FDA Cigarette Warning Labels: Eye Tracking Study

NCT04936724 | Completed Results

• 3 other identifiers: UPCC 04021U54CA229973843703
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking, Cigarette

Keywords

Pictorial warning labels; Cigarette smoking; Eye-tracking

Outcome Measures

Primary Outcomes (9)

• 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.

  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

Study Arms (2)

Condition A (Lesser-known harms)

EXPERIMENTAL

Participants randomized to this condition will view cigarette warning labels highlighting lesser-known harms of tobacco use.

Other: Pictorial Warning Labels

Condition B (Well-known harms)

EXPERIMENTAL

Participants randomized to this condition will view cigarette warning labels highlighting the well-known harms of tobacco use.

Other: Pictorial Warning Labels

Interventions

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.

Condition A (Lesser-known harms); Condition B (Well-known harms)

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead
• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator

Study Sites (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Limitations and Caveats

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.

Results Point of Contact

• Title: Andrew Strasser Ph.D.
• Organization: University of Pennsylvania

strasse3@pennmedicine.upenn.edu

215-746-5788

Study Officials

• Andrew Strasser, Ph.D.

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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)
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 23, 2021
• Study Start: December 22, 2020
• Primary Completion: November 19, 2021
• Study Completion: November 19, 2021
• Last Updated: July 22, 2024
• Results First Posted: April 29, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 1 year after the conclusion of recruitment
• Access Criteria: Researchers should contact the project Principal Investigator via email.

Locations

US (1)