Smoking, Cigarette
Conditions
Keywords
Pictorial warning labels, Cigarette smoking, Eye-tracking
Brief summary
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.
Detailed description
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.
Interventions
OTHERPictorial 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.
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Abramson Cancer Center at Penn Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
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)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Current cigarette smokers using only filtered commercially manufactured cigarettes; smoking at least 5 cigarettes daily and smoking for at least last 1 year. * Participants must physically present a pack of their preferred brand of cigarettes at the lab session to confirm their status as a cigarette smoker. * Not currently undergoing smoking cessation treatment or planning to quit smoking currently or in the next month. * Plan to live in the area for the duration of the study. * Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the combined Informed Consent and HIPAA form. * Able to communicate fluently in English (i.e., speaking, writing, and reading) as determined by the research assistant.
Exclusion criteria
* Use of any nicotine-containing products other than cigarettes. Participants reporting isolated use of other nicotine-containing products less than 5 times per month are eligible to participate. * Not actively trying to quit smoking currently and had not made a quit attempt in the past month. * Self-report current alcohol consumption that exceeds 25 standard drinks/week. * Self-report current pregnancy or breastfeeding. * Any self-reported impairment - visual (colorblindness or impairments such as glass eye), physical, and/or neurological impairments preventing the proper completion of the study procedures. * Serious or unstable medical condition. * Lifetime history of schizophrenia, psychosis, and/or bipolar disorder. * Current use or discontinuation of anti-psychotic medications within the last 6 months. * Current diagnosis of active major depression. Participants who maintain a diagnosis of major depression who have not experienced any major depressive episodes in the past 6 months and are stable on antidepressant medication(s) are eligible to participate. * Inability to provide informed consent or complete any of the study tasks as determined by the principal investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Attention: Latency (Time Until First Fixation) for Image | Day 1 | 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. |
| Attention: Latency (Time Until First Fixation) for Text | Day 1 | 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. |
| Attention: Latency Duration (Time of Fixation) for Image | Day 1 | 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. |
| Attention: Latency Duration (Time of Fixation) for Text | Day 1 | 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. |
| Attention: Total Fixation Time for Image | Day 1 | 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. |
| Attention: Total Fixation Time for Text | Day 1 | 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. |
| Recall: Participants Ability to Recall Condition Image | Day 1 | 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). |
| Recall: Participants Ability to Recall Condition Text | Day 1 | 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). |
| Knowledge of Smoking Harms | Day 1 | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 35 |
| 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. | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Condition A (Lesser-known Harms) | Condition B (Well-known Harms) | Total |
|---|---|---|---|
| Age, Customized ≥21 and ≤ 65 | 35 Participants | 35 Participants | 70 Participants |
| Race/Ethnicity, Customized Race Black or African American | 22 Participants | 19 Participants | 41 Participants |
| Race/Ethnicity, Customized Race Other | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Race White or Caucasian | 11 Participants | 15 Participants | 26 Participants |
| Region of Enrollment United States | 35 participants | 35 participants | 70 participants |
| Sex/Gender, Customized Sex at birth Female | 13 Participants | 13 Participants | 26 Participants |
| Sex/Gender, Customized Sex at birth Male | 22 Participants | 22 Participants | 44 Participants |
| Smoking History Information_Fagerstrom Test for Nicotine Dependence (FTND) | 4.6 units on a scale STANDARD_DEVIATION 1.9 | 5.3 units on a scale STANDARD_DEVIATION 2.2 | 4.9 units on a scale STANDARD_DEVIATION 2.1 |
| Smoking History Information_Past 7-day cigarettes per day | 13.6 Cigarettes STANDARD_DEVIATION 6.6 | 15.1 Cigarettes STANDARD_DEVIATION 7.6 | 14.4 Cigarettes STANDARD_DEVIATION 7.1 |
| Smoking History Information_Years Smoked | 33.5 Years STANDARD_DEVIATION 11.5 | 32.1 Years STANDARD_DEVIATION 10.8 | 32.8 Years STANDARD_DEVIATION 11.1 |
| Smoking History_Type of Cigarette Menthol | 24 Participants | 25 Participants | 49 Participants |
| Smoking History_Type of Cigarette Non-Menthol | 11 Participants | 10 Participants | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition A (Lesser-known Harms) | Attention: Latency Duration (Time of Fixation) for Image | 160 ms | Standard Deviation 11 |
| Condition B (Well-known Harms) | Attention: Latency Duration (Time of Fixation) for Image | 183 ms | Standard Deviation 13 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition A (Lesser-known Harms) | Attention: Latency Duration (Time of Fixation) for Text | 150 ms | Standard Deviation 9 |
| Condition B (Well-known Harms) | Attention: Latency Duration (Time of Fixation) for Text | 165 ms | Standard Deviation 9 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition A (Lesser-known Harms) | Attention: Latency (Time Until First Fixation) for Image | 2612 ms | Standard Deviation 308 |
| Condition B (Well-known Harms) | Attention: Latency (Time Until First Fixation) for Image | 978 ms | Standard Deviation 313 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition A (Lesser-known Harms) | Attention: Latency (Time Until First Fixation) for Text | 1001 ms | Standard Deviation 214 |
| Condition B (Well-known Harms) | Attention: Latency (Time Until First Fixation) for Text | 798 ms | Standard Deviation 218 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition A (Lesser-known Harms) | Attention: Total Fixation Time for Image | 3532 ms | Standard Deviation 524 |
| Condition B (Well-known Harms) | Attention: Total Fixation Time for Image | 7887 ms | Standard Deviation 532 |
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.
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition A (Lesser-known Harms) | Attention: Total Fixation Time for Text | 4889 ms | Standard Deviation 436 |
| Condition B (Well-known Harms) | Attention: Total Fixation Time for Text | 3643 ms | Standard Deviation 443 |
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).
Time frame: Day 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Head and Neck Cancer | 1.4 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Heart Disease | 1.4 units on a scale | Standard Error 0.1 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Hearing Loss | 3.3 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Type II Diabetes | 2.0 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Lung Disease | 1.3 units on a scale | Standard Error 0.1 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Stroke | 1.7 units on a scale | Standard Error 0.1 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Vertigo | 3.0 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | COPD (Chronic Obstructive Pulmonary Disease) | 1.6 units on a scale | Standard Error 0.1 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Cataracts | 1.8 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Macular Degeneration | 2.8 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Depression | 2.7 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Stunted Fetal Growth | 1.6 units on a scale | Standard Error 0.1 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Erectile Dysfunction | 3.2 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Blindness | 2.0 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Bladder Cancer | 1.9 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Harm to Children | 1.4 units on a scale | Standard Error 0.1 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | Bloody Urine | 1.8 units on a scale | Standard Error 0.2 |
| Condition A (Lesser-known Harms) | Knowledge of Smoking Harms | COVID-19 | 4.0 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Bloody Urine | 3.5 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Blindness | 3.5 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | COPD (Chronic Obstructive Pulmonary Disease) | 1.3 units on a scale | Standard Error 0.1 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Type II Diabetes | 3.6 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Stunted Fetal Growth | 1.5 units on a scale | Standard Error 0.1 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Heart Disease | 1.5 units on a scale | Standard Error 0.1 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Stroke | 1.9 units on a scale | Standard Error 0.1 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Macular Degeneration | 3.0 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | COVID-19 | 4.1 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Head and Neck Cancer | 3.0 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Hearing Loss | 3.9 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Lung Disease | 1.3 units on a scale | Standard Error 0.1 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Vertigo | 3.3 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Cataracts | 3.4 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Depression | 3.1 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Erectile Dysfunction | 3.3 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Bladder Cancer | 2.8 units on a scale | Standard Error 0.2 |
| Condition B (Well-known Harms) | Knowledge of Smoking Harms | Harm to Children | 1.5 units on a scale | Standard Error 0.1 |
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).
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition A (Lesser-known Harms) | Recall: Participants Ability to Recall Condition Image | 98.6 percentage of correct images | Standard Error 1 |
| Condition B (Well-known Harms) | Recall: Participants Ability to Recall Condition Image | 95.7 percentage of correct images | Standard Error 1.6 |
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).
Time frame: Day 1
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Condition A (Lesser-known Harms) | Recall: Participants Ability to Recall Condition Text | 82.9 percentage of correct text | Standard Error 3.9 |
| Condition B (Well-known Harms) | Recall: Participants Ability to Recall Condition Text | 86.5 percentage of correct text | Standard Error 3.1 |