A Cluster-RCT of SHS Among Primary School Students

Not Applicable

Completed

• Conditions: Thirdhand Smoke; Smoking; Secondhand Smoke
• Interventions: Other: Leaflet; Other: Worksheets; Other: Whatsapp messages; Other: Online quizzes

• Registration Number: NCT03380234
• Lead Sponsor: The University of Hong Kong

Brief Summary

This is a school- and family-based prospective trial among Primary/Grade 2-4 (P2-4) students in randomly selected 12 schools in Hong Kong. This study will assess the intervention effects on children's exposure to environmental tobacco smoke (including SHS and THS at home, SHS at home from neighbours and SHS outside home), children's SHS-related knowledge and attitude, intention to smoke, respiratory symptoms, parents' smoking cessation, and family happiness.

Detailed Description

Around 12 primary schools in Hong Kong will be randomly selected and recruited and the 3 grades (P2-4) in each of the recruited schools will be randomly allocated to intervention or control arms. After the consenting process and baseline survey, we will conduct a 3-month intervention and then 2-month boosters which include 8 worksheets, around 15 online question quizzes and 30 WhatsApp messages. After 3-month and 6-month follow-up periods, we will assess the differences of children's exposure to environmental tobacco smoke (including SHS and THS at home, SHS at home from neighbours and SHS outside home), children's SHS-related knowledge and attitude, intention to smoke, respiratory symptoms, parents' smoking cessation, and family happiness. According to the results of baseline survey, we will also invite all the students exposed to SHS at home to provide their hair samples before intervention and at the 6th month in order to obtain objective results (hair nicotine measurements).

Aims of this study: (1) To reduce children's exposure to environmental tobacco smoke. (2) To reduce objectively measured exposure to tobacco smoke (hair nicotine) among children who are exposed to SHS at home at baseline. (6-month, laboratory test). (3) To promote SHS-related knowledge and attitudes, and avoidance of SHS among children. (4) To reduce children's intention to smoke. (5) To reduce children's respiratory symptoms. (6) To promote smoking cessation (past 7 days) of parents. (child report) (7) To promote children's perception of family happiness.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-15
• Study First Posted: 2017-12-21
• Study Start: 2018-09-20
• Primary Completion: 2019-11-30
• Study Completion: 2019-11-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3432

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Leaflet	Control students will receive the following minimal intervention to reduce their intention to smoke and SHS - a leaflet on smoking and SHS published by the Department of Health.
Intervention	Whatsapp messages	8 worksheets and around 15 online quizzes and 30 WhatsApp messages.
Intervention	Online quizzes	8 worksheets and around 15 online quizzes and 30 WhatsApp messages.
Intervention	Worksheets	8 worksheets and around 15 online quizzes and 30 WhatsApp messages.

Primary Outcome Measures

Name	Time	Method
To reduce children's exposure to environmental tobacco smoke.	3 and 6-month	In the 3th and 6th month, students will conduct a survey to assess their exposure to environmental tobacco smoke.

Secondary Outcome Measures

Name	Time	Method
To reduce the hair nicotine levels of students who are exposed to SHS at home at baseline.	6-month	At the 6th months, parents will be invited to post their children's hair for laboratory test and identify the change of the nicotine levels (objective measurement) before and after intervention.
To promote SHS-related knowledge and attitudes, and avoidance of SHS among children.	3 and 6-month	In the 3th and 6th month, students will conduct a survey to assess their SHS-related knowledge and attitudes, and avoidance of SHS.
To reduce children's intention to smoke.	3 and 6-month	In the 3th and 6th month, students will conduct a survey to assess children's intention to smoke.
To reduce children's respiratory symptoms.	3 and 6-month	In the 3th and 6th month, students will conduct a survey to assess children's respiratory symptoms.
To promote smoking cessation (past 7 days) of parents. (child report)	6-month and 12-month3 and 6-month	In the 3th and 6th month, students will conduct a survey to report their parents' smoking cessation.
To promote children's perception of family happiness.	3 and 6-month	In the 3th and 6th month, students will conduct a survey to report their perception of family happiness.

Trial Locations

Locations (1)

Local primary schools; 🇭🇰 Hong Kong, Hong Kong