A Cluster RCT on TID

Study Overview
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Brief Summary
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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.

Official Title
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A Cluster Randomised Controlled Trial on Tobacco Industry Denormalisation

Conditions
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Tobacco Industry, Denormalisation

Intervention / Treatment
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* Other: TID video
* Other: TID worksheet
* Other: SSB worksheet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents' consent to their children's participation; Parents and children could understand Chinese. Exclusion Criteria: -

Ages Eligible for Study
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Minimum Age: 8 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TID video<br> | Other: TID video<br>* 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.<br>|
| Active Comparator: TID worksheet<br> | Other: TID worksheet<br>* 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.<br>|
| Placebo Comparator: SSB worksheet<br> | Other: SSB worksheet<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Immediately after the main intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Three months after the main intervention |