- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05985538
Impact of E-Cigarette Prevention Messages on Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Tobacco prevention communication is a key tool for reducing tobacco use among adolescents and young adults. While the use of e-cigarettes and vaping has increased greatly among adolescents and young adults, there has been a dearth of research on effective communication strategies to reduce vaping. This study will test the impact of a text-messaging program on reducing susceptibility to vaping in a randomized controlled trial, illuminating whether such programs can be effective. The investigators focus on adolescents and young adults (ages 13-20) who currently vape or who are at risk of vaping.
Participants will be randomly assigned to receive either a vaping prevention text message program or a wellness text message program (control). Participants in the study will take 4 online surveys over an 8-week period - at Visit 1 (baseline), Visit 2 (2 weeks), Visit 3 (4 weeks), and Visit 4 (8 weeks).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina, Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Ages 13-20 years old (inclusive)
- Have a phone that sends and receives text messages
- Ever vaped or are susceptible to using e-cigarettes or vaping
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Vaping prevention text messages
Participants will receive text messages (2 daily, on average) about the harms of e-cigarette use and vaping for 28 days, with introductory messages sent on day 1 and concluding messages sent on day 28.
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Participants will receive text messages (2 daily, on average) about the harms of e-cigarette use and vaping for 28 days, with introductory messages sent on day 1 and concluding messages sent on day 28.
Each vaping prevention text message will focus on one of six topics: nicotine addiction, monetary costs of vaping, chemical exposures from e-cigarette vapor, cosmetic effects of vaping, mental and physical use symptoms of vaping, and health impact on organs from vaping.
Some text messages will ask participants for a reply (i.e., two-way messages).
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Active Comparator: Wellness behavior text messages
Participants will receive text messages (2 daily, on average) about general wellness topics, with introductory messages sent on day 1 and concluding messages sent on day 28.
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Participants will receive text messages (2 daily, on average) about general wellness topics, with introductory messages sent on day 1 and concluding messages sent on day 28.
Each wellness text message will focus on one of six topics: sleep hygiene, safe driving, sun safety, study habits, nutrition, and exercise.
This attention control condition is matched with the intervention condition in that participants will receive the same number of text messages over the same number of days, the same intervention structure (e.g., 6 topics), and the same number and types of two-way messages.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Mean Susceptibility to Vaping Score
Time Frame: Visit 3 (4 weeks)
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The mean susceptibility to vaping score will be assessed using the questionnaire.
Response options are on a 1 to 4 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-4), with higher scores representing a greater susceptibility to vaping (a worse outcome).
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Visit 3 (4 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean Vaping Instrumental Attitudes Score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping instrumental attitudes score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing a belief that vaping is more beneficial, safe and healthy.
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Visit 3 (4 weeks)
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Mean Vaping Affective Attitudes Score
Time Frame: Visit 3 (4 weeks)
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.The mean vaping affective attitudes score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing a belief that vaping is more enjoyable, pleasant, and fun.
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Visit 3 (4 weeks)
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Mean Vaping Addiction Risk Beliefs Score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping addiction risk beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing more tendency to addiction.
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Visit 3 (4 weeks)
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Mean Vaping Monetary Cost Beliefs Score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping monetary cost beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores represents participants' believes that vaping is a costly activity.
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Visit 3 (4 weeks)
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Mean Vaping Chemical Risk Beliefs Score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping chemical risk beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing participant's believes that e-cigarette vapor contains chemicals that pose health risks.
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Visit 3 (4 weeks)
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Mean Vaping Cosmetic Risk Beliefs Score
Time Frame: Visit 3 (4 weeks)
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The mean vaping cosmetic risk beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing participant belief that use will harm their cosmetic appearance.
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Visit 3 (4 weeks)
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Mean Vaping Health Symptoms Beliefs Score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping physical symptoms of use beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores represent participant believes that e-cigarette use will cause certain physical symptoms.
|
Visit 3 (4 weeks)
|
|
Mean Vaping Mental Health Symptoms of Use Beliefs Score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping mental health symptoms of use beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores represent participant believes that e-cigarette use will cause or worsen mental health symptoms.
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Visit 3 (4 weeks)
|
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Mean Vaping Health Organ Risk Beliefs Score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping health organ risk beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing participant believes that e-cigarette use will harm the health of certain organs.
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Visit 3 (4 weeks)
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Mean Susceptibility to Smoking Cigarettes Score
Time Frame: Visit 3 (4 weeks)
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The mean susceptibility to smoking cigarettes score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores represent participant more open to smoking.
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Visit 3 (4 weeks)
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Mean Smoking Instrumental Attitude Score
Time Frame: Visit 3 (4 weeks)
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The 1-item mean smoking instrumental attitude measure assesses a participant's attitude toward smoking.
Response options are on a 1 to 5 scale, with higher scores representing a more harmful perception of smoking.
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Visit 3 (4 weeks)
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Mean Smoking Affective Attitude Score
Time Frame: Visit 3 (4 weeks)
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The 1-item mean smoking affective attitude measure assesses a participant's attitude toward smoking (unenjoyable/enjoyable). Response options are on a 1 to 5 scale, with higher scores representing a more enjoyable attitude toward smoking.
|
Visit 3 (4 weeks)
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Mean Smoking Addiction Risk Belief Score
Time Frame: Visit 3 (4 weeks)
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The 1-item mean smoking addiction risk belief measure assesses the extent to which a participant believes that smoking will lead to addiction.
Response options are on a 1 to 5 scale, with higher scores representing beliefs that smoking will lead to addiction.
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Visit 3 (4 weeks)
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Mean Smoking Health Harm Risk Belief Score
Time Frame: Visit 3 (4 weeks)
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The 1-item mean smoking health harm risk belief measure assesses the extent to which a participant believes that smoking will lead to health harm.
Response options are on a 1 to 5 scale, with higher scores representing higher beliefs that smoking will cause to health harm.
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Visit 3 (4 weeks)
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Mean Vaping Injunctive Norms Score
Time Frame: Visit 3 (4 weeks)
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The 3-item mean vaping injunctive norms scale assesses a participant's perception of others' approval or disapproval of their vaping behavior.
Response options are on a 1 to 5 scale.
Overall scores are determined by summing the scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing a participant's perception of others' approval about vaping.
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Visit 3 (4 weeks)
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Mean Vaping Refusal Self-efficacy Score
Time Frame: Visit 3 (4 weeks)
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The 3-item mean vaping refusal self-efficacy scale assesses a participant's confidence that they could refuse to vape in a social situation.
Response options are on a 1 to 5 scale.
Overall scores are determined by summing the scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing a higher amount of refuse to vape in a social situation.
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Visit 3 (4 weeks)
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Frequency of Vaping
Time Frame: Visit 3 (4 weeks)
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Participants will be asked the number of days they vaped over the past 30 days, with higher scores indicating more days vaped.
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Visit 3 (4 weeks)
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Frequency of Cigarette Smoking
Time Frame: Visit 3 (4 weeks)
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Participants will be asked the number of days they smoked cigarettes over the past 30 days, with higher scores indicating more days smoked.
|
Visit 3 (4 weeks)
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Frequency of Using Other Tobacco Products
Time Frame: Visit 3 (4 weeks)
|
Participants will be asked if they used other tobacco products (OTP) over the past 30 days.
OTP use will be determined as follows: no use = person who doesn't use OTPs; used = person who uses OTPs; no response = person who skipped or refused to answer
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Visit 3 (4 weeks)
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean vaping affective attitudes score
Time Frame: Visit 3 (4 weeks)
|
.The mean vaping affective attitudes score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing more enjoyable.
|
Visit 3 (4 weeks)
|
|
Mean vaping addiction risk beliefs score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping addiction risk beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing more tendency to addiction.
|
Visit 3 (4 weeks)
|
|
Mean vaping monetary cost beliefs score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping monetary cost beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores represents participants' believes that vaping is a costly activity.
|
Visit 3 (4 weeks)
|
|
Mean vaping chemical risk beliefs score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping chemical risk beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing participant's believes that e-cigarette vapor contains chemicals that pose health risks.
|
Visit 3 (4 weeks)
|
|
Mean vaping cosmetic risk beliefs score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping cosmetic risk beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing participant belief that use will harm their cosmetic appearance.
|
Visit 3 (4 weeks)
|
|
Mean vaping physical symptoms
Time Frame: Visit 3 (4 weeks)
|
The mean vaping physical symptoms of use beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores represent participant believes that e-cigarette use will cause certain physical symptoms.
|
Visit 3 (4 weeks)
|
|
Mean vaping mental health symptoms of use beliefs score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping mental health symptoms of use beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores represent participant believes that e-cigarette use will cause or worsen mental health symptoms.
|
Visit 3 (4 weeks)
|
|
Mean vaping health organ risk beliefs score
Time Frame: Visit 3 (4 weeks)
|
The mean vaping health organ risk beliefs score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing participant believes that e-cigarette use will harm the health of certain organs.
|
Visit 3 (4 weeks)
|
|
Mean susceptibility to smoking cigarettes score
Time Frame: Visit 3 (4 weeks)
|
The mean susceptibility to smoking cigarettes score will be assessed using the questionnaire.
Response options are on a 1 to 5 scale.
Overall scale scores are determined by summing scores of the 3 items and dividing them by 3 (range 1-5), with higher scores represent participant more open to smoking.
|
Visit 3 (4 weeks)
|
|
Mean smoking instrumental attitude score
Time Frame: Visit 3 (4 weeks)
|
The 1-item mean smoking instrumental attitude measure assesses a participant's attitude toward smoking.
Response options are on a 1 to 5 scale, with higher scores representing a harmful attitude.
|
Visit 3 (4 weeks)
|
|
Mean smoking affective attitude score
Time Frame: Visit 3 (4 weeks)
|
The 1-item mean smoking affective attitude measure assesses a participant's attitude toward smoking (unenjoyable/enjoyable). Response options are on a 1 to 5 scale, with higher scores representing a higher amount of the construct.
|
Visit 3 (4 weeks)
|
|
Mean smoking addiction risk belief score
Time Frame: Visit 3 (4 weeks)
|
The 1-item mean smoking addiction risk belief measure assesses the extent to which a participant believes that smoking will lead to addiction.
Response options are on a 1 to 5 scale, with higher scores representing beliefs that smoking will lead to addiction.
|
Visit 3 (4 weeks)
|
|
Mean smoking health harm risk belief score
Time Frame: Visit 3 (4 weeks)
|
The 1-item mean smoking health harm risk belief measure assesses the extent to which a participant believes that smoking will lead to health harm.
Response options are on a 1 to 5 scale, with higher scores representing higher beliefs that smoking will cause to addiction.
|
Visit 3 (4 weeks)
|
|
Mean vaping injunctive norms score
Time Frame: Visit 3 (4 weeks)
|
The 3-item mean vaping injunctive norms scale assesses a participant's perception of others' approval or disapproval of their vaping behavior.
Response options are on a 1 to 5 scale.
Overall scores are determined by summing the scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing a participant's perception of others' approval.
|
Visit 3 (4 weeks)
|
|
Mean vaping refusal self-efficacy score
Time Frame: Visit 3 (4 weeks)
|
The 3-item mean vaping refusal self-efficacy scale assesses a participant's confidence that they could refuse to vape in a social situation.
Response options are on a 1 to 5 scale.
Overall scores are determined by summing the scores of the 3 items and dividing them by 3 (range 1-5), with higher scores representing a higher amount of refuse to vape in a social situation.
|
Visit 3 (4 weeks)
|
|
Frequency of vaping
Time Frame: Visit 3 (4 weeks)
|
Participants will be asked the number of days they vaped over the past 30 days, with higher scores indicating more days vaped.
|
Visit 3 (4 weeks)
|
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Frequency of cigarette smoking
Time Frame: Visit 3 (4 weeks)
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Participants will be asked the number of days they smoked cigarettes over the past 30 days, with higher scores indicating more days smoked.
|
Visit 3 (4 weeks)
|
|
Participants will be asked if they used other tobacco products
Time Frame: Visit 3 (4 weeks)
|
Participants will be asked if they used other tobacco products (OTP) over the past 30 days.
OTP use will be determined as follows: 0 days = person who doesn't use OTPs; 1 or more days = person who uses OTPs
|
Visit 3 (4 weeks)
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Collaborators and Investigators
Investigators
- Principal Investigator: Seth Noar, PhD, UNC Lineberger Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20-1245
- 5R01DA049155-02 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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