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Clinical Trials/NCT05500235
NCT05500235Active, not recruitingNot Applicable

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

Harvard School of Public Health (HSPH)1 site in 1 country2,040 target enrollmentStarted: June 27, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
2,040
Locations
1
Primary Endpoint
Tobacco use cessation among teachers

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All teachers and principals employed in schools in both study arms

Exclusion Criteria

  • Not provided

Arms & Interventions

Smart phone based training

Experimental

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

Intervention: Smart phone based training (Behavioral)

In person training

Experimental

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

Intervention: In person training (Behavioral)

Outcomes

Primary Outcomes

Tobacco use cessation among teachers

Time Frame: Baseline and Immediate post intervention

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Harvard School of Public Health (HSPH)
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Eve Nagler

Principal Investigator

Harvard School of Public Health (HSPH)

Study Sites (1)

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