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| ID | Type | Description | Link |
|---|---|---|---|
| K99DA046563 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. The use of ECs during young adulthood, particularly 18 years of age, is especially alarming because it is not only a critical period in development but also a time when tobacco use is established. Additionally, the tobacco industry targets individuals of this age with the hope that they will one day progress to using combustible cigarettes. Advertising may be one of the reasons leading young people to use ECs, and the Food and Drug Administration (FDA) now has the authority to regulate EC advertisement features. The goal of the study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs. Fifteen ads from the most popular EC brands that employ a brand, product descriptions, and modeling features were selected. Young adults who are susceptible to EC use will come into the lab and view these ads. During exposure, they will be assessed for real-time visual attention using eye-tracking, orienting responses using heart rate, and arousal using skin conductance as well as pre- and post-ad self-report measures of attitudes, susceptibility, and behavioral intentions. These factors will help determine the most high impact features, which will be associated with the greatest visual attention, orienting responses, and arousal levels and changes in attitudes. Findings from this study will provide public health officials important and urgently needed information as to what advertising features are contributing to the sharp rise in the use of ECs among young adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| E-Cigarette Ads | Experimental | All individuals in the study will see the same e-cigarette advertisements presented in a random order. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viewing e-cigarette ads | Other | All participants will see the same e-cigarette ads presented in a random order. |
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| Measure | Description | Time Frame |
|---|---|---|
| Attention to Specific ad Feature | 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. | Change from the first second of viewing to each subsequent second of the intervention (10 seconds per ad), averaged for each participant. |
| Arousal | 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. | The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand. |
| Attention to Specific ad Feature | 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. | Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brand |
| Measure | Description | Time Frame |
|---|---|---|
| Motivations to Avoid E-cigarettes | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elise M Stevens, PhD | UMass Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Massachusetts Medical School | Worcester | Massachusetts | 01605 | United States |
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All enrolled participants were assigned to the one arm of the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | E-Cigarette Ads | All individuals in the study will see the same e-cigarette advertisements presented in a random order. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | E-Cigarette Ads | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Attention to Specific ad Feature | 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. | All individuals in the study saw the same advertisements. | Posted | Mean | Standard Deviation | Beats per minute | 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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The specific period of time over which adverse event data were collected was between the beginning of the participant's visit and the end. The time frame for each participant was one hour and 30 minutes.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | E-Cigarette Ads | All individuals in the study will see the same e-cigarette advertisements presented in a random order. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elise Stevens | University of Massachusetts Chan Medical School | (774) 455-6684 | 56684 | elise.stevens@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2023 | Jul 26, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000072137 | Vaping |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D001519 | Behavior |
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| Immediately after viewing each ad |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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. |
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| Primary | Arousal | 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. | All individuals in the study saw the same e-cigarette advertisements. | Posted | Mean | Standard Deviation | microSiemens | The average amplitude of skin conductance peaks over the 10 second viewing window for each ad brand. |
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| Primary | Attention to Specific ad Feature | 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. | All individuals in the study saw the same e-cigarette advertisements. | Posted | Mean | Standard Deviation | milliseconds | Duration of seconds spent on all areas of interest during 10 second viewing window for each ad brand |
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| Secondary | Motivations to Avoid E-cigarettes | 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. | All individuals in the study saw the same e-cigarette advertisements. | Posted | Mean | Standard Deviation | score on a scale | Immediately after viewing each ad |
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