- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01722747
Bihar School Teachers Study (BSTS)
March 19, 2013 updated by: Glorian Sorensen, Harvard School of Public Health (HSPH)
Promoting Tobacco Control Among Teachers in India
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
945
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Bihar
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Patna, Bihar, India
- School of Preventive Oncology
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Government schools including grades 8-10 from within 10 school districts
Exclusion Criteria:
- Schools with fewer than 8 teachers
- Schools located in flood zones
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Condition
Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)
|
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.
|
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No Intervention: Delayed Intervention Control condition
Receives abbreviated 3-month delayed intervention after final data collection time point
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
6-month abstinence from tobacco
Time Frame: assessed 9-months post-intervention
|
assessed 9-months post-intervention
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Adoption of a school tobacco policy
Time Frame: 9-month post-intervention
|
9-month post-intervention
|
|
short-term tobacco use cessation
Time Frame: Average of 3 weeks post-intervention
|
Average of 3 weeks post-intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Glorian C. Sorensen, PhD, MPH, Harvard School of Public Health (HSPH)
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2009
Primary Completion (Actual)
July 1, 2012
Study Registration Dates
First Submitted
November 1, 2012
First Submitted That Met QC Criteria
November 5, 2012
First Posted (Estimate)
November 7, 2012
Study Record Updates
Last Update Posted (Estimate)
March 20, 2013
Last Update Submitted That Met QC Criteria
March 19, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- R01CA120958 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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