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| ID | Type | Description | Link |
|---|---|---|---|
| U54CA229973 | U.S. NIH Grant/Contract | View source | |
| 843703 | Other Identifier | IRB Protocol Number |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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The purpose of this study is to examine the effect of cigarette pictorial warning label content (lesser-known vs well-known risks) on visual engagement, recall, and knowledge of tobacco use harms.
This laboratory-based study will aim to enroll 120 current cigarette users to complete a 1-day randomized, parallel design protocol.
The participants will be randomized to one of two conditions, pictorial warning labels (PWLs) with well-known or lesser-known tobacco harms. After completing a baseline questionnaire, the participants will view 4 warning labels from the assigned group and complete a follow-up questionnaire. Eye-tracking will provide data on visual processing of the warning labels and the effect of these labels on knowledge, attitudes, and beliefs about smoking will be supplemented by self-report.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition A (Lesser-known harms) | Experimental | Participants randomized to this condition will view cigarette warning labels highlighting lesser-known harms of tobacco use. |
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| Condition B (Well-known harms) | Experimental | Participants randomized to this condition will view cigarette warning labels highlighting the well-known harms of tobacco use. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pictorial Warning Labels | Other | Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task. |
| Measure | Description | Time Frame |
|---|---|---|
| Attention: Latency (Time Until First Fixation) for Image | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Day 1 |
| Attention: Latency (Time Until First Fixation) for Text | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Day 1 |
| Attention: Latency Duration (Time of Fixation) for Image | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Day 1 |
| Attention: Latency Duration (Time of Fixation) for Text | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Strasser, Ph.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
Deidentified study data will be made available to other researchers who contact the project Principal Investigator via email. Data will be available to such requests 1 year after the conclusion of recruitment.
1 year after the conclusion of recruitment
Researchers should contact the project Principal Investigator via email.
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70 adult daily cigarette users completed a single laboratory session. We recruited non-treatment-seeking adults who use cigarettes daily to complete a single session utilizing a randomized, parallel design. We recruited individuals from the greater Philadelphia area using print and digital media advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Condition A (Lesser-known Harms) | Participants randomized to this condition will view cigarette warning labels highlighting lesser-known harms of tobacco use. Pictorial Warning Labels: Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task. |
| FG001 | Condition B (Well-known Harms) | Participants randomized to this condition will view cigarette warning labels highlighting the well-known harms of tobacco use. Pictorial Warning Labels: Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Condition A (Lesser-known Harms) | Participants randomized to this condition will view cigarette warning labels highlighting lesser-known harms of tobacco use. Pictorial Warning Labels: Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task. |
| BG001 |
| 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, Customized | 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: Latency (Time Until First Fixation) for Image | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Posted | Mean | Standard Deviation | ms | Day 1 |
|
This is a single session study where adverse event data was not collected.
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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 | Condition A (Lesser-known Harms) | Participants randomized to this condition will view cigarette warning labels highlighting lesser-known harms of tobacco use. Pictorial Warning Labels: Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task. |
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Our small sample size and lack of variability in recall and post-exposure knowledge outcomes prevented exploring causal associations between these measures and attention outcomes. We operationalized "understanding" of harms as an increase in knowledge and used aided recall measures, which may have higher endorsement rates compared to unaided recall. other approaches to assessing these outcomes may yield different results and require further investigation.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Andrew Strasser Ph.D. | University of Pennsylvania | 215-746-5788 | strasse3@pennmedicine.upenn.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 | Mar 10, 2022 | Dec 1, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 20, 2020 | Dec 1, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000073865 | Cigarette Smoking |
| ID | Term |
|---|---|
| D000073869 | Tobacco Smoking |
| D012907 | Smoking |
| D001519 | Behavior |
| D064424 | Tobacco Use |
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It is a randomized, parallel design experimental study using objective measures and self-report survey. We will recruit 120 daily smokers (60 young adults and 60 adults) to participate in a single-session laboratory-based study. The participants will be assigned to either the lesser-known or well-known PWL group. After completing a baseline questionnaire, the participants will view 4 warning labels in a randomized order from their assigned group followed by a follow-up questionnaire. Primary outcomes will be eye-tracking measures, label recall and recognition, and knowledge of tobacco harms.
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Participants will be informed that they will be viewing cigarette warning labels during the eye-tracking task, but will be unaware of their randomization condition (lesser-known vs well-known harms)
| Day 1 |
| Attention: Total Fixation Time for Image | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Day 1 |
| Attention: Total Fixation Time for Text | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Day 1 |
| Recall: Participants Ability to Recall Condition Image | Participants will view 11 warning label images and would be required to identify the warning label images they saw during their eye tracking portion of the session. This outcome measure (Recall -Image) was assessed in a percentage unit of measure. The percentages are not whole numbers for these items because it's the mean % correct for the condition, or the average percent correct across the four images for the group. The results in the Outcome Measure Data table demonstrate the percentage of participants who correctly identified the images from their condition (4 of the 11 images presented to participants were from their randomized condition; A or B). | Day 1 |
| Recall: Participants Ability to Recall Condition Text | Participants will view 11 warning label text statements and would be required to identify the warning label text statements they saw during their eye tracking portion of the session. This outcome measure (Recall -Text) was assessed in a percentage unit of measure. The percentages are not whole numbers for these items because it's the mean % correct for the condition, or the average percent correct across the four images for the group. The results in the Outcome Measure Data table demonstrate the percentage of participants who correctly identified the text statements from their condition (4 of the 11 images presented to participants were from their randomized condition; A or B). | Day 1 |
| Knowledge of Smoking Harms | All participants will select harms caused by tobacco from a list of health issues and diseases, before as well as after viewing the warning labels on the screen. Pre and post warning label exposure knowledge of smoking harms were assessed by using an exploratory scale that asked participants if cigarette smoking caused a list of 18 health conditions with a 5-point response scale, (1=definitely yes 2= probably yes, 3 = might or might not, 4 = probably not, 5 = definitely not). | Day 1 |
| Condition B (Well-known Harms) |
Participants randomized to this condition will view cigarette warning labels highlighting the well-known harms of tobacco use. Pictorial Warning Labels: Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Smoking History Information_Past 7-day cigarettes per day | During the study session, participants were asked to report on the number of cigarettes smoked in the past 7 days. | Mean | Standard Deviation | Cigarettes |
|
| Smoking History Information_Fagerstrom Test for Nicotine Dependence (FTND) | At their study session, participants were asked to complete the Fagerstrom Test for Nicotine Dependence (FTND) measure, which assesses a Baseline level of Nicotine Dependence for cigarette smokers. In scoring the Fagerstrom Test for Nicotine Dependence, yes/no items are scored from 0 to 1 and multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. The higher the total Fagerström score, the more intense is the patient's physical dependence on nicotine. | Mean | Standard Deviation | units on a scale |
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| Smoking History Information_Years Smoked | During the study session, participants were asked to report on the total number of years they have smoked cigarettes. | Mean | Standard Deviation | Years |
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| Smoking History_Type of Cigarette | During the study session participants were asked to report the type of cigarette they smoked, menthol versus non-menthol. | Number | Participants |
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| OG001 | Condition B (Well-known Harms) | Participants randomized to this condition will view cigarette warning labels highlighting the well-known harms of tobacco use. Pictorial Warning Labels: Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task. |
|
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| Primary | Attention: Latency (Time Until First Fixation) for Text | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Posted | Mean | Standard Deviation | ms | Day 1 |
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| Primary | Attention: Latency Duration (Time of Fixation) for Image | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Posted | Mean | Standard Deviation | ms | Day 1 |
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| Primary | Attention: Latency Duration (Time of Fixation) for Text | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Posted | Mean | Standard Deviation | ms | Day 1 |
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| Primary | Attention: Total Fixation Time for Image | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Posted | Mean | Standard Deviation | ms | Day 1 |
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| Primary | Attention: Total Fixation Time for Text | We defined areas of interest (AOIs) encompassing the image and text portions of each PWL. For each AOI, we examined attention measures of latency (time until the first fixation in the AOI; i.e., how quickly attention is drawn to the AOI), latency duration (length of the first fixation; i.e., how long the AOI is initially viewed), and total fixation time (sum of all fixations in the AOI; i.e., overall viewing allocation, accounting for viewing the same AOI multiple times). Analyses examined the mean of each outcome across the four PWLs within each condition. | Posted | Mean | Standard Deviation | ms | Day 1 |
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| Primary | Recall: Participants Ability to Recall Condition Image | Participants will view 11 warning label images and would be required to identify the warning label images they saw during their eye tracking portion of the session. This outcome measure (Recall -Image) was assessed in a percentage unit of measure. The percentages are not whole numbers for these items because it's the mean % correct for the condition, or the average percent correct across the four images for the group. The results in the Outcome Measure Data table demonstrate the percentage of participants who correctly identified the images from their condition (4 of the 11 images presented to participants were from their randomized condition; A or B). | Posted | Mean | Standard Error | percentage of correct images | Day 1 |
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| Primary | Recall: Participants Ability to Recall Condition Text | Participants will view 11 warning label text statements and would be required to identify the warning label text statements they saw during their eye tracking portion of the session. This outcome measure (Recall -Text) was assessed in a percentage unit of measure. The percentages are not whole numbers for these items because it's the mean % correct for the condition, or the average percent correct across the four images for the group. The results in the Outcome Measure Data table demonstrate the percentage of participants who correctly identified the text statements from their condition (4 of the 11 images presented to participants were from their randomized condition; A or B). | Posted | Mean | Standard Error | percentage of correct text | Day 1 |
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| Primary | Knowledge of Smoking Harms | All participants will select harms caused by tobacco from a list of health issues and diseases, before as well as after viewing the warning labels on the screen. Pre and post warning label exposure knowledge of smoking harms were assessed by using an exploratory scale that asked participants if cigarette smoking caused a list of 18 health conditions with a 5-point response scale, (1=definitely yes 2= probably yes, 3 = might or might not, 4 = probably not, 5 = definitely not). | Posted | Mean | Standard Error | units on a scale | Day 1 |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Condition B (Well-known Harms) | Participants randomized to this condition will view cigarette warning labels highlighting the well-known harms of tobacco use. Pictorial Warning Labels: Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task. | 0 | 0 | 0 | 0 | 0 | 0 |
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| Lung Disease |
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| Vertigo |
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| Cataracts |
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| Depression |
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| Erectile Dysfunction |
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| Bladder Cancer |
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| Bloody Urine |
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| Harm to Children |
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| Blindness |
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| COPD (Chronic Obstructive Pulmonary Disease) |
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| Type II Diabetes |
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| Stunted Fetal Growth |
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| Heart Disease |
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| Stroke |
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| Macular Degeneration |
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| COVID-19 |
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