SLCTR Registration Number
Date of Registration
The date of last modification
Aug 15, 2018
Scientific Title of Trial
Prevalence of tobacco smoking and the knowledge and attitudes on prevention of tobacco smoking among schooling adolescents and effect of an educational intervention to prevent tobacco smoking among adolescents in Kandy district
Public Title of Trial
A non randomized controlled trial on the efficacy of an education programme in changing attitudes to prevent smoking among schooling adolescents in the Kandy district
Disease or Health Condition(s) Studied
Smoking prevention trial among adolescents in the Kandy district
Universal Trial Number
Any other number(s) assigned to the trial and issuing authority
Ref. No: 2017/EC/86 (Ethics review committee, Faculty of Medicine, University of Peradeniya)
What is the research question being addressed?
Can improving knowledge and attitudes on tobacco smoking via an educational intervention prevent the habit of smoking among schooling adolescents in the Kandy district?
Type of study
Non-randomized controlled trial
Masking not used
Intervention is an educational programme delivered via life skills teaching sessions to grade 9 students implemented during school hours. There will be four lessons of 40 minutes conducted over 4 consecutive weeks.
There will be an interventional arm and non interventional (control arm). These arms will be selected from schools of two separate educational zones in the Kandy district.
Intervention arm will receive routine life skills lessons including the educational intervention. Non interventional arms will receive only the life skills lessons.
A pre interventional assessment of knowledge and attitudes will be carried out 1 weeks prior to the start of the intervention.
A 6-8 hour seminar will be conducted to teachers beforehand in the form of lesson plans to convey what information should be delivered to the students during the above mentioned education programme.
Private schools in Kandy district
A change in knowledge and attitudes regarding tobacco smoking between the pre intervention and post intervention stage of each arm and between both arms.
Scores for knowledge and attitudes will be generated using Likert scales.
A change in the proportion of smokers between the pre intervention and post intervention stage of each arm and between both arms
One week and three months following the intervention]
Target number/sample size
2896 (1448 students in each arm)
Countries of recruitment
Anticipated start date
Anticipated end date
Date of first enrollment
Date of study completion
None (Investigator funded)
Date of Approval
Details of Ethics Review Committee
Contact person for Scientific Queries/Principal Investigator
Dr. H.W.S.R. Rambukwella
Postgraduate trainee in MD Community Medicine
Regional Health Training Centre, Kadugannawa, Sri Lanka
Contact Person for Public Queries
Dr. Devani S. Dissanayake
Senior Lecturer in Community Medicine
Department of Community Medicine, Faculty of Medicine, University of Peradeniya, Sri Lanka.
Primary study sponsor/organization
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Results summary available
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results