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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Behavioral: School-based smoking prevention and cessation program (The KOTAK program)

• Registration Number: NCT04378725
• Lead Sponsor: University of Malaya

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.

Study Timeline

• Study Start: 2019-01-15
• Primary Completion: 2019-12-30
• Study Completion: 2020-01-30
• Study First Submitted: 2020-05-04
• Study First Submitted QC: 2020-05-06
• Study First Posted: 2020-05-07
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-19
• Last Update Posted: 2020-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 349

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention School	School-based smoking prevention and cessation program (The KOTAK program)	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.

Primary Outcome Measures

Name	Time	Method
Self-reported prolonged smoking abstinence for 7 days	6 month follow-up	Prolonged 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

Trial Locations

Locations (1)

Faculty of Dentistry, University of Malaya; 🇲🇾 Kuala Lumpur, Petaling Jaya, Malaysia