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CompletedNCT04036474Updated Jul 30, 2019

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

An interventional study of Smoking Prevention Education Program in Smoking Behaviors, sponsored by National University of Singapore. Completed. Open to participants aged 11 Years to 11 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-07-30.

Sponsored by National University of Singapore · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 3 years after the study started (first participant enrolled Jul 2016, registered Jul 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
145
Allocation
Randomized
Ages
11 Years to 11 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Smoking Behaviors
03

In context

Lead sponsor

National University of Singapore is the lead sponsor of 206 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 11 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
145 participants (actual)

Study arms

  • 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.

    Other: Smoking Prevention Education Program

  • 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.

Interventions

  • OtherSmoking Prevention Education Program

    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.

06

What researchers measure

Primary outcomes

  1. Number of students who smoke

    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).

    Time frame: 3 months

Secondary outcomes

  1. Mean score of students' intention to smoke

    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".

    Time frame: 3 months

  2. Mean score of students' attitudes towards smoking

    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".

    Time frame: 3 months

  3. Mean score of students' perception of subjective norms

    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".

    Time frame: 3months

  4. Mean score of students' perceived behavioural control

    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".

    Time frame: 3 months

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04036474
Lead sponsor
National University of Singapore
Responsible party
Esperanza Debby Ng (Research Assistant, National University of Singapore) — Principal investigator
First posted
Jul 29, 2019
Start date
Jul 1, 2016
Primary completion
Jan 28, 2017
Completion
Jan 28, 2017
Last update
Jul 30, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.

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