Development, Implementation, and Evaluation of School-based Smoking Prevention Education Program Among Non-smoking Adolescents

July 28, 2019 updated by: Esperanza Debby Ng, National University, Singapore
Preventing smoking among adolescents is critical to end the epidemic of smoking in Malaysia. Despite the implementation of several smoking prevention programs, the prevalence of adolescent smoking and experimenting with tobacco in Malaysia is still increasing. Therefore, the purpose of this quasi-experimental study was to evaluate the effectiveness of Smoking Prevention Education Programs (SPEP) in preventing the smoking initiation among non-smoker adolescents based on their smoking status on follow-up and smoking intention, which includes; attitude, subjective norms, and perceived behavioural control as described by the Theory of Planned Behaviour. A total of 140 Primary five students (non- smokers) were involved in this study. Four schools in Kuantan district were randomly assigned to intervention and control groups. The intervention schools received a lecture on the hazards of smoking and SPEP intervention whereas the control schools received just a lecture on the hazards of smoking. The questionnaires and exhale carbon monoxide levels were first assessed at baseline and then again after three months.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 11 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary school students (standard 5)
  • 11years' old
  • Non- smoker (CO level less than 4ppm) to maintain baseline never- smoker
  • Both genders
  • Consented by parent

Exclusion Criteria:

  • Ex-smoker (self- reporting) and smoker (CO level more than 4ppm)
  • Students unable to understand and read the national language (Bahasa Malaysia)
  • Children with special needs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Smoking Prevention Education Program
In addition to the lecture on the hazards of smoking, students received the SPEP intervention. The SPEP consisted of three lessons and each lesson took one to two hours to be implemented. The SPEP intervention was delivered to participants in their usual classroom setting, during school hours combined with relevant school subjects such as physical education class. The duration of SPEP intervention took approximately one month.
The SPEP consisted of three lessons and each lesson took one to two hours to be implemented. SPEP was conducted through direct and indirect method. Direct method was conducted through lectures, question and answer, role play and educational videos. The tools used were video projectors and Power Point presentations. On the other hand, the indirect method was done through distributing of badge buttons and fridge magnets "Be Free from Smoking". This method brought a simple message to increase awareness among adolescents to prevent smoking uptake. All instruments and protocols in this intervention were pilot tested to confirm feasibility and cultural appropriateness.
NO_INTERVENTION: Control
Immediately after the collection of baseline data, students received a one-time lecture on the hazards of smoking by the research assistant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of students who smoke
Time Frame: 3 months
Number of students who started smoking by the end of 3 months as assessed by a self-reported questionnaire and through measurement of exhaled CO levels using a handheld CO analyzer (piCO Smokerlyzer, Bedfont Scientific Ltd, England).
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean score of students' intention to smoke
Time Frame: 3 months

Self-administering questionnaires were used to collect the baseline (before intervention) and follow-up (at 3 months post-intervention) data in this study. The questionnaires with translated versions (in English and Malay) were adapted and modified from the previous study by Melson (2014) based on the Theory of Planned Behaviour.

Out of 24-items in the questionnaire, there are 3 items measuring behaviour intention on a 5-point Likert scale (1 = 'strongly disagree', 5 = 'strongly agree'), a higher value represents less intention to initiate smoking. Sample question for measuring behaviour intention include "I intend to be a non-smoker".

3 months
Mean score of students' attitudes towards smoking
Time Frame: 3 months
Out of 24-items, there are 9 items measuring attitude on a 5-point Likert scale, a higher value represents an attitude of being in favor of smoking initiation. A sample question for measuring attitude include "I want to be a non-smoker".
3 months
Mean score of students' perception of subjective norms
Time Frame: 3months
There are 6 items measuring subjective norms on the 5-point Likert scale, a higher value represents an individual experiencing social pressure not to initiate smoking. Sample question for measuring subjective norms include "Most people who are important to me think that I should be a non-smoker".
3months
Mean score of students' perceived behavioural control
Time Frame: 3 months
There are 6 items measuring perceived behaviour control on a 5-point Likert scale, a higher value represents an individual feeling in control from initiating smoking. Sample question for measuring perceived behavior control include "For me to be a non-smoker would be easy".
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ACTUAL)

January 28, 2017

Study Completion (ACTUAL)

January 28, 2017

Study Registration Dates

First Submitted

July 24, 2019

First Submitted That Met QC Criteria

July 26, 2019

First Posted (ACTUAL)

July 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 30, 2019

Last Update Submitted That Met QC Criteria

July 28, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • IIUM/504/14/11/2/IREC650

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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