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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

1369 participants

Primary outcome timeframe

Up to 4 weeks

Results posted on

2025-09-12

Participant Flow

Participant milestones

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

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 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.

Outcome measures

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 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).

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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).

Outcome measures

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 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).

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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.

Outcome measures

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 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).

Outcome measures

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Label With Pictorial Health Warning

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Label With Neutral Statements About Vaping

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator

UNC

Phone: (919) 966-3282

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place