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A Cluster-RCT of SHS Among Primary School Students

Reducing Exposure to Tobacco Smoke Among Primary School Students - a Cluster Randomised Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03380234
Acronym
SHS-cRCT
Enrollment
3432
Registered
2017-12-21
Start date
2018-09-20
Completion date
2019-11-30
Last updated
2020-02-12

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

Conditions

Secondhand Smoke, Thirdhand Smoke, Smoking

Keywords

Smoking, Secondhand smoke, Thirdhand smoke, Children, Cluster randomised controlled trial

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.

Interventions

OTHERWorksheets

Worksheets will be distributed to students for them and their parents to complete together. During the first 3 months, the teachers will distribute 1 worksheet every two weeks to the intervention grades, and 1 worksheet in the 4th and 5th months as boosters. The worksheets will deliver information about tobacco smoke, SHS and THS, inviting students and their family members to complete other interesting tasks together.

OTHERWhatsapp messages

A mobile phone number of this study is also provided on the worksheets, through which participants can receive WhatsApp/WeChat/instant messages (1-2 times every week) designed to encourage behavioural change \[15\]. They can then forward selected messages to other members of their household, especially smokers.

OTHEROnline quizzes

At the end of each worksheet, a QR code is inserted. By scanning this code, students or parents will be invited to answer 2-3 simple quizzes which allow us to assess students' knowledge obtained from the intervention materials and their avoidance of environmental tobacco smoke.

OTHERLeaflet

A leaflet on smoking and SHS published by the Department of Health will be mailed to the control grades.

Sponsors

Hong Kong Council on Smoking and Health
CollaboratorOTHER
The University of Hong Kong
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

Cluster randomised controlled trial

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

We will invite all P2-4 students from 12 schools randomly selected from the 100 schools (which watched the performance by Hong Kong Council on Smoking and Health) to participate in this cluster RCT, as they are able to understand simple questionnaires and other self-help intervention materials, yet remain very receptive to intervention activities from our experience. Inclusion criteria for hair nicotine test: 1\) exposed to secondhand smoke at home from smokers inside home in any of the past 7 days; 2) living with at least 1 smoker; 3) Never smoking or using e-cigarettes.

Design outcomes

Primary

MeasureTime frameDescription
To reduce children's exposure to environmental tobacco smoke.3 and 6-monthIn the 3th and 6th month, students will conduct a survey to assess their exposure to environmental tobacco smoke.

Secondary

MeasureTime frameDescription
To promote SHS-related knowledge and attitudes, and avoidance of SHS among children.3 and 6-monthIn 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-monthIn the 3th and 6th month, students will conduct a survey to assess children's intention to smoke.
To reduce the hair nicotine levels of students who are exposed to SHS at home at baseline.6-monthAt 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 smoking cessation (past 7 days) of parents. (child report)6-month and 12-month3 and 6-monthIn 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-monthIn the 3th and 6th month, students will conduct a survey to report their perception of family happiness.
To reduce children's respiratory symptoms.3 and 6-monthIn the 3th and 6th month, students will conduct a survey to assess children's respiratory symptoms.

Countries

Hong Kong

Outcome results

None listed

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