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

NCT04378725 | Completed

• 1 other identifier: DFC01811/0080(P)
• Study Type: interventional
• Target: 349
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Outcome Measures

Primary Outcomes (1)

• 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; 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

  6 month follow-up

Study Arms (2)

Control School

NO INTERVENTION

When a student is screened as a smoker. The student will only be receiving Brief Intervention Advice from the dentist. Brief Intervention advice: delivered to all schoolchildren regardless of smoking status by the dentist. Brief information of dangers of smoking was embedded in the generic lecture of Dental Health Education given to the whole school in large group.

Intervention School

EXPERIMENTAL

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.

Behavioral: School-based smoking prevention and cessation program (The KOTAK program)

Interventions

School-based smoking prevention and cessation program (The KOTAK program) BEHAVIORAL

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.

Intervention School

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Students who were a smoker enrolled in;
• Private schools
• Boarding school
• Same-gendered school
• Vernacular schools

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Faculty of Dentistry, University of Malaya

Kuala Lumpur, Petaling Jaya, 50603, Malaysia

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Roslan Saub, BDS MDSc PhD

  University of Malaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: January 15, 2019
• Primary Completion: December 30, 2019
• Study Completion: January 30, 2020
• Last Updated: June 22, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)