Trial Outcomes & Findings for Impact of E-cigarette Device Warnings (NCT NCT05714982)
NCT ID: NCT05714982
Last Updated: 2025-09-12
Results Overview
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.
COMPLETED
NA
1369 participants
Up to 4 weeks
2025-09-12
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
457
|
456
|
456
|
|
Overall Study
COMPLETED
|
452
|
454
|
452
|
|
Overall Study
NOT COMPLETED
|
5
|
2
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Impact of E-cigarette Device Warnings
Baseline characteristics by cohort
| Measure |
Label With Text Health Warning
n=456 Participants
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.
|
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Total
n=1369 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
21-29 years
|
133 Participants
n=93 Participants
|
130 Participants
n=4 Participants
|
141 Participants
n=27 Participants
|
404 Participants
n=483 Participants
|
|
Age, Customized
30-39 years
|
170 Participants
n=93 Participants
|
159 Participants
n=4 Participants
|
166 Participants
n=27 Participants
|
495 Participants
n=483 Participants
|
|
Age, Customized
40-49 years
|
100 Participants
n=93 Participants
|
100 Participants
n=4 Participants
|
95 Participants
n=27 Participants
|
295 Participants
n=483 Participants
|
|
Age, Customized
50+ years
|
53 Participants
n=93 Participants
|
68 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
175 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Female
|
193 Participants
n=93 Participants
|
197 Participants
n=4 Participants
|
208 Participants
n=27 Participants
|
598 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Male
|
249 Participants
n=93 Participants
|
237 Participants
n=4 Participants
|
221 Participants
n=27 Participants
|
707 Participants
n=483 Participants
|
|
Sex/Gender, Customized
Nonbinary/Another gender
|
14 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
64 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaskan Native
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Asian
|
54 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
118 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
78 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
74 Participants
n=27 Participants
|
229 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
32 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
129 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern or North African
|
2 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
1 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
194 Participants
n=93 Participants
|
196 Participants
n=4 Participants
|
183 Participants
n=27 Participants
|
573 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Multiracial or another race or ethnicity
|
90 Participants
n=93 Participants
|
91 Participants
n=4 Participants
|
106 Participants
n=27 Participants
|
287 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Missing
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
456 participants
n=93 Participants
|
457 participants
n=4 Participants
|
456 participants
n=27 Participants
|
1369 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Up to 4 weeksThe 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Mean Vaping Quit Intentions Score
|
2.5 score on a scale
Standard Deviation 1.1
|
2.2 score on a scale
Standard Deviation 1.0
|
2.5 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Up to 4 weeksKnowledge 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).
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Mean Knowledge Score
|
0.6 score on a scale
Standard Deviation 0.3
|
0.4 score on a scale
Standard Deviation 0.3
|
0.6 score on a scale
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Up to 4 weeksCognitive 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=385 Participants
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.
|
Label With Neutral Statements About Vaping
n=383 Participants
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.
|
Label With Text Health Warning
n=395 Participants
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.
|
|---|---|---|---|
|
Mean Cognitive Elaboration Score
|
2.9 score on a scale
Standard Deviation 0.9
|
2.0 score on a scale
Standard Deviation 0.8
|
2.7 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to 4 weeksPerceived 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Mean Perceived Likelihood of Illness Score
|
3.1 score on a scale
Standard Deviation 0.8
|
2.9 score on a scale
Standard Deviation 0.9
|
3.1 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Up to 4 weeksNegative 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Mean Negative Affect Score
|
2.3 score on a scale
Standard Deviation 1.0
|
1.4 score on a scale
Standard Deviation 0.6
|
2.1 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to 4 weeksAttention 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=385 Participants
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.
|
Label With Neutral Statements About Vaping
n=383 Participants
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.
|
Label With Text Health Warning
n=395 Participants
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.
|
|---|---|---|---|
|
Mean Attention Score
|
3.3 score on a scale
Standard Deviation 0.9
|
2.8 score on a scale
Standard Deviation 0.9
|
3.1 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to 4 weeksInformation 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=385 Participants
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.
|
Label With Neutral Statements About Vaping
n=383 Participants
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.
|
Label With Text Health Warning
n=395 Participants
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.
|
|---|---|---|---|
|
Mean Information Seeking Score
|
1.4 number of times sought information
Standard Deviation 1.3
|
0.8 number of times sought information
Standard Deviation 1.0
|
1.3 number of times sought information
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Up to 4 weeksNumber 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=385 Participants
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.
|
Label With Neutral Statements About Vaping
n=383 Participants
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.
|
Label With Text Health Warning
n=395 Participants
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.
|
|---|---|---|---|
|
Mean Number of Conversations in Past Week
|
1.7 number of conversations
Standard Deviation 2.1
|
1.2 number of conversations
Standard Deviation 1.8
|
1.5 number of conversations
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: Up to 4 weeksPositive 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Mean Vaping Reinforcement Attitudes Score
|
4.1 units on a scale
Standard Deviation 0.8
|
4.2 units on a scale
Standard Deviation 0.8
|
4.1 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Up to 4 weeksSubjective 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=385 Participants
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.
|
Label With Neutral Statements About Vaping
n=383 Participants
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.
|
Label With Text Health Warning
n=395 Participants
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.
|
|---|---|---|---|
|
Mean Uncontrolled Vaping Score
|
2.4 score on a scale
Standard Deviation 1.0
|
2.3 score on a scale
Standard Deviation 1.0
|
2.4 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to 4 weeksNumber 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=385 Participants
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.
|
Label With Neutral Statements About Vaping
n=383 Participants
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.
|
Label With Text Health Warning
n=395 Participants
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.
|
|---|---|---|---|
|
Mean Number of Times Forgoing a Vape in Past Week
|
1.7 number of times forgoing a vape
Standard Deviation 1.5
|
1.3 number of times forgoing a vape
Standard Deviation 1.4
|
1.7 number of times forgoing a vape
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: Up to 4 weeksMade 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).
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Percent of Participants Who Made a Vaping Quit Attempt in Past 4 Weeks
|
204 Participants
|
211 Participants
|
217 Participants
|
SECONDARY outcome
Timeframe: At 4 weeksSuccessful 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).
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Percent of Participants Who Successfully Quit Vaping
|
7.4 percentage of participants
|
3.7 percentage of participants
|
7.2 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 4 weeksInaccurate 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Mean Inaccurate Risk Perception Score
|
0.44 proportion of correct answers
Standard Deviation 0.43
|
0.48 proportion of correct answers
Standard Deviation 0.43
|
0.42 proportion of correct answers
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: Up to 4 weeksStigma (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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Mean Stigma Score
|
2.0 score on a scale
Standard Deviation 0.9
|
1.6 score on a scale
Standard Deviation 0.7
|
1.9 score on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Up to 4 weeksSmoking 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.
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Mean Smoking Quit Intentions Score
|
2.5 score on a scale
Standard Deviation 0.9
|
2.3 score on a scale
Standard Deviation 0.9
|
2.4 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: Up to 4 weeksMade 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).
Outcome measures
| Measure |
Label With Pictorial Health Warning
n=457 Participants
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.
|
Label With Neutral Statements About Vaping
n=456 Participants
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.
|
Label With Text Health Warning
n=456 Participants
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.
|
|---|---|---|---|
|
Percent of Participants Who Made a Smoking Quit Attempt in Past 4 Weeks
|
67.9 percentage of participants
|
63.1 percentage of participants
|
54.3 percentage of participants
|
Adverse Events
Label With Text Health Warning
Label With Pictorial Health Warning
Label With Neutral Statements About Vaping
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place