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Responses to Regulated E-Cigarette Advertisements

Young Adults' Responses to E-Cigarette Advertisement Features and the Effect of Restricting Features on Tobacco Use - Phase 2

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05207033
Enrollment
195
Registered
2022-01-26
Start date
2022-04-01
Completion date
2024-07-01
Last updated
2025-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tobacco Use

Brief summary

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest.

Detailed description

While conventional cigarette use continues to decline among youth and young adults, e-cigarette (EC) use is on the rise. The use of ECs during young adulthood, particularly 18 years of age, is especially alarming because it is not only a critical period in development but also a time when tobacco use is established. Additionally, the tobacco industry targets individuals of this age with the hope that they will one day progress to using combustible cigarettes. Advertising may be one of the reasons leading young people to use ECs, and the Food and Drug Administration (FDA) now has the authority to regulate EC advertisement features. The goal of the proposed study is to determine which EC ad features most strongly influence young adults' attitudes, susceptibility, and intentions to use ECs, and determine if the restriction of these ad features influences EC attitudes, experimentation, and sustained use. The investigators will experimentally estimate the causal effect of restricting high impact EC ad features on tobacco use behavior. Specifically, the investigators will conduct a randomized control trial (RCT) where young adults are randomized to one of two conditions: 1) a regulated ad environment, with high impact EC ad features removed or 2) an unregulated ad environment, with high impact EC ad features left intact. Participants will view EC ads embedded in an online magazine 24 times over the course of 6 months. EC experimentation and sustained use will be the primary outcome of interest. We will also examine how sensation seeking, impulsivity, and sleep health impact EC use. Findings from this study will provide public health officials important and urgently needed information as to what advertising features are contributing to the sharp rise in the use of ECs among young adults, and if restrictions reduce the use of ECs among young adults.

Interventions

OTHERRegulated ad condition

This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.

OTHERUnregulated ad condition

This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.

Sponsors

National Institute on Drug Abuse (NIDA)
CollaboratorNIH
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 26 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 to 26 years old, * fluent in English (earn a score of at least 4 on the Rapid Estimate of Adult Literacy in Medicine) * biochemically confirmed abstinence of alcohol (BrAC=.00) and combusted tobacco or marijuana exhaled carbon monoxide (eCO\<6 parts per million) at time of visit, * reporting never trying an e-cigarette, not even a puff OR reporting tried and e-cigarette in the past but not in the past 30 days. Susceptibility to EC use, will be determined using the Susceptibility to Use Tobacco Products questionnaire, with only those identifying anything besides no curiosity/interest to all three susceptibility questions as susceptible users.

Exclusion criteria

* Out of age range 18-26 years * Use of an e-cigarette in past 30 days * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Tobacco Use at 1 Month1 monthUse of any tobacco products
Tobacco Use at 3 Months3 monthsUse of any tobacco products
Tobacco Use at 6 Months6 monthsUse of any tobacco products
Perceived Severity of Using E-Cigarettes at 1 Month1 monthPerceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Perceived Severity of Using E-Cigarettes at 3 Months3 monthsPerceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Perceived Severity of Using E-Cigarettes at 6 Months6 monthsPerceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Motivation to Avoid E-Cigarettes at 1 Month1 MonthMotivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Motivation to Avoid E-Cigarettes at 3 Months3 MonthsMotivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Motivation to Avoid E-Cigarettes at 6 Months6 MonthsMotivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Behavioral Intentions at 1 Month1 monthBehavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Behavioral Intentions at 3 Months3 monthsBehavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Behavioral Intentions at 6 Months6 monthsBehavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Number of Participants With Biochemical Verification of Tobacco Use at 1 Month1 monthBiochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \ 3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.
Number of Participants With Biochemical Verification of Tobacco Use at 3 Months3 monthsBiochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \ 3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.
Number of Participants With Biochemical Verification of Tobacco Use at 6 Months6 monthsBiochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \ 3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

Countries

United States

Participant flow

Pre-assignment details

Enrollment was N=195, however, prior to assignment, 9 participants stopped responding to communications from study staff including the initial survey, and thus were never assigned to a arm/group.

Participants by arm

ArmCount
Unregulated ad Condition
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media. Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
88
Regulated ad Condition
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features. Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
84
Total172

Baseline characteristics

CharacteristicUnregulated ad ConditionTotalRegulated ad Condition
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
88 Participants172 Participants84 Participants
Age, Continuous22.13 years
STANDARD_DEVIATION 2.32
22.5 years
STANDARD_DEVIATION 2.46
22.88 years
STANDARD_DEVIATION 2.54
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
7 Participants25 Participants18 Participants
Race (NIH/OMB)
Black or African American
1 Participants9 Participants8 Participants
Race (NIH/OMB)
More than one race
7 Participants17 Participants10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
16 Participants20 Participants4 Participants
Race (NIH/OMB)
White
57 Participants101 Participants44 Participants
Region of Enrollment
United States
88 participants171 participants84 participants
Sex/Gender, Customized
female
67 Participants136 Participants69 Participants
Sex/Gender, Customized
male
16 Participants29 Participants13 Participants
Sex/Gender, Customized
other
5 Participants7 Participants2 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 940 / 92
other
Total, other adverse events
0 / 940 / 92
serious
Total, serious adverse events
0 / 940 / 92

Outcome results

Primary

Behavioral Intentions at 1 Month

Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionBehavioral Intentions at 1 Month3.23 score on a scaleStandard Deviation 0.76
Regulated ad ConditionBehavioral Intentions at 1 Month3.32 score on a scaleStandard Deviation 0.76
Primary

Behavioral Intentions at 3 Months

Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionBehavioral Intentions at 3 Months3.19 score on a scaleStandard Deviation 0.83
Regulated ad ConditionBehavioral Intentions at 3 Months3.37 score on a scaleStandard Deviation 0.8
Primary

Behavioral Intentions at 6 Months

Behavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionBehavioral Intentions at 6 Months3.24 score on a scaleStandard Deviation 0.75
Regulated ad ConditionBehavioral Intentions at 6 Months3.20 score on a scaleStandard Deviation 0.88
Primary

Motivation to Avoid E-Cigarettes at 1 Month

Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

Time frame: 1 Month

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionMotivation to Avoid E-Cigarettes at 1 Month7.66 score on a scaleStandard Deviation 2.03
Regulated ad ConditionMotivation to Avoid E-Cigarettes at 1 Month8.05 score on a scaleStandard Deviation 1.89
Primary

Motivation to Avoid E-Cigarettes at 3 Months

Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

Time frame: 3 Months

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionMotivation to Avoid E-Cigarettes at 3 Months7.74 score on a scaleStandard Deviation 2.13
Regulated ad ConditionMotivation to Avoid E-Cigarettes at 3 Months8.02 score on a scaleStandard Deviation 1.87
Primary

Motivation to Avoid E-Cigarettes at 6 Months

Motivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.

Time frame: 6 Months

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionMotivation to Avoid E-Cigarettes at 6 Months7.87 score on a scaleStandard Deviation 2.08
Regulated ad ConditionMotivation to Avoid E-Cigarettes at 6 Months8.00 score on a scaleStandard Deviation 1.87
Primary

Number of Participants With Biochemical Verification of Tobacco Use at 1 Month

Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \ 3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Unregulated ad ConditionNumber of Participants With Biochemical Verification of Tobacco Use at 1 Month0 Participants
Regulated ad ConditionNumber of Participants With Biochemical Verification of Tobacco Use at 1 Month1 Participants
Primary

Number of Participants With Biochemical Verification of Tobacco Use at 3 Months

Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \ 3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Unregulated ad ConditionNumber of Participants With Biochemical Verification of Tobacco Use at 3 Months1 Participants
Regulated ad ConditionNumber of Participants With Biochemical Verification of Tobacco Use at 3 Months2 Participants
Primary

Number of Participants With Biochemical Verification of Tobacco Use at 6 Months

Biochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \ 3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Unregulated ad ConditionNumber of Participants With Biochemical Verification of Tobacco Use at 6 Months0 Participants
Regulated ad ConditionNumber of Participants With Biochemical Verification of Tobacco Use at 6 Months3 Participants
Primary

Perceived Severity of Using E-Cigarettes at 1 Month

Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

Time frame: 1 month

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionPerceived Severity of Using E-Cigarettes at 1 Month4.41 units on a scaleStandard Deviation 0.66
Regulated ad ConditionPerceived Severity of Using E-Cigarettes at 1 Month4.46 units on a scaleStandard Deviation 0.61
Primary

Perceived Severity of Using E-Cigarettes at 3 Months

Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

Time frame: 3 months

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionPerceived Severity of Using E-Cigarettes at 3 Months4.41 units on a scaleStandard Deviation 0.67
Regulated ad ConditionPerceived Severity of Using E-Cigarettes at 3 Months4.36 units on a scaleStandard Deviation 0.71
Primary

Perceived Severity of Using E-Cigarettes at 6 Months

Perceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Unregulated ad ConditionPerceived Severity of Using E-Cigarettes at 6 Months4.48 units on a scaleStandard Deviation 0.63
Regulated ad ConditionPerceived Severity of Using E-Cigarettes at 6 Months4.48 units on a scaleStandard Deviation 0.59
Primary

Tobacco Use at 1 Month

Use of any tobacco products

Time frame: 1 month

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Unregulated ad ConditionTobacco Use at 1 Month5 Participants
Regulated ad ConditionTobacco Use at 1 Month5 Participants
Primary

Tobacco Use at 3 Months

Use of any tobacco products

Time frame: 3 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Unregulated ad ConditionTobacco Use at 3 Months3 Participants
Regulated ad ConditionTobacco Use at 3 Months2 Participants
Primary

Tobacco Use at 6 Months

Use of any tobacco products

Time frame: 6 months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Unregulated ad ConditionTobacco Use at 6 Months1 Participants
Regulated ad ConditionTobacco Use at 6 Months2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026