Bihar School Teachers Study

Tobacco Use Cessation Clinical Trial

— BSTS  

Official title:

Promoting Tobacco Control Among Teachers in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722747
• Other study ID #: R01CA120958
• Status: Completed
• Phase: N/A
• First received: November 1, 2012
• Last updated: March 19, 2013
• Start date: June 2009

Study information

• Verified date: March 2013
• Source: Harvard School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Harvard School of Public Health Office of Regulatory Affairs and Research ComplianceUnited States: New England Research Institutes Institutional Review BoardIndia: Healis-Sekhsaria Institute for Public Health Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 945
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
India	School of Preventive Oncology	Patna	Bihar

Sponsors (5)

Lead Sponsor	Collaborator
Harvard School of Public Health	Healis-Sekhsaria Institute for Public Health, New England Research Institutes, School of Preventive Oncology, University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

India, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month abstinence from tobacco		assessed 9-months post-intervention	Yes
Secondary	Adoption of a school tobacco policy		9-month post-intervention	No
Secondary	short-term tobacco use cessation		Average of 3 weeks post-intervention	Yes