Clinical trial NCT05346991: Disseminating an Evidence-based Tobacco Control Intervention for School Teachers in India
Official title: Disseminating an Evidence-based Tobacco Control Intervention for School Teachers in India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Lead sponsor: Harvard School of Public Health (HSPH)
Sponsor class: OTHER
Collaborators: name: Healis-Sekhsaria Institute for Public Health
First posted: 2022-04-26
Enrollment: 1102
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Disseminating an evidence-based tobacco control intervention for School Teachers

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.

Eligibility criteria: Inclusion Criteria:

* All teachers and principals employed in intervention and control schools

Exclusion Criteria:

* None

Primary outcomes:
measure: Tobacco use cessation among teachers
timeFrame: Immediately post-intervention
Secondary outcomes:
measure: School tobacco control policy implementation - School Observation
timeFrame: Immediately post-intervention
measure: School tobacco control policy implementation - Teachers' Report
timeFrame: Immediately post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Mumbai
country: India
facility: Healis Sekhsaria Institute for Public Health
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Glorian Sorensen, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: