NCT04036474

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 29, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

7 months

First QC Date

July 24, 2019

Last Update Submit

July 28, 2019

Conditions

Outcome Measures

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).

    3 months

Secondary Outcomes (4)

  • Mean score of students' intention to smoke

    3 months

  • Mean score of students' attitudes towards smoking

    3 months

  • Mean score of students' perception of subjective norms

    3months

  • Mean score of students' perceived behavioural control

    3 months

Study Arms (2)

Smoking Prevention Education Program

EXPERIMENTAL

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

Control

NO INTERVENTION

Immediately after the collection of baseline data, students received a one-time lecture on the hazards of smoking by the research assistant.

Interventions

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.

Smoking Prevention Education Program

Eligibility Criteria

Age11 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

July 24, 2019

First Posted

July 29, 2019

Study Start

July 1, 2016

Primary Completion

January 28, 2017

Study Completion

January 28, 2017

Last Updated

July 30, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share