School-EduSmoke: A Cluster Randomized Controlled Trial for Promoting Smoking Cessation Among Parents of Schoolchildren
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Biochemically validated 24-hour point smoking cessation rate at 6 month
研究概览
简要总结
This study is a pragmatic two-group, multi-center, randomized controlled superiority trial, including an internal pilot, economic evaluation and process evaluation, aiming to assess the impact of a school-based comprehensive intervention on smoking cessation actions among parents who smoke.
详细描述
The School-EduSmoke project will be based on the Behavior change wheel (BCW) and theoretical domain framework. The goal of our project is to promote smoking cessation actions by parents through smoking cessation education for children and their parents in schools. The programme will enhance the implementation of smoking cessation behaviours by identifying key risk factors that influence smoking behaviour, helping to design specific interventions that will particularly help to address ambivalence and defensiveness among smokers. A set of randomized controlled trials will be used to evaluate the effectiveness of the intervention. The findings will provide evidence and support for the provision of low-cost, low-resource, widely accessible smoking cessation support to the smoking community, thereby promoting the effective implementation of smoke-free health actions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Primary 4 students and their smoking parents.
- •The student has a parent who is a smoker (a smoker is defined as smoking at least 1 cigarette per day).
- •The student and participating parent reside together on a long-term basis.
- •The student and parents have the cognitive, understanding and communication skills to voluntarily participate in this project.
排除标准
- •1) The parent who smokes is currently using other tobacco substances, has recently participated in nicotine replacement therapy, or has other substance abuse.
- •2) The parent or student has a serious organic or somatic disease. 3) The parent or student is unwilling to cooperate with the test or refuses to answer questions.
- •4) The parent or student has a serious illness that is life-threatening or requires regular hospitalisation.
研究组 & 干预措施
Control group
Students in control group will have regular health education classes . Parents in control group will not receive any intervention other than completion questionnaires and cotinine testing.
Intervention group
Students and parents of smokers in the intervention group will work together to receive home-school based smoking cessation intervention strategies.
干预措施: Family-School based smoking cessation intervention package (Behavioral)
结局指标
主要结局
Biochemically validated 24-hour point smoking cessation rate at 6 month
时间窗: 6-month followup
Assessing smoking cessation in parents by measuring their urine cotinine levels
次要结局
- The level of readiness to quit(1-month and 6-month follow-up)
- Self-reported 7-day point prevalence quit rate(6 month follow-up)
- 50% reduction in the number of cigarettes smoked(6-month follow-up)
研究者
Yanhong Gong
Professor
Huazhong University of Science and Technology