Clinical trial NCT04378725: Evaluation of a School-based Smoking Prevention and Cessation Programme in Negeri Sembilan
Official title: Evaluation of The KOTAK, a School-based Smoking Prevention and Cessation Programme in Negeri Sembilan, Malaysia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Lead sponsor: University of Malaya
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 349
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Self-reported prolonged smoking abstinence for 7 days
timeFrame: 6 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: Faculty of Dentistry, University of Malaya
state: Petaling Jaya
Study officials:
affiliation: University of Malaya
name: Roslan Saub, BDS MDSc PhD
role: STUDY_CHAIR
References: