Alcohol Drinking, Esophageal Cancer, Larynx Cancer, Oral Cancer
Conditions
Brief summary
The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be randomized to view either three narrative or non-narrative PWLs. Key outcome variables include visual attention, message reactance, risk perceptions, and intentions to reduce and stop drinking.
Detailed description
The goal of this study is to determine the effectiveness of pictorial warning labels (PWLs) featuring narrative (vs. non-narrative) content in communicating the cancer risk of alcohol. Participants will be recruited from online panels. Participants will first be invited to participate in an online screening survey. Eligible participants will be invited to participate in the main experiment. In the main experiment, participants will first answer questions concerning baseline alcohol consumption and other background information. Then they will engage with a webcam-based eye-tracking task through Sticky by Tobii. Participants will first read instructions and tips related to completing the eye-tracking task. They will complete a brief calibration procedure and be presented with either three narrative PWLs or three non-narrative PWLs. Sticky by Tobii will record participants' gaze, thereby measuring visual attention to each PWL. After viewing each PWL, participants will answer a few questions. After viewing all three PWLs, they will answer questions based on all images combined. Upon study completion, participants will be compensated. A follow-up survey will be sent to participants after two weeks, which includes questions about their drinking behaviors, information seeking behaviors, and social interactions.
Interventions
BEHAVIORALNarrative pictorial warning labels for alcoholic beverages
Pictorial warning labels consisting of text and narrative imagery (e.g., photos of cancer patients) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer.
BEHAVIORALNon-narrative pictorial warning labels for alcoholic beverages
Pictorial warning labels consisting of text and non-narrative imagery (e.g., images of diseased organs) conveying the risk of alcohol for oral cancer, esophageal cancer, and larynx cancer.
Sponsors
Oakland University
National Cancer Institute (NCI)
University of Connecticut
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. be at least 21 years old; 2. have consumed more than three alcoholic drinks per week over the past year; 3. be willing to participate in remote eye tracking tasks and have necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed Internet and a computer/tablet/phone equipped with a high-speed camera).
Exclusion criteria
1. be younger than 21 years old; 2. has not consumed more than three alcoholic drinks per week over the past year; 3. be not willing to participate in remote eye tracking tasks and have no necessary technical support to complete remote eye tracking tasks (i.e., having access to high-speed Internet and a computer/tablet/phone equipped with a high-speed camera).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dwell Time | Assessed during the one-time 15-minute online survey experiment. | Dwell time measures the total duration of attention to an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Dwell time for each AOI was averaged across three PWLs within each arm. |
| Visit Count | Assessed during the one-time 15-minute online survey experiment. | Visit count measures the total number of times participants viewed an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Visit count for each AOI was averaged across three PWLs within each arm. |
| Reactance | Assessed during the one-time 15-minute online survey experiment. | Reactance were measured after exposure to each PWL (i.e., three times in total). It was assessed using the brief Reactance to Health Warnings Scale (Hall et al., 2017). Participants were asked to indicate how much each warning tried to manipulate them, annoyed them, and was overblown (1 = not at all, 5 = a great deal). Reactance for each PWL was averaged across three PWLs within each arm. |
| Affective Risk Perceptions | Assessed during the one-time 15-minute online survey experiment. | Affective risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how worried they are about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all worried, 2=Slightly worried, 3=Moderately worried, 4=Very worried, 5=Extremely worried). |
| Experiential Risk Perceptions | Assessed during the one-time 15-minute online survey experiment. | Experiential risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how vulnerable they feel about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all vulnerable, 2=Slightly vulnerable, 3=Moderately vulnerable, 4=Very vulnerable, 5=Extremely vulnerable). |
| Perceived Susceptibility | Assessed during the one-time 15-minute online survey experiment. | Perceived susceptibility were assessed once after participants viewed all three PWLs. Participants were asked to indicate how likely it is that they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all likely, 2=A little likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely). |
| Comparative Risk | Assessed during the one-time 15-minute online survey experiment. | Comparative risk were assessed once after participants viewed all three PWLs. Participants were asked to indicate compared to an average person their age, race, and sex, how likely do they think they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1=Much less likely, 2=Less likely, 3=About as likely, 4=More likely, 5=Much more likely). |
| Perceived Severity of Harm | Assessed during the one-time 15-minute online survey experiment. | Perceived severity of harm were assessed once after participants viewed all three PWLs. Participants were asked to indicate how much getting a specific type of cancer because of drinking would affect their life. Participants responded on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal). |
| Intentions to Reduce Drinking | Assessed during the one-time 15-minute online survey experiment. | Intentions to reduce drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer questions such as How interested are you in reducing drinking in the next 6 months? Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested). |
| Intentions to Stop Drinking | Assessed during the one-time 15-minute online survey experiment. | Intentions to stop drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer three questions such as How interested are you in stopping drinking in the next 6 months? Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Narrative Pictorial Warning Labels Participants in this arm were presented with three narrative pictorial warning labels (PWLs) for alcoholic beverages. Narrative PWLs included a photo showing the lived experiences of individuals affected by alcohol-related cancer (e.g., a headshot of a man with a misshapen jaw) and a text warning statement (e.g., WARNING: Drinking alcohol can cause oral cancer). The warnings focused on oral, esophageal, and laryngeal cancers, respectively. | 328 |
| Non-Narrative Pictorial Warning Labels Participants in this arm will be presented with three non-narrative pictorial warning labels (PWLs) for alcoholic beverages. Non-narrative PWLs contained graphic images of diseased organs (e.g., a closeup image of a mouth with rotten teeth and oral thrush) and a text warning statement (e.g., WARNING: Drinking alcohol can cause oral cancer). The warnings focused on oral, esophageal, and laryngeal cancers, respectively. | 321 |
| Total | 649 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Data loss was due to technical issues related to eye tracking. | 198 | 206 |
Baseline characteristics
| Characteristic | Narrative Pictorial Warning Labels | Total | Non-Narrative Pictorial Warning Labels |
|---|---|---|---|
| Age, Continuous | 38.68 years STANDARD_DEVIATION 11.66 | 39.54 years STANDARD_DEVIATION 11.93 | 40.41 years STANDARD_DEVIATION 12.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 41 Participants | 83 Participants | 42 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 287 Participants | 566 Participants | 279 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 4 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 18 Participants | 35 Participants | 17 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 83 Participants | 44 Participants |
| Race (NIH/OMB) More than one race | 16 Participants | 36 Participants | 20 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 251 Participants | 489 Participants | 238 Participants |
| Sex/Gender, Customized Sex at birth Female | 152 Participants | 283 Participants | 131 Participants |
| Sex/Gender, Customized Sex at birth Male | 174 Participants | 362 Participants | 188 Participants |
| Sex/Gender, Customized Sex at birth Prefer not to say | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Affective Risk Perceptions
Affective risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how worried they are about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all worried, 2=Slightly worried, 3=Moderately worried, 4=Very worried, 5=Extremely worried).
Time frame: Assessed during the one-time 15-minute online survey experiment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Affective Risk Perceptions | 2.27 score on a scale | Standard Error 0.062 |
| Non-Narrative Pictorial Warning Labels | Affective Risk Perceptions | 2.38 score on a scale | Standard Error 0.063 |
Primary
Comparative Risk
Comparative risk were assessed once after participants viewed all three PWLs. Participants were asked to indicate compared to an average person their age, race, and sex, how likely do they think they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1=Much less likely, 2=Less likely, 3=About as likely, 4=More likely, 5=Much more likely).
Time frame: Assessed during the one-time 15-minute online survey experiment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Comparative Risk | 2.71 score on a scale | Standard Error 0.056 |
| Non-Narrative Pictorial Warning Labels | Comparative Risk | 2.85 score on a scale | Standard Error 0.057 |
Primary
Dwell Time
Dwell time measures the total duration of attention to an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Dwell time for each AOI was averaged across three PWLs within each arm.
Time frame: Assessed during the one-time 15-minute online survey experiment.
Population: Sticky's internal algorithms determined cases where the eye tracking data is less than perfect and only returns usable data. Thus, only usable eye tracking data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Dwell Time | 8.75 seconds | Standard Error 0.069 |
| Non-Narrative Pictorial Warning Labels | Dwell Time | 8.47 seconds | Standard Error 0.066 |
Primary
Experiential Risk Perceptions
Experiential risk perceptions were assessed once after participants viewed all three PWLs. Participants were asked to indicate how vulnerable they feel about getting a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all vulnerable, 2=Slightly vulnerable, 3=Moderately vulnerable, 4=Very vulnerable, 5=Extremely vulnerable).
Time frame: Assessed during the one-time 15-minute online survey experiment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Experiential Risk Perceptions | 2.35 score on a scale | Standard Error 0.058 |
| Non-Narrative Pictorial Warning Labels | Experiential Risk Perceptions | 2.46 score on a scale | Standard Error 0.058 |
Primary
Intentions to Reduce Drinking
Intentions to reduce drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer questions such as How interested are you in reducing drinking in the next 6 months? Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).
Time frame: Assessed during the one-time 15-minute online survey experiment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Intentions to Reduce Drinking | 3.08 score on a scale | Standard Error 0.05 |
| Non-Narrative Pictorial Warning Labels | Intentions to Reduce Drinking | 3.14 score on a scale | Standard Error 0.05 |
Primary
Intentions to Stop Drinking
Intentions to stop drinking were assessed once after participants viewed all three PWLs. Participants were asked to answer three questions such as How interested are you in stopping drinking in the next 6 months? Participants responded to these questions on an appropriately labeled 5-point scale (e.g., 1 = Not at all interested, 2=Slightly interested, 3=Moderately interested, 4=Very interested, 5=Extremely interested).
Time frame: Assessed during the one-time 15-minute online survey experiment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Intentions to Stop Drinking | 2.26 score on a scale | Standard Error 0.068 |
| Non-Narrative Pictorial Warning Labels | Intentions to Stop Drinking | 2.37 score on a scale | Standard Error 0.069 |
p-value: 0.256ANCOVA
Primary
Perceived Severity of Harm
Perceived severity of harm were assessed once after participants viewed all three PWLs. Participants were asked to indicate how much getting a specific type of cancer because of drinking would affect their life. Participants responded on a five-point scale (1=Not at all, 2=Very little, 3=Somewhat, 4=Quite a bit, 5=A great deal).
Time frame: Assessed during the one-time 15-minute online survey experiment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Perceived Severity of Harm | 4.47 score on a scale | Standard Error 0.05 |
| Non-Narrative Pictorial Warning Labels | Perceived Severity of Harm | 4.55 score on a scale | Standard Error 0.05 |
Primary
Perceived Susceptibility
Perceived susceptibility were assessed once after participants viewed all three PWLs. Participants were asked to indicate how likely it is that they will get a specific type of cancer if they keep drinking the amount of alcohol like they do now. Participants responded on a five-point scale (1 = Not at all likely, 2=A little likely, 3=Somewhat likely, 4=Very likely, 5=Extremely likely).
Time frame: Assessed during the one-time 15-minute online survey experiment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Perceived Susceptibility | 2.072 score on a scale | Standard Error 0.053 |
| Non-Narrative Pictorial Warning Labels | Perceived Susceptibility | 2.102 score on a scale | Standard Error 0.054 |
Primary
Reactance
Reactance were measured after exposure to each PWL (i.e., three times in total). It was assessed using the brief Reactance to Health Warnings Scale (Hall et al., 2017). Participants were asked to indicate how much each warning tried to manipulate them, annoyed them, and was overblown (1 = not at all, 5 = a great deal). Reactance for each PWL was averaged across three PWLs within each arm.
Time frame: Assessed during the one-time 15-minute online survey experiment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Reactance | 2.38 score on a scale | Standard Error 0.055 |
| Non-Narrative Pictorial Warning Labels | Reactance | 2.54 score on a scale | Standard Error 0.055 |
Primary
Visit Count
Visit count measures the total number of times participants viewed an area of interest (AOI). Each warning label consisted of two AOIs: image AOI and text AOI. Visit count for each AOI was averaged across three PWLs within each arm.
Time frame: Assessed during the one-time 15-minute online survey experiment.
Population: Sticky's internal algorithms determined cases where the eye tracking data is less than perfect and only returns usable data. Thus, only usable eye tracking data were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Narrative Pictorial Warning Labels | Visit Count | 13.74 visit | Standard Error 0.443 |
| Non-Narrative Pictorial Warning Labels | Visit Count | 13.58 visit | Standard Error 0.42 |