Effectiveness of Combined Facilitator-driven and Peer-led Educational Intervention on Intention to use Tobacco among Adolescents in Mangalore: A School based Cluster Randomized Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 400
- Locations
- 1
- Primary Endpoint
- Change in student’s intention to use tobacco product scores before and after the intervention across two groups.
Study Overview
Brief Summary
The study protocol is a two-phase school-based cluster randomized controlled trial aimed at reducing the intention to use tobacco among adolescents in Mangalore. The intervention will be built around a comprehensive educational module titled IMPACTS (Initiative for Motivating and Promoting Adolescent Cessation of Tobacco in Schools), developed through stakeholder consensus using the Delphi technique.
In Phase 1, key stakeholders—including teachers, parents, medico-social workers, students etc.—will participate in structured interviews to contribute to the design and content of the module. Thematic analysis of these interviews, combined with literature review and expert inputs, will inform the creation of age-appropriate, culturally sensitive educational materials.
Phase 2 involves implementation of the IMPACTS module across 10 randomly selected private schools. Five Schools will be allocated to the intervention arm and five to the control arm. A total of 400 eighth-standard students will participate (200 per group). The intervention group will receive both facilitator-led and peer-led sessions, while the control group will receive only facilitator-led education. Facilitator led interventions will be at the baseline, at 3 months and 6 months. Peer-led sessions will occur monthly, supported by informal peer engagements in the form of group discussions every two weeks.
Data will be collected at baseline and at 6 months using a validated questionnaire assessing knowledge, attitudes, risk perception, and intention to use tobacco. The primary outcome is assessing the change in students’ intention to use tobacco after six months. Secondary outcomes include changes in knowledge, perception, and risk awareness about tobacco use.
The study aligns with the objectives of the National Tobacco Control Programme and the School Health Programme under Ayushman Bharat, with potential for policy integration if proven effective. If successful, this model can serve as a scalable and sustainable strategy for adolescent tobacco prevention in school settings.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 12.00 Year(s) to 15.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Adolescents in 8th standard from the selected private schools who have given written assent and whose parents have given written consent to participate in the study.
Exclusion Criteria
- •Adolescents who are not present on the day of baseline evaluation.
Outcomes
Primary Outcomes
Change in student’s intention to use tobacco product scores before and after the intervention across two groups.
Time Frame: At baseline | At 6th month
Secondary Outcomes
- 1. Prevalence, patterns and correlates of tobacco use in adolescents.(2. Change in knowledge, perception and attitude scores baseline to endline across two groups.)
Investigators
Dr Sreeram Ravi Varma V
Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India