Vaping Behaviors
Conditions
Keywords
Vaping, Tobacco use, E-cigarette use
Brief summary
The purpose of this randomized clinical trial is to determine whether e-cigarette warnings increase intentions to quit vaping without the unintended consequence of pushing users toward smoking. This trial addresses these issues by evaluating the impact of e-cigarette warnings by randomly assigning vapers to have their devices and refills labeled with control messages, text warnings, or pictorial warnings. Participants will be US adult (ages 21+) vapers. The trial expects \ 1,200 participants to complete Visits 1, 3, and 5.
Detailed description
This trial will assess the impact of e-cigarette warnings on vapers' devices and refills in a randomized clinical trial. Recruitment: Vapers will first undergo screening online or call the study center to complete the screening survey over the phone. Trial staff will schedule eligible vapers for 2 in-person visits. For each of the 2 visits, vapers will be asked to bring the vapes and refill materials they plan to use over the next 2 weeks. Informed Consent: Prior to consenting vapers, trial staff will visually inspect photo identification of vapers to confirm that they are 21 years or older. At the beginning of the first appointment, trial staff will explain the consent form and ask the vaper to read the form. Once the participant has finished reading the form, the trial staff member will ask the participant if he or she has any questions. Then both parties will sign the consent form and the participant will receive a copy of the consent form. Randomization: At the first visit, trial staff will randomly assign participants to one of the three trial arms by using Qualtrics software. Vapers have an equal chance of being randomized to have labels with control, text, or pictorial warnings. Assessment: Participants will attend 2 in-person appointments at the study office (at Visit 1 and Visit 3 that are spaced 2 weeks apart). The visits will last about 45-60 minutes. At Visit 1 participants will take a survey, have their vape device and refills labeled based on their trial arm, and take another survey. At Visit 3, participants take a survey and have their vape device and refills labeled based on their trial arm. Participants will also be e-mailed 3 more surveys to complete online at home (taken at Visit 2, 4, and 5). Thus participants will take 5 weekly surveys overall. Detailed description of the intervention: At each in-person appointment, participants will bring in the vapes and refills they plan to use over the next 2 weeks for labeling. While participants are taking the survey, trial staff will label the devices and refills based on their trial arm. Participants randomized to the text warning arm will have labels with information about the health harms of vaping applied to their vapes and refills. Participants randomized to the pictorial arm will have labels with pictorial images and text about the health harms of vaping. Participants assigned to the control arm will have labels with neutral statements about vaping. Each trial arm will have four labels (two labels for Visit 1 and two additional labels for Visit 3). Trial staff will return labeled vapes and refills in a clear plastic bag with the e-cigarette warning labels applied to a card. Trial investigators developed the text, images, and design of these labels. The trial staff will instruct participants in all trial arms to vape or not vape as they normally would. At the end of the trial, participants will receive a link to more information about the risks of vaping and tobacco use.
Interventions
OTHERLabel with text health warning
Labels with e-cigarette health warning that include text about health harms of vaping will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 warnings based on their assigned trial arm; at Visit 3, they will get 2 additional warnings based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.
OTHERLabel with pictorial health warning
Labels with e-cigarette health warning that include the same text about health harms of vaping and corresponding pictorial images will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 warnings based on their assigned trial arm; at Visit 3, they will get 2 additional warnings based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.
OTHERLabel with neutral statements about vaping
Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 statements based on their assigned trial arm; at Visit 3, they will get 2 additional statements based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels.
Sponsors
National Institute on Drug Abuse (NIDA)
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be 21 years or older * Currently vape every day or some days * Use an e-cigarette that contains nicotine * Be able to attend 2 in-person appointments * Be able to bring in e-cigarette device and 2 weeks' worth or refills to 2 in-person appointments * Be willing to let us apply a sticker to the device and refill materials * Be willing to use only the labeled e-cigarette during the study * Be able to complete 3 surveys online at home * Be able to read and speak English * Be able to complete a survey on a computer without help
Exclusion criteria
* Pregnant people * If e-cigarette device cannot be labeled * Vapers concurrently enrolled in any research studies about vaping or using other tobacco products * Vapers who live in the same household as someone who has enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Vaping Quit Intentions Score | Up to 4 weeks | The primary outcome is vaping quit intentions measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher quit intentions. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Cognitive Elaboration Score | Up to 4 weeks | Cognitive elaboration (thinking about the label) will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more cognitive elaboration. |
| Mean Perceived Likelihood of Illness Score | Up to 4 weeks | Perceived likelihood of illness from vaping will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visit 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher perceived likelihood. |
| Mean Negative Affect Score | Up to 4 weeks | Negative affective reactions to the labels will be measured by 5 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more negative affect. |
| Mean Attention Score | Up to 4 weeks | Attention to the labels will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating greater attention. |
| Mean Information Seeking Score | Up to 4 weeks | Information seeking about the harms of vaping will be measured by 1 survey item at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score responses (0 times=0, 1-2 times=1.5, 3-5 times=4, 6+ times=6) and take an average across the time points. The range for this measure will be 0 times to 6 times), with higher values indicating more information seeking. |
| Mean Number of Conversations in Past Week | Up to 4 weeks | Number of conversations with others about the labels, health harms caused by vaping, and quitting vaping will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 0 times to 100 times, with higher values indicating more conversations. |
| Mean Vaping Reinforcement Attitudes Score | Up to 4 weeks | Positive vaping reinforcement attitudes will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). We will take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more positive vaping reinforcement attitudes. |
| Mean Knowledge Score | Up to 4 weeks | Knowledge of health harms from vaping will be measured by 5 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score each item for accuracy (correct or incorrect) and average the scores (% correct) for each time point and take an average across the time points. The range for this measure will be 0% to 100%, with higher values indicating more accurate knowledge). |
| Mean Number of Times Forgoing a Vape in Past Week | Up to 4 weeks | Number of times forgoing a vape in the last week will be measured by 4 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score responses (never=0, 1 time=1, 2 times=2, 3-5 times=4, 6+ times=6), average the items to create a score for each time point, and take an average across the time points. The range for this measure will be 0 times to 6 times, with higher values indicating more forgoing. |
| Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks | Up to 4 weeks | Made vaping quit attempt will be measured by 1 survey item (not vaping for 1 day or longer in the last week because they were trying to stop vaping) at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). There will be an additional item (not vaping for 1 day or longer since the start of the study) at 4 weeks (Visit 5). Study investigators will score the items for any quit attempts: 0 (no quit attempts) or 1 (one or more quit attempt across the 4 weeks). |
| Percent of Participants Who Successfully Quit Vaping | At 4 weeks | Successful quitting of vaping during the trial will be measured by 1 survey item at 1 time point (participants' last survey, usually Visit 5). Study investigators will score the item for successful quitting: 0 (vaping on one or more of the last 7 days) or 1 (no vaping). |
| Mean Inaccurate Risk Perception Score | Up to 4 weeks | Inaccurate risk perception of vaping (believing vaping is the same or more harmful than smoking cigarettes) will be measured by 1 survey item at 5 time points: post-labeling (Visit 1) and 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score the item for accuracy (vaping less harmful than smoking cigarettes=correct; other answers=incorrect) and take an average across the time points. The range for this measure will be 0% (no correct answers) to 100% (all correct answers), with higher values indicating more accurate risk perceptions. |
| Mean Stigma Score | Up to 4 weeks | Stigma (expecting the labels will cause social disapproval of vaping) will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more stigma. |
| Mean Smoking Quit Intentions Score | Up to 4 weeks | Smoking quit intentions will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The construct will be assessed only among cigarette smokers. The range for this measure will be 1 to 5, with higher values indicating higher intentions. |
| Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks | Up to 4 weeks | Made smoking quit attempt will be measured by 1 survey item (not smoking for 1 day or longer in the last week because they were trying to stop smoking) at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). There will be an additional item (not smoking for 1 day or longer since the start of the study) at 4 weeks (Visit 5). Study investigators will score the items for any quit attempts: 0 (no quit attempts) or 1 (at least one quit attempt across the 4 weeks). |
| Mean Uncontrolled Vaping Score | Up to 4 weeks | Subjective uncontrolled vaping (vaping more than the user prefers) will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visit 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating vaping that is more uncontrolled. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Label With Text Health Warning Labels with e-cigarette health warning that include text about health harms of vaping will be applied to participants' vaping devices and refills.
Label with text health warning: Labels with e-cigarette health warning that include text about health harms of vaping will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 warnings based on their assigned trial arm; at Visit 3, they will get 2 additional warnings based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels. | 456 |
| Label With Pictorial Health Warning Labels with e-cigarette health warning that include the same text about health harms of vaping and corresponding pictorial images will be applied to participants' vaping devices and refills.
Label with pictorial health warning: Labels with e-cigarette health warning that include the same text about health harms of vaping and corresponding pictorial images will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 warnings based on their assigned trial arm; at Visit 3, they will get 2 additional warnings based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels. | 457 |
| Label With Neutral Statements About Vaping Labels with neutral statements about vaping will be applied to participants' vaping devices and refills.
Label with neutral statements about vaping: Labels with neutral statements about vaping will be applied to participants' vaping devices and refills. At Visit 1, devices and refills will be labeled with 2 statements based on their assigned trial arm; at Visit 3, they will get 2 additional statements based on their assigned trial arm. The order of the 4 labels within this trial arm will be randomized using a Latin square design. Study investigators developed the text and design of these labels. | 456 |
| Total | 1,369 |
Baseline characteristics
| Characteristic | Label With Text Health Warning | Label With Pictorial Health Warning | Label With Neutral Statements About Vaping | Total |
|---|---|---|---|---|
| Age, Customized 21-29 years | 133 Participants | 130 Participants | 141 Participants | 404 Participants |
| Age, Customized 30-39 years | 170 Participants | 159 Participants | 166 Participants | 495 Participants |
| Age, Customized 40-49 years | 100 Participants | 100 Participants | 95 Participants | 295 Participants |
| Age, Customized 50+ years | 53 Participants | 68 Participants | 54 Participants | 175 Participants |
| Race/Ethnicity, Customized American Indian or Alaskan Native | 5 Participants | 4 Participants | 3 Participants | 12 Participants |
| Race/Ethnicity, Customized Asian | 54 Participants | 25 Participants | 39 Participants | 118 Participants |
| Race/Ethnicity, Customized Black or African American | 78 Participants | 77 Participants | 74 Participants | 229 Participants |
| Race/Ethnicity, Customized Hispanic | 32 Participants | 51 Participants | 46 Participants | 129 Participants |
| Race/Ethnicity, Customized Middle Eastern or North African | 2 Participants | 8 Participants | 2 Participants | 12 Participants |
| Race/Ethnicity, Customized Missing | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Multiracial or another race or ethnicity | 90 Participants | 91 Participants | 106 Participants | 287 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 4 Participants | 3 Participants | 8 Participants |
| Race/Ethnicity, Customized White | 194 Participants | 196 Participants | 183 Participants | 573 Participants |
| Region of Enrollment United States | 456 participants | 457 participants | 456 participants | 1369 participants |
| Sex/Gender, Customized Female | 193 Participants | 197 Participants | 208 Participants | 598 Participants |
| Sex/Gender, Customized Male | 249 Participants | 237 Participants | 221 Participants | 707 Participants |
| Sex/Gender, Customized Nonbinary/Another gender | 14 Participants | 23 Participants | 27 Participants | 64 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 456 | 0 / 457 | 0 / 456 |
| other Total, other adverse events | 0 / 456 | 0 / 457 | 0 / 456 |
| serious Total, serious adverse events | 0 / 456 | 0 / 457 | 0 / 456 |
Outcome results
Primary
Mean Vaping Quit Intentions Score
The primary outcome is vaping quit intentions measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher quit intentions.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Vaping Quit Intentions Score | 2.5 score on a scale | Standard Deviation 1.3 |
| Label With Pictorial Health Warning | Mean Vaping Quit Intentions Score | 2.5 score on a scale | Standard Deviation 1.1 |
| Label With Neutral Statements About Vaping | Mean Vaping Quit Intentions Score | 2.2 score on a scale | Standard Deviation 1 |
p-value: <0.001General linear model
p-value: 0.78General linear model
Secondary
Mean Attention Score
Attention to the labels will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating greater attention.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Attention Score | 3.1 score on a scale | Standard Deviation 0.9 |
| Label With Pictorial Health Warning | Mean Attention Score | 3.3 score on a scale | Standard Deviation 0.9 |
| Label With Neutral Statements About Vaping | Mean Attention Score | 2.8 score on a scale | Standard Deviation 0.9 |
p-value: <0.0001General linear model
p-value: <0.001General linear model
Secondary
Mean Cognitive Elaboration Score
Cognitive elaboration (thinking about the label) will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more cognitive elaboration.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Cognitive Elaboration Score | 2.7 score on a scale | Standard Deviation 0.9 |
| Label With Pictorial Health Warning | Mean Cognitive Elaboration Score | 2.9 score on a scale | Standard Deviation 0.9 |
| Label With Neutral Statements About Vaping | Mean Cognitive Elaboration Score | 2.0 score on a scale | Standard Deviation 0.8 |
p-value: <0.001General linear model
p-value: <0.001General linear model
Secondary
Mean Inaccurate Risk Perception Score
Inaccurate risk perception of vaping (believing vaping is the same or more harmful than smoking cigarettes) will be measured by 1 survey item at 5 time points: post-labeling (Visit 1) and 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score the item for accuracy (vaping less harmful than smoking cigarettes=correct; other answers=incorrect) and take an average across the time points. The range for this measure will be 0% (no correct answers) to 100% (all correct answers), with higher values indicating more accurate risk perceptions.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Inaccurate Risk Perception Score | 0.42 proportion of correct answers | Standard Deviation 0.42 |
| Label With Pictorial Health Warning | Mean Inaccurate Risk Perception Score | 0.44 proportion of correct answers | Standard Deviation 0.43 |
| Label With Neutral Statements About Vaping | Mean Inaccurate Risk Perception Score | 0.48 proportion of correct answers | Standard Deviation 0.43 |
p-value: 0.02General linear model
p-value: 0.5General linear model
Secondary
Mean Information Seeking Score
Information seeking about the harms of vaping will be measured by 1 survey item at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score responses (0 times=0, 1-2 times=1.5, 3-5 times=4, 6+ times=6) and take an average across the time points. The range for this measure will be 0 times to 6 times), with higher values indicating more information seeking.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Information Seeking Score | 1.3 number of times sought information | Standard Deviation 1.3 |
| Label With Pictorial Health Warning | Mean Information Seeking Score | 1.4 number of times sought information | Standard Deviation 1.3 |
| Label With Neutral Statements About Vaping | Mean Information Seeking Score | 0.8 number of times sought information | Standard Deviation 1 |
p-value: <0.001General linear model
p-value: 0.4General linear model
Secondary
Mean Knowledge Score
Knowledge of health harms from vaping will be measured by 5 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score each item for accuracy (correct or incorrect) and average the scores (% correct) for each time point and take an average across the time points. The range for this measure will be 0% to 100%, with higher values indicating more accurate knowledge).
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Knowledge Score | 0.6 score on a scale | Standard Deviation 0.3 |
| Label With Pictorial Health Warning | Mean Knowledge Score | 0.6 score on a scale | Standard Deviation 0.3 |
| Label With Neutral Statements About Vaping | Mean Knowledge Score | 0.4 score on a scale | Standard Deviation 0.3 |
p-value: <0.001General linear model
p-value: 0.66General linear model
Secondary
Mean Negative Affect Score
Negative affective reactions to the labels will be measured by 5 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more negative affect.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Negative Affect Score | 2.1 score on a scale | Standard Deviation 0.9 |
| Label With Pictorial Health Warning | Mean Negative Affect Score | 2.3 score on a scale | Standard Deviation 1 |
| Label With Neutral Statements About Vaping | Mean Negative Affect Score | 1.4 score on a scale | Standard Deviation 0.6 |
p-value: <0.001General linear model
p-value: <0.001General linear model
Secondary
Mean Number of Conversations in Past Week
Number of conversations with others about the labels, health harms caused by vaping, and quitting vaping will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 0 times to 100 times, with higher values indicating more conversations.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Number of Conversations in Past Week | 1.5 number of conversations | Standard Deviation 2.2 |
| Label With Pictorial Health Warning | Mean Number of Conversations in Past Week | 1.7 number of conversations | Standard Deviation 2.1 |
| Label With Neutral Statements About Vaping | Mean Number of Conversations in Past Week | 1.2 number of conversations | Standard Deviation 1.8 |
p-value: 0.03General linear model
p-value: 0.4General linear model
Secondary
Mean Number of Times Forgoing a Vape in Past Week
Number of times forgoing a vape in the last week will be measured by 4 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will score responses (never=0, 1 time=1, 2 times=2, 3-5 times=4, 6+ times=6), average the items to create a score for each time point, and take an average across the time points. The range for this measure will be 0 times to 6 times, with higher values indicating more forgoing.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Number of Times Forgoing a Vape in Past Week | 1.7 number of times forgoing a vape | Standard Deviation 1.6 |
| Label With Pictorial Health Warning | Mean Number of Times Forgoing a Vape in Past Week | 1.7 number of times forgoing a vape | Standard Deviation 1.5 |
| Label With Neutral Statements About Vaping | Mean Number of Times Forgoing a Vape in Past Week | 1.3 number of times forgoing a vape | Standard Deviation 1.4 |
p-value: 0.001General linear model
p-value: 0.9General linear model
Secondary
Mean Perceived Likelihood of Illness Score
Perceived likelihood of illness from vaping will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visit 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating higher perceived likelihood.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Perceived Likelihood of Illness Score | 3.1 score on a scale | Standard Deviation 0.8 |
| Label With Pictorial Health Warning | Mean Perceived Likelihood of Illness Score | 3.1 score on a scale | Standard Deviation 0.8 |
| Label With Neutral Statements About Vaping | Mean Perceived Likelihood of Illness Score | 2.9 score on a scale | Standard Deviation 0.9 |
p-value: 0.001General linear model
p-value: 0.95General linear model
Secondary
Mean Smoking Quit Intentions Score
Smoking quit intentions will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The construct will be assessed only among cigarette smokers. The range for this measure will be 1 to 5, with higher values indicating higher intentions.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Smoking Quit Intentions Score | 2.4 score on a scale | Standard Deviation 0.9 |
| Label With Pictorial Health Warning | Mean Smoking Quit Intentions Score | 2.5 score on a scale | Standard Deviation 0.9 |
| Label With Neutral Statements About Vaping | Mean Smoking Quit Intentions Score | 2.3 score on a scale | Standard Deviation 0.9 |
p-value: 0.3General linear model
p-value: 0.5General linear model
Secondary
Mean Stigma Score
Stigma (expecting the labels will cause social disapproval of vaping) will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more stigma.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Stigma Score | 1.9 score on a scale | Standard Deviation 0.8 |
| Label With Pictorial Health Warning | Mean Stigma Score | 2.0 score on a scale | Standard Deviation 0.9 |
| Label With Neutral Statements About Vaping | Mean Stigma Score | 1.6 score on a scale | Standard Deviation 0.7 |
p-value: <0.001General linear model
p-value: 0.004General linear model
Secondary
Mean Uncontrolled Vaping Score
Subjective uncontrolled vaping (vaping more than the user prefers) will be measured by 3 survey items at 4 time points: 1, 2, 3, and 4 weeks (Visit 2-5). Study investigators will average the items to create a score for each time point and take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating vaping that is more uncontrolled.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Uncontrolled Vaping Score | 2.4 score on a scale | Standard Deviation 0.9 |
| Label With Pictorial Health Warning | Mean Uncontrolled Vaping Score | 2.4 score on a scale | Standard Deviation 1 |
| Label With Neutral Statements About Vaping | Mean Uncontrolled Vaping Score | 2.3 score on a scale | Standard Deviation 1 |
p-value: 0.4General linear model
p-value: 0.5General linear model
Secondary
Mean Vaping Reinforcement Attitudes Score
Positive vaping reinforcement attitudes will be measured by 3 survey items at 5 time points: post-labeling (Visit 1) and at 1, 2, 3, and 4 weeks (Visits 2-5). We will take an average across the time points. The range for this measure will be 1 to 5, with higher values indicating more positive vaping reinforcement attitudes.
Time frame: Up to 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Label With Text Health Warning | Mean Vaping Reinforcement Attitudes Score | 4.1 units on a scale | Standard Deviation 0.8 |
| Label With Pictorial Health Warning | Mean Vaping Reinforcement Attitudes Score | 4.1 units on a scale | Standard Deviation 0.8 |
| Label With Neutral Statements About Vaping | Mean Vaping Reinforcement Attitudes Score | 4.2 units on a scale | Standard Deviation 0.8 |
p-value: 0.61General linear model
p-value: 0.68General linear model
Secondary
Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks
Made smoking quit attempt will be measured by 1 survey item (not smoking for 1 day or longer in the last week because they were trying to stop smoking) at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). There will be an additional item (not smoking for 1 day or longer since the start of the study) at 4 weeks (Visit 5). Study investigators will score the items for any quit attempts: 0 (no quit attempts) or 1 (at least one quit attempt across the 4 weeks).
Time frame: Up to 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Label With Text Health Warning | Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks | 54.3 percentage of participants |
| Label With Pictorial Health Warning | Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks | 67.9 percentage of participants |
| Label With Neutral Statements About Vaping | Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks | 63.1 percentage of participants |
95% CI: [0.99, 2.1]
95% CI: [1.2, 2.6]
Secondary
Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks
Made vaping quit attempt will be measured by 1 survey item (not vaping for 1 day or longer in the last week because they were trying to stop vaping) at 4 time points: 1, 2, 3, and 4 weeks (Visits 2-5). There will be an additional item (not vaping for 1 day or longer since the start of the study) at 4 weeks (Visit 5). Study investigators will score the items for any quit attempts: 0 (no quit attempts) or 1 (one or more quit attempt across the 4 weeks).
Time frame: Up to 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Label With Text Health Warning | Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks | 217 Participants |
| Label With Pictorial Health Warning | Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks | 204 Participants |
| Label With Neutral Statements About Vaping | Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks | 211 Participants |
95% CI: [0.73, 1.2]
95% CI: [0.69, 1.2]
Secondary
Percent of Participants Who Successfully Quit Vaping
Successful quitting of vaping during the trial will be measured by 1 survey item at 1 time point (participants' last survey, usually Visit 5). Study investigators will score the item for successful quitting: 0 (vaping on one or more of the last 7 days) or 1 (no vaping).
Time frame: At 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Label With Text Health Warning | Percent of Participants Who Successfully Quit Vaping | 7.2 percentage of participants |
| Label With Pictorial Health Warning | Percent of Participants Who Successfully Quit Vaping | 7.4 percentage of participants |
| Label With Neutral Statements About Vaping | Percent of Participants Who Successfully Quit Vaping | 3.7 percentage of participants |
95% CI: [0.3, 0.9]
95% CI: [0.6, 1.7]