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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06853483
Enrollment
700
Registered
2025-03-03
Start date
2025-05-03
Completion date
2026-06-01
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

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.

Interventions

BEHAVIORALFamily-School based smoking cessation intervention package

The Family-School based smoking cessation intervention programme will be developed using the multiple strategies provided by the BCW framework, with face-to-face + online as the primary mode of implementation. Specifically, educational training based on the school curriculum will be conducted to create a supportive environment for smokers to quit, guide smokers to discover motivation to quit, encourage smokers to cope with key barriers to quitting, as well as incorporate relapse prevention strategies, using formats such as online videos and supplemental materials, with interventions designed to help students and parents of smokers to understand the health hazards of smoking, to enhance cessation action and supportive skills, and inspire healthy action.

Sponsors

Huazhong University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Biochemically validated 24-hour point smoking cessation rate at 6 month6-month followupAssessing smoking cessation in parents by measuring their urine cotinine levels

Secondary

MeasureTime frameDescription
Self-reported 7-day point prevalence quit rate6 month follow-upSubjects reporting not smoking in the past 7-days at 6-month will be regarded asabstinence from smoking. The self-reported 7-days prevalence quit rate will be assessedat the baseline and 6-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 smoked6-month follow-upCigarette consumption reduced by at least 50% compared with the baseline, the cigarette consumption will be assessed at the baseline and 6-month late after the intervention. How many cigarettes do you smoke on average per day?
The level of readiness to quit1-month and 6-month follow-upWhen 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).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026