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

Tobacco Use Cessation Clinical Trial

Official title:

Scaling up Tobacco Control in Lndia: Comparing Smartphone to In-person Training for Implementing an Evidence-based Intervention to Reduce Tobacco Use Among Schoolteachers

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05500235
• Other study ID #: IRB20-2157
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: July 2025

Study information

• Verified date: September 2023
• Source: Harvard School of Public Health (HSPH)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1800
• Est. completion date: July 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

Inclusion Criteria:

All teachers and principals employed in schools in both study arms

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
India	Healis Sekhsaria Institute for Public Health	Indore	Madhya Pradesh

Sponsors (2)

Lead Sponsor	Collaborator
Harvard School of Public Health (HSPH)	Healis-Sekhsaria Institute for Public Health

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tobacco use cessation among teachers	Self-administered school personnel survey completed by teachers and principals. Based on the school personnel surveys, the investigators will assess self-report tobacco use at baseline and immediate post intervention and compare measures between the two arms to assess the effectiveness of the intervention.	Baseline and Immediate post intervention