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

Smoking Behaviors Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04036474
• Other study ID #: IIUM/504/14/11/2/IREC650
• Status: Completed
• Phase: N/A
• Start date: July 1, 2016
• Est. completion date: January 28, 2017

Study information

• Verified date: July 2019
• Source: National University, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 145
• Est. completion date: January 28, 2017
• Est. primary completion date: January 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking Behaviors

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University, Singapore

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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".	3 months
Secondary	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".	3 months
Secondary	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".	3months
Secondary	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".	3 months