- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04249219
Responses to E-Cigarette Advertising
Young Adults Responses to E-Cigarette Advertisement Features and the Effect of Restricting Features on Tobacco Use
Study Overview
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Massachusetts
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Worcester, Massachusetts, United States, 01605
- University of Massachusetts Medical School
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-26 years old,
- Fluent in English,
- Biochemically confirmed abstinence combusted tobacco or marijuana (eCO: exhaled carbon monoxide <6 parts per million) at time of visit
- Reporting never trying an e-cigarette, not even a puff OR reporting having used an e-cigarette in the past but has not used in the past 30 days
- Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire
Exclusion Criteria:
- Younger than 18 years or older than 26 years
- Not fluent in English
- Not confirmed abstinent of combusted tobacco or marijuana
- Use of an e-cigarette
- Not susceptible to e-cigarette use
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: E-Cigarette Ads
All individuals in the study will see the same e-cigarette advertisements presented in a random order.
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All participants will see the same e-cigarette ads presented in a random order.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Attention to Specific ad Feature
Time Frame: Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.
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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.
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Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant.
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Arousal
Time Frame: The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand.
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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.
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The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand.
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Attention to Specific ad Feature
Time Frame: Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brand
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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.
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Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brand
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motivations to Avoid E-cigarettes
Time Frame: Immediately after viewing each ad
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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. |
Immediately after viewing each ad
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Elise M Stevens, PhD, UMass Medical School
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H00022646
- K99DA046563 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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