Impact of Aversive Warnings on E-Cigarette Cessation

NCT ID: NCT05892445

Last Updated: 2024-06-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-09-30

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.

Conditions

E Cigarette Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Graphic Warning Labels

Intervention Type: BEHAVIORAL

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 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 18-29 years
• Basic understanding of English
• Not institutionalized
• Currently use e-cigarettes at least once per week

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 29 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Diego

OTHER

Sponsor Role: lead

Responsible Party

Raphael Cuomo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Raphael E Cuomo, PhD

Role: CONTACT

racuomo@ucsd.edu

858-822-3552

Other Identifiers

1422045

Identifier Type: -

Identifier Source: org_study_id