Secondhand SmokeSHS-cRCTNCT03380234
A Cluster-RCT of SHS Among Primary School Students
A study testing Worksheets, Whatsapp messages and Online quizzes in people with Secondhand Smoke and Thirdhand Smoke, run by The University of Hong Kong at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Secondhand Smoke, Thirdhand Smoke, Smoking
- What is being tested?
- Worksheets, Whatsapp messages and Online quizzes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,432 participants
- Where
- 1 siteHong Kong
- Study dates
- 20 Sep 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reducing Exposure to Tobacco Smoke Among Primary School Students - a Cluster Randomised Controlled Trial
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.
Read the 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.
- Conditions
- Secondhand Smoke, Thirdhand Smoke, Smoking
- Being tested
- Worksheets, Whatsapp messages, Online quizzes, Leaflet
- Keywords
- Smoking, Secondhand smoke, Thirdhand smoke, Children, Cluster randomised controlled trial
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WorksheetsOther
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 messagesOther
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 quizzesOther
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.
LeafletOther
A leaflet on smoking and SHS published by the Department of Health will be mailed to the control grades.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 8 worksheets and around 15 online quizzes and 30 WhatsApp messages. Receives: Other: Worksheets; Other: Whatsapp messages; Other: Online quizzes |
| Control | Other | 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. Receives: Other: Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 and 6-month
Secondary outcomes (6)
To reduce the hair nicotine levels of students who are exposed to SHS at home at baseline.
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.
Measured: 6-month
To promote SHS-related knowledge and attitudes, and avoidance of SHS among children.
In the 3th and 6th month, students will conduct a survey to assess their SHS-related knowledge and attitudes, and avoidance of SHS.
Measured: 3 and 6-month
To reduce children's intention to smoke.
In the 3th and 6th month, students will conduct a survey to assess children's intention to smoke.
Measured: 3 and 6-month
To reduce children's respiratory symptoms.
In the 3th and 6th month, students will conduct a survey to assess children's respiratory symptoms.
Measured: 3 and 6-month
To promote smoking cessation (past 7 days) of parents. (child report)
In the 3th and 6th month, students will conduct a survey to report their parents' smoking cessation.
Measured: 6-month and 12-month3 and 6-month
To promote children's perception of family happiness.
In the 3th and 6th month, students will conduct a survey to report their perception of family happiness.
Measured: 3 and 6-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start20 Sep 2018
- Primary completion30 Nov 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondhand SmokeStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 3,432 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Responsible party
- Principal investigator, Dr. Daniel Sai-Yin Ho, The University of Hong Kong
- Investigators
- Sai Yin Ho, PhD, Principal investigator, School of Public Health, the University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380234
- Sponsor's protocol ID
- coshshs
- Acronym
- SHS-cRCT
- Status last verified
- Feb 2020
- First submitted
- 11 Dec 2017
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Exposure to Tobacco Smoke Among Primary School Students - a Cluster Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03380234
- Acronym / sponsor ID
- SHS-cRCT / coshshs
- Conditions
- Secondhand Smoke, Thirdhand Smoke, Smoking
- Keywords
- Smoking, Secondhand smoke, Thirdhand smoke, Children, Cluster randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,432 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Hong Kong Council on Smoking and Health
- Study start
- 20 Sep 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 21 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Worksheets, Other: Whatsapp messages, Other: Online quizzes8 worksheets and around 15 online quizzes and 30 WhatsApp messages. |
| Control | Other | Other: LeafletControl 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WorksheetsWorksheets 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 | Intervention |
| Whatsapp messagesA 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 | Intervention |
| Online quizzesAt 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. | Other | Intervention |
| LeafletA leaflet on smoking and SHS published by the Department of Health will be mailed to the control grades. | Other | Control |
Primary outcome
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.
6 secondary outcomes
To reduce the hair nicotine levels of students who are exposed to SHS at home at baseline.
Time frame: 6-month
To promote SHS-related knowledge and attitudes, and avoidance of SHS among children.
Time frame: 3 and 6-month
To reduce children's intention to smoke.
Time frame: 3 and 6-month
To reduce children's respiratory symptoms.
Time frame: 3 and 6-month
To promote smoking cessation (past 7 days) of parents. (child report)
Time frame: 6-month and 12-month3 and 6-month
To promote children's perception of family happiness.
Time frame: 3 and 6-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sai Yin Ho, PhD principal investigator
School of Public Health, the University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Worksheets, Whatsapp messages and Online quizzes in people with Secondhand Smoke and Thirdhand Smoke, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To reduce children's exposure to environmental tobacco smoke. (time frame: 3 and 6-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2020.