Smoking CessationNCT06853483
School-EduSmoke: A Cluster Randomized Controlled Trial for Promoting Smoking Cessation Among Parents of Schoolchildren
A study testing Family-School based smoking cessation intervention package in people with Smoking Cessation, run by Huazhong University of Science and Technology at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Family-School based smoking cessation intervention package
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Family-School based smoking cessation intervention package
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-School based smoking cessation intervention packageBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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 | Experimental | Students and parents of smokers in the intervention group will work together to receive home-school based smoking cessation intervention strategies. Receives: Behavioral: Family-School based smoking cessation intervention package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically validated 24-hour point smoking cessation rate at 6 month
Assessing smoking cessation in parents by measuring their urine cotinine levels
Measured: 6-month followup
Secondary outcomes (3)
Self-reported 7-day point prevalence quit rate
Subjects 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?""
Measured: 6 month follow-up
50% reduction in the number of cigarettes smoked
Cigarette 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?"
Measured: 6-month follow-up
The level of readiness to quit
"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).
Measured: 1-month and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2025
- Study start3 May 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Gong, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06853483
- Sponsor's protocol ID
- S133
- Status last verified
- Sep 2025
- First submitted
- 23 Feb 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-EduSmoke: A Cluster Randomized Controlled Trial for Promoting Smoking Cessation Among Parents of Schoolchildren
- ClinicalTrials.gov ID
- NCT06853483
- Acronym / sponsor ID
- S133
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 3 May 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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 | Experimental | Behavioral: Family-School based smoking cessation intervention packageStudents and parents of smokers in the intervention group will work together to receive home-school based smoking cessation intervention strategies. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Family-School based smoking cessation intervention packageThe 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. | Behavioural | Intervention group |
Primary outcome
Biochemically validated 24-hour point smoking cessation rate at 6 month
Time frame: 6-month followup
Assessing smoking cessation in parents by measuring their urine cotinine levels
3 secondary outcomes
Self-reported 7-day point prevalence quit rate
Time frame: 6 month follow-up
50% reduction in the number of cigarettes smoked
Time frame: 6-month follow-up
The level of readiness to quit
Time frame: 1-month and 6-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Family-School based smoking cessation intervention package in people with Smoking Cessation, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically validated 24-hour point smoking cessation rate at 6 month (time frame: 6-month followup). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025; AzTrials last refreshed its copy on 29 Oct 2026.