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?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Attention: Latency Duration (Time of Fixation) for Text
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
盲法说明
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)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Attention: Latency Duration (Time of Fixation) for Text
时间窗: 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.
Attention: Latency Duration (Time of Fixation) for Image
时间窗: 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.
Recall: Participants Ability to Recall Condition Image
时间窗: 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).
Attention: Latency (Time Until First Fixation) for Text
时间窗: 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.
Attention: Total Fixation Time for Image
时间窗: 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.
Attention: Latency (Time Until First Fixation) for Image
时间窗: 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.
Attention: Total Fixation Time for Text
时间窗: 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.
Knowledge of Smoking Harms
时间窗: 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).
Recall: Participants Ability to Recall Condition Text
时间窗: 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).
次要结局
未报告次要终点
研究者
Andrew Strasser
Associate Professor
Abramson Cancer Center at Penn Medicine