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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378725
• Other study ID #: DFC01811/0080(P)
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: January 30, 2020

Study information

• Verified date: June 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 349
• Est. completion date: January 30, 2020
• Est. primary completion date: December 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Smoking

Intervention

Behavioral:
• School-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: Introduction: Identifying students who smoke Cigarette and addiction The danger of smoking and passive smokers Advantages of smoke-free lifestyle and adolescent perception on smoking Legal and religious perception of smoking The benefits of smoking cessation Preparation and how to stop smoking 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.

Locations

Country	Name	City	State
Malaysia	Faculty of Dentistry, University of Malaya	Kuala Lumpur	Petaling Jaya

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported prolonged smoking abstinence for 7 days	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; Exhaled Carbon Monoxide (ppm) reading; 0-4 CO ppm = non-smoker 5-6 CO ppm = light smoker 7 and above CO ppm = frequent smoker; 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	6 month follow-up