Home » Trials » SLCTR/2018/026


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

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SLCTR Registration Number

SLCTR/2018/026


Date of Registration

15 Aug 2018

The date of last modification

Jan 28, 2019



Application Summary


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

Tobacco smoking


Scientific Acronym

None


Public Acronym

None


Brief title

Smoking prevention trial among adolescents in the Kandy district


Universal Trial Number

U1111-1216-1200


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)


Trial Details


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

Interventional


Study design

Allocation

Non-randomized controlled trial


Masking

Masking not used


Control

Active


Assignment

Parallel


Purpose

Prevention


Study Phase

Not Applicable


Intervention(s) planned

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.


Inclusion criteria

  1. Male and female students of age 13 -15 studying in all three language media
  2. Government schools from the functional category 1AB, 1C and Type 2 in Kandy district
  3. Presence of a designated teacher in teaching the subject of life skills.

Exclusion criteria

Private schools in Kandy district



Primary outcome(s)

    1. 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.

    2. 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

    ]

Secondary outcome(s)

  1. None

    [

    None

    ]

Target number/sample size

2896 (1448 students in each arm)


Countries of recruitment

Sri Lanka


Anticipated start date

2018-09-01


Anticipated end date

2018-12-15


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

None (Investigator funded)


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2017-12-21


Approval number

2017/EC/86


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Peradeniya
Institutional Address: Galaha Road, Kandy, Sri Lanka.
Telephone: +94-812396361
Email: chairpersonierc@gmail.com


Contact & Sponsor Information


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
Tel: +94812396490
Mob: +94718368758
Fax: +94812389106
roshanrambukwella1@gmail.com

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.
Tel: +94812396490
Mob: +94772094548
Fax: +94812389106
devanisaku@gmail.com


Primary study sponsor/organization

Faculty of Medicine, University of Peradeniya

P.O 34, Galaha road, Peradeniya, 20400, Sri Lanka
Tel: 0812396000, 0812396490
Fax: +94812389106

Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?


IPD sharing plan description

Not available


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results