Disseminating an Evidence-based Tobacco Control Intervention for School Teachers in India

Tobacco Use Cessation Clinical Trial

Official title:

Disseminating an Evidence-based Tobacco Control Intervention for School Teachers in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05346991
• Other study ID #: IRB16-1055
• Status: Completed
• Phase: N/A
• Start date: June 1, 2018
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2022
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Disseminating an evidence-based tobacco control intervention for School Teachers

Description:

There is a profound need for evidence-based interventions that promote tobacco control on a large scale, particularly in low- and middle-income countries. In India in 2010 alone, tobacco use accounted for over one million deaths. The overall goal of this study is to identify effective strategies for broad-based implementation of evidence-based tobacco control interventions that can be embedded in existing organizational infrastructures and accommodate the realities of low-resource settings. This study builds on an intervention for school teachers, called the Tobacco-Free Teachers/Tobacco-Free Society (TFT-TFS) program, shown to be efficacious in increasing tobacco use cessation and tobacco policy implementation in a cluster randomized controlled trial in the Bihar School Teachers' Study (BSTS). Teachers in India are an important channel for promoting tobacco control, given their roles as community leaders and role models. The next logical step in this research is to develop the knowledge, products and processes needed to take this intervention to scale and disseminate it through readily accessible and sustainable channels. Investigators will test an implementation model for building capacity within education departments to support and deliver this program within schools, using the existing infrastructure for curriculum training in state education departments. Within each state in India, schools are organized within clusters, and cluster coordinators are responsible for directly training principals about curriculum issues. The investigators will build the capacity of cluster coordinators to train and support principals in implementing the TFT-TFS program in their schools. The central research question of this study is: Will this evidence-based intervention be successfully adopted, implemented, and sustained through existing channels using this implementation process? The specific aims are to: (1) determine the extent to which this implementation model meets acceptable rates of program adoption, implementation, reach and maintenance of the TFT-TFS program among schools in the Indian state of Bihar; (2) determine program effectiveness in increasing tobacco use cessation and implementation of tobacco control policies in schools; (3) determine the feasibility of building the capacity of cluster coordinators to train and support principals in program implementation and maintenance in schools, and for the Department of Education to sustain the program; and (4) determine the direct financial costs of program implementation and maintenance. This study uses a non-inferiority design to test the primary hypothesis that program adoption, implementation, and reach will not be inferior to the high standards demonstrated in BSTS; and assesses program effectiveness in improving tobacco use cessation and increasing policy implementation using a cluster randomized design. This research is innovative because it systematically examines the process of scaling up one of the first evidence-based approaches to tobacco use cessation among adults in India. This study is significant because it is expected to improve understanding of implementation processes needed for taking evidence-based interventions to scale.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1102
• Est. completion date: July 31, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• All teachers and principals employed in intervention and control schools

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Other:
• Tobacco Free Teachers, Tobacco Free Society program
The Tobacco Free Teachers, Tobacco Free Society (TFT-TFS) program provides teachers with the knowledge and skills to quit tobacco use, or to help someone else quit; it also helps schools comply with national tobacco control policies. School principals implement four TFT-TFS program components with teachers in their schools during school hours across an academic year (August-April): Adopting a school tobacco control policy Providing cessation support (e.g. distribution of self-help quit booklets and referrals to government cessation resources) Conducting monthly group discussions with teachers about tobacco Hanging six thematic posters in the school With the goal of establishing a tobacco-free school environment, the program incorporates six program themes: 1. Teachers as Role Models; 2. Health Effects of Tobacco; 3. Motivation to Quit-or Help Others to Quit; 4. Skills to Quit; 5. Dealing with Withdrawal; and 6. Maintenance and Celebration.

Locations

Country	Name	City	State
India	Healis Sekhsaria Institute for Public Health	Mumbai
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Glorian Sorensen	Healis-Sekhsaria Institute for Public Health

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use cessation among teachers	Self-administered Teacher's Survey completed by teachers. Using survey data, compute 7- and 30-day quit prevalence among teachers who reported using any tobacco in the last 9 months (the length of the academic year), and compare measures between intervention and control schools	Immediately post-intervention
Secondary	School tobacco control policy implementation - School Observation	School Observation Checklist completed by an independent evaluator. Observations include the number of physical locations in the school and grounds with evidence of tobacco use (range 0 - 10, lower score indicates less evidence of tobacco use).	Immediately post-intervention
Secondary	School tobacco control policy implementation - Teachers' Report	Self-administered Teacher's Survey completed by teachers. Using survey data, compute a composite score of five questions regarding presence of a tobacco policy and it's enforcement at the school (range 0-5, higher score indicates stricter policy.	Immediately post-intervention