one academic year &amp; included the following core components: 1. A Lead Teacher (LT) in each school was appointed and trained to facilitate the program on-site; 2. A tobacco policy was implemented; 3. Study health educators and LTs conducted group discussions with teachers addressing 6 intervention themes; 4. Materials; 5. Support for tobacco use cessation. Schools randomized to delayed intervention control condition did not receive any intervention until after final data collection, when they were given a 3-month shortened intervention.</description>
    <arm_group_label>Intervention Condition</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Government schools including grades 8-10 from within 10 school districts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Schools with fewer than 8 teachers&#xD;
&#xD;
          -  Schools located in flood zones&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Glorian C. Sorensen, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Harvard School of Public Health (HSPH)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>School of Preventive Oncology</name>
      <address>
        <city>Patna</city>
        <state>Bihar</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Nagler EM, Pednekar MS, Viswanath K, Sinha DN, Aghi MB, Pischke CR, Ebbeling CB, Lando HA, Gupta PC, Sorensen GC. Designing in the social context: using the social contextual model of health behavior change to develop a tobacco control intervention for teachers in India. Health Educ Res. 2013 Feb;28(1):113-29. doi: 10.1093/her/cys060. Epub 2012 Jun 4.</citation>
    <PMID>22669010</PMID>
  </reference>
  <reference>
    <citation>Pischke CR, Galarce EM, Nagler E, Aghi M, Sorensen G, Gupta PC, Pednekar MS, Sinha DN, Viswanath K. Message formats and their influence on perceived risks of tobacco use: a pilot formative research project in India. Health Educ Res. 2013 Apr;28(2):326-38. doi: 10.1093/her/cys112. Epub 2012 Dec 6.</citation>
    <PMID>23221589</PMID>
  </reference>
  <verification_date>March 2013</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>March 19, 2013</last_update_submitted>
  <last_update_submitted_qc>March 19, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Harvard School of Public Health (HSPH)</investigator_affiliation>
    <investigator_full_name>Glorian Sorensen</investigator_full_name>
    <investigator_title>Professor of Society, Human Development and Health</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/NCT01722747
org study id: R01CA120958
nct id: NCT01722747
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
BRIEF SUMMARY: This study, which is closed to enrollment, is testing the efficacy of a
      tobacco-control intervention geared towards school teachers in Bihar, India. This cluster
      randomized trial aims to promote tobacco use cessation among teachers and increase tobacco
      policy adoption in 72 Bihar schools. Teachers are the focus of the study because as role
      models for youth and key opinion leaders related to community norms, they represent an
      important group for tobacco control. Teachers in Bihar also have reported high rates of
      tobacco use. According to the Global School Personnel Survey conducted in 2006, 39% of
      teachers in the eastern region of India (which includes Bihar) use some form of tobacco,
      compared to the national average of 29%. This study aims to reduce these numbers through
      discussion groups with teachers, individual cessation counseling, educational materials, and
      a tobacco policy workgroup in each intervention school. This study is a collaboration between
      US researchers and researchers at the Healis-Sekhsaria Institute for Public Health, Mumbai
      India.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: 6-month abstinence from tobacco
time frame: assessed 9-months post-intervention
measure: Adoption of a school tobacco policy
time frame: 9-month post-intervention
measure: short-term tobacco use cessation
time frame: Average of 3 weeks post-intervention
arm group label: Intervention Condition
arm group type: Experimental
description: Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)
arm group label: Delayed Intervention Control condition
arm group type: No Intervention
description: Receives abbreviated 3-month delayed intervention after final data collection time point
intervention type: Behavioral
intervention name: Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)
description: A 7-month intervention was conducted over one academic year & included the following core components: 1. A Lead Teacher (LT) in each school was appointed and trained to facilitate the program on-site; 2. A tobacco policy was implemented; 3. Study health educators and LTs conducted group discussions with teachers addressing 6 intervention themes; 4. Materials; 5. Support for tobacco use cessation. Schools randomized to delayed intervention control condition did not receive any intervention until after final data collection, when they were given a 3-month shortened intervention.
arm group label: Intervention Condition
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Glorian C. Sorensen, PhD, MPH
role: Principal Investigator
affiliation: Harvard School of Public Health (HSPH)
facility: 
country: India
citation: Nagler EM, Pednekar MS, Viswanath K, Sinha DN, Aghi MB, Pischke CR, Ebbeling CB, Lando HA, Gupta PC, Sorensen GC. Designing in the social context: using the social contextual model of health behavior change to develop a tobacco control intervention for teachers in India. Health Educ Res. 2013 Feb;28(1):113-29. doi: 10.1093/her/cys060. Epub 2012 Jun 4.
PMID: 22669010
citation: Pischke CR, Galarce EM, Nagler E, Aghi M, Sorensen G, Gupta PC, Pednekar MS, Sinha DN, Viswanath K. Message formats and their influence on perceived risks of tobacco use: a pilot formative research project in India. Health Educ Res. 2013 Apr;28(2):326-38. doi: 10.1093/her/cys112. Epub 2012 Dec 6.
PMID: 23221589
responsible party type: Principal Investigator
investigator affiliation: Harvard School of Public Health (HSPH)
investigator full name: Glorian Sorensen
investigator title: Professor of Society, Human Development and Health