Trial Outcomes & Findings for FDA Cigarette Warning Labels: Eye Tracking Study (NCT NCT04936724)

Last Updated: 2024-07-22

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

Day 1

Results posted on

2024-07-22

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	35	35
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FDA Cigarette Warning Labels: Eye Tracking Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.	Total n=70 Participants Total of all reporting groups
Age, Customized ≥21 and ≤ 65	35 Participants n=5 Participants	35 Participants n=7 Participants	70 Participants n=5 Participants
Sex/Gender, Customized Sex at birth · Male	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Sex/Gender, Customized Sex at birth · Female	13 Participants n=5 Participants	13 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	22 Participants n=5 Participants	19 Participants n=7 Participants	41 Participants n=5 Participants
Race/Ethnicity, Customized Race · White or Caucasian	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants	35 participants n=7 Participants	70 participants n=5 Participants
Smoking History Information_Past 7-day cigarettes per day	13.6 Cigarettes STANDARD_DEVIATION 6.6 • n=5 Participants	15.1 Cigarettes STANDARD_DEVIATION 7.6 • n=7 Participants	14.4 Cigarettes STANDARD_DEVIATION 7.1 • n=5 Participants
Smoking History Information_Fagerstrom Test for Nicotine Dependence (FTND)	4.6 units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	5.3 units on a scale STANDARD_DEVIATION 2.2 • n=7 Participants	4.9 units on a scale STANDARD_DEVIATION 2.1 • n=5 Participants
Smoking History Information_Years Smoked	33.5 Years STANDARD_DEVIATION 11.5 • n=5 Participants	32.1 Years STANDARD_DEVIATION 10.8 • n=7 Participants	32.8 Years STANDARD_DEVIATION 11.1 • n=5 Participants
Smoking History_Type of Cigarette Menthol	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Smoking History_Type of Cigarette Non-Menthol	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Attention: Latency (Time Until First Fixation) for Image	2612 ms Standard Deviation 308	978 ms Standard Deviation 313

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Attention: Latency (Time Until First Fixation) for Text	1001 ms Standard Deviation 214	798 ms Standard Deviation 218

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Attention: Latency Duration (Time of Fixation) for Image	160 ms Standard Deviation 11	183 ms Standard Deviation 13

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Attention: Latency Duration (Time of Fixation) for Text	150 ms Standard Deviation 9	165 ms Standard Deviation 9

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Attention: Total Fixation Time for Image	3532 ms Standard Deviation 524	7887 ms Standard Deviation 532

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Attention: Total Fixation Time for Text	4889 ms Standard Deviation 436	3643 ms Standard Deviation 443

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Recall: Participants Ability to Recall Condition Image	98.6 percentage of correct images Standard Error 1.0	95.7 percentage of correct images Standard Error 1.6

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Recall: Participants Ability to Recall Condition Text	82.9 percentage of correct text Standard Error 3.9	86.5 percentage of correct text Standard Error 3.1

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Condition A (Lesser-known Harms) n=35 Participants 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.	Condition B (Well-known Harms) n=35 Participants 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.
Knowledge of Smoking Harms Harm to Children	1.4 units on a scale Standard Error 0.1	1.5 units on a scale Standard Error 0.1
Knowledge of Smoking Harms COPD (Chronic Obstructive Pulmonary Disease)	1.6 units on a scale Standard Error 0.1	1.3 units on a scale Standard Error 0.1
Knowledge of Smoking Harms Type II Diabetes	2.0 units on a scale Standard Error 0.2	3.6 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Stunted Fetal Growth	1.6 units on a scale Standard Error 0.1	1.5 units on a scale Standard Error 0.1
Knowledge of Smoking Harms Heart Disease	1.4 units on a scale Standard Error 0.1	1.5 units on a scale Standard Error 0.1
Knowledge of Smoking Harms Stroke	1.7 units on a scale Standard Error 0.1	1.9 units on a scale Standard Error 0.1
Knowledge of Smoking Harms Macular Degeneration	2.8 units on a scale Standard Error 0.2	3.0 units on a scale Standard Error 0.2
Knowledge of Smoking Harms COVID-19	4.0 units on a scale Standard Error 0.2	4.1 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Head and Neck Cancer	1.4 units on a scale Standard Error 0.2	3.0 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Hearing Loss	3.3 units on a scale Standard Error 0.2	3.9 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Lung Disease	1.3 units on a scale Standard Error 0.1	1.3 units on a scale Standard Error 0.1
Knowledge of Smoking Harms Vertigo	3.0 units on a scale Standard Error 0.2	3.3 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Cataracts	1.8 units on a scale Standard Error 0.2	3.4 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Depression	2.7 units on a scale Standard Error 0.2	3.1 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Erectile Dysfunction	3.2 units on a scale Standard Error 0.2	3.3 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Bladder Cancer	1.9 units on a scale Standard Error 0.2	2.8 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Bloody Urine	1.8 units on a scale Standard Error 0.2	3.5 units on a scale Standard Error 0.2
Knowledge of Smoking Harms Blindness	2.0 units on a scale Standard Error 0.2	3.5 units on a scale Standard Error 0.2

Adverse Events

Condition A (Lesser-known Harms)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Condition B (Well-known Harms)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Andrew Strasser Ph.D.

University of Pennsylvania

Phone: 215-746-5788

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place