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

Disseminating an evidence-based tobacco control intervention for School Teachers

Study Overview

• Status: Completed
• Conditions: Tobacco Use Cessation
• Intervention / Treatment: Other: Tobacco Free Teachers, Tobacco Free Society program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 1102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Mumbai, India
    • Healis Sekhsaria Institute for Public Health
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All teachers and principals employed in intervention and control schools

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention arm; Implementation of the Tobacco-Free Teachers, Tobacco Free Society program in government schools in Bihar, India	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.
No Intervention: Control arm; Delayed intervention - control arm schools receive the program after all data collection is complete

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Glorian Sorensen
• Collaborators: Healis-Sekhsaria Institute for Public Health
• Investigators: Principal Investigator: Glorian Sorensen, PhD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Actual): June 30, 2019
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: April 15, 2022
• First Submitted That Met QC Criteria: April 23, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Actual): April 26, 2022
• Last Update Submitted That Met QC Criteria: April 23, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB16-1055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No