Impact of E-Cigarette Prevention Messages on Adolescents

Sponsor
UNC Lineberger Comprehensive Cancer Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05985538
Collaborator
National Institute on Drug Abuse (NIDA) (NIH), Food and Drug Administration (FDA) (U.S. Fed)
500
1
2
15
33.3

Study Details

Study Description

Brief Summary

The purpose of this trial is to determine whether a vaping prevention text message program reduces susceptibility to vaping among adolescents and young adults. This study addresses this issue by exposing participants to a vaping prevention text message program over a 28-day period in a randomized controlled trial with a matched attention control condition. A follow-up assessment is also made 4 weeks after the text messaging ends.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Vaping prevention text messages
  • Behavioral: Wellness behaviors text messages
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Impact of E-Cigarette Prevention Messages on Adolescents
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
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.

Behavioral: 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. 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).

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.

Behavioral: Wellness behaviors 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. 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.

Outcome Measures

Primary Outcome Measures

  1. Mean susceptibility to vaping score [Visit 3 (4 weeks)]

    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 higher tendency.

Secondary Outcome Measures

  1. Mean vaping instrumental attitudes score [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 higher tendency.

Other Outcome Measures

  1. Mean vaping affective attitudes score [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.

  2. Mean vaping addiction risk beliefs score [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.

  3. Mean vaping monetary cost beliefs score [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.

  4. Mean vaping chemical risk beliefs score [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.

  5. Mean vaping cosmetic risk beliefs score [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.

  6. Mean vaping physical symptoms [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.

  7. Mean vaping mental health symptoms of use beliefs score [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.

  8. Mean vaping health organ risk beliefs score [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.

  9. Mean susceptibility to smoking cigarettes score [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.

  10. Mean smoking instrumental attitude score [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.

  11. Mean smoking affective attitude score [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.

  12. Mean smoking addiction risk belief score [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.

  13. Mean smoking health harm risk belief score [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.

  14. Mean vaping injunctive norms score [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.

  15. Mean vaping refusal self-efficacy score [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.

  16. Frequency of vaping [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.

  17. Frequency of cigarette smoking [Visit 3 (4 weeks)]

    Participants will be asked the number of days they smoked cigarettes over the past 30 days, with higher scores indicating more days smoked.

  18. Participants will be asked if they used other tobacco products [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
13 Years to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of North Carolina, Chapel Hill Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

  • UNC Lineberger Comprehensive Cancer Center
  • National Institute on Drug Abuse (NIDA)
  • Food and Drug Administration (FDA)

Investigators

  • Principal Investigator: Seth Noar, PhD, UNC Lineberger Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT05985538
Other Study ID Numbers:
  • 20-1245
  • 5R01DA049155-02
First Posted:
Aug 14, 2023
Last Update Posted:
Aug 14, 2023
Last Verified:
Jun 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by UNC Lineberger Comprehensive Cancer Center

Study Results

No Results Posted as of Aug 14, 2023