Impact of Vaping Prevention Advertisements

NCT04836455 | Completed Results

• 2 other identifiers: 19-31741R01CA246600-01
• Study Type: interventional
• Target: 1,565
• Locations: 1 country
• Sites: 1

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.

Conditions

Vaping

Outcome Measures

Primary Outcomes (1)

• Mean Susceptibility to Vaping Score

  The 3-item Susceptibility to Vaping Scale assesses the extent to which adolescents are open to vaping, using a 1 to 4 response option scale. Here, 1 indicates the lowest susceptibility to vaping, and 4 represents the highest, with higher values indicating a greater susceptibility to vaping - essentially, a worse outcome. The overall scale score is determined by averaging the scores of the three items, summing these scores and dividing by 3. This method results in a score range from a minimum of 1 to a maximum of 4.

  Week 3

Secondary Outcomes (13)

• Mean Attention Score

  Week 2

• Mean Negative Affect Score

  Week 2

• Mean Cognitive Elaboration Score

  Week 3

• Mean Social Interactions Score

  Week 3

• Mean Vaping Health Harm Risk Beliefs Score

  Week 3

Other Outcomes (8)

• Mean Perceived Message Effectiveness Score (UNC Youth Scale)

  Week 2

• Mean Perceived Message Effectiveness Score (FDA Scale)

  Week 2

• Mean Avoidance Score

  Week 2

Study Arms (3)

The Real Cost vaping prevention ads - Health effects theme

EXPERIMENTAL

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

The Real Cost vaping prevention ads - Addiction theme

EXPERIMENTAL

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

Neutral vaping ads

OTHER

Behavioral: Neutral vaping ads

Interventions

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

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

The Real Cost vaping prevention ads - Addiction theme

Neutral vaping ads 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.

Neutral vaping ads

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• None

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Institutes of Health (NIH): collaborator
• Food and Drug Administration (FDA): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (2)

• 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.

  PMID: 39342464 DERIVED

• 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.

  PMID: 36227597 DERIVED

MeSH Terms

Conditions

Vaping

Condition Hierarchy (Ancestors)

Smoking; Behavior

Results Point of Contact

• Title: Dr. Seth M. Noar
• Organization: University of North Carolina at Chapel Hill

noar@unc.edu

9192607269

Study Officials

• Seth Noar, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 8, 2021
• Study Start: July 3, 2021
• Primary Completion: November 3, 2021
• Study Completion: November 3, 2021
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 9 to 36 months following publication
• Access Criteria: Investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)