Tobacco IndustryNCT05403957
A Cluster RCT on TID
A study testing TID video, TID worksheet and SSB worksheet in people with Tobacco Industry and Denormalisation, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The brief intervention comprised the main intervention (tobacco industry denormalisation [TID] video, TID worksheet and sugar-sweetened beverages [SSB] worksheet) and booster intervention (worksheets where key contents in the main intervention reappeared). Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Industry, Denormalisation
- What is being tested?
- TID video, TID worksheet and SSB worksheet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2,881 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jun 2021to 19 Feb 2022
- 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 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Parents' consent to their children's participation;
- Parents and children could understand Chinese.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomised Controlled Trial on Tobacco Industry Denormalisation
The brief intervention comprised the main intervention (tobacco industry denormalisation [TID] video, TID worksheet and sugar-sweetened beverages [SSB] worksheet) and booster intervention (worksheets where key contents in the main intervention reappeared).
The worksheets in the main intervention were printed in colour and contained eight pictures and eight texts which described the pictures. Students needed to match the pictures and texts. The booster worksheets contained the previous eight coloured pictures for the TID and SSB worksheet groups or six coloured screenshots from the TID video. Students needed to complete the six true or false questions based on the pictures provided.
Assessments were conducted immediately (T1), two weeks (T2), one month (T3) and three months (T4) after the main intervention.
- Conditions
- Tobacco Industry, Denormalisation
- Being tested
- TID video, TID worksheet, SSB worksheet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TID videoOther
Main intervention: A video introducing the tobacco industry's marketing tactics to attract children and adolescents to smoke and their manipulation of tobacco control policy formation.
Booster intervention: 6 screenshots from the video and 6 true or false questions.
TID worksheetOther
Main intervention: A worksheet using pictures and texts to introduce the tobacco industry's marketing tactics to attract children and adolescents to smoke and their manipulation of tobacco control policy formation.
Booster intervention: 8 pictures from the TID worksheet in the main intervention and 6 true or false questions.
SSB worksheetOther
Main intervention: A worksheet using pictures and texts to introduce the beverage industry's marketing tactics to attract children and adolescents to drink SSBs and the health risks of SSBs.
Booster intervention: 8 pictures from the SSB worksheet in the main intervention and 6 true or false questions.
| Study group | Role | What they receive |
|---|---|---|
| TID video | Experimental | Not described Receives: Other: TID video |
| TID worksheet | Active comparator | Not described Receives: Other: TID worksheet |
| SSB worksheet | Placebo comparator | Not described Receives: Other: SSB worksheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
TID beliefs
- Tobacco industry's philanthropy is to care about community well-being.
- Tobacco industry does everything possible to make children smoke.
- Tobacco industry deceives the public for commercial gain.
- Tobacco industry uses many tactics to resist tobacco control regulations.
All the statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5 or 5-1, as appropriate, with higher scores indicating stronger TID beliefs.
Measured: Immediately after the main intervention
Alternative smoking product (ASP)-related knowledge
Electronic cigarettes (ECs) and heated tobacco products (HTPs) are less harmful than cigarettes.
The statement has 5 options from strongly disagree to strongly agree. The options were scored as 5-1, with higher scores indicating better knowledge.
Measured: Immediately after the main intervention
Risk perceptions of ASPs
- Do you think trying a few puffs of ECs will harm your health?
- Do you think trying a few puffs of HTPs will harm your health?
Both statements have 11 options from not harmful at all to very harmful. The options were scored as 0-10, with higher scores indicating stronger anti-tobacco attitudes.
Measured: Immediately after the main intervention
Acceptability of ASPs
- Do you think it is acceptable for primary school students to try a few puffs of ECs?
- Do you think it is acceptable for primary school students to try a few puffs of HTPs?
Both statements have 11 options from very unacceptable to very acceptable. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.
Measured: Immediately after the main intervention
General views on the tobacco industry
What do you think of the tobacco industry?
The statement has 11 options from very bad to very good. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.
Measured: Immediately after the main intervention
Secondary outcomes (13)
Susceptibility to use ASPs
- If your good friend passes you an EC, will you use it?
- Do you think you will use EC within the next 12 months?
- If your good friend passes you an HTP, will you use it?
- Do you think you will use HTP within the next 12 months?
All the statements have 5 options from definitely yes to definitely not. Responses were dichotomised as a binary outcome, students who chose "definitely not" for both items were deemed not susceptible to a specific smoking product and otherwise susceptible.
Measured: Immediately after the main intervention
TID beliefs
- Tobacco industry conceals the harms of smoking products for commercial gain.
- Tobacco industry deceives the public for commercial gain.
- Tobacco industry uses many tactics to resist tobacco control regulations.
All the statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5, with higher scores indicating stronger TID beliefs.
Measured: One month after the main intervention
ASP-related knowledge
- ECs and HTPs are less harmful than cigarettes.
- HTPs contain many carcinogens.
Both statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5 or 5-1, as appropriate, with higher scores indicating better knowledge.
Measured: One month after the main intervention
Risk perceptions of ASPs
- Do you think trying a few puffs of ECs will harm your health?
- Do you think trying a few puffs of HTPs will harm your health?
Both statements have 11 options from not harmful at all to very harmful. The options were scored as 0-10, with higher scores indicating stronger anti-tobacco attitudes.
Measured: One month after the main intervention
Acceptability of ASPs
- Do you think it is acceptable for primary school students to try a few puffs of ECs?
- Do you think it is acceptable for primary school students to try a few puffs of HTPs?
Both statements have 11 options from very unacceptable to very acceptable. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.
Measured: One month after the main intervention
General views on the tobacco industry
What do you think of the tobacco industry?
The statement has 11 options from very bad to very good. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.
Measured: One month after the main intervention
Susceptibility to use ASPs
- If your good friend passes you an EC, will you use it?
- Do you think you will use EC within the next 12 months?
- If your good friend passes you an HTP, will you use it?
- Do you think you will use HTP within the next 12 months?
All the statements have 5 options from definitely yes to definitely not. Responses were dichotomised as a binary outcome, students who chose "definitely not" for both items were deemed not susceptible to a specific smoking product and otherwise susceptible.
Measured: One month after the main intervention
TID beliefs
- Tobacco industry uses many tactics to resist tobacco control regulations.
- Tobacco industry struggles to build a corporate image to improve tobacco products sales.
Both statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5, with higher scores indicating stronger TID beliefs.
Measured: Three months after the main intervention
ASP-related Knowledge
- HTPs contain many carcinogens.
- ECs are less harmful than cigarettes.
- Secondhand aerosols of ECs and HTPs are less harmful.
All the statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5 or 5-1, as appropriate, with higher scores indicating better knowledge.
Measured: Three months after the main intervention
Risk perceptions of ASPs
- Do you think trying a few puffs of ECs will harm your health?
- Do you think trying a few puffs of HTPs will harm your health?
Both statements have 11 options from not harmful at all to very harmful. The options were scored as 0-10, with higher scores indicating stronger anti-tobacco attitudes.
Measured: Three months after the main intervention
Acceptability of ASPs
- Do you think it is acceptable for primary school students to try a few puffs of ECs?
- Do you think it is acceptable for primary school students to try a few puffs of HTPs?
Both statements have 11 options from very unacceptable to very acceptable. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.
Measured: Three months after the main intervention
General views on the tobacco industry
What do you think of the tobacco industry?
The statement has 11 options from very bad to very good. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.
Measured: Three months after the main intervention
Susceptibility to use ASPs
- If your good friend passes you an EC, will you use it?
- Do you think you will use EC within the next 12 months?
- If your good friend passes you an HTP, will you use it?
- Do you think you will use HTP within the next 12 months?
All the statements have 5 options from definitely yes to definitely not. Responses were dichotomised as a binary outcome, students who chose "definitely not" for both items were deemed not susceptible to a specific smoking product and otherwise susceptible.
Measured: Three months after the main intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start1 Jun 2021
- Primary completion22 Oct 2021
- Study completion19 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,881 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, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05403957
- Sponsor's protocol ID
- TIDvideo202021
- Status last verified
- May 2022
- First submitted
- 30 May 2022
- Last updated
- 3 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomised Controlled Trial on Tobacco Industry Denormalisation
- ClinicalTrials.gov ID
- NCT05403957
- Acronym / sponsor ID
- TIDvideo202021
- Conditions
- Tobacco Industry, Denormalisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,881 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 22 Oct 2021 (actual)
- Study completion
- 19 Feb 2022 (actual)
- First posted
- 3 Jun 2022 (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 intervention comprised the main intervention (tobacco industry denormalisation [TID] video, TID worksheet and sugar-sweetened beverages [SSB] worksheet) and booster intervention (worksheets where key contents in the main intervention reappeared).
The worksheets in the main intervention were printed in colour and contained eight pictures and eight texts which described the pictures. Students needed to match the pictures and texts. The booster worksheets contained the previous eight coloured pictures for the TID and SSB worksheet groups or six coloured screenshots from the TID video. Students needed to complete the six true or false questions based on the pictures provided.
Assessments were conducted immediately (T1), two weeks (T2), one month (T3) and three months (T4) after the main intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TID video | Experimental | Other: TID video |
| TID worksheet | Active comparator | Other: TID worksheet |
| SSB worksheet | Placebo comparator | Other: SSB worksheet |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents' consent to their children's participation;
- Parents and children could 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 |
|---|---|---|
| TID videoMain intervention: A video introducing the tobacco industry's marketing tactics to attract children and adolescents to smoke and their manipulation of tobacco control policy formation. Booster intervention: 6 screenshots from the video and 6 true or false questions. | Other | TID video |
| TID worksheetMain intervention: A worksheet using pictures and texts to introduce the tobacco industry's marketing tactics to attract children and adolescents to smoke and their manipulation of tobacco control policy formation. Booster intervention: 8 pictures from the TID worksheet in the main intervention and 6 true or false questions. | Other | TID worksheet |
| SSB worksheetMain intervention: A worksheet using pictures and texts to introduce the beverage industry's marketing tactics to attract children and adolescents to drink SSBs and the health risks of SSBs. Booster intervention: 8 pictures from the SSB worksheet in the main intervention and 6 true or false questions. | Other | SSB worksheet |
Primary outcome
TID beliefs
Time frame: Immediately after the main intervention
1. Tobacco industry's philanthropy is to care about community well-being. 2. Tobacco industry does everything possible to make children smoke. 3. Tobacco industry deceives the public for commercial gain. 4. Tobacco industry uses many tactics to resist tobacco control regulations. All the statements have 5 options from strongly disagree to strongly agree. The options were scored as 1-5 or 5-1, as appropriate, with higher scores indicating stronger TID beliefs.
Alternative smoking product (ASP)-related knowledge
Time frame: Immediately after the main intervention
Electronic cigarettes (ECs) and heated tobacco products (HTPs) are less harmful than cigarettes. The statement has 5 options from strongly disagree to strongly agree. The options were scored as 5-1, with higher scores indicating better knowledge.
Risk perceptions of ASPs
Time frame: Immediately after the main intervention
1. Do you think trying a few puffs of ECs will harm your health? 2. Do you think trying a few puffs of HTPs will harm your health? Both statements have 11 options from not harmful at all to very harmful. The options were scored as 0-10, with higher scores indicating stronger anti-tobacco attitudes.
Acceptability of ASPs
Time frame: Immediately after the main intervention
1. Do you think it is acceptable for primary school students to try a few puffs of ECs? 2. Do you think it is acceptable for primary school students to try a few puffs of HTPs? Both statements have 11 options from very unacceptable to very acceptable. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.
General views on the tobacco industry
Time frame: Immediately after the main intervention
What do you think of the tobacco industry? The statement has 11 options from very bad to very good. The options were scored as 0-10, with lower scores indicating stronger anti-tobacco attitudes.
13 secondary outcomes
Susceptibility to use ASPs
Time frame: Immediately after the main intervention
TID beliefs
Time frame: One month after the main intervention
ASP-related knowledge
Time frame: One month after the main intervention
Risk perceptions of ASPs
Time frame: One month after the main intervention
Acceptability of ASPs
Time frame: One month after the main intervention
General views on the tobacco industry
Time frame: One month after the main intervention
Susceptibility to use ASPs
Time frame: One month after the main intervention
TID beliefs
Time frame: Three months after the main intervention
ASP-related Knowledge
Time frame: Three months after the main intervention
Risk perceptions of ASPs
Time frame: Three months after the main intervention
Acceptability of ASPs
Time frame: Three months after the main intervention
General views on the tobacco industry
Time frame: Three months after the main intervention
Susceptibility to use ASPs
Time frame: Three months after the main intervention
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 3 Jun 2022.
- Individual participant dataSharing planned: No
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 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 TID video, TID worksheet and SSB worksheet in people with Tobacco Industry and Denormalisation, 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 2 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 3 Jun 2022. 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?
TID beliefs (time frame: Immediately after the main intervention). The study lists 5 primary outcomes in all. 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 3 Jun 2022.