A Brief Intervention Programme on ASP

Alternative Smoking Products Clinical Trial

Official title:

A Brief Intervention Programme on Alternative Smoking Products

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04302480
• Other study ID #: coshdrama2020
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: March 2020
• Source: The University of Hong Kong
• Contact: Tingting Chen, MS
• Phone: 51657486
• Email: phttchen[@]connect.hku.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The brief intervention comprises a 4-page worksheet used in the classroom (main intervention) and subsequent weekly e-messages through WhatsApp (booster intervention). The worksheets for both groups will be printed in colour, and mainly contain pictures and simple texts. Students will be asked to provide smartphone numbers of themselves and their parents for receiving the booster interventions. After sending 4-6 e-messages in 4 weeks, students will complete a 1-month follow-up assessment.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1000
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Parents and children should understand Chinese.

• Parents' consent to their children's participation.

Exclusion Criteria:

• N/A

Related Conditions & MeSH terms

• Alternative Smoking Products

Intervention

Other:
• Worksheets for ASP
The ASP intervention will cover the harms and misleading marketing strategies of ASPs and other related information.
• Worksheets for SSB
The SSB intervention will cover the general information on SSBs, such as the sugar content of SSBs, nutrition labels and the harms of SSBs.
• E-messages for ASP
In the subsequent month after the main intervention, students in the ASP group will receive 4-6 e-messages on ASPs, after which students will be invited to complete a 1-month follow-up assessment.
• E-messages for SSB
In the subsequent month after the main intervention, students in the SSB group will receive 4-6 e-messages on SSBs, after which students will be invited to complete a 1-month follow-up assessment.

Locations

Country	Name	City	State
Hong Kong	Local primary schools	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Knowledge on the harms and misleading marketing strategies of ASPs	Students will report their opinions towards 5 statements: Children who use e-cigarettes are more likely to smoke cigarettes in the future; Hazards of secondhand smoke of e-cigarettes and heated tobacco products are slight; Nicotine content in heated tobacco products is lower than in the cigarettes, which is more difficult to get addicted; There are a variety of carcinogens in the heated tobacco products; Tobacco industries do everything they can to get young people to use tobacco products.; All the statements have 5 options from definitely no to definitely yes. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating knowing more about the harms and misleading marketing strategies of ASPs.	Immediately after intervention
Primary	Attitudes towards ASPs	Students will report their opinions towards 2 questions: Do you think the usage of e-cigarettes and heated tobacco products will harm your health?; There will be 11 options from definitely no harm to definitely harm.; Do you accept the primary students use e-cigarettes and heated tobacco products?; There will be 11 options from definitely unacceptable to definitely acceptable.	Immediately after intervention
Secondary	Intention to use ASPs	If one of your good friends offers you an e-cigarette or heated tobacco product, ask you to have a few puffs, and no one will know about this as no more smoking in the future. Will you use them?; There will be 11 options from definitely no to definitely yes.	Immediately after intervention
Secondary	Knowledge on the harms and misleading marketing strategies of ASPs	Students will report their opinions towards 5 statements: Hazards of e-cigarettes are slight, can only cause minor health problems; Reliable evidence shows that e-cigarettes can help quit smoking cigarettes; Heated tobacco products contain tar, can cause a variety of cancers; Heated tobacco products are harm reduction products, which is less harmful than cigarettes; Tobacco industries conceal the harms of tobacco products for commercial gain.; All the statements have 5 options from definitely no to definitely yes. The options will be recoded into 0-4 or 4-0, as appropriate, with higher scores indicating knowing more about the harms and misleading marketing strategies of ASPs.	1-month follow-up
Secondary	Attitudes towards ASPs	Students will report their opinions towards 2 questions: Do you think the usage of e-cigarettes and heated tobacco products will harm your health?; There will be 11 options from definitely no harm to definitely harm.; Do you accept the primary students use e-cigarettes and heated tobacco products?; There will be 11 options from definitely unacceptable to definitely acceptable.	1-month follow-up
Secondary	Intention to use ASPs	If one of your good friends offers you an e-cigarette or heated tobacco product, ask you to have a few puffs, and no one will know about this as no more smoking in the future. Will you use them?; There will be 11 options from definitely no to definitely yes.	1-month follow-up