School-EduSmoke: a Cluster Randomized Controlled Trial for Promoting Smoking Cessation Among Parents of Schoolchildren

Not Applicable

Not yet recruiting

• Conditions: Smoking Cessation

• Registration Number: NCT06853483
• Lead Sponsor: Huazhong University of Science and Technology

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.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-23
• Study First Submitted QC: 2025-02-28
• Last Update Submitted: 2025-02-28
• Study Start: 2025-03-01
• Study First Posted: 2025-03-03
• Last Update Posted: 2025-03-03
• Primary Completion: 2026-03-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 700

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.

  3. The parent or student has a serious illness that is life-threatening or requires regular hospitalisation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemically validated 24-hour point smoking cessation rate at 3 month	3-month followup	Assessing smoking cessation in parents by measuring their urine cotinine levels

Secondary Outcome Measures

Name	Time	Method
Self-reported 7-day point prevalence quit rate	3 month follow-up	Subjects reporting not smoking in the past 7-days at 3-month will be regarded asabstinence from smoking. The self-reported 7-days prevalence quit rate will be assessedat the baseline and 3-month later after the intervention.; "Have you smoked a cigarette (even a puff) in the past 7 days?""
50% reduction in the number of cigarettes smoked	3-month follow-up	Cigarette consumption reduced by at least 50% compared with the baseline, the cigarette consumption will be assessed at the baseline and 3-month late after the intervention. "How many cigarettes do you smoke on average per day?"
The level of readiness to quit	3-month follow-up	"When do you plan to start quitting smoking?" The readiness to quit is divided into pre-contemplation stage (attempt to quitmore that 30 days later), contemplation stage (attempt to quit within 30 daysbut more than 7 days), preparation stage (attempt to quit within 7 days), andaction stage (quitting).