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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Disseminating an evidence-based tobacco control intervention for School Teachers

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing Smartphone to In-person Training to Scale Up a Tobacco Control Program for Teachers in India

NCT05500235

Tobacco Use Cessation

ACTIVE_NOT_RECRUITING NA

Adapting and Evaluating a Brief Advice Tobacco Intervention in High-Reach, Low-Resource Settings in India

NCT05234983

Tobacco Use Cessation

ACTIVE_NOT_RECRUITING NA

Motivating Smokers--Reduce Child Environmental Tobacco Smoke Exposure

NCT00005396

Lung Diseases

COMPLETED

Providers for Smoking Prevention Programs

NCT00005331

Cardiovascular Diseases Coronary Heart Disease Risk Reduction Heart Diseases +1 more

COMPLETED

QuitGuide for American Indians: Aims 2 & 3

NCT05447156

Tobacco Use Tobacco Use Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Tobacco Use Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention arm

Implementation of the Tobacco-Free Teachers, Tobacco Free Society program in government schools in Bihar, India

Group Type EXPERIMENTAL

Tobacco Free Teachers, Tobacco Free Society program

Intervention Type OTHER

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.

Control arm

Delayed intervention - control arm schools receive the program after all data collection is complete

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER