Effectiveness of a Complex Intervention on Reducing the Prevalence of Smoking Among Adolescents: a Cluster Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2,226
- 试验地点
- 40
- 主要终点
- Smoking prevalence of adolescents in each group
研究概览
简要总结
In this multicenter cluster randomized controlled trial stratified by school baseline prevalence of smoking will be randomly allocated to the control or intervention group. Control schools will receive normal smoking education and intrvention schools will receive a four year class-based curriculum intervention (22 Classroom lessons), reinforcement of smoke-free school policy, smoking cessation in parents, pupils, and teachers and information and annual meeting with parents.
Study participants will be children aged 12 to 15 years old ; they will be followed to 2 years after high school. External evaluator and analyst will be blinded to school allocation.
The aim of this study is to analyze the effectiveness of a complex intervention to reduce the prevalence of smoking at 3º ESO (14-15 yrs-old) and 2 years after high school (17-18 yrs-old) .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children at first of Secondary education.
- •Adolescents and parents accept and sign informed consent
排除标准
- 未提供
结局指标
主要结局
Smoking prevalence of adolescents in each group
时间窗: six years
We will compare the smoking prevalence of adolescents in each group at six years against the usual null hypothesis of no difference between groups. We will use the Chi-squared test, taking into account the "variance inflation factor" of the adolescent cluster and intraclass correlation coefficient.
次要结局
未报告次要终点