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

NCT ID: NCT05500235

Last Updated: 2024-11-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 2040 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-27
• Study Completion Date: 2025-07-31

Brief Summary

This study aims to compare the implementation and effectiveness of the Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS) program when delivered through in-person training vs. a smartphone-based training model. Investigators will conduct a comparative effectiveness trial using a cluster-randomized design in which headmasters at schools in the Indian state of Madhya Pradesh (MP) will be trained in person or via a smartphone to deliver TFT-TFS in their schools. Schools will be randomly assigned to each training arm, and investigators will compare program effectiveness (tobacco use cessation), implementation outcomes, and program cost and reach.

Detailed Description

Tobacco-related deaths are rising rapidly in low and middle-income countries (LMICs). India's population is the second largest consumer of tobacco products in the world: 29% of the adult population uses smoked, smokeless, or both forms of tobacco, and around 1.2 million die each year from tobacco-related causes. Reducing tobacco-related deaths in LMICs will require large-scale implementation of evidence-based interventions (EBIs) that promote tobacco control. Currently, the implementation of tobacco control EBIs in LMICs relies on in-person training, which has inherent logistical challenges that limit the ability to scale up these programs. New training models are needed to ensure tobacco control EBIs can be implemented broadly, rapidly, and at low cost, especially in rural and under-resourced areas where tobacco use is prevalent.

The long-term goal is to identify effective, low-resource strategies to promote the broad-based implementation of tobacco control EBIs in LMICs. In India, school teachers are respected community leaders, role models, and an important channel for promoting tobacco control in schools and society. Investigators previously demonstrated the effectiveness of the Tobacco-Free Teachers, Tobacco-Free Society (TFT-TFS) program in a cluster-randomized study of schoolteachers in Bihar state, India. Tobacco use cessation rates were doubled among teachers in intervention schools compared to control schools, along with significant improvements in the adoption and implementation of tobacco control policies. As a critical next step in scaling up the TFT-TFS tobacco control EBI, investigators are focusing on expanding the training of those implementing the program in schools, i.e., school headmasters. The investigators will compare two models of TFT-TFS training of headmasters-in-person vs. smartphone-based-and the effect of each approach on TFT-TFS program implementation and effectiveness. India has the world's second-largest mobile phone user subscription base of 1.2 billion, with good penetration even in rural areas. The use of smartphones in educational settings is already pervasive in India, offering a readily available, low-cost strategy for expanding training of the TFT-TFS program. Training via smartphones can be delivered anytime and anywhere and allows flexibility and individualization of the learning experience through on-demand access to training content and virtual interactions among trainees. By delivering TFT-TFS training through smartphones, the program's potential reach can be multiplied over what can be achieved with in-person training.

Investigators will conduct a comparative effectiveness trial using a cluster-randomized design in which headmasters of schools in the Indian state of Madhya Pradesh (MP) will be randomly assigned to receive in-person training or training via smartphone for the TFT-TFS program. Once trained, headmasters in both groups will implement the TFT-TFS program within schools. Investigators will compare the training arms regarding program effectiveness (tobacco use cessation), implementation, cost, and reach.

Conditions

Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Smart phone based training

Smartphone-based training for Headmasters to implement the Tobacco Free Teachers-Tobacco Free Society program in their schools in Madhya Pradesh, India

Group Type: EXPERIMENTAL

Smart phone based training

Intervention Type: BEHAVIORAL

The study team will acquaint headmasters with the Tobacco Free Teachers-Tobacco Free Society (TFT-TFS) program and the smartphone training app. Headmasters will receive six monthly trainings on smartphones, including brief videos followed by quizzes with feedback, discussion forums to promote peer learning, demonstration of techniques, and the ability to review the content as needed. Headmasters will implement TFT-TFS at monthly school meetings with teachers and parents. TFT-TFS consists of four program components: (1) six group discussions with teachers, (2) cessation support and referrals to government resources, (3) posting six thematic tobacco control posters in the school, and (4) implementing a school tobacco policy. These four components incorporate the program's six themes: Teachers as Role Models; Health Effects of Tobacco; Motivation to Quit Tobacco Use; Skills to Quit Tobacco and to Help Others Quit; Dealing with Withdrawal; and Maintenance and Celebration.

In person training

In person training for Headmasters to implement the Tobacco Free Teachers-Tobacco Free Society program in their schools in Madhya Pradesh, India

Group Type: EXPERIMENTAL

In person training

Intervention Type: BEHAVIORAL

Headmasters will receive three face-to-face trainings, each 60-75 minutes long and held at convenient locations. The study team will introduce headmasters to the TFT-TFS program and teach participants how to use paper-based materials. The trainings will encourage participants to discuss successes and come up with solutions to overcome challenges. Headmasters will implement TFT-TFS at monthly school meetings with teachers and parents. TFT-TFS consists of four program components: (1) 6 group discussions with teachers, (2) cessation support and referrals to government resources, (3) posting six thematic tobacco control posters in the school, and (4) implementing a school tobacco policy. These four components incorporate the program's six themes: Teachers as Role Models; Health Effects of Tobacco; Motivation to Quit Tobacco Use; Skills to Quit Tobacco and to Help Others Quit; Dealing with Withdrawal; and Maintenance and Celebration.

Interventions

Smart phone based training

The study team will acquaint headmasters with the Tobacco Free Teachers-Tobacco Free Society (TFT-TFS) program and the smartphone training app. Headmasters will receive six monthly trainings on smartphones, including brief videos followed by quizzes with feedback, discussion forums to promote peer learning, demonstration of techniques, and the ability to review the content as needed. Headmasters will implement TFT-TFS at monthly school meetings with teachers and parents. TFT-TFS consists of four program components: (1) six group discussions with teachers, (2) cessation support and referrals to government resources, (3) posting six thematic tobacco control posters in the school, and (4) implementing a school tobacco policy. These four components incorporate the program's six themes: Teachers as Role Models; Health Effects of Tobacco; Motivation to Quit Tobacco Use; Skills to Quit Tobacco and to Help Others Quit; Dealing with Withdrawal; and Maintenance and Celebration.

Intervention Type: BEHAVIORAL

In person training

Headmasters will receive three face-to-face trainings, each 60-75 minutes long and held at convenient locations. The study team will introduce headmasters to the TFT-TFS program and teach participants how to use paper-based materials. The trainings will encourage participants to discuss successes and come up with solutions to overcome challenges. Headmasters will implement TFT-TFS at monthly school meetings with teachers and parents. TFT-TFS consists of four program components: (1) 6 group discussions with teachers, (2) cessation support and referrals to government resources, (3) posting six thematic tobacco control posters in the school, and (4) implementing a school tobacco policy. These four components incorporate the program's six themes: Teachers as Role Models; Health Effects of Tobacco; Motivation to Quit Tobacco Use; Skills to Quit Tobacco and to Help Others Quit; Dealing with Withdrawal; and Maintenance and Celebration.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

All teachers and principals employed in schools in both study arms

Exclusion Criteria

• None

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Healis-Sekhsaria Institute for Public Health

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: lead

Responsible Party

Eve Nagler

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eve Nagler, ScD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Healis Sekhsaria Institute for Public Health

Indore, Madhya Pradesh, India

Countries

India

Other Identifiers

R01CA248910-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB20-2157

Identifier Type: -

Identifier Source: org_study_id