Regulation ComplianceNCT05962411
Effects of Dress by Adolescents on Electronic Cigarette Retailer Behaviors in China
A study testing Dress in Professional Attire in people with Regulation Compliance and Electronic Nicotine Delivery Systems, run by Peking University at 1 site in China.
Trial summary
This study is a national-level randomized control trial to measure the effects of dressing in professional attire by adolescents on regulation compliance-related behaviors of electronic cigarette (e-cigarette) retailers defined by both age verification and potential underage sales. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Regulation Compliance, Electronic Nicotine Delivery Systems
- What is being tested?
- Dress in Professional Attire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,089 participants
- Where
- 1 siteChina
- Study dates
- 29 Jul 2023to 3 Sep 2023
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Retailers can be identified from the AutoNavi Map through keyword searches
- Retailers have reachable contact information
- Retailers are contacted and claim being open for business on a regular basis
- Include only one retailer if multiple ones have the same contact information
Who cannot join
- Retailers that are not located in main districts of the cities (usually old town and economically developed central areas)
- Perceived danger surrounding the retailers (e.g., remote alleys with no pedestrians at all)
- Closed when arriving
- Retailers that cannot be located based on map information
Trial locations and contacts
1 site in 1 country.
China1 site
36 major metropolitan areas (Beijing included)
Beijing, Beijing Municipality, 100191
About this study
Official title: A Large-Scale Randomized Control Trial to Determine the Effects of Dress by Adolescents on Electronic Cigarette Retailer Behaviors in Regulation Compliance in China
This study is a national-level randomized control trial to measure the effects of dressing in professional attire by adolescents on regulation compliance-related behaviors of electronic cigarette (e-cigarette) retailers defined by both age verification and potential underage sales. The corresponding null hypothesis that will be tested is that dressing in professional attire by adolescents will have no effect upon retailer behaviors in regulation compliance. The secondary objectives are to determine the impacts of type of dress by adolescents on marketing and communication strategies adopted by retailers, as well as to document the differences in the behaviors between e-cigarette and tobacco retailers.
Read the detailed description
Electronic cigarette (e-cigarette) use has been growing dramatically and poses a significant public health threat to adolescents in China. After the online sales of these products has been banned, purchases from brick-and-mortar stores became the only legal option for the users. However, little research has been conducted to document sales behaviors of the physical retailers and identify the associated factors. The study will investigate the extent to which dressing in professional attire by adolescents on regulation compliance in retailer behaviors, including inquiring about age, requesting identity cards for age verification, and completing transactions even when identity cards are not presented. Adopting the simulated client method, the study will collect information on regulation compliance, store environment, product availability, and marketing strategies through interacting with retailers across China. Considering that e-cigarette retailers are predominately located in the most densely populated cities, the investigators will include approximately 1,080 e-cigarette retailers from 36 cities, including 4 municipalities directly under the Central Government, 27 provincial capital cities, and 5 cities specially designated in the state plan. Store addresses and contact information will be obtained through web scraping from the AutoNavi map (the most popular map app in China). The investigators plan to randomly sample 32 retailers in each city if the number allows, and cities with less than 32 retailers identified will all be included. To capture reality, retailers will not be informed during visit. The sampled ones within each city will be randomized into the intervention and control group, with a balance gender ratio of the simulated clients. These clients will be recruited from university students younger than 20 years old, who can easily be considered as minors (under 18) when purely judged by their appearance. Clients visiting retailers in the control group will dress in school uniforms and carry a school bag, while those in the intervention group will dress in professional attire with a business-style backpack for males or a leather bag for females. The clients will record retailer responses, including (1) inquiring about age verbally, (2) requesting identity cards for age verification, and (3) whether retailers still sell products even when identity cards are not presented. For each e-cigarette retailer, the nearest tobacco retailer identified through the AutoNavi Map will be used for comparison to document the differences in the behaviors between the two types of retailers. Additionally, communication and marketing strategies, e.g., mentioning available flavored products, dissuading clients not to purchase, are also collected.
- Being tested
- Dress in Professional Attire
- Keywords
- Electronic Cigarette, Retailer, Adolescent, Regulation Compliance, China
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dress in Professional AttireOther
"Adolescents" pretend to be "adult e-cigarette buyers" by dressing in professional attire.
| Study group | Role | What they receive |
|---|---|---|
| Dress in School Uniforms | No intervention | Simulated clients dress in school uniforms, enter e-cigarette stores, and act as minor buyers. |
| Dress in Professional Attire | Experimental | Simulated clients dress in business casuals, enter e-cigarette stores, and act as potential "adult e-cigarette buyers". Receives: Other: Dress in Professional Attire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-compliant sales
The simulated clients will report whether retailers sell e-cigarette products to possible minors even when identity cards are not presented for age verification.
Measured: During visit (day 1)
Secondary outcomes (2)
Inquiring about age
The simulated clients will report whether retailers inquire about their age verbally in stores.
Measured: During visit (day 1)
Requesting identity cards
The simulated clients will report whether retailers request them to show identity cards for the purpose of age verification.
Measured: During visit (day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start29 Jul 2023
- Primary completion3 Sep 2023
- Study completion3 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Regulation ComplianceStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 1,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- China Medical Board
- Responsible party
- Sponsor
- Investigators
- Yang Wang, PhD, Principal investigator, Peking University Health Science CenterHai Fang, PhD, Principal investigator, Peking University Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962411
- Sponsor's protocol ID
- 21-430
- Status last verified
- Jul 2023
- First submitted
- 18 Jul 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Wang Y, Lv X, Laestadius LI, Guidry JPD, Mahmoudi E, Kong G, Chang J, Martin A, Yang M, Yan D, Si L, Bustamante AV, Fang H. E-Cigarette Sales to School-Uniformed Adolescents in China: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2535623. doi: 10.1001/jamanetworkopen.2025.35623.
PubMed 41071555
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Large-Scale Randomized Control Trial to Determine the Effects of Dress by Adolescents on Electronic Cigarette Retailer Behaviors in Regulation Compliance in China
- ClinicalTrials.gov ID
- NCT05962411
- Acronym / sponsor ID
- 21-430
- Keywords
- Electronic Cigarette, Retailer, Adolescent, Regulation Compliance, China
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,089 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- China Medical Board
- Study start
- 29 Jul 2023 (actual)
- Primary completion
- 3 Sep 2023 (actual)
- Study completion
- 3 Sep 2023 (actual)
- First posted
- 27 Jul 2023 (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.
This study is a national-level randomized control trial to measure the effects of dressing in professional attire by adolescents on regulation compliance-related behaviors of electronic cigarette (e-cigarette) retailers defined by both age verification and potential underage sales. The corresponding null hypothesis that will be tested is that dressing in professional attire by adolescents will have no effect upon retailer behaviors in regulation compliance. The secondary objectives are to determine the impacts of type of dress by adolescents on marketing and communication strategies adopted by retailers, as well as to document the differences in the behaviors between e-cigarette and tobacco retailers.
Detailed description
Electronic cigarette (e-cigarette) use has been growing dramatically and poses a significant public health threat to adolescents in China. After the online sales of these products has been banned, purchases from brick-and-mortar stores became the only legal option for the users. However, little research has been conducted to document sales behaviors of the physical retailers and identify the associated factors. The study will investigate the extent to which dressing in professional attire by adolescents on regulation compliance in retailer behaviors, including inquiring about age, requesting identity cards for age verification, and completing transactions even when identity cards are not presented. Adopting the simulated client method, the study will collect information on regulation compliance, store environment, product availability, and marketing strategies through interacting with retailers across China. Considering that e-cigarette retailers are predominately located in the most densely populated cities, the investigators will include approximately 1,080 e-cigarette retailers from 36 cities, including 4 municipalities directly under the Central Government, 27 provincial capital cities, and 5 cities specially designated in the state plan. Store addresses and contact information will be obtained through web scraping from the AutoNavi map (the most popular map app in China). The investigators plan to randomly sample 32 retailers in each city if the number allows, and cities with less than 32 retailers identified will all be included. To capture reality, retailers will not be informed during visit. The sampled ones within each city will be randomized into the intervention and control group, with a balance gender ratio of the simulated clients. These clients will be recruited from university students younger than 20 years old, who can easily be considered as minors (under 18) when purely judged by their appearance. Clients visiting retailers in the control group will dress in school uniforms and carry a school bag, while those in the intervention group will dress in professional attire with a business-style backpack for males or a leather bag for females. The clients will record retailer responses, including (1) inquiring about age verbally, (2) requesting identity cards for age verification, and (3) whether retailers still sell products even when identity cards are not presented. For each e-cigarette retailer, the nearest tobacco retailer identified through the AutoNavi Map will be used for comparison to document the differences in the behaviors between the two types of retailers. Additionally, communication and marketing strategies, e.g., mentioning available flavored products, dissuading clients not to purchase, are also collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dress in School Uniforms | No intervention | –Simulated clients dress in school uniforms, enter e-cigarette stores, and act as minor buyers. |
| Dress in Professional Attire | Experimental | Other: Dress in Professional AttireSimulated clients dress in business casuals, enter e-cigarette stores, and act as potential "adult e-cigarette buyers". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Retailers can be identified from the AutoNavi Map through keyword searches
- Retailers have reachable contact information
- Retailers are contacted and claim being open for business on a regular basis
- Include only one retailer if multiple ones have the same contact information
Key exclusion criteria (4 listed)
- Retailers that are not located in main districts of the cities (usually old town and economically developed central areas)
- Perceived danger surrounding the retailers (e.g., remote alleys with no pedestrians at all)
- Closed when arriving
- Retailers that cannot be located based on map information
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 |
|---|---|---|
| Dress in Professional Attire"Adolescents" pretend to be "adult e-cigarette buyers" by dressing in professional attire. | Other | Dress in Professional Attire |
Primary outcome
Non-compliant sales
Time frame: During visit (day 1)
The simulated clients will report whether retailers sell e-cigarette products to possible minors even when identity cards are not presented for age verification.
2 secondary outcomes
Inquiring about age
Time frame: During visit (day 1)
Requesting identity cards
Time frame: During visit (day 1)
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 6 Aug 2024.
- Derived from this study: PubMed 41071555Wang Y, Lv X, Laestadius LI, Guidry JPD, Mahmoudi E, Kong G, Chang J, Martin A, Yang M, Yan D, Si L, Bustamante AV, Fang H. E-Cigarette Sales to School-Uniformed Adolescents in China: A Randomized Clinical Trial. JAMA Netw Open. 2025 Oct 1;8(10):e2535623. doi: 10.1001/jamanetworkopen.2025.35623.
- Individual participant dataSharing planned: Yes
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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.
Yang Wang, PhD principal investigator
Peking University Health Science Center
Hai Fang, PhD principal investigator
Peking University Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dress in Professional Attire in people with Regulation Compliance and Electronic Nicotine Delivery Systems, run by Peking University at 1 site in China.
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 4 inclusion and 4 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 6 Aug 2024. 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 China. 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?
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?
Non-compliant sales (time frame: During visit (day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962411, which also lists 1 linked publication.
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 6 Aug 2024.