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An cRCT of SHS Among Primary School Students (SHS-cRCT)

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ClinicalTrials.gov Identifier: NCT03380234
Recruitment Status : Not yet recruiting
First Posted : December 21, 2017
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Daniel Sai-Yin Ho, 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.

Condition or disease Intervention/treatment Phase
Secondhand Smoke Thirdhand Smoke Smoking Other: Worksheets Other: Whatsapp messages Other: Online quizzes Other: Leaflet Not Applicable

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. During the 6-month intervention and follow-up period, we will assess the variation 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 in the 3rd month and the 6th month. According to the results of baseline survey, we will also invite all the students exposed to SHS at home to provide their hair samples after baseline survey 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1616 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cluster randomised controlled trial
Masking: Double (Participant, Investigator)
Masking Description: All participants will be told that they will be randomly allocated to one of two interventions, and will be advised not to discuss with other parents and students about the intervention. The group status of hair samples will not be revealed to the Laboratory. Variables applicable only to the intervention arm (e.g. process evaluation items) will be kept in a separate data set, and the data analysts will be blinded to the group status of the data sets.
Primary Purpose: Prevention
Official Title: Reducing Exposure to Tobacco Smoke Among Primary School Students - a Cluster Randomised Controlled Trial
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2019

Arm Intervention/treatment
Experimental: Intervention
8 worksheets and around 15 online quizzes and 30 WhatsApp messages.
Other: 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.

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.

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.

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




Primary Outcome Measures :
  1. To reduce children's exposure to environmental tobacco smoke. [ Time Frame: 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 :
  1. To reduce the hair nicotine levels of students who are exposed to SHS at home at baseline. [ Time Frame: 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.

  2. To promote SHS-related knowledge and attitudes, and avoidance of SHS among children. [ Time Frame: 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.

  3. To reduce children's intention to smoke. [ Time Frame: 3 and 6-month ]
    In the 3th and 6th month, students will conduct a survey to assess children's intention to smoke.

  4. To reduce children's respiratory symptoms. [ Time Frame: 3 and 6-month ]
    In the 3th and 6th month, students will conduct a survey to assess children's respiratory symptoms.

  5. To promote smoking cessation (past 7 days) of parents. (child report) [ Time Frame: 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.

  6. To promote children's perception of family happiness. [ Time Frame: 3 and 6-month ]
    In the 3th and 6th month, students will conduct a survey to report their perception of family happiness.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03380234


Contacts
Contact: Lijun Wang, MPhil 39179918 ext 852 wanglj1003@163.com

Sponsors and Collaborators
The University of Hong Kong
Investigators
Principal Investigator: Sai Yin Ho, PhD School of Public Health, the University of Hong Kong

Responsible Party: Dr. Daniel Sai-Yin Ho, Principle investigator and associate professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT03380234     History of Changes
Other Study ID Numbers: coshshs
First Posted: December 21, 2017    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr. Daniel Sai-Yin Ho, The University of Hong Kong:
Smoking
Secondhand smoke
Thirdhand smoke
Children
Cluster randomised controlled trial