Attitudes Towards Tobacco IndustryNCT03800966
A Brief Intervention Programme for TID
A study testing Leaflet in people with Attitudes Towards Tobacco Industry, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The brief RCT will be conducted in the form of a questionnaire survey, with two kinds of leaflets embedded in the same questionnaire. The RCT will be conducted in classrooms by teachers who will be given two kinds of questionnaires (with leaflet embedded) used for intervention and control groups. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Attitudes Towards Tobacco Industry
- What is being tested?
- Leaflet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,069 participants
- Where
- 1 siteHong Kong
- Study dates
- 3 Jan 2019to 25 Mar 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents and children should all understand Chinese
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Leaflet-based Programme for Tobacco Industry Denormalisation - a Brief Randomised Controlled Trial
The brief RCT will be conducted in the form of a questionnaire survey, with two kinds of leaflets embedded in the same questionnaire. The RCT will be conducted in classrooms by teachers who will be given two kinds of questionnaires (with leaflet embedded) used for intervention and control groups. The questionnaires will be mixed in a way that two adjacent questionnaires are always different. The intervention leaflets will contain information for tobacco industry denormalisation. The control leaflets will contain information for tobacco control policy in Hong Kong. The study aims to test the effect of a leaflet-based intervention on primary school students' attitudes towards tobacco industry.
- Conditions
- Attitudes Towards Tobacco Industry
- Being tested
- Leaflet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LeafletOther
Leaflets for both groups will be printed in colour. Leaflet in each group contains 8 pictures and 8 statement, whose sequences will be scrambled. Primary school students need to do the matching, to ensure they read the statements.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention leaflets will contain information on the TI's tactics to get young people to smoke. Receives: Other: Leaflet |
| Control | Placebo comparator | The control leaflets will contain information on the tobacco control in Hong Kong. Receives: Other: Leaflet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes towards tobacco industry in children
Children will report their opinions towards 4 statements: 1); Tobacco companies are a trustworthy industry; 2) Tobacco industries use many tactics to resist tobacco control regulations; 3) Tobacco industries do everything they can to get young people to smoke; 4) Tobacco industries cheated the public for commercial gain. All the 4 questions have 5 options from definitely yes to definitely no. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry. A sum of scores from the 4 questions will be deemed as measurement of attitudes towards tobacco industry in primary school students.
Measured: 1 month
Secondary outcomes (4)
Intention to smoke cigarettes in children
Two questions will be used to assess this outcome: 1) If one of your good friends offers you a cigarette, will you smoke it? 2) Do you think you will smoke cigarettes in the next 12 months? Response options are definitely not /probably not /not sure /probably yes /definitely yes. Those choosing options "definitely not" for all the two questions will be deemed having no intention to smoke cigarettes; other responses will be deemed having intention to smoke cigarettes.
Measured: 1 month
Intention to use e-cigarettes in children
Two questions will be used to assess this outcome: 1) If one of your good friends offers you an e-cigarette, will you use it? 2) Do you think you will use e-cigarettes in the next 12 months? Response options are definitely not /probably not /not sure /probably yes /definitely yes. Those choosing options "definitely not" for all the two questions will be deemed having no intention to use e-cigarettes; other responses will be deemed having intention to use e-cigarettes.
Measured: 1 month
Tobacco control policy support in children
Children will report their opinions towards 2 statements: 1) The Hong Kong government should enact a total ban on e-cigarettes promptly; 2) The Hong Kong government should prohibit the sale of all tobacco products by legislation. All the 2 questions have 5 options from definitely yes to definitely no. The options will be recoded into 4-0, with higher scores indicating stronger support towards the tobacco control policy in Hong Kong. A sum of scores from the 2 questions will be deemed as measurement of support for tobacco control policy in Hong Kong in primary school students.
Measured: 1 month
Attitude towards smoking in children
Children will report their opinions towards one statement: Smoking is personal choice, there is no right and wrong. The question has 5 options from definitely yes to definitely no. The options will be recoded into 4-0, with higher scores indicating more negative attitudes towards smoking. Score from that question will be deemed as measurement of attitude towards smoking in primary school students.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2019
- Study start3 Jan 2019
- Primary completion25 Mar 2019
- Study completion25 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attitudes Towards Tobacco IndustryStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,069 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Daniel Sai-Yin Ho, The University of Hong Kong
- Investigators
- Sai Yin Ho, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03800966
- Sponsor's protocol ID
- coshdrama201819
- Status last verified
- May 2019
- First submitted
- 9 Jan 2019
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Leaflet-based Programme for Tobacco Industry Denormalisation - a Brief Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT03800966
- Acronym / sponsor ID
- coshdrama201819
- Conditions
- Attitudes Towards Tobacco Industry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,069 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 25 Mar 2019 (actual)
- Study completion
- 25 Mar 2019 (actual)
- First posted
- 11 Jan 2019 (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.
The brief RCT will be conducted in the form of a questionnaire survey, with two kinds of leaflets embedded in the same questionnaire. The RCT will be conducted in classrooms by teachers who will be given two kinds of questionnaires (with leaflet embedded) used for intervention and control groups. The questionnaires will be mixed in a way that two adjacent questionnaires are always different. The intervention leaflets will contain information for tobacco industry denormalisation. The control leaflets will contain information for tobacco control policy in Hong Kong. The study aims to test the effect of a leaflet-based intervention on primary school students' attitudes towards tobacco industry.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: LeafletThe intervention leaflets will contain information on the TI's tactics to get young people to smoke. |
| Control | Placebo comparator | Other: LeafletThe control leaflets will contain information on the tobacco control in Hong Kong. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Parents and children should all understand Chinese
Key exclusion criteria (1 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 |
|---|---|---|
| LeafletLeaflets for both groups will be printed in colour. Leaflet in each group contains 8 pictures and 8 statement, whose sequences will be scrambled. Primary school students need to do the matching, to ensure they read the statements. | Other | Control, Intervention |
Primary outcome
Attitudes towards tobacco industry in children
Time frame: 1 month
Children will report their opinions towards 4 statements: 1); Tobacco companies are a trustworthy industry; 2) Tobacco industries use many tactics to resist tobacco control regulations; 3) Tobacco industries do everything they can to get young people to smoke; 4) Tobacco industries cheated the public for commercial gain. All the 4 questions have 5 options from definitely yes to definitely no. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating more negative attitudes towards the industry. A sum of scores from the 4 questions will be deemed as measurement of attitudes towards tobacco industry in primary school students.
4 secondary outcomes
Intention to smoke cigarettes in children
Time frame: 1 month
Intention to use e-cigarettes in children
Time frame: 1 month
Tobacco control policy support in children
Time frame: 1 month
Attitude towards smoking in children
Time frame: 1 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 23 May 2019.
- Individual participant dataSharing planned: Undecided
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
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 Leaflet in people with Attitudes Towards Tobacco Industry, 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 1 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 23 May 2019. 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. Some participants in this study may receive a placebo. 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?
Attitudes towards tobacco industry in children (time frame: 1 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 23 May 2019.