Clinical trial NCT05985538: Impact of E-Cigarette Prevention Messages on Adolescents
Official title: Impact of E-Cigarette Prevention Messages on Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vaping Behavior
Keywords: Health communication
Tobacco use
vaping prevention
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Food and Drug Administration (FDA)
First posted: 2023-08-14
Enrollment: 480
Sex: ALL
Minimum age (years): 13
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Mean susceptibility to vaping score
timeFrame: Visit 3 (4 weeks)
Secondary outcomes:
measure: Mean vaping instrumental attitudes score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping affective attitudes score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping addiction risk beliefs score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping monetary cost beliefs score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping chemical risk beliefs score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping cosmetic risk beliefs score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping physical symptoms
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping mental health symptoms of use beliefs score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping health organ risk beliefs score
timeFrame: Visit 3 (4 weeks)
measure: Mean susceptibility to smoking cigarettes score
timeFrame: Visit 3 (4 weeks)
measure: Mean smoking instrumental attitude score
timeFrame: Visit 3 (4 weeks)
measure: Mean smoking affective attitude score
timeFrame: Visit 3 (4 weeks)
measure: Mean smoking addiction risk belief score
timeFrame: Visit 3 (4 weeks)
measure: Mean smoking health harm risk belief score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping injunctive norms score
timeFrame: Visit 3 (4 weeks)
measure: Mean vaping refusal self-efficacy score
timeFrame: Visit 3 (4 weeks)
measure: Frequency of vaping
timeFrame: Visit 3 (4 weeks)
measure: Frequency of cigarette smoking
timeFrame: Visit 3 (4 weeks)
measure: Frequency of using other tobacco products
timeFrame: Visit 3 (4 weeks)
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Seth Noar, PhD
role: PRINCIPAL_INVESTIGATOR
References: