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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Smoking Cessation
• Intervention / Treatment: Behavioral: Family-School based smoking cessation intervention package

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 Type: Interventional
• Enrollment (Estimated): 700
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 453000
      • Dongxihu Primary School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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.
Experimental: Intervention group; Students and parents of smokers in the intervention group will work together to receive home-school based smoking cessation intervention strategies.	Behavioral: Family-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically validated 24-hour point smoking cessation rate at 6 month	Assessing smoking cessation in parents by measuring their urine cotinine levels	6-month followup

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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?""	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?"	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).	1-month and 6-month follow-up

Collaborators and Investigators

• Sponsor: Huazhong University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 23, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 2, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Smoking Cessation
• Other Study ID Numbers: S133

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No