Alternative Smoking ProductsNCT04302480
A Brief Intervention Programme on ASP
A study testing Worksheets for ASP, Worksheets for SSB and E-messages for ASP in people with Alternative Smoking Products, run by The University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alternative Smoking Products
- What is being tested?
- Worksheets for ASP, Worksheets for SSB and E-messages for ASP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 May 2020to 31 Jul 2020
- 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 understand Chinese.
- Parents' consent to their children's participation.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Brief Intervention Programme on Alternative Smoking Products
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.
- Conditions
- Alternative Smoking Products
- Being tested
- Worksheets for ASP, Worksheets for SSB, E-messages for ASP, E-messages for SSB
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Worksheets for ASPOther
The ASP intervention will cover the harms and misleading marketing strategies of ASPs and other related information.
Worksheets for SSBOther
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 ASPOther
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 SSBOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Alternative smoking products (ASP) | Experimental | Not described Receives: Other: Worksheets for ASP; Other: E-messages for ASP |
| Sugar-sweetened beverages (SSB) | Active comparator | Not described Receives: Other: Worksheets for SSB; Other: E-messages for SSB |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after intervention
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.
Measured: Immediately after intervention
Secondary outcomes (4)
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.
Measured: Immediately after intervention
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.
Measured: 1-month follow-up
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.
Measured: 1-month follow-up
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.
Measured: 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start18 May 2020 (estimated)
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alternative Smoking ProductsStudies 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
- None (open label)
- Enrolment
- 1,000 participants (estimated)
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
- NCT04302480
- Sponsor's protocol ID
- coshdrama2020
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 10 Mar 2020
- 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 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Intervention Programme on Alternative Smoking Products
- ClinicalTrials.gov ID
- NCT04302480
- Acronym / sponsor ID
- coshdrama2020
- Conditions
- Alternative Smoking Products
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 18 May 2020 (estimated)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 10 Mar 2020 (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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative smoking products (ASP) | Experimental | Other: Worksheets for ASP, Other: E-messages for ASP |
| Sugar-sweetened beverages (SSB) | Active comparator | Other: Worksheets for SSB, Other: E-messages for SSB |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Parents and children should understand Chinese.
- Parents' consent to their children's participation.
Key exclusion criteria (1 listed)
- N/A
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 |
|---|---|---|
| Worksheets for ASPThe ASP intervention will cover the harms and misleading marketing strategies of ASPs and other related information. | Other | Alternative smoking products (ASP) |
| Worksheets for SSBThe SSB intervention will cover the general information on SSBs, such as the sugar content of SSBs, nutrition labels and the harms of SSBs. | Other | Sugar-sweetened beverages (SSB) |
| E-messages for ASPIn 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. | Other | Alternative smoking products (ASP) |
| E-messages for SSBIn 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. | Other | Sugar-sweetened beverages (SSB) |
Primary outcome
Knowledge on the harms and misleading marketing strategies of ASPs
Time frame: Immediately after intervention
Students will report their opinions towards 5 statements: 1. Children who use e-cigarettes are more likely to smoke cigarettes in the future; 2. Hazards of secondhand smoke of e-cigarettes and heated tobacco products are slight; 3. Nicotine content in heated tobacco products is lower than in the cigarettes, which is more difficult to get addicted; 4. There are a variety of carcinogens in the heated tobacco products; 5. 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.
Attitudes towards ASPs
Time frame: Immediately after intervention
Students will report their opinions towards 2 questions: 1. 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. 2. Do you accept the primary students use e-cigarettes and heated tobacco products? There will be 11 options from definitely unacceptable to definitely acceptable.
4 secondary outcomes
Intention to use ASPs
Time frame: Immediately after intervention
Knowledge on the harms and misleading marketing strategies of ASPs
Time frame: 1-month follow-up
Attitudes towards ASPs
Time frame: 1-month follow-up
Intention to use ASPs
Time frame: 1-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- 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, 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 Worksheets for ASP, Worksheets for SSB and E-messages for ASP in people with Alternative Smoking Products, 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: status not confirmed, as of the sponsor's last update on 10 Mar 2020. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tingting Chen, MS (51657486 ext. 852, phttchen@connect.hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge on the harms and misleading marketing strategies of ASPs (time frame: Immediately after intervention). The study lists 2 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 10 Mar 2020; AzTrials last refreshed its copy on 6 Nov 2026.