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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University, Singapore

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 28, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 28, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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