Clinical trial NCT05500235: Comparing Smartphone to In-person Training to Scale Up a Tobacco Control Program for Teachers in India
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
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: 2022-08-15
Enrollment: 2040
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparative effectiveness trial
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

All teachers and principals employed in schools in both study arms

Exclusion Criteria:

• None

Primary outcomes:
measure: Tobacco use cessation among teachers
timeFrame: Baseline and Immediate post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Indore
country: India
facility: Healis Sekhsaria Institute for Public Health
state: Madhya Pradesh
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Eve Nagler, ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References: