Smoking BehaviorsNCT04036474
Development, Implementation, and Evaluation of School-based Smoking Prevention Education Program Among Non-smoking Adolescents
A study testing Smoking Prevention Education Program in people with Smoking Behaviors, run by National University of Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- Smoking Prevention Education Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2016to 28 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Primary school students (standard 5)
- 11years' old
- Non- smoker (CO level less than 4ppm) to maintain baseline never- smoker
- Both genders
- Consented by parent
Who cannot join
- 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
About this study
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.
- Conditions
- Smoking Behaviors
- Being tested
- Smoking Prevention Education Program
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Prevention Education ProgramOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (4)
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".
Measured: 3 months
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".
Measured: 3 months
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".
Measured: 3months
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".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start1 Jul 2016
- Primary completion28 Jan 2017
- Study completion28 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esperanza Debby Ng, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036474
- Sponsor's protocol ID
- IIUM/504/14/11/2/IREC650
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2019
- Last updated
- 30 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development, Implementation, and Evaluation of School-based Smoking Prevention Education Program Among Non-smoking Adolescents
- ClinicalTrials.gov ID
- NCT04036474
- Acronym / sponsor ID
- IIUM/504/14/11/2/IREC650
- Conditions
- Smoking Behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 1 Jul 2016 (actual)
- Primary completion
- 28 Jan 2017 (actual)
- Study completion
- 28 Jan 2017 (actual)
- First posted
- 29 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking Prevention Education Program | Experimental | Other: Smoking Prevention Education ProgramIn 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. |
| 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. |
Who may qualify
- Ages
- 11 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Primary school students (standard 5)
- 11years' old
- Non- smoker (CO level less than 4ppm) to maintain baseline never- smoker
- Both genders
- Consented by parent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Prevention Education ProgramThe 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. | Other | Smoking Prevention Education Program |
Primary outcome
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).
4 secondary outcomes
Mean score of students' intention to smoke
Time frame: 3 months
Mean score of students' attitudes towards smoking
Time frame: 3 months
Mean score of students' perception of subjective norms
Time frame: 3months
Mean score of students' perceived behavioural control
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking Prevention Education Program in people with Smoking Behaviors, run by National University of Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of students who smoke (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2019.