Clinical trial NCT04936724: FDA Cigarette Warning Labels: Eye Tracking Study
Official 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?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking, Cigarette
Keywords: Pictorial warning labels
Cigarette smoking
Eye-tracking
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2021-06-23
Enrollment: 70
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Attention: Latency (Time Until First Fixation) for Image
timeFrame: Day 1
measure: Attention: Latency (Time Until First Fixation) for Text
timeFrame: Day 1
measure: Attention: Latency Duration (Time of Fixation) for Image
timeFrame: Day 1
measure: Attention: Latency Duration (Time of Fixation) for Text
timeFrame: Day 1
measure: Attention: Total Fixation Time for Image
timeFrame: Day 1
measure: Attention: Total Fixation Time for Text
timeFrame: Day 1
measure: Recall: Participants Ability to Recall Condition Image
timeFrame: Day 1
measure: Recall: Participants Ability to Recall Condition Text
timeFrame: Day 1
measure: Knowledge of Smoking Harms
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Andrew Strasser, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: