NCT04936724: FLT

FDA Cigarette Warning Labels: Eye Tracking Study

Completed NA Results posted Last updated 22 July 2024

What this trial tests

NA trial testing Pictorial Warning Labels in Smoking, Cigarette in 70 participants. Completed in 19 November 2021.

Timeline

22 December 2020

Primary endpoint
19 November 2021

19 November 2021

Quick facts

Lead sponsor	Abramson Cancer Center at Penn Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	70
Start date	22 December 2020
Primary completion	19 November 2021
Estimated completion	19 November 2021
Sites	1 location across United States

Drugs / interventions tested

• Pictorial Warning Labels

Conditions studied

• Smoking, Cigarette — all drugs for Smoking, Cigarette →

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

Adults 21 to 65, any sex, with Smoking, Cigarette. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Attention: Latency (Time Until First Fixation) for Image Primary · 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.

Group	Value	95% CI
Condition A (Lesser-known Harms)	2612	± 308
Condition B (Well-known Harms)	978	± 313

Attention: Latency (Time Until First Fixation) for Text Primary · 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.

Group	Value	95% CI
Condition A (Lesser-known Harms)	1001	± 214
Condition B (Well-known Harms)	798	± 218

Attention: Latency Duration (Time of Fixation) for Image Primary · 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.

Group	Value	95% CI
Condition A (Lesser-known Harms)	160	± 11
Condition B (Well-known Harms)	183	± 13

Attention: Latency Duration (Time of Fixation) for Text Primary · 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.

Group	Value	95% CI
Condition A (Lesser-known Harms)	150	± 9
Condition B (Well-known Harms)	165	± 9

Attention: Total Fixation Time for Image Primary · 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.

Group	Value	95% CI
Condition A (Lesser-known Harms)	3532	± 524
Condition B (Well-known Harms)	7887	± 532

Attention: Total Fixation Time for Text Primary · 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.

Group	Value	95% CI
Condition A (Lesser-known Harms)	4889	± 436
Condition B (Well-known Harms)	3643	± 443

Recall: Participants Ability to Recall Condition Image Primary · 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

Group	Value	95% CI
Condition A (Lesser-known Harms)	98.6	± 1.0
Condition B (Well-known Harms)	95.7	± 1.6

Recall: Participants Ability to Recall Condition Text Primary · 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

Group	Value	95% CI
Condition A (Lesser-known Harms)	82.9	± 3.9
Condition B (Well-known Harms)	86.5	± 3.1

Knowledge of Smoking Harms Primary · 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).

Head and Neck Cancer

Group	Value	95% CI
Condition A (Lesser-known Harms)	1.4	± 0.2
Condition B (Well-known Harms)	3.0	± 0.2

Hearing Loss

Group	Value	95% CI
Condition A (Lesser-known Harms)	3.3	± 0.2
Condition B (Well-known Harms)	3.9	± 0.2

Lung Disease

Group	Value	95% CI
Condition A (Lesser-known Harms)	1.3	± 0.1
Condition B (Well-known Harms)	1.3	± 0.1

Vertigo

Group	Value	95% CI
Condition A (Lesser-known Harms)	3.0	± 0.2
Condition B (Well-known Harms)	3.3	± 0.2

Cataracts

Group	Value	95% CI
Condition A (Lesser-known Harms)	1.8	± 0.2
Condition B (Well-known Harms)	3.4	± 0.2

Depression

Group	Value	95% CI
Condition A (Lesser-known Harms)	2.7	± 0.2
Condition B (Well-known Harms)	3.1	± 0.2

Erectile Dysfunction

Group	Value	95% CI
Condition A (Lesser-known Harms)	3.2	± 0.2
Condition B (Well-known Harms)	3.3	± 0.2

Bladder Cancer

Group	Value	95% CI
Condition A (Lesser-known Harms)	1.9	± 0.2
Condition B (Well-known Harms)	2.8	± 0.2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effects of pictorial warning labels depicting lesser-known and well-known risks of smoking on viewing patterns, recall, and knowledge of smoking harms.
   Mercincavage M, Sidhu AK, Waugh L, Kreider C, et al · · 2023 · cited 3× · PMID 37660524 · DOI 10.1016/j.drugalcdep.2023.110939