Effects of Dress by Adolescents on Electronic Cigarette Retailer Behaviors in China

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.

Study Overview

• Status: Completed
• Conditions: Regulation Compliance; Electronic Nicotine Delivery Systems
• Intervention / Treatment: Other: Dress in Professional Attire

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 Type: Interventional
• Enrollment (Actual): 1089
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • 36 major metropolitan areas (Beijing included)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Dress in School Uniforms; Simulated clients dress in school uniforms, enter e-cigarette stores, and act as minor buyers.
Experimental: Dress in Professional Attire; Simulated clients dress in business casuals, enter e-cigarette stores, and act as potential "adult e-cigarette buyers".	Other: Dress in Professional Attire; "Adolescents" pretend to be "adult e-cigarette buyers" by dressing in professional attire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	During visit (day 1)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inquiring about age	The simulated clients will report whether retailers inquire about their age verbally in stores.	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.	During visit (day 1)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Online contact	The simulated clients will report if they are able to add retailers as WeChat (the online most popular chat app in China) contacts.	During visit (day 1)
Delivery service offered	The simulated clients will report if salespersons mention that products ordered online can be delivered to them.	During visit (day 1)
Illegal flavored e-cigarette products available	The simulated clients will report if salespersons mention that flavored (non-national-standard) e-cigarette products are available in stores.	During visit (day 1)

Collaborators and Investigators

• Sponsor: Peking University
• Collaborators: China Medical Board
• Investigators: Principal Investigator: Yang Wang, PhD, Peking University Health Science Center; Principal Investigator: Hai Fang, PhD, Peking University Health Science Center

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2023
• Primary Completion (Actual): September 3, 2023
• Study Completion (Actual): September 3, 2023

Study Registration Dates

• First Submitted: July 18, 2023
• First Submitted That Met QC Criteria: July 25, 2023
• First Posted (Actual): July 27, 2023

Study Record Updates

• Last Update Posted (Actual): August 6, 2024
• Last Update Submitted That Met QC Criteria: August 1, 2024
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Adolescent; China; Electronic Cigarette; Retailer; Regulation Compliance
• Other Study ID Numbers: 21-430

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

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