VapingNCT04450537
PACE Vape Messaging Study
A study testing Vape Messaging Intervention in people with Vaping and E-cigarette Use, run by University of Vermont at 1 site in United States.
Trial summary
The purpose of this study is to examine the effect of exposure to vape education messages on beliefs, perceptions, norms, and behaviors related to electronic vapor product use. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping, E-cigarette Use, Electronic Cigarette Use
- What is being tested?
- Vape Messaging Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 569 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jun 2020to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-24
- Vermont resident
- Access to a smartphone with internet
- Use of one or more social media site(s) at least weekly
Who cannot join
- Aged 25 years or older
- Not Vermont resident
- No access to a smartphone with internet
- Use of one or more social media site(s) less than weekly
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Anti-JUUL-type Messages on Beliefs, Perceived Harms, and Behavioral Intentions Among Young Adults
The purpose of this study is to examine the effect of exposure to vape education messages on beliefs, perceptions, norms, and behaviors related to electronic vapor product use.
Read the detailed description
Using content developed from the formative research phase, participants in this randomized controlled trial will either be exposed to ten vape education messages or to ten messages on sun safety, with all messages formatted for social media.
This study will take place over a 1-month period. Individuals who complete the screening survey and are eligible to participate will be invited to complete a 10-15 minute baseline survey at the start of the study. This survey will ask questions about tobacco and electronic vapor product use, and beliefs about and perceptions of vape products. This survey will also ask about exposure to tobacco and e-cigarette marketing, exposure to prevention messaging on vaping and tobacco use, and peer and family influences on tobacco use. During the survey, participants will be presented with and be asked to provide feedback for short health-related messages.
One month after completing this survey, participants will be sent an invitation to the follow-up survey. This survey will again ask about tobacco and electronic vapor product use, and beliefs about and perceptions of vape products.
All study procedures will take place remotely, with surveys conducted online. At the end of the first survey, participants will be eligible to receive a $10 online gift card. Upon completion of the follow-up survey, participants will be eligible to receive a $15 online gift card. In total, participants will be eligible to receive up to $25 for completing both surveys. Those who are ineligible will not be asked to complete the baseline survey and will not be compensated.
- Conditions
- Vaping, E-cigarette Use, Electronic Cigarette Use
- Being tested
- Vape Messaging Intervention
- Keywords
- surveys, vaping
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vape Messaging InterventionBehavioural
Participants will be exposed to 10 vape education messages
| Study group | Role | What they receive |
|---|---|---|
| Vape Messaging Intervention | Experimental | Participants will be exposed to 10 vape education messages Receives: Behavioral: Vape Messaging Intervention |
| Sun Safety Control | No intervention | Participants will be exposed 10 sun safety messages |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nicotine/e-cigarette beliefs
True/false/don't know questions about nicotine and electronic vapor/tobacco products
Measured: Assessed at 1-month follow-up
Vape harm perceptions
Harm perception questions about use of electronic vapor/vape products
Measured: Assessed at 1-month follow-up
Vaping-related norms
Questions (5-point Likert scale: 1=Very negative, 5 = Very positive) about others' opinion of using electronic vapor/vape products like JUUL
Measured: Assessed at 1-month follow-up
Secondary outcomes (1)
Behavioral intentions
Questions about intent to use electronic vapor/vape products in the next 12 months
Measured: Assessed at 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2020
- Study start23 Jun 2020
- Primary completion30 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VapingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 569 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Andrea Villanti, University of Vermont
- Investigators
- Andrea C Villanti, PhD, MPH, Principal investigator, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450537
- Sponsor's protocol ID
- 00000693
- Other IDs
- U54DA036114
- Status last verified
- Nov 2020
- First submitted
- 23 Jun 2020
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Anti-JUUL-type Messages on Beliefs, Perceived Harms, and Behavioral Intentions Among Young Adults
- ClinicalTrials.gov ID
- NCT04450537
- Acronym / sponsor ID
- 00000693
- Conditions
- Vaping, E-cigarette Use, Electronic Cigarette Use
- Keywords
- surveys, vaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 569 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 29 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effect of exposure to vape education messages on beliefs, perceptions, norms, and behaviors related to electronic vapor product use.
Detailed description
Using content developed from the formative research phase, participants in this randomized controlled trial will either be exposed to ten vape education messages or to ten messages on sun safety, with all messages formatted for social media.
This study will take place over a 1-month period. Individuals who complete the screening survey and are eligible to participate will be invited to complete a 10-15 minute baseline survey at the start of the study. This survey will ask questions about tobacco and electronic vapor product use, and beliefs about and perceptions of vape products. This survey will also ask about exposure to tobacco and e-cigarette marketing, exposure to prevention messaging on vaping and tobacco use, and peer and family influences on tobacco use. During the survey, participants will be presented with and be asked to provide feedback for short health-related messages.
One month after completing this survey, participants will be sent an invitation to the follow-up survey. This survey will again ask about tobacco and electronic vapor product use, and beliefs about and perceptions of vape products.
All study procedures will take place remotely, with surveys conducted online. At the end of the first survey, participants will be eligible to receive a $10 online gift card. Upon completion of the follow-up survey, participants will be eligible to receive a $15 online gift card. In total, participants will be eligible to receive up to $25 for completing both surveys. Those who are ineligible will not be asked to complete the baseline survey and will not be compensated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vape Messaging Intervention | Experimental | Behavioral: Vape Messaging InterventionParticipants will be exposed to 10 vape education messages |
| Sun Safety Control | No intervention | –Participants will be exposed 10 sun safety messages |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-24
- Vermont resident
- Access to a smartphone with internet
- Use of one or more social media site(s) at least weekly
Key exclusion criteria (4 listed)
- Aged 25 years or older
- Not Vermont resident
- No access to a smartphone with internet
- Use of one or more social media site(s) less than weekly
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vape Messaging InterventionParticipants will be exposed to 10 vape education messages | Behavioural | Vape Messaging Intervention |
Primary outcome
Nicotine/e-cigarette beliefs
Time frame: Assessed at 1-month follow-up
True/false/don't know questions about nicotine and electronic vapor/tobacco products
Vape harm perceptions
Time frame: Assessed at 1-month follow-up
Harm perception questions about use of electronic vapor/vape products
Vaping-related norms
Time frame: Assessed at 1-month follow-up
Questions (5-point Likert scale: 1=Very negative, 5 = Very positive) about others' opinion of using electronic vapor/vape products like JUUL
1 secondary outcome
Behavioral intentions
Time frame: Assessed at 1-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea C Villanti, PhD, MPH principal investigator
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vape Messaging Intervention in people with Vaping and E-cigarette Use, run by University of Vermont 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 4 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 3 Nov 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Nicotine/e-cigarette beliefs (time frame: Assessed at 1-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2020; AzTrials last refreshed its copy on 27 Oct 2026.