Tobacco Use CessationBSTSNCT01722747
Bihar School Teachers Study
A study testing Tobacco Free Teachers, Tobacco Free Society (TFT/TFS) in people with Tobacco Use Cessation, run by Harvard School of Public Health (HSPH) at 1 site in India.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 945 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2009to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Government schools including grades 8-10 from within 10 school districts
Who cannot join
- Schools with fewer than 8 teachers
- Schools located in flood zones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Tobacco Use Cessation
- Being tested
- Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | Tobacco Free Teachers, Tobacco Free Society (TFT/TFS) Receives: Behavioral: Tobacco Free Teachers, Tobacco Free Society (TFT/TFS) |
| Delayed Intervention Control condition | No intervention | Receives abbreviated 3-month delayed intervention after final data collection time point |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-month abstinence from tobacco
Measured: assessed 9-months post-intervention
Secondary outcomes (2)
Adoption of a school tobacco policy
Measured: 9-month post-intervention
short-term tobacco use cessation
Measured: Average of 3 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startJun 2009
- Primary completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 945 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Public Health (HSPH)
- Sponsor type
- University, hospital or other
- Collaborators
- Healis-Sekhsaria Institute for Public Health, Carelon Research, University of Minnesota, School of Preventive Oncology
- Responsible party
- Principal investigator, Glorian Sorensen, Harvard School of Public Health (HSPH)
- Investigators
- Glorian C. Sorensen, PhD, MPH, Principal investigator, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722747
- Sponsor's protocol ID
- R01CA120958
- Acronym
- BSTS
- Status last verified
- Mar 2013
- First submitted
- 1 Nov 2012
- Last updated
- 20 Mar 2013
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 22669010Pischke 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.
PubMed 23221589
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Tobacco Control Among Teachers in India
- ClinicalTrials.gov ID
- NCT01722747
- Acronym / sponsor ID
- BSTS / R01CA120958
- Conditions
- Tobacco Use Cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 945 participants (actual)
- Lead sponsor
- Harvard School of Public Health (HSPH)University, hospital or other
- Collaborators
- Healis-Sekhsaria Institute for Public Health, Carelon Research, University of Minnesota, School of Preventive Oncology
- Study start
- Jun 2009
- Primary completion
- Jul 2012 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)Tobacco Free Teachers, Tobacco Free Society (TFT/TFS) |
| Delayed Intervention Control condition | No intervention | –Receives abbreviated 3-month delayed intervention after final data collection time point |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Government schools including grades 8-10 from within 10 school districts
Key exclusion criteria (2 listed)
- Schools with fewer than 8 teachers
- Schools located in flood zones
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Intervention Condition |
Primary outcome
6-month abstinence from tobacco
Time frame: assessed 9-months post-intervention
2 secondary outcomes
Adoption of a school tobacco policy
Time frame: 9-month post-intervention
short-term tobacco use cessation
Time frame: Average of 3 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2013.
- Background: PubMed 22669010Nagler 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.
- Background: PubMed 23221589Pischke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Glorian C. Sorensen, PhD, MPH principal investigator
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco Free Teachers, Tobacco Free Society (TFT/TFS) in people with Tobacco Use Cessation, run by Harvard School of Public Health (HSPH) at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-month abstinence from tobacco (time frame: assessed 9-months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01722747, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2013.