A Cluster-RCT of SHS Among Primary School Students
SHS-cRCT
Reducing Exposure to Tobacco Smoke Among Primary School Students - a Cluster Randomised Controlled Trial
1 other identifier
interventional
3,432
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2017
CompletedFirst Posted
Study publicly available on registry
December 21, 2017
CompletedStudy Start
First participant enrolled
September 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedFebruary 12, 2020
February 1, 2020
1.2 years
December 11, 2017
February 10, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To reduce children's exposure to environmental tobacco smoke.
In the 3th and 6th month, students will conduct a survey to assess their exposure to environmental tobacco smoke.
3 and 6-month
Secondary Outcomes (6)
To reduce the hair nicotine levels of students who are exposed to SHS at home at baseline.
6-month
To promote SHS-related knowledge and attitudes, and avoidance of SHS among children.
3 and 6-month
To reduce children's intention to smoke.
3 and 6-month
To reduce children's respiratory symptoms.
3 and 6-month
To promote smoking cessation (past 7 days) of parents. (child report)
6-month and 12-month3 and 6-month
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTAL8 worksheets and around 15 online quizzes and 30 WhatsApp messages.
Control
OTHERControl 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.
Interventions
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.
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.
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.
A leaflet on smoking and SHS published by the Department of Health will be mailed to the control grades.
Eligibility Criteria
You may qualify if:
- \) 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Local primary schools
Hong Kong, Hong Kong
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sai Yin Ho, PhD
School of Public Health, the University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle investigator and associate professor
Study Record Dates
First Submitted
December 11, 2017
First Posted
December 21, 2017
Study Start
September 20, 2018
Primary Completion
November 30, 2019
Study Completion
November 30, 2019
Last Updated
February 12, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share