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Evaluation of a School-based Smoking Prevention and Cessation Programme in Negeri Sembilan

Evaluation of The KOTAK, a School-based Smoking Prevention and Cessation Programme in Negeri Sembilan, Malaysia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04378725
Enrollment
349
Registered
2020-05-07
Start date
2019-01-15
Completion date
2020-01-30
Last updated
2020-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking

Brief summary

School-based smoking cessation programmes stretched longer than a year had 12% reduction in preventing smoking uptake. With regards to smoking intervention programme among adolescents, there is a lack of evidences regarding its long-term effectiveness. This was due to lack of clear guidelines, methodological issues and the fact that adolescents were likely to be sporadic or non-daily smoker, leading to discrepancies in their self-reported claim. Adolescent's smoking relapse rate was at 47% while those who never smoke have a 13% chance to become smoker. Light and regular smokers have 30% and 75% chance becoming an adult smoker respectively. A review paper in smoking research in Malaysia showed that the provision of anti-smoking education in school was associated with reduced susceptibility in female smoking.Male students perceived printable media, radio and the Internet as effective in delivering anti-smoking messages.School-based smoking cessation programme has been shown to be cost-effective in helping the students to quit smoking both in developed and developing countries.For this reason, it is essential to explore what are the factors that amplify the success rate of smoking cessation effect of the KOTAK programme.

Detailed description

Through this study the investigators will seek to answer the following questions: * To determine the quit-smoking rate of the KOTAK programme * To determine the factors associated with quitting smoking with the KOTAK programme Important aspects of the KOTAK programme evaluation will involve assessing its impacts on preventing smoking initiation and promoting smoking cessation among the adolescents. This form of assessment is vital in achieving the KOTAK's objectives to reduce the prevalence of smokers in Malaysian schools. An average of 8 hours of training were required for dental officers and dental nurses to deliver the modules in the KOTAK programme. This programme has an important financial implication as it involved almost 4 thousand dental officers and 3 thousand dental nurses to screen almost 4.6 million Malaysian schoolchildren in 2018. Factors yielding promising results for adolescents to quit smoking are important to be researched. This will provide us with valuable insights from the perspectives of the stakeholders pertaining on areas that needed improvement. Despite the existence of various tobacco-prevention program in public schools, KOTAK is deemed significant as it is a yearly collaboration of School Dental Services with the schools. This study will compare the quit smoking rate between Intervention (with KOTAK Programme) and Control (without KOTAK programme ) schools. The sampling unit was the school.

Interventions

BEHAVIORALSchool-based smoking prevention and cessation program (The KOTAK program)

Advance Intervention: Following the screening process, this intervention package was inclusive of group-briefing for the smokers in at least 3 subsequent sessions in one academic year. The content delivered by the dentist were based on the KOTAK guidebook consisted of 8 Modules.The modules were as follows: 1. Introduction: Identifying students who smoke 2. Cigarette and addiction 3. The danger of smoking and passive smokers 4. Advantages of smoke-free lifestyle and adolescent perception on smoking 5. Legal and religious perception of smoking 6. The benefits of smoking cessation 7. Preparation and how to stop smoking 8. Nicotine withdrawal symptom and relapse prevention The Intervention schools: Screened smokers were given Advanced Intervention sessions. After discussion with the State's oral health deputy director and district's programme coordinator, for the purpose of this study, the interval of the Advance Intervention session was decided at 1-month interval.

Sponsors

University of Malaya
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The schoolchildren in the intervention and control schools were not aware of the differed treatment. The dentist involved in delivery the content of the KOTAK program were aware of the allocation of the schools.

Intervention model description

The study design is a cluster (cluster = school) randomized trial of schoolchildren participating in the school-based smoking prevention and cessation program (The KOTAK) . Randomization were done at the school level,after the schools were paired and matched base on the schools' overall academic achievement.The matched pairs were randomly selected.The selected pairs were then randomly allocated to either Intervention or Control schools. The Advance Intervention section of the KOTAK program will be assigned to the Intervention Schools.The cluster size will be treated as balancing factors in stratified allocation or as covariate in the statistical analysis.

Eligibility

Sex/Gender
ALL
Age
13 Years to 17 Years
Healthy volunteers
Yes

Inclusion criteria

Smoker, medically fit and consented (parental) students enrolled in; 1. Public funded school 2. Daily school 3. Non- same gendered schools (co-ed ) 4. Multiracial school

Exclusion criteria

Students who were a smoker enrolled in; 1. Private schools 2. Boarding school 3. Same-gendered school 4. Vernacular schools

Design outcomes

Primary

MeasureTime frameDescription
Self-reported prolonged smoking abstinence for 7 days6 month follow-upProlonged smoking abstinence (self-reported) for 7 days was validated by breath carbon monoxide reading (ppm) and salivary cotinine concentration (ng/ml). The cut-off points for both clinical measure were as follows; 1. Exhaled Carbon Monoxide (ppm) reading; 0-4 CO ppm = non-smoker 5-6 CO ppm = light smoker 7 and above CO ppm = frequent smoker 2. Salivary cotinine concentration (ng/mL) Code 0 (0-10 ng/mL)= non-smoker Code 1 (10-30 ng/mL)= light smoker Code 2-3 (30-200 ng/mL)= light smoker Code 4-6 (200- \>1000) = heavy smoker

Countries

Malaysia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026