Responses to E-Cigarette Advertising

NCT04249219 | Completed Early Phase 1 Results

• 2 other identifiers: H00022646K99DA046563
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. The use of ECs during young adulthood, particularly 18 years of age, is especially alarming because it is not only a critical period in development but also a time when tobacco use is established. Additionally, the tobacco industry targets individuals of this age with the hope that they will one day progress to using combustible cigarettes. Advertising may be one of the reasons leading young people to use ECs, and the Food and Drug Administration (FDA) now has the authority to regulate EC advertisement features. The goal of the study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs. Fifteen ads from the most popular EC brands that employ a brand, product descriptions, and modeling features were selected. Young adults who are susceptible to EC use will come into the lab and view these ads. During exposure, they will be assessed for real-time visual attention using eye-tracking, orienting responses using heart rate, and arousal using skin conductance as well as pre- and post-ad self-report measures of attitudes, susceptibility, and behavioral intentions. These factors will help determine the most high impact features, which will be associated with the greatest visual attention, orienting responses, and arousal levels and changes in attitudes. Findings from this study will provide public health officials important and urgently needed information as to what advertising features are contributing to the sharp rise in the use of ECs among young adults.

Conditions

E-Cig Use

Outcome Measures

Primary Outcomes (3)

• Attention to Specific ad Feature

  Heart rate was measured to assess the cognitive resources allocated to the message. Using three sensors applied to participants' fingers, electrocardiogram (ECG) signals were recorded with a Shimmer 3 EXG module, while viewing the advertisements and were sampled at 512 Hz. Heart change scores were computed using beats per minute (BPM) and subtracting the first second of the stimuli (participant had seen a black screen just prior) from scores for each second of message exposure for each participant. Then, scores were averaged across each advertisement. Lesser values indicated greater deceleration in heart rate, signaling more cognitive resources allocated to the message.

  Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.

• Arousal

  Skin conductance or galvanic skin response was measured using three sensors applied to participants' fingers. Skin conductance measured if there was an emotional response and the intensity of the emotional response. A "peak" is a biological indicator that something happened, and the participant had an emotional response to it. The amplitude of each peak for each participant was measured and averaged per ad.

  The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand.

• Attention to Specific ad Feature

  Visual attention was assessed using an eye-tracker connected to the base of the computer screen. For each message, four areas of interest (AOI) were identified: 1) brand, 2) descriptor, 3) modeling, and 4) warning. All four AOIs were summed for a total number of milliseconds that a participant viewed the AOIs.

  Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brand

Secondary Outcomes (1)

• Motivations to Avoid E-cigarettes

  Immediately after viewing each ad

Study Arms (1)

E-Cigarette Ads

EXPERIMENTAL

All individuals in the study will see the same e-cigarette advertisements presented in a random order.

Other: Viewing e-cigarette ads

Interventions

Viewing e-cigarette ads OTHER

All participants will see the same e-cigarette ads presented in a random order.

E-Cigarette Ads

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old,
• Fluent in English,
• Biochemically confirmed abstinence combusted tobacco or marijuana (eCO: exhaled carbon monoxide \<6 parts per million) at time of visit
• Reporting never trying an e-cigarette, not even a puff OR reporting having used an e-cigarette in the past but has not used in the past 30 days
• Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire

You may not qualify if:

• Younger than 18 years or older than 26 years
• Not fluent in English
• Not confirmed abstinent of combusted tobacco or marijuana
• Use of an e-cigarette
• Not susceptible to e-cigarette use

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of Massachusetts Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Results Point of Contact

• Title: Elise Stevens
• Organization: University of Massachusetts Chan Medical School

elise.stevens@umassmed.edu

(774) 455-6684

Study Officials

• Elise M Stevens, PhD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 24, 2020
• First Posted: January 30, 2020
• Study Start: August 4, 2021
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)