Impact of Vaping Prevention Advertisements

NCT ID: NCT04836455

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1565 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-03
• Study Completion Date: 2021-11-03

Brief Summary

The purpose of this randomized controlled trial is to determine whether exposure to vaping prevention advertisements (ads) reduce susceptibility to vaping among adolescents. Previous studies have been informative, but they have tended to be one-time experimental studies that do not replicate the repeated exposures to ads that people have in the real world. This study addresses this issue by repeatedly exposing participants to vaping prevention ads over time. Participants will be adolescents aged 13-17 who currently vape or who are susceptible to vaping.

Participants will be randomly assigned to ad stimuli. They will be assigned to one of two The Real Cost trial arms-health harms or addiction-or to a control trial arm (probability of assignment is 1/3 for all trial arms). Participants in the study will take 4 online surveys over a 3-week period, once per week (At week 0, 1, 2, and 3). All participants will view randomized ad stimuli based on their trial arm and answer surveys items at each session.

Detailed Description

Tobacco prevention mass media campaigns are a key tool for reducing tobacco use among adolescents. While vaping has increased greatly among adolescents, there has been a dearth of research on effective communication strategies to reduce vaping. This study will test the impact of advertisements from the Food and Drug Administration's The Real Cost campaign on reducing susceptibility to vaping in a randomized controlled trial, illuminating whether such ads are effective as well as what themes are most effective (i.e., health harms, addiction). The investigators focus on adolescents (ages 13-17) who currently vape or are at risk of vaping.

Setting: The trial will be a longitudinal online study with 4 surveys over a 3 week period - 1 survey per week.

Recruitment: Adolescent participants will be recruited through Qualtrics, an online survey panel platform. Interested prospective participants will complete a screening questionnaire to determine their eligibility. If eligible, Qualtrics will invite them to enroll in the trial.

Informed Consent: Qualtrics will obtain parental consent online for adolescents who are eligible and interested in participating. After parental consent, adolescents will provide online assent prior to taking the survey.

Randomization: After providing informed assent, Qualtrics survey software will randomly assign participants to one of the three trial arms. Participants will have an equal chance of being randomized to any of the 3 trial arms.

Assessment: Participants in the study will take 4 surveys over a 3-week period. This will allow for multiple exposures to campaign ads. At week 0, randomize participants will be randomized to 1 of 2 FDA The Real Cost vaping prevention ad trial arms (health harms or addiction) or to a control arm (investigator created neutral ads about vaping). In each condition, participants will view 3 ads at each session, in a random order, corresponding to the theme they were assigned. At the first session (week 0), each participant will complete measures of vaping and smoking behavior, and will then view the ads that correspond to their trial arm. They will complete measures assessing message reactions after viewing each ad, followed by measures of susceptibility to vaping, vaping and smoking beliefs, and finally questions assessing demographics. For week 1 and 2 assessments, participants will complete measures of susceptibility to vaping, vaping and smoking beliefs, and vaping and smoking behavior. They will then view the same 3 ads from their trial arm and complete the message reactions measures. For the week 3 assessment, participants will only complete measures of susceptibility to vaping, vaping and smoking beliefs, and vaping and smoking behavior. Each survey will take approximately 15 minutes.

Conditions

Vaping

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

The Real Cost vaping prevention ads - Health effects theme

Group Type: EXPERIMENTAL

The FDA's The REal Cost vaping prevention ads - Health harms theme

Intervention Type: BEHAVIORAL

Three vaping prevention video ads from the FDA's The Real Cost prevention campaign about the health harms of vaping will be shown to participants at weeks 0, 1, and 2. Ads will be shown in a random order.

The Real Cost vaping prevention ads - Addiction theme

Group Type: EXPERIMENTAL

The FDA's The Real Cost vaping prevention ads - Addiction theme

Intervention Type: BEHAVIORAL

Three vaping prevention video ads from the FDA's The Real Cost prevention campaign about vaping addiction will be shown to participants at week 0, 1, and 2. Ads will be shown in a random order.

Neutral vaping ads

Group Type: OTHER

Neutral vaping ads

Intervention Type: BEHAVIORAL

Three neutral (i.e., purely informational and without graphics) vaping video ads developed by the Investigators will be shown to participants at weeks 0, 1, and 2. Ads will be shown in a random order.

Interventions

The FDA's The REal Cost vaping prevention ads - Health harms theme

Three vaping prevention video ads from the FDA's The Real Cost prevention campaign about the health harms of vaping will be shown to participants at weeks 0, 1, and 2. Ads will be shown in a random order.

Intervention Type: BEHAVIORAL

The FDA's The Real Cost vaping prevention ads - Addiction theme

Three vaping prevention video ads from the FDA's The Real Cost prevention campaign about vaping addiction will be shown to participants at week 0, 1, and 2. Ads will be shown in a random order.

Intervention Type: BEHAVIORAL

Neutral vaping ads

Three neutral (i.e., purely informational and without graphics) vaping video ads developed by the Investigators will be shown to participants at weeks 0, 1, and 2. Ads will be shown in a random order.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between ages 13-17 years old
• Be able to read and speak English
• Be able to take an online survey in English
• Be susceptible to vaping

Exclusion Criteria

• None

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Food and Drug Administration (FDA)

FED

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Seth Noar, PhD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

Kieu T, Ma H, Rohde JA, Gottfredson O'Shea N, Hall MG, Brewer NT, Noar SM. Understanding Potential Mechanisms of Vaping Prevention Messages: A Mediation Analysis of the Real Cost Campaign Advertisements. Health Educ Behav. 2025 Feb;52(1):102-112. doi: 10.1177/10901981241278565. Epub 2024 Sep 29.

Reference Type: DERIVED

PMID: 39342464 (View on PubMed)

Noar SM, Gottfredson NC, Kieu T, Rohde JA, Hall MG, Ma H, Fendinger NJ, Brewer NT. Impact of Vaping Prevention Advertisements on US Adolescents: A Randomized Clinical Trial. JAMA Netw Open. 2022 Oct 3;5(10):e2236370. doi: 10.1001/jamanetworkopen.2022.36370.

Reference Type: DERIVED

PMID: 36227597 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

1R01CA246600-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19-3174

Identifier Type: -

Identifier Source: org_study_id