NCT05962411

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,089

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 18, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 27, 2023

Completed
2 days until next milestone

Study Start

First participant enrolled

July 29, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2023

Completed
Last Updated

August 6, 2024

Status Verified

July 1, 2023

Enrollment Period

1 month

First QC Date

July 18, 2023

Last Update Submit

August 1, 2024

Conditions

Regulation ComplianceElectronic Nicotine Delivery Systems

Keywords

Electronic CigaretteRetailerAdolescentRegulation ComplianceChina

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Inquiring about age

    During visit (day 1)

  • Requesting identity cards

    During visit (day 1)

Other Outcomes (3)

  • Online contact

    During visit (day 1)

  • Delivery service offered

    During visit (day 1)

  • Illegal flavored e-cigarette products available

    During visit (day 1)

Study Arms (2)

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".

Other: Dress in Professional Attire

Interventions

Dress in Professional AttireOTHER

"Adolescents" pretend to be "adult e-cigarette buyers" by dressing in professional attire.

Dress in Professional Attire

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

36 major metropolitan areas (Beijing included)

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (1)

  • 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.

    PMID: 41071555DERIVED

MeSH Terms

Conditions

Vaping

Interventions

Bandages

Condition Hierarchy (Ancestors)

SmokingBehavior

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

  • Yang Wang, PhD

    Peking University Health Science Center

    PRINCIPAL INVESTIGATOR

  • Hai Fang, PhD

    Peking University Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 27, 2023

Study Start

July 29, 2023

Primary Completion

September 3, 2023

Study Completion

September 3, 2023

Last Updated

August 6, 2024

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE

Locations

CN(1)