NCT04936724 - FDA Cigarette Warning Labels: Eye Tracking Study | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

70

Conditions

Smoking, Cigarette

Interventions

Pictorial Warning LabelsOTHER

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Center for Interdisciplinary Research on Nicotine Addiction, University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.