VapingNCT06269003
Responses to Message Source and Presentation Using Psychophysiology
A study testing Expert, one-sided, Expert, two-sided and Peer, one-sided in people with Vaping, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape. Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Vaping
- What is being tested?
- Expert, one-sided, Expert, two-sided and Peer, one-sided
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2024to 10 Jun 2024
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Ages 18-24
- Fluent in English
- Either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping
- Self-reported abstinence of combusted tobacco or marijuana at time of visit
Who cannot join
- Ages below 18 or above 24
- Not fluent in English
- Not confirmed self-reported abstinence of combusted tobacco or marijuana at time of visit
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School Shaw Building
Worcester, Massachusetts, 01605
About this study
Official title: Identifying and Examining the Effects of Source and Presentation on Responses to Electronic Cigarette Public Education Messages in Young Adult Vapers and Non-vapers - Part 2
The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.
- Conditions
- Vaping
- Being tested
- Expert, one-sided, Expert, two-sided, Peer, one-sided, Peer, two-sided
- Medical subject headings
- Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expert, one-sidedOther
Participants will view a brief description of an expert source and see one-sided e-cigarette education messages.
Expert, two-sidedOther
Participants will view a brief description of an expert source and see two-sided e-cigarette education messages.
Peer, one-sidedOther
Participants will view a brief description of a peer source and see one-sided e-cigarette education messages.
Peer, two-sidedOther
Participants will view a brief description of a peer source and see two-sided e-cigarette education messages.
| Study group | Role | What they receive |
|---|---|---|
| Expert, one-sided | Experimental | Participants assigned to the expert, one-sidedness condition will receive one-sided e-cigarette messages from an expert source. Receives: Other: Expert, one-sided |
| Expert, two-sided | Experimental | Participants assigned to the expert, two-sidedness condition will receive two-sided e-cigarette messages from an expert source. Receives: Other: Expert, two-sided |
| Peer, one-sided | Experimental | Participants assigned to the peer, one-sidedness condition will receive one-sided e-cigarette messages from a peer source. Receives: Other: Peer, one-sided |
| Peer, two-sided | Experimental | Participants assigned to the peer, two-sidedness condition will receive two-sided e-cigarette messages from a peer source. Receives: Other: Peer, two-sided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Attention
Visual attention was assessed by measuring dwell time, which is the length of time participants spent on looking at the specific areas of interest (AOIs) collected in miliseconds. Dwell time values were collected for 18 messages, and aggregated to provide the average dwell time scores for each arm. This was done for each vaping status (current vapers and susceptible non-vapers). Higher dwell time scores indicate higher visual attention, indicating better message outcomes.
Measured: The entire duration of message from beginning of its delivery to the completion of viewing, up to 45 minutes.
Allocation of Cognitive Resources
Heart rate values were collected in beats per minute (BPM) on a per-second basis during the presentation of each 18 distinct messages as well as during the immediately preceding black screen (baseline) for each message. Descriptive statistics were used to summarize changes in the BPM values during the message exposure period by comparing the BPM values collected during each message second to the BPM values collected during the immediately preceding baseline period. These change scores were then averaged across all messages within each study arm to generate a mean BPM value per condition, and this was done for each vaping status (current vapers and susceptible non-vapers). Lower BPM values reflect greater cognitive response, therefore indicate better message outcomes.
Measured: Baseline and immediately after viewing all the messages (approximately 45 minutes).
Arousal
Galvanic Skin Response (GSR) values were recorded in microsiemens on a per-second basis during the presentation of each 18 distinct messages as well as during the immediately preceding black screen (baseline) for each message. Descriptive statistics were used to summarize changes in GSR values by comparing each message response to its preceding baseline period. These change scores were then averaged across all messages within each study arm to generate a mean GSR score per condition, and this was done for each vaping status group (current vapers and susceptible non-vapers). Higher GSR values reflect greater physiological arousal, and indicate better message outcomes.
Measured: Baseline and immediately after viewing all the messages (approximately 45 minutes).
Secondary outcomes (2)
Attitudes
Participants' self-reported vaping attitudes were measured by using a five-point bipolar scale using 7 subscale items assessing whether participants thought vaping was enjoyable, healthy, safe, fun, smart, cool, and attractive on a scale from 1 (negative attitudes) to 5 (positive attitudes). Items were summed and averaged to create a single composite score, and this was done for each arm for each vaping status. Higher scores indicate more positive e-cigarette attitudes, therefore worse outcomes.
Measured: After exposure to all messages, approximately up to 45 minutes.
Behavioral Intentions
Participants' vaping intentions was measured by using a 3 subscale items assessing participants' intentions to vape: soon/anytime during the next year/would use offered by one of their best friends, on a scale from 1 (Definitely not) to 5 (Definitely yes). Items were summed and averaged to create a single composite score. This was done for each vaping status (current vapers and susceptible non-vapers). Higher scores indicate greater vaping intentions, therefore indicating worse outcome.
Measured: After exposure to all messages, approximately up to 45 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start18 Feb 2024
- Primary completion10 Jun 2024
- Study completion10 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Donghee Nicole Lee, University of Massachusetts, Worcester
- Investigators
- Donghee N Lee, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269003
- Sponsor's protocol ID
- STUDY00001223
- Other IDs
- 1K99CA281094-01A1
- Status last verified
- Jul 2025
- First submitted
- 17 Jan 2024
- Last updated
- 1 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Examining the Effects of Source and Presentation on Responses to Electronic Cigarette Public Education Messages in Young Adult Vapers and Non-vapers - Part 2
- ClinicalTrials.gov ID
- NCT06269003
- Acronym / sponsor ID
- STUDY00001223
- Conditions
- Vaping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 10 Jun 2024 (actual)
- Study completion
- 10 Jun 2024 (actual)
- First posted
- 21 Feb 2024 (actual)
- Results
- Posted 1 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to use psychophysiological methods to test the effects of a message source (expert and peer) and message presentation types (one-sided and two-sided) to identify the optimal message type for young adults who vape and do not vape.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Expert, one-sided | Experimental | Other: Expert, one-sidedParticipants assigned to the expert, one-sidedness condition will receive one-sided e-cigarette messages from an expert source. |
| Expert, two-sided | Experimental | Other: Expert, two-sidedParticipants assigned to the expert, two-sidedness condition will receive two-sided e-cigarette messages from an expert source. |
| Peer, one-sided | Experimental | Other: Peer, one-sidedParticipants assigned to the peer, one-sidedness condition will receive one-sided e-cigarette messages from a peer source. |
| Peer, two-sided | Experimental | Other: Peer, two-sidedParticipants assigned to the peer, two-sidedness condition will receive two-sided e-cigarette messages from a peer source. |
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Ages 18-24
- Fluent in English
- Either vaping in the past 30 days or not having vaped in the past 30 days but susceptible to vaping
- Self-reported abstinence of combusted tobacco or marijuana at time of visit
Key exclusion criteria (3 listed)
- Ages below 18 or above 24
- Not fluent in English
- Not confirmed self-reported abstinence of combusted tobacco or marijuana at time of visit
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 |
|---|---|---|
| Expert, one-sidedParticipants will view a brief description of an expert source and see one-sided e-cigarette education messages. | Other | Expert, one-sided |
| Expert, two-sidedParticipants will view a brief description of an expert source and see two-sided e-cigarette education messages. | Other | Expert, two-sided |
| Peer, one-sidedParticipants will view a brief description of a peer source and see one-sided e-cigarette education messages. | Other | Peer, one-sided |
| Peer, two-sidedParticipants will view a brief description of a peer source and see two-sided e-cigarette education messages. | Other | Peer, two-sided |
Primary outcome
Visual Attention
Time frame: The entire duration of message from beginning of its delivery to the completion of viewing, up to 45 minutes.
Visual attention was assessed by measuring dwell time, which is the length of time participants spent on looking at the specific areas of interest (AOIs) collected in miliseconds. Dwell time values were collected for 18 messages, and aggregated to provide the average dwell time scores for each arm. This was done for each vaping status (current vapers and susceptible non-vapers). Higher dwell time scores indicate higher visual attention, indicating better message outcomes.
Allocation of Cognitive Resources
Time frame: Baseline and immediately after viewing all the messages (approximately 45 minutes).
Heart rate values were collected in beats per minute (BPM) on a per-second basis during the presentation of each 18 distinct messages as well as during the immediately preceding black screen (baseline) for each message. Descriptive statistics were used to summarize changes in the BPM values during the message exposure period by comparing the BPM values collected during each message second to the BPM values collected during the immediately preceding baseline period. These change scores were then averaged across all messages within each study arm to generate a mean BPM value per condition, and this was done for each vaping status (current vapers and susceptible non-vapers). Lower BPM values reflect greater cognitive response, therefore indicate better message outcomes.
Arousal
Time frame: Baseline and immediately after viewing all the messages (approximately 45 minutes).
Galvanic Skin Response (GSR) values were recorded in microsiemens on a per-second basis during the presentation of each 18 distinct messages as well as during the immediately preceding black screen (baseline) for each message. Descriptive statistics were used to summarize changes in GSR values by comparing each message response to its preceding baseline period. These change scores were then averaged across all messages within each study arm to generate a mean GSR score per condition, and this was done for each vaping status group (current vapers and susceptible non-vapers). Higher GSR values reflect greater physiological arousal, and indicate better message outcomes.
2 secondary outcomes
Attitudes
Time frame: After exposure to all messages, approximately up to 45 minutes.
Behavioral Intentions
Time frame: After exposure to all messages, approximately up to 45 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Donghee N Lee, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expert, one-sided, Expert, two-sided and Peer, one-sided in people with Vaping, run by University of Massachusetts, Worcester 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 3 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 1 Aug 2025. 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 1 Aug 2025). 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?
Visual Attention (time frame: The entire duration of message from beginning of its delivery to the completion of viewing, up to 45 minutes.). 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 1 Aug 2025.