Vaping
Conditions
Brief 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.
Interventions
Participants will view a brief description of an expert source and see one-sided e-cigarette education messages.
Participants will view a brief description of an expert source and see two-sided e-cigarette education messages.
Participants will view a brief description of a peer source and see one-sided e-cigarette education messages.
Participants will view a brief description of a peer source and see two-sided e-cigarette education messages.
Sponsors
Study design
Eligibility
Inclusion criteria
* 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
Exclusion criteria
* Ages below 18 or above 24 * Not fluent in English * Not confirmed self-reported abstinence of combusted tobacco or marijuana at time of visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Attention | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attitudes | After exposure to all messages, approximately up to 45 minutes. | 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. |
| Behavioral Intentions | After exposure to all messages, approximately up to 45 minutes. | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited based on their age (18-24 years old), vaping status (past-30-day vaping and/susceptible to vaping), location (living in the US) between January 2024 to June 2024. The first participant was enrolled in February 18, 2024, and the last participant was enrolled in June 10, 2024.
Participants by arm
| Arm | Count |
|---|---|
| Expert, One-sided Participants first saw a brief description of a expert source. Then they viewed an e-cigarette message that discussed only the health harms of e-cigarette use. This sequence was repeated 18 times during a single study visit. | 28 |
| Peer, One-sided Participants first saw a brief description of a peer source. They then viewed an e-cigarette message that discussed only the health harms of e-cigarette use. This sequence was repeated 18 times during a single study visit. | 27 |
| Expert, Two-sided Participants first saw a brief description of an expert source. They then viewed an e-cigarette message that acknowledged both the potential benefits of e-cigarette use and the associated health risks. This sequence was repeated 18 times during a single study visit. | 28 |
| Peer, Two-sided Participants first saw a brief description of an peer source. They then viewed an e-cigarette message that acknowledged both the potential benefits of e-cigarette use and the associated health risks. This sequence was repeated 18 times during a single study visit. | 28 |
| Total | 111 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | One participant was excluded for being outside the eligible age range. | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Expert, One-sided | Peer, One-sided | Expert, Two-sided | Peer, Two-sided | Total |
|---|---|---|---|---|---|
| Age, Continuous | 22.25 years STANDARD_DEVIATION 1.4 | 21.59 years STANDARD_DEVIATION 2.12 | 21.57 years STANDARD_DEVIATION 1.75 | 21.82 years STANDARD_DEVIATION 1.85 | 21.81 years STANDARD_DEVIATION 1.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 7 Participants | 3 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 22 Participants | 21 Participants | 25 Participants | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 7 Participants | 4 Participants | 6 Participants | 20 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 2 Participants | 1 Participants | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 1 Participants | 4 Participants | 4 Participants | 12 Participants |
| Race (NIH/OMB) White | 19 Participants | 17 Participants | 17 Participants | 14 Participants | 67 Participants |
| Region of Enrollment United States | 28 Participants | 27 Participants | 28 Participants | 28 Participants | 111 Participants |
| Sex/Gender, Customized Female | 14 Participants | 21 Participants | 17 Participants | 18 Participants | 70 Participants |
| Sex/Gender, Customized Male | 11 Participants | 4 Participants | 9 Participants | 6 Participants | 30 Participants |
| Sex/Gender, Customized Others | 3 Participants | 2 Participants | 2 Participants | 4 Participants | 11 Participants |
| Vaping Status Current vaping | 15 Participants | 14 Participants | 16 Participants | 16 Participants | 61 Participants |
| Vaping Status Susceptible to vaping | 13 Participants | 13 Participants | 12 Participants | 12 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 |
| other Total, other adverse events | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 | 0 / 28 | 0 / 27 | 0 / 28 |
Outcome results
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.
Time frame: Baseline and immediately after viewing all the messages (approximately 45 minutes).
Population: n=41 were removed from analysis due to poor quality. The data were stratified based on participants' vaping status (Current vapers and Susceptible non-vapers). The Number of Participants Analyzed for each row reflects the actual number of participants within that vaping status group who were included in the analysis. The Overall Number of Participants Analyzed represents the total number of both subgroups. Any differences have been clarified to specify participant numbers at the row level.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Expert, One-sided | Allocation of Cognitive Resources | Current vapers | -4.885 Beats per minute | Standard Error 1.108 |
| Expert, One-sided | Allocation of Cognitive Resources | Susceptible non-vapers | -3.723 Beats per minute | Standard Error 0.834 |
| Expert, Two-sided | Allocation of Cognitive Resources | Susceptible non-vapers | -3.444 Beats per minute | Standard Error 0.834 |
| Expert, Two-sided | Allocation of Cognitive Resources | Current vapers | -4.098 Beats per minute | Standard Error 1.324 |
| Peer, One-sided | Allocation of Cognitive Resources | Current vapers | -2.079 Beats per minute | Standard Error 1.239 |
| Peer, One-sided | Allocation of Cognitive Resources | Susceptible non-vapers | -3.232 Beats per minute | Standard Error 0.945 |
| Peer, Two-sided | Allocation of Cognitive Resources | Current vapers | -1.652 Beats per minute | Standard Error 1.168 |
| Peer, Two-sided | Allocation of Cognitive Resources | Susceptible non-vapers | -4.696 Beats per minute | Standard Error 1.119 |
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.
Time frame: Baseline and immediately after viewing all the messages (approximately 45 minutes).
Population: n=29 were removed from analysis due to poor quality. The data were stratified based on participants' vaping status (Current vapers and Susceptible non-vapers). The Number of Participants Analyzed for each row reflects the actual number of participants within that vaping status group who were included in the analysis. The Overall Number of Participants Analyzed represents the total number of both subgroups. Any differences have been clarified to specify participant numbers at the row level.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Expert, One-sided | Arousal | Current vapers | 17.225 microsiemens | Standard Error 272.99 |
| Expert, One-sided | Arousal | Susceptible non-vapers | 215.883 microsiemens | Standard Error 372.223 |
| Expert, Two-sided | Arousal | Susceptible non-vapers | -9.867 microsiemens | Standard Error 372.223 |
| Expert, Two-sided | Arousal | Current vapers | 597.772 microsiemens | Standard Error 272.99 |
| Peer, One-sided | Arousal | Current vapers | -49.682 microsiemens | Standard Error 285.129 |
| Peer, One-sided | Arousal | Susceptible non-vapers | 526.856 microsiemens | Standard Error 394.802 |
| Peer, Two-sided | Arousal | Current vapers | 267.135 microsiemens | Standard Error 272.99 |
| Peer, Two-sided | Arousal | Susceptible non-vapers | -157.043 microsiemens | Standard Error 372.223 |
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.
Time frame: The entire duration of message from beginning of its delivery to the completion of viewing, up to 45 minutes.
Population: The data were stratified based on participants' vaping status (Current vapers and Susceptible non-vapers). The Number of Participants Analyzed for each row reflects the actual number of participants within that vaping status group who were included in the analysis. The Overall Number of Participants Analyzed represents the total number of both subgroups. Any differences have been clarified to specify participant numbers at the row level.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Expert, One-sided | Visual Attention | Current vapers | 6217.016667 milliseconds | Standard Deviation 1278.03706 |
| Expert, One-sided | Visual Attention | Susceptible non-vapers | 6750.67 milliseconds | Standard Deviation 798.60759 |
| Expert, Two-sided | Visual Attention | Susceptible non-vapers | 6423.3025 milliseconds | Standard Deviation 1069.16916 |
| Expert, Two-sided | Visual Attention | Current vapers | 6333.70375 milliseconds | Standard Deviation 909.82927 |
| Peer, One-sided | Visual Attention | Current vapers | 6567.725714 milliseconds | Standard Deviation 934.62436 |
| Peer, One-sided | Visual Attention | Susceptible non-vapers | 6701.923077 milliseconds | Standard Deviation 604.30866 |
| Peer, Two-sided | Visual Attention | Current vapers | 6667.185625 milliseconds | Standard Deviation 633.14744 |
| Peer, Two-sided | Visual Attention | Susceptible non-vapers | 6231.6275 milliseconds | Standard Deviation 933.71167 |
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.
Time frame: After exposure to all messages, approximately up to 45 minutes.
Population: The data were stratified based on participants' vaping status (Current vapers and Susceptible non-vapers). The Number of Participants Analyzed for each row reflects the actual number of participants within that vaping status group who were included in the analysis. The Overall Number of Participants Analyzed represents the total number of both subgroups. Any differences have been clarified to specify participant numbers at the row level.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Expert, One-sided | Attitudes | Current vapers | 1.9619 score on a scale | Standard Deviation 0.45326 |
| Expert, One-sided | Attitudes | Susceptible non-vapers | 1.6593 score on a scale | Standard Deviation 0.40632 |
| Expert, Two-sided | Attitudes | Susceptible non-vapers | 1.5833 score on a scale | Standard Deviation 0.48141 |
| Expert, Two-sided | Attitudes | Current vapers | 2.1771 score on a scale | Standard Deviation 0.54931 |
| Peer, One-sided | Attitudes | Current vapers | 2.1480 score on a scale | Standard Deviation 0.62299 |
| Peer, One-sided | Attitudes | Susceptible non-vapers | 1.6044 score on a scale | Standard Deviation 0.51228 |
| Peer, Two-sided | Attitudes | Current vapers | 1.8824 score on a scale | Standard Deviation 0.39817 |
| Peer, Two-sided | Attitudes | Susceptible non-vapers | 1.8571 score on a scale | Standard Deviation 0.40913 |
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.
Time frame: After exposure to all messages, approximately up to 45 minutes.
Population: The data were stratified based on participants' vaping status (Current vapers and Susceptible non-vapers). The Number of Participants Analyzed for each row reflects the actual number of participants within that vaping status group who were included in the analysis. The Overall Number of Participants Analyzed represents the total number of both subgroups. Any differences have been clarified to specify participant numbers at the row level.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Expert, One-sided | Behavioral Intentions | Current vapers | 2.7556 score on a scale | Standard Deviation 0.98776 |
| Expert, One-sided | Behavioral Intentions | Susceptible non-vapers | 1.3333 score on a scale | Standard Deviation 0.49065 |
| Expert, Two-sided | Behavioral Intentions | Susceptible non-vapers | 1.0278 score on a scale | Standard Deviation 0.09623 |
| Expert, Two-sided | Behavioral Intentions | Current vapers | 3.0313 score on a scale | Standard Deviation 0.87817 |
| Peer, One-sided | Behavioral Intentions | Current vapers | 3.0238 score on a scale | Standard Deviation 0.90075 |
| Peer, One-sided | Behavioral Intentions | Susceptible non-vapers | 1.2564 score on a scale | Standard Deviation 0.47442 |
| Peer, Two-sided | Behavioral Intentions | Current vapers | 2.5833 score on a scale | Standard Deviation 0.96992 |
| Peer, Two-sided | Behavioral Intentions | Susceptible non-vapers | 1.3056 score on a scale | Standard Deviation 0.30011 |