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CTRI Number

CTRI/2025/07/090983 [Registered on: 16/07/2025] Trial Registered Prospectively

Last Modified On:

14/07/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Preventive
Screening
Behavioral

Study Design

Cluster Randomized Trial

Public Title of Study

Teaching teens to stay tobacco free: A school based educational intervention in Mangalore.

Scientific Title of Study

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 Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Sreeram Ravi Varma V
Designation	Post Graduate
Affiliation	Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India
Address	Department of Community Medicine, Kasturba Medical College Mangalore, Light House Hill Road, Hampankatta, Mangalore Dakshina Kannada KARNATAKA 575001 India
Phone	8281341080
Fax
Email	sreeram.kmcmlr2024@learner.manipal.edu

Details of Contact Person
Scientific Query

Name	Dr Nithin Kumar
Designation	Associate Professor
Affiliation	Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India
Address	Department of Community Medicine, Kasturba Medical College Mangalore, Light House Hill Road, Hampankatta, Mangalore Dakshina Kannada KARNATAKA 575001 India
Phone	9591895839
Fax
Email	nithin.gatty@manipal.edu

Details of Contact Person
Public Query

Name	Dr Nithin Kumar
Designation	Associate Professor
Affiliation	Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India
Address	Department of Community Medicine, Kasturba Medical College Mangalore, Light House Hill Road, Hampankatta, Mangalore Dakshina Kannada KARNATAKA 575001 India
Phone	9591895839
Fax
Email	nithin.gatty@manipal.edu

Source of Monetary or Material Support

Kasturba Medical College Mangalore, Manipal Academy of Higher Education, Manipal, India

Primary Sponsor

Name	Dr. Sreeram Ravi Varma V
Address	Department of Community Medicine, Kasturba Medical College Mangalore, Light House Hill Road, Hampankatte, Mangalore, Dakshina Kannada, Karnataka
Type of Sponsor	Other [Self Funded]

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 1
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Sreeram Ravi Varma V	Kasturba Medical College Mangalore	Department of Community Medicine, Kasturba Medical College Mangalore, Light House Hill Road, Hampankatta, Mangalore Dakshina Kannada KARNATAKA	8281341080 sreeram.kmcmlr2024@learner.manipal.edu

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Institutional Ethics Committee Kasturba Medical College Mangalore	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Adolescents in 8th standard of selected private schools

Intervention / Comparator Agent

Type	Name	Details
Intervention	Combined facilitator-driven and peer-led educational intervention	Intervention arm will receive combined facilitator-driven and peer-led educational intervention. Facilitator driven intervention will be delivered by the principal investigator during the first visit followed by reinforcement at 3rd month and 6th month. Peer-led educational intervention will be delivered by identified peer educators in the selected schools of intervention arm. Module based peer sessions would happen once a month and brief peer sessions in the form of group discussions would happen once in two weeks.
Comparator Agent	Facilitator driven intervention.	Facilitator driven intervention will be delivered by the principal investigator during the first visit followed by reinforcement at 3rd month and 6th month to the comparator arm.

Inclusion Criteria

Age From	12.00 Year(s)
Age To	15.00 Year(s)
Gender	Both
Details	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.

ExclusionCriteria

Details

Adolescents who are not present on the day of baseline evaluation.

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Sequentially numbered, sealed, opaque envelopes

Blinding/Masking

Not Applicable

Primary Outcome

Outcome	TimePoints
Change in student’s intention to use tobacco product scores before and after the intervention across two groups.	At baseline At 6th month

Secondary Outcome

Outcome	TimePoints
1. Prevalence, patterns and correlates of tobacco use in adolescents. 2. Change in knowledge, perception and attitude scores baseline to endline across two groups. 3. Change in the risk perception before and after the intervention across two groups.	At baseline At 6th month

Target Sample Size

Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

01/09/2025

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="2"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

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.