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VapingNCT04836455

Impact of Vaping Prevention Advertisements

A study testing The FDA's The REal Cost vaping prevention ads - Health harms theme, The FDA's The Real Cost vaping prevention ads - Addiction theme and Neutral vaping ads in people with Vaping, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 13 to 17 yearsHealthy volunteers can take part
Conditions the study is for
Vaping
What is being tested?
The FDA's The REal Cost vaping prevention ads - Health harms theme, The FDA's The Real Cost vaping prevention ads - Addiction theme and Neutral vaping ads
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,565 participants
Where
1 siteUnited States
Study dates
3 Jul 2021to 3 Nov 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 17 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of North Carolina, Chapel Hill

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: Impact of The Real Cost Vaping Prevention Advertisements on Adolescents

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.

Read the 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
Being tested
The FDA's The REal Cost vaping prevention ads - Health harms theme, The FDA's The Real Cost vaping prevention ads - Addiction theme, Neutral vaping ads
Medical subject headings
Vaping

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

    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 adsBehavioural

    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.

Study groups in NCT04836455
Study groupRoleWhat they receive
The Real Cost vaping prevention ads - Health effects themeExperimentalNot described
Receives: Behavioral: The FDA's The REal Cost vaping prevention ads - Health harms theme
The Real Cost vaping prevention ads - Addiction themeExperimentalNot described
Receives: Behavioral: The FDA's The Real Cost vaping prevention ads - Addiction theme
Neutral vaping adsOtherNot described
Receives: Behavioral: Neutral vaping ads

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 3

Secondary outcomes (13)
  1. Mean Attention Score

    The 1-item mean attention measure assesses the extent to which a participant reports that an advertisement captures their attention. Response options range from 1 to 5, with higher scores indicating stronger attention, which is considered a better outcome.

    Measured: Week 2

  2. Mean Negative Affect Score

    The 3-item Negative Affect Scale assesses the extent to which an advertisement elicits negative emotions from the participant, such as fear or disgust. Response options range from 1 to 5. The overall scale score is calculated by averaging the scores of the three items, resulting in a minimum possible score of 1 and a maximum of 5. Higher scores indicate stronger negative emotions. In the context of this assessment, higher negative emotions are considered a more effective (better) outcome.

    Measured: Week 2

  3. Mean Cognitive Elaboration Score

    The 3-item Mean Cognitive Elaboration Scale assesses the extent to which participants have thought about the addictiveness or harmfulness of vaping over the past 7 days. Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with scores ranging from a minimum of 1 to a maximum of 5. Higher scores indicate greater cognitive elaboration, suggesting a more effective engagement with the content (a better outcome).

    Measured: Week 3

  4. Mean Social Interactions Score

    The 3-item Mean Social Interactions Scale assesses the extent to which a participant has discussed the addictiveness or harmfulness of vaping with others in the past 7 days. Response options range from 1 (0 times) to 6 (11 or more times). The overall scale score is calculated by averaging the three items, resulting in a score range from a minimum of 1 to a maximum of 6. Higher scores indicate more frequent social interactions, which are considered a better outcome.

    Measured: Week 3

  5. Mean Vaping Health Harm Risk Beliefs Score

    The 3-item Vaping Health Harm Risk Beliefs Scale assesses the extent to which participants believe that vaping will lead to health harms. Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with possible scores ranging from a minimum of 1 to a maximum of 5. Higher scores indicate stronger beliefs in the health risks associated with vaping, which is considered a better outcome.

    Measured: Week 3

  6. Mean Vaping Addiction Risk Beliefs Score

    The 3-item Vaping Addiction Risk Beliefs Scale assesses the extent to which participants believe that vaping will lead to addiction. Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with a score range from 1 to 5. Higher scores indicate stronger beliefs in the risk of addiction due to vaping, which is considered a better outcome.

    Measured: Week 3

  7. Mean Vaping Attitudes Score

    The 3-item Vaping Attitudes Scale assesses a participant's attitude towards vaping (e.g., good/bad). Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with scores ranging from 1 to 5. Higher scores indicate a more positive attitude toward vaping, which is considered a less desirable outcome (i.e., worse outcome).

    Measured: Week 3

  8. Number of Days Participants Vape (E-cigarette Use)

    Participants will be asked to report the number of days they vaped over the past 21 days. We chose to retain the continuous measure of the number of days spent vaping rather than dichotomizing this outcome, due to the substantial variability observed in the number of days e-cigarettes were used. A higher value indicates more days that participants vaped, which is considered a less desirable outcome (i.e., worse outcome).

    Measured: Week 3

  9. Mean Smoking Health Harm Risk Belief Score

    The 1-item Mean Smoking Health Harm Risk Belief Measure assesses the extent to which a participant believes that smoking will lead to health harms. Response options range from 1 to 5, with higher scores indicating stronger beliefs in the health risks associated with smoking, which is considered a desirable outcome (i.e., better outcome).

    Measured: Week 3

  10. Mean Smoking Addiction Risk Belief Score

    The 1-item mean smoking health harm risk belief measure assesses the extent to which a participant believes that smoking will lead to health harms. Response options are on a 1 to 5 scale, with higher scores representing a stronger health harm beliefs about smoking, which is a desirable outcome (i.e., better outcome).

    Measured: Week 3

  11. Mean Smoking Attitude Score

    The 1-item mean smoking attitude measure assesses a participant's attitude toward smoking (i.e., good/bad). Response options are on a 1 to 5 scale, with higher scores representing a more positive attitude toward smoking, which is considered as less desirable outcome (i.e., worse outcome).

    Measured: Week 3

  12. Mean Susceptibility to Smoking Cigarettes

    The 3-item Mean Susceptibility to Smoking Cigarettes Scale assesses a participant's susceptibility to smoking cigarettes. Response options range from 1 to 5. The overall scale score is calculated by averaging the three items, with possible scores ranging from 1 to 5. Higher scores indicate a stronger susceptibility to smoking, which is considered a less desirable outcome (i.e., worse outcome).

    Measured: Week 3

  13. Number of Days That Participants Who Smoke Cigarettes

    Participants will be asked to report the number of days they smoked cigarettes over the past 21 days. We chose to retain the continuous measure of the number of days smoking rather than dichotomizing this outcome, due to the substantial variability observed in the number of days cigarettes were used. A higher value indicates more days that participants smoked cigarettes, which is considered a less desirable outcome (i.e., worse outcome).

    Measured: Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2021
  2. Study start3 Jul 2021
  3. Primary completion3 Nov 2021
  4. Study completion3 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,565 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04836455
Sponsor's protocol ID
19-3174
Other IDs
1R01CA246600-01
Status last verified
Mar 2024
First submitted
5 Apr 2021
Last updated
24 Apr 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

Publications

  • 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.

    PubMed 39342464
  • 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.

    PubMed 36227597

Questions about this trial

What is this clinical trial studying?

A study testing The FDA's The REal Cost vaping prevention ads - Health harms theme, The FDA's The Real Cost vaping prevention ads - Addiction theme and Neutral vaping ads in people with Vaping, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Susceptibility to Vaping Score (time frame: Week 3). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04836455, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.

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