Trial Outcomes & Findings for Responses to Message Source and Presentation Using Psychophysiology (NCT NCT06269003)

NCT ID: NCT06269003

Last Updated: 2025-08-01

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

112 participants

Primary outcome timeframe

The entire duration of message from beginning of its delivery to the completion of viewing, up to 45 minutes.

Results posted on

2025-08-01

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Expert, One-sided
Participants assigned to the expert, one-sidedness condition were first presented with a brief description of a expert 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.
Expert, Two-sided
Participants assigned to the expert, two-sidedness condition were first presented with 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.
Peer, One-sided
Participants assigned to the peer, one-sidedness condition were first presented with 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.
Peer, Two-sided
Participants assigned to the peer, two-sidedness condition were first presented with 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.
Overall Study
STARTED
28
28
28
28
Overall Study
COMPLETED
28
28
27
28
Overall Study
NOT COMPLETED
0
0
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Expert, One-sided
Participants assigned to the expert, one-sidedness condition were first presented with a brief description of a expert 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.
Expert, Two-sided
Participants assigned to the expert, two-sidedness condition were first presented with 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.
Peer, One-sided
Participants assigned to the peer, one-sidedness condition were first presented with 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.
Peer, Two-sided
Participants assigned to the peer, two-sidedness condition were first presented with 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.
Overall Study
One participant was excluded for being outside the eligible age range.
0
0
1
0

Baseline Characteristics

Responses to Message Source and Presentation Using Psychophysiology

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Expert, One-sided
n=28 Participants
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.
Peer, One-sided
n=27 Participants
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.
Expert, Two-sided
n=28 Participants
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.
Peer, Two-sided
n=28 Participants
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.
Total
n=111 Participants
Total of all reporting groups
Age, Continuous
22.25 years
STANDARD_DEVIATION 1.40 • n=5 Participants
21.59 years
STANDARD_DEVIATION 2.12 • n=7 Participants
21.57 years
STANDARD_DEVIATION 1.75 • n=5 Participants
21.82 years
STANDARD_DEVIATION 1.85 • n=4 Participants
21.81 years
STANDARD_DEVIATION 1.79 • n=21 Participants
Sex/Gender, Customized
Female
14 Participants
n=5 Participants
21 Participants
n=7 Participants
17 Participants
n=5 Participants
18 Participants
n=4 Participants
70 Participants
n=21 Participants
Sex/Gender, Customized
Male
11 Participants
n=5 Participants
4 Participants
n=7 Participants
9 Participants
n=5 Participants
6 Participants
n=4 Participants
30 Participants
n=21 Participants
Sex/Gender, Customized
Others
3 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
4 Participants
n=4 Participants
11 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
3 Participants
n=5 Participants
5 Participants
n=7 Participants
7 Participants
n=5 Participants
3 Participants
n=4 Participants
18 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
25 Participants
n=5 Participants
22 Participants
n=7 Participants
21 Participants
n=5 Participants
25 Participants
n=4 Participants
93 Participants
n=21 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Asian
3 Participants
n=5 Participants
7 Participants
n=7 Participants
4 Participants
n=5 Participants
6 Participants
n=4 Participants
20 Participants
n=21 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
3 Participants
n=4 Participants
5 Participants
n=21 Participants
Race (NIH/OMB)
White
19 Participants
n=5 Participants
17 Participants
n=7 Participants
17 Participants
n=5 Participants
14 Participants
n=4 Participants
67 Participants
n=21 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=5 Participants
2 Participants
n=7 Participants
2 Participants
n=5 Participants
1 Participants
n=4 Participants
7 Participants
n=21 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
1 Participants
n=7 Participants
4 Participants
n=5 Participants
4 Participants
n=4 Participants
12 Participants
n=21 Participants
Region of Enrollment
United States
28 Participants
n=5 Participants
27 Participants
n=7 Participants
28 Participants
n=5 Participants
28 Participants
n=4 Participants
111 Participants
n=21 Participants
Vaping Status
Current vaping
15 Participants
n=5 Participants
14 Participants
n=7 Participants
16 Participants
n=5 Participants
16 Participants
n=4 Participants
61 Participants
n=21 Participants
Vaping Status
Susceptible to vaping
13 Participants
n=5 Participants
13 Participants
n=7 Participants
12 Participants
n=5 Participants
12 Participants
n=4 Participants
50 Participants
n=21 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Expert, One-sided
n=28 Participants
Participants assigned to the expert, one-sidedness condition were first presented with a brief description of a expert 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.
Expert, Two-sided
n=28 Participants
Participants assigned to the expert, two-sidedness condition were first presented with 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.
Peer, One-sided
n=27 Participants
Participants assigned to the peer, one-sidedness condition were first presented with 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.
Peer, Two-sided
n=28 Participants
Participants assigned to the peer, two-sidedness condition were first presented with 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.
Visual Attention
Current vapers
6217.016667 milliseconds
Standard Deviation 1278.03706
6333.70375 milliseconds
Standard Deviation 909.82927
6567.725714 milliseconds
Standard Deviation 934.62436
6667.185625 milliseconds
Standard Deviation 633.14744
Visual Attention
Susceptible non-vapers
6750.67 milliseconds
Standard Deviation 798.60759
6423.3025 milliseconds
Standard Deviation 1069.16916
6701.923077 milliseconds
Standard Deviation 604.30866
6231.6275 milliseconds
Standard Deviation 933.71167

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Expert, One-sided
n=20 Participants
Participants assigned to the expert, one-sidedness condition were first presented with a brief description of a expert 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.
Expert, Two-sided
n=18 Participants
Participants assigned to the expert, two-sidedness condition were first presented with 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.
Peer, One-sided
n=16 Participants
Participants assigned to the peer, one-sidedness condition were first presented with 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.
Peer, Two-sided
n=16 Participants
Participants assigned to the peer, two-sidedness condition were first presented with 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.
Allocation of Cognitive Resources
Current vapers
-4.885 Beats per minute
Standard Error 1.108
-4.098 Beats per minute
Standard Error 1.324
-2.079 Beats per minute
Standard Error 1.239
-1.652 Beats per minute
Standard Error 1.168
Allocation of Cognitive Resources
Susceptible non-vapers
-3.723 Beats per minute
Standard Error 0.834
-3.444 Beats per minute
Standard Error 0.834
-3.232 Beats per minute
Standard Error 0.945
-4.696 Beats per minute
Standard Error 1.119

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Expert, One-sided
n=21 Participants
Participants assigned to the expert, one-sidedness condition were first presented with a brief description of a expert 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.
Expert, Two-sided
n=21 Participants
Participants assigned to the expert, two-sidedness condition were first presented with 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.
Peer, One-sided
n=19 Participants
Participants assigned to the peer, one-sidedness condition were first presented with 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.
Peer, Two-sided
n=21 Participants
Participants assigned to the peer, two-sidedness condition were first presented with 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.
Arousal
Current vapers
17.225 microsiemens
Standard Error 272.990
597.772 microsiemens
Standard Error 272.990
-49.682 microsiemens
Standard Error 285.129
267.135 microsiemens
Standard Error 272.990
Arousal
Susceptible non-vapers
215.883 microsiemens
Standard Error 372.223
-9.867 microsiemens
Standard Error 372.223
526.856 microsiemens
Standard Error 394.802
-157.043 microsiemens
Standard Error 372.223

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Expert, One-sided
n=28 Participants
Participants assigned to the expert, one-sidedness condition were first presented with a brief description of a expert 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.
Expert, Two-sided
n=28 Participants
Participants assigned to the expert, two-sidedness condition were first presented with 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.
Peer, One-sided
n=27 Participants
Participants assigned to the peer, one-sidedness condition were first presented with 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.
Peer, Two-sided
n=28 Participants
Participants assigned to the peer, two-sidedness condition were first presented with 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.
Attitudes
Current vapers
1.9619 score on a scale
Standard Deviation .45326
2.1771 score on a scale
Standard Deviation .54931
2.1480 score on a scale
Standard Deviation .62299
1.8824 score on a scale
Standard Deviation .39817
Attitudes
Susceptible non-vapers
1.6593 score on a scale
Standard Deviation .40632
1.5833 score on a scale
Standard Deviation .48141
1.6044 score on a scale
Standard Deviation .51228
1.8571 score on a scale
Standard Deviation .40913

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure
Expert, One-sided
n=28 Participants
Participants assigned to the expert, one-sidedness condition were first presented with a brief description of a expert 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.
Expert, Two-sided
n=28 Participants
Participants assigned to the expert, two-sidedness condition were first presented with 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.
Peer, One-sided
n=27 Participants
Participants assigned to the peer, one-sidedness condition were first presented with 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.
Peer, Two-sided
n=28 Participants
Participants assigned to the peer, two-sidedness condition were first presented with 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.
Behavioral Intentions
Current vapers
2.7556 score on a scale
Standard Deviation 0.98776
3.0313 score on a scale
Standard Deviation 0.87817
3.0238 score on a scale
Standard Deviation 0.90075
2.5833 score on a scale
Standard Deviation 0.96992
Behavioral Intentions
Susceptible non-vapers
1.3333 score on a scale
Standard Deviation .49065
1.0278 score on a scale
Standard Deviation .09623
1.2564 score on a scale
Standard Deviation .47442
1.3056 score on a scale
Standard Deviation .30011

Adverse Events

Expert 1-sided

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Expert 2-sided

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Peer 1-sided

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Peer 2-sided

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Donghee Nicole Lee, Assistant Professor

University of Hawaii Cancer Center

Phone: 8084418184

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place