Impact of Aversive Warnings on E-Cigarette Cessation

Sponsor
University of California, San Diego (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05892445
Collaborator
(none)
1,000
2
5

Study Details

Study Description

Brief Summary

This project aims to evaluate the effectiveness of aversive visual health warnings on e-cigarette cessation among young adults through a randomized controlled trial, as e-cigarette use among this population has been steadily increasing, posing significant public health concerns. While traditional tobacco products have long featured health warnings, e-cigarettes lack similarly aversive visual warnings, and this study seeks to inform the development of targeted e-cigarette cessation strategies and contribute to a deeper understanding of how visual health warnings can be utilized to reduce e-cigarette use and ultimately improve public health. The project has three main aims, which include a rigorous assessment of the academic literature on e-cigarette risks and adverse effects to develop evidence-based mock visual health warnings for e-cigarettes; assessing the effectiveness of aversive visual health warnings in increasing intent to cessate e-cigarettes, with a particular focus on individuals who have experienced adverse events; and examining the long-term impacts of visual health warnings on e-cigarette cessation. This study will also investigate the underlying mechanisms that may explain the relationship of the intervention on cessation. To generate visual warnings, the research team will conduct a thorough review of the scientific literature on e-cigarette risks and adverse effects and collaborate with a graphic designer. Experimental warnings will be annotated and categorized in order to understand the influence of different imagery on variations in participant response. The study will be conducted as a randomized controlled trial, recruiting participants through market research firms that will distribute an online survey to their panels of e-cigarette users. Participants will be eligible for inclusion if they are 18-29 years old and currently use e-cigarettes at least once per week. A quota will be included to ensure sufficient responses from individuals who have experienced at least one adverse event related to e-cigarette use in the past 12 months. The intervention group will be exposed to a series of aversive visual health warnings about the potential health risks of e-cigarette use, delivered through the online survey platform, while the control group will not receive any intervention and will complete the same survey as the intervention group. Data will be analyzed using appropriate statistical techniques, including logistic regression and mediation/moderation analysis, to assess the effectiveness of the aversive visual health warnings in reducing e-cigarette use and the moderating effects of prior adverse event experience. Participants will be contacted for follow-up assessments at 3-months post-intervention to investigate the impact of aversive visual health warnings on e-cigarette cessation among young adults, including the moderating effects of prior adverse event experience, and assess the underlying mechanisms that may explain the relationship between the intervention and e-cigarette cessation.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Graphic Warning Labels
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1000 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
Official Title:
Impact of Aversive Visual Health Warnings on E-Cigarette Cessation Intentions and Behaviors Among Young Adults
Anticipated Study Start Date :
May 1, 2025
Anticipated Primary Completion Date :
Sep 30, 2025
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aversive Visual Health Warnings

Study subjects in this arm will be exposed to experimental aversive visual health warnings depicting risks and adverse effects of e-cigarette use. They will answer survey questions about e-cigarette perceptions before and after exposure to health warnings.

Behavioral: Graphic Warning Labels
Based on a thorough review of the literature on e-cigarette risks and adverse effects, a graphic designer will be contracted to create ten experimental aversive health warnings related to e-cigarettes. These warnings will be exported as high-quality images and shown to participants in the intervention group prior to questions that obtain data on the primary endpoint.

No Intervention: No Warnings

Study subjects in this arm will answer the same survey questions about e-cigarette perceptions as those in the experimental arm, but they will not be shown aversive visual health warnings.

Outcome Measures

Primary Outcome Measures

  1. Intent to Cessate Use of E-Cigarettes [Immediately after exposure to intervention]

    Every participant will take a survey with a question that asks about willingness to cease e-cigarettes using the seven-point Motivation To Stop Scale, adapted for e-cigarettes, in order to assess the influence of the intervention.

Secondary Outcome Measures

  1. E-Cigarette Cessation Attempt [Six months after exposure to intervention]

    Participants completing the first survey will be recontacted six months after their completion date to complete a second survey. This survey will ask whether the participant has made an attempt to quit using e-cigarettes, as well as the approximate date of the quit attempt.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 29 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
  • Age 18-29 years

  • Basic understanding of English

  • Not institutionalized

  • Currently use e-cigarettes at least once per week

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of California, San Diego

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Raphael Cuomo, Assistant Professor, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT05892445
Other Study ID Numbers:
  • 1422045
First Posted:
Jun 7, 2023
Last Update Posted:
Jun 7, 2023
Last Verified:
May 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 7, 2023