How to reduce tobacco use among school children? A cluster randomised controlled trial in Gadchiroli, Maharashtra
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,650
- 试验地点
- 1
- 主要终点
- Reduction in the prevalence of self-reported use of tobacco among students from the schools receiving intervention compared to the schools in the control arm at the end of the school-based tobacco awareness and cessation intervention programme
研究概览
简要总结
This study is a cluster randomized, parallel group, two arm controlled trial to assess the effectiveness of a school-based tobacco awareness and cessation programme on tobacco use among school children in Gadchiroli, Maharashtra, India. The study will be conducted in the selected 50 schools of Dhanora and Gadchiroli blocks of Gadchiroli district. The tobacco cessation intervention package will target children studying in 5th to 10th standard of primary and secondary Marathi schools of the above two blocks. The intervention will include- i) Oral examination by a dentist and counseling to quit tobacco, ii) School-level activities by the anti-tobacco committeeof the schoolto increase awareness about the harmful effects of tobacco among school students through poster and elocution competitions and monitoring the use of tobacco products on the school campus iii) Group-level activities for selected standards with support group formation and peer-led discussion on normative beliefs, healthy lifestyle and methods to quit tobacco, and iv) Increasing awareness about the Cigarette and Other Tobacco Products Act (COTPA) among school authorities and promoting its implementation in the schools. The intervention package will be implemented for 4 months among 25 schools in the intervention arm. The primary outcome will be reduction in the prevalence of self-reported use of tobacco use among students from schools in the intervention arm compared to the schools in the control arm at the end of the intervention. The secondary outcomes will be reduction in the daily frequency of tobacco use, increase in the awareness of harmful effects of tobacco and improvement in tobacco refusal intention in the intervention arm compared to the control arm. If the intervention is found to be effective it will be implemented in schools of the control arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 10.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Cluster/School level:
- •The primary and secondary Marathi schools in the Gadchiroli and Dhanora block of Gadchiroli district
- •The schools should provide written consent for the participation in study.
- •The schools should be located within 50 kilometers of the campus of SEARCH Individual/student level:
- •Children studying in 5th to 10th Standard among selected schools
- •Should providing assent for participation in the group level activities under the intervention.
排除标准
- •Cluster level:
- •Schools with less than 50 students on roll.
结局指标
主要结局
Reduction in the prevalence of self-reported use of tobacco among students from the schools receiving intervention compared to the schools in the control arm at the end of the school-based tobacco awareness and cessation intervention programme
时间窗: 4 months
次要结局
- Reduction in the self-reported frequency of daily tobacco use among tobacco users(4 months)
- Increase in the awareness about tobacco and its harmful effects among students as determined by the listing of 5 appropriate harmful effects by the students(4 months)
- Improvement in the tobacco refusal intention among students in intervention arm compared to those in the control arm. This will be assessed by the response to the question- “will you accept tobacco if your friends offer it to you?â€(4 months)