- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04036474
Development, Implementation, and Evaluation of School-based Smoking Prevention Education Program Among Non-smoking Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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