Clinical trial NCT06704295: High Impact E-cigarette Advertisement Features
Official title: High Impact E-cigarette Advertisement Features
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping Behavior
Keywords: E-cigarette advertisement
Vaping
Complete switching
Cigarette smoking cessation
Young adults
E-cigarette marketing
Tobacco policy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-11-26
Enrollment: 3083
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial aims to examine the effects of high-impact e-cigarette advertisement features among young adults of various tobacco-use statuses. Previous research on examining the effects of e-cigarette advertisement features found that flavor-related features (e.g., flavor-associated product color, name and image, flavor sensation descriptor, and flavor choice claim) may have the largest impact on shaping young adults' perceptions and use intentions of e-cigarettes. No research so far has solely focused on examining the effects of those high-impact flavor-related advertisement features. The present study assessed the effects of high-impact flavor-related advertisement features, including flavor descriptor name, e-cigarette product color (which indicates flavors), flavor-related image, flavor sensation descriptor, and flavor choice claim on perceptions and behavioral intentions among a large online sample of young adults aged 18-30 who either smoke cigarettes or do not use tobacco products. The study is a six-group RCT with parallel assignments that will be delivered through an online self-administered questionnaire consisting of one session. Participants will be randomly assigned to one of six trial arms: 1) dark gray product with tobacco flavor name, 2) dark gray product with strawberry flavor name, 3) colorful (strawberry color) product with strawberry flavor name, 4) colorful (strawberry color) product with strawberry flavor name and strawberry image, 5) colorful (strawberry color) product with strawberry flavor name, strawberry image, strawberry flavor sensation descriptor, and 6) colorful (strawberry color) product with strawberry flavor name, strawberry image, strawberry flavor sensation descriptor, and flavor choice claim. Participants will be exposed to one advertisement corresponding to the assigned condition, and answer survey questions immediately after message exposure.

Detailed description: The FDA considers the marketing plans of new e-cigarette products for premarket tobacco product application approval. Flavor-related advertisement features may entice young adults who do not use tobacco products to use the products but may also generate complete product switching interests among young adults who smoke cigarettes. This study tested the effects of several high-impact e-cigarette advertisement features related to flavors to inform the FDA's policymaking and public health preventive messages.

Setting: The trial will be an experiment delivered through an online self-administered questionnaire consisting of one session over 20 minutes.

Recruitment: Participants will be recruited from the research company Qualtrics from its research panels.

Informed Consent: Participants will provide online consent prior to taking the survey.

Randomization: After providing informed consent and answering pre-exposure questions, the investigator will use Qualtrics programming to randomize participants into one of the six trial conditions. The randomization will use least fill for the allocation of conditions where if the counts for the conditions were equal, the survey would assign the condition sequentially.

Assessment: Participants will take part in one session (estimated at about 20 mins): participants will answer questions assessing tobacco use status, cigarette smoking quit intentions and attempts (only asked young adults who smoke cigarettes), e-cigarette use, and other tobacco product use. They will then view one e-cigarette advertisement for at least 12 seconds and report immediate outcomes, including perceptions and behavioral intentions related to the e-cigarette product they see in the advertisement.

Eligibility criteria: Inclusion Criteria:

* Three groups of young adult subjects will be included in the study. The first group is those who are exclusive cigarette smokers (n=1000), defined as those who have smoked at least 100 cigarettes in their lifetime and have smoked at least one cigarette in the past 30 days but have not used e-cigarettes in the past 30 days. The second group is those who are dual users of cigarettes and e-cigarettes (n=1000). Those in this group have smoked more than 100 cigarettes in their lifetime and have smoked a cigarette and also used an e-cigarette in the past 30 days. The third group is those who are non-tobacco users (n=1000), defined as those who have never used any tobacco product before or have never "regularly" used tobacco products before and are currently not using any tobacco products (in the past 30 days).

Exclusion Criteria:

* Any subjects not meeting the inclusion criteria will be excluded from the study. Individuals will be further excluded if they do not provide consent to participate in the study.

Primary outcomes:
measure: Intentions of using the e-cigarette
timeFrame: Immediately after exposure
measure: Intentions of switching completely to the e-cigarette
timeFrame: Immediately after exposure
Secondary outcomes:
measure: Intentions of using the e-cigarette compared to cigarettes
timeFrame: Immediately after exposure
measure: Intentions of using the e-cigarette compared to other e-cigarettes
timeFrame: Immediately after exposure
measure: Ad appeal
timeFrame: Immediately after exposure
measure: Perceived absolute harm of using the e-cigarette
timeFrame: Immediately after exposure
measure: Perceived absolute addictiveness of using the e-cigarette
timeFrame: Immediately after exposure
Other outcomes:
measure: Sensory appeal of the e-cigarette
timeFrame: Immediately after exposure
measure: Positive expectancy of using the e-cigarette
timeFrame: Immediately after exposure
measure: Negative expectancy of using the e-cigarette
timeFrame: Immediately after exposure
Locations:
city: New Brunswick
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
References: