Clinical trial NCT06853483: School-EduSmoke: a Cluster Randomized Controlled Trial for Promoting Smoking Cessation Among Parents of Schoolchildren
Official title: School-EduSmoke: a Cluster Randomized Controlled Trial for Promoting Smoking Cessation Among Parents of Schoolchildren
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Primary 4 students and their smoking parents.
2. The student has a parent who is a smoker (a smoker is defined as smoking at least 1 cigarette per day).
3. The student and participating parent reside together on a long-term basis.
4. The student and parents have the cognitive, understanding and communication skills to voluntarily participate in this project.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Biochemically validated 24-hour point smoking cessation rate at 3 month
timeFrame: 3-month followup
Secondary outcomes:
measure: Self-reported 7-day point prevalence quit rate
timeFrame: 3 month follow-up
measure: 50% reduction in the number of cigarettes smoked
timeFrame: 3-month follow-up
measure: The level of readiness to quit
timeFrame: 3-month follow-up
Other outcomes:
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