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Completed

NCT Number: NCT04936724

FDA Cigarette Warning Labels: Eye Tracking Study

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.

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Key information

Conditions

Smoking, Cigarette Behavior Cigarette Smoking Smoking Tobacco Smoking Tobacco Use

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  5. Attention: Total Fixation Time for Image

    Time frame: 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.

  6. Attention: Total Fixation Time for Text

    Time frame: 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.

  7. Recall: Participants Ability to Recall Condition Image

    Time frame: 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).

  8. Recall: Participants Ability to Recall Condition Text

    Time frame: 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).

  9. Knowledge of Smoking Harms

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)

Registry information

Official study title

Evaluation of the New FDA Warning Labels: Does Highlighting Lesser Known Harms of Tobacco Use Increase Attention, Recall and Knowledge of Tobacco Harms for Young Adults?

Acronym: FLT

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2021
Registry last updated
Jul 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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