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临床试验/NCT04378725
NCT04378725已完成不适用

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

University of Malaya2 个研究点 分布在 1 个国家目标入组 349 人开始时间: 2019年1月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
349
试验地点
2
主要终点
Self-reported prolonged smoking abstinence for 7 days

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

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.

入排标准

年龄范围
13 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Self-reported prolonged smoking abstinence for 7 days

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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