A Cluster-RCT of SHS Among Primary School Students

NCT ID: NCT03380234

Last Updated: 2020-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-20

Study Completion Date

2019-11-30

Brief Summary

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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

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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.

Conditions

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Secondhand Smoke Thirdhand Smoke Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomised controlled trial
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention

8 worksheets and around 15 online quizzes and 30 WhatsApp messages.

Group Type EXPERIMENTAL

Worksheets

Intervention Type OTHER

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.

Whatsapp messages

Intervention Type OTHER

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.

Online quizzes

Intervention Type OTHER

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.

Control

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.

Group Type OTHER

Leaflet

Intervention Type OTHER

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

Interventions

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Worksheets

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.

Intervention Type OTHER

Whatsapp 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.

Intervention Type OTHER

Online 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.

Intervention Type OTHER

Leaflet

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hong Kong Council on Smoking and Health

OTHER

Sponsor Role collaborator

The University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Daniel Sai-Yin Ho

Principle investigator and associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sai Yin Ho, PhD

Role: PRINCIPAL_INVESTIGATOR

School of Public Health, the University of Hong Kong

Locations

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Local primary schools

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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coshshs

Identifier Type: -

Identifier Source: org_study_id

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