A Cluster RCT on TID

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Industry; Denormalisation
• Intervention / Treatment: Other: TID video; Other: TID worksheet; Other: SSB worksheet

• Study Type: Interventional
• Enrollment (Actual): 2881
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Local primary schools

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Parents' consent to their children's participation;
• Parents and children could understand Chinese.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TID video	Other: TID video; 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.
Active Comparator: TID worksheet	Other: TID worksheet; 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.
Placebo Comparator: SSB worksheet	Other: SSB worksheet; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Investigators: Principal Investigator: SAI YIN HO, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Actual): October 22, 2021
• Study Completion (Actual): February 19, 2022

Study Registration Dates

• First Submitted: May 30, 2022
• First Submitted That Met QC Criteria: May 30, 2022
• First Posted (Actual): June 3, 2022

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 30, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TIDvideo202021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No