Trial Outcomes & Findings for Responses to E-Cigarette Advertising (NCT NCT04249219)
NCT ID: NCT04249219
Last Updated: 2023-09-08
Results Overview
Heart rate was measured to assess the cognitive resources allocated to the message. Using three sensors applied to participants' fingers, electrocardiogram (ECG) signals were recorded with a Shimmer 3 EXG module, while viewing the advertisements and were sampled at 512 Hz. Heart change scores were computed using beats per minute (BPM) and subtracting the first second of the stimuli (participant had seen a black screen just prior) from scores for each second of message exposure for each participant. Then, scores were averaged across each advertisement. Lesser values indicated greater deceleration in heart rate, signaling more cognitive resources allocated to the message.
COMPLETED
EARLY_PHASE1
62 participants
Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.
2023-09-08
Participant Flow
All enrolled participants were assigned to the one arm of the study.
Participant milestones
| Measure |
E-Cigarette Ads
All individuals in the study will see the same e-cigarette advertisements presented in a random order.
|
|---|---|
|
Overall Study
STARTED
|
62
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Responses to E-Cigarette Advertising
Baseline characteristics by cohort
| Measure |
E-Cigarette Ads
n=62 Participants
All individuals in the study will see the same e-cigarette advertisements presented in a random order.
Viewing e-cigarette ads: All participants will see the same e-cigarette ads presented in a random order.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
62 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Age, Continuous
|
22.5 years
STANDARD_DEVIATION 2.31 • n=99 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
14 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
62 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.Population: All individuals in the study saw the same advertisements.
Heart rate was measured to assess the cognitive resources allocated to the message. Using three sensors applied to participants' fingers, electrocardiogram (ECG) signals were recorded with a Shimmer 3 EXG module, while viewing the advertisements and were sampled at 512 Hz. Heart change scores were computed using beats per minute (BPM) and subtracting the first second of the stimuli (participant had seen a black screen just prior) from scores for each second of message exposure for each participant. Then, scores were averaged across each advertisement. Lesser values indicated greater deceleration in heart rate, signaling more cognitive resources allocated to the message.
Outcome measures
| Measure |
E-Cigarette Ads
n=62 Participants
All individuals in the study will see the same e-cigarette advertisements presented in a random order.
Viewing e-cigarette ads: All participants will see the same e-cigarette ads presented in a random order.
|
|---|---|
|
Attention to Specific ad Feature
Blu ads
|
-1.7062 Beats per minute
Standard Deviation 1.318833535
|
|
Attention to Specific ad Feature
Juul ads
|
-0.9676 Beats per minute
Standard Deviation 0.918885902
|
|
Attention to Specific ad Feature
MarkTen ads
|
-1.8238 Beats per minute
Standard Deviation 1.209606837
|
PRIMARY outcome
Timeframe: The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand.Population: All individuals in the study saw the same e-cigarette advertisements.
Skin conductance or galvanic skin response was measured using three sensors applied to participants' fingers. Skin conductance measured if there was an emotional response and the intensity of the emotional response. A "peak" is a biological indicator that something happened, and the participant had an emotional response to it. The amplitude of each peak for each participant was measured and averaged per ad.
Outcome measures
| Measure |
E-Cigarette Ads
n=62 Participants
All individuals in the study will see the same e-cigarette advertisements presented in a random order.
Viewing e-cigarette ads: All participants will see the same e-cigarette ads presented in a random order.
|
|---|---|
|
Arousal
Blu ads
|
0.094441599 microSiemens
Standard Deviation 0.039786446
|
|
Arousal
Juul ads
|
0.080156704 microSiemens
Standard Deviation 0.014821968
|
|
Arousal
MarkTen ads
|
0.107337121 microSiemens
Standard Deviation 0.047972698
|
PRIMARY outcome
Timeframe: Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brandPopulation: All individuals in the study saw the same e-cigarette advertisements.
Visual attention was assessed using an eye-tracker connected to the base of the computer screen. For each message, four areas of interest (AOI) were identified: 1) brand, 2) descriptor, 3) modeling, and 4) warning. All four AOIs were summed for a total number of milliseconds that a participant viewed the AOIs.
Outcome measures
| Measure |
E-Cigarette Ads
n=62 Participants
All individuals in the study will see the same e-cigarette advertisements presented in a random order.
Viewing e-cigarette ads: All participants will see the same e-cigarette ads presented in a random order.
|
|---|---|
|
Attention to Specific ad Feature
Blu ads
|
5464.656 milliseconds
Standard Deviation 557.5287713
|
|
Attention to Specific ad Feature
Juul ads
|
5963.704 milliseconds
Standard Deviation 676.8965371
|
|
Attention to Specific ad Feature
MarkTen ads
|
5107.014 milliseconds
Standard Deviation 394.2662056
|
SECONDARY outcome
Timeframe: Immediately after viewing each adPopulation: All individuals in the study saw the same e-cigarette advertisements.
Self-report Please rate on a scale from 0 (not at all) to 10 (very much). "How important is it to avoid e-cigarettes in the future?" "How confident are in avoiding e-cigarettes in the future?" "How ready are you to avoid e-cigarettes in the future?" "How committed are you to avoid e-cigarettes in the future?" Scores were averaged for each ad for each participant. Then, an overall average was taken among all participants for each ad. Higher values indicate greater motivation to avoid e-cigarettes.
Outcome measures
| Measure |
E-Cigarette Ads
n=62 Participants
All individuals in the study will see the same e-cigarette advertisements presented in a random order.
Viewing e-cigarette ads: All participants will see the same e-cigarette ads presented in a random order.
|
|---|---|
|
Motivations to Avoid E-cigarettes
Blu ads
|
8.618 score on a scale
Standard Deviation 0.027748874
|
|
Motivations to Avoid E-cigarettes
Juul ads
|
8.62 score on a scale
Standard Deviation 0.051961524
|
|
Motivations to Avoid E-cigarettes
MarkTen ads
|
8.61 score on a scale
Standard Deviation 0
|
Adverse Events
E-Cigarette Ads
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elise Stevens
University of Massachusetts Chan Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place