FDA Cigarette Warning Labels: Eye Tracking Study

Study Overview
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Brief Summary
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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
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This laboratory-based study will aim to enroll 120 current cigarette users to complete a 1-day cross-sectional, 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.

Official Title
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Evaluation of the New FDA Warning Labels: Does Highlighting Lesser-known Harms of Tobacco Use Increase Attention, Recall, and Knowledge of Tobacco Harms Compared to Well-known Harms?

Conditions
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Smoking, Cigarette

Intervention / Treatment
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* Other: Pictorial Warning Labels


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: It is a 2 x 2 factorial 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Condition A (Lesser-known harms)<br>Participants randomized to this condition will view cigarette warning labels highlighting lesser-known harms of tobacco use. | Other: Pictorial Warning Labels<br>* 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.<br>|
| Experimental: Condition B (Well-known harms)<br>Participants randomized to this condition will view cigarette warning labels highlighting the well-known harms of tobacco use. | Other: Pictorial Warning Labels<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eye Tracking Measures | Participants will view the warning labels on a computer screen with an eye movement tracker. The eye-tracking device will provide key measures such as latency, latency duration and fixation duration for text as well as image areas of interest. | Day 1 | 
| Recall | After completing the eye-tracking task, the participants will provide answers to an open-ended recall question. For the recognition task, the participants will view 11 warning label images and text statements, and would be required to identify the warning labels and text statements they saw earlier. | Day 1 | 
| Knowledge | 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. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Effectiveness Warning Label Ratings | Participants will provide subjective ratings of all the warning labels released by the FDA on measures of most and least avoidant, believable and informative. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pictorial warning labels, Cigarette smoking, Eye-tracking