Tobacco Cessation
Conditions
Keywords
E-cigarette Cessation, Vaping Cessation, Mobile Intervention, Digital Intervention
Brief summary
This research study, conducted by Truth Initiative, will help us learn how text messaging can help young adults between 18 and 24 years of age quit vaping.
Detailed description
The Quit Vaping Study (QVS)'s primary aim is to conduct a fully powered comparative effectiveness trial to evaluate the effectiveness of a quit vaping text message program in promoting abstinence from e-cigarettes among young users aged 18-24. This study is a 2-arm randomized controlled trial conducted among young users aged 18-24 recruited through online channels. Participants will be randomized to a quit vaping text message intervention or to an assessment-only control condition and followed for 7 months to roughly correspond to 6-months post-treatment. The secondary aim is to examine potential mediators of program effectiveness, including treatment engagement and changes in self-efficacy and perceived social support for quitting.
Interventions
OTHERThis is Quitting
Text message-based intervention for quit vaping support.
Assessment only
Sponsors
Truth Initiative
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are not explicitly told they are in the control group, although they may deduce their assignment from presence or lack of regular text message intervention.
Intervention model description
Arm 1: Intervention - Text message intervention Arm 2: Control - Assessment only
Eligibility
Sex/Gender
ALL
Age
18 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
* Age 18-24 * Past 30-day use of e-cigarettes containing nicotine * Interest in quitting e-cigarette use in the next 30 days * US residence
Exclusion criteria
* Failure to confirm mobile number after initial sign-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT) | 7 months post enrollment | Number of participant who responded No to the question In the past 30 days, did you vape at all, even a puff of someone else's? Denominator is all randomized participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only) | 7 month post enrollment | Number of participants with who responded 'No to the question In the past 30 days, did you vape at all, even a puff of someone else's? Denominator is participants with responses only. |
| Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT) | 7 months post enrollment | Number of participants who responded No to the question Have you used any vape, even one puff, in the past 7 days? Denominator is all randomized participants. |
| Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only) | 7 months post enrollment | Number of participants who responded No to the question Have you used any vape, even one puff, in the past 7 days? Denominator is those who responded to the question only. |
Countries
United States
Participant flow
Recruitment details
Recruitment conducted from December 29, 2019 and March 18, 2020. Recruitment occurred online using advertisements on social media platforms.
Participants by arm
| Arm | Count |
|---|---|
| This is Quitting Participants will be enrolled to receive messages from This is Quitting.
Users receive one age-appropriate message per day tailored to their enrollment date or quit date, which can be set and reset via text message. Those not ready to quit receive 4 weeks of messages focused on building skills and confidence. Users who set a quit date receive messages for a week preceding it and 8 weeks afterward that include encouragement and support, skill- and self-efficacy building exercises, coping strategies, and information about the risks of vaping, benefits of quitting, and cutting down to quit. Keywords COPE, STRESS, SLIP, and MORE provide on-demand support.
This is Quitting: Text message-based intervention for quit vaping support. | 1,304 |
| Assessment Only Control After an initial enrollment message, participants will be contacted periodically to assess e-cigarette use. At the end of the intervention period, they will receive information on how to sign up for This is Quitting if they are interested in the program
Assessment only Control: Assessment only | 1,284 |
| Total | 2,588 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 331 | 290 |
Baseline characteristics
| Characteristic | Total | This is Quitting | Assessment Only Control |
|---|---|---|---|
| Age, Continuous | 20.4 Years STANDARD_DEVIATION 1.7 | 20.4 Years STANDARD_DEVIATION 1.7 | 20.4 Years STANDARD_DEVIATION 1.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 275 Participants | 141 Participants | 134 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2313 Participants | 1163 Participants | 1150 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Income Don't meet basic expenses | 137 Participants | 76 Participants | 61 Participants |
| Income Just meet basic expenses | 778 Participants | 399 Participants | 379 Participants |
| Income Live comfortably | 673 Participants | 324 Participants | 349 Participants |
| Income Meet needs with a little left | 1000 Participants | 505 Participants | 495 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 18 Participants | 11 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 123 Participants | 71 Participants | 52 Participants |
| Race (NIH/OMB) Black or African American | 38 Participants | 19 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 162 Participants | 72 Participants | 90 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 88 Participants | 39 Participants | 49 Participants |
| Race (NIH/OMB) White | 2159 Participants | 1092 Participants | 1067 Participants |
| Region of Enrollment United States | 2588 participants | 1304 participants | 1284 participants |
| Sex/Gender, Customized Gender Female | 1303 Participants | 651 Participants | 652 Participants |
| Sex/Gender, Customized Gender Male | 1253 Participants | 634 Participants | 619 Participants |
| Sex/Gender, Customized Gender Non-binary or other | 26 Participants | 18 Participants | 8 Participants |
| Sex/Gender, Customized Gender Unknown | 6 Participants | 1 Participants | 5 Participants |
| Sexual orientation Not sexual minority (heterosexual) | 2095 Participants | 1061 Participants | 1034 Participants |
| Sexual orientation Sexual minority | 493 Participants | 243 Participants | 250 Participants |
| Student status Current student | 1932 Participants | 976 Participants | 956 Participants |
| Student status Not current student | 656 Participants | 328 Participants | 328 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,304 | 0 / 1,284 |
| other Total, other adverse events | 0 / 1,304 | 0 / 1,284 |
| serious Total, serious adverse events | 0 / 1,304 | 0 / 1,284 |
Outcome results
Primary
Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT)
Number of participant who responded No to the question In the past 30 days, did you vape at all, even a puff of someone else's? Denominator is all randomized participants.
Time frame: 7 months post enrollment
Population: All randomized participants (Intent-to-treat analysis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| This is Quitting | Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT) | 314 Participants |
| Assessment Only Control | Number of Participants With Self-reported 30-day Point Prevalence Abstinence (ITT) | 239 Participants |
Secondary
Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only)
Number of participants with who responded 'No to the question In the past 30 days, did you vape at all, even a puff of someone else's? Denominator is participants with responses only.
Time frame: 7 month post enrollment
Population: 7 month assessment responders only (Responder Only)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| This is Quitting | Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only) | 314 Participants |
| Assessment Only Control | Number of Participants With Self-reported 30-day Point Prevalence Abstinence (Responder Only) | 239 Participants |
Secondary
Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT)
Number of participants who responded No to the question Have you used any vape, even one puff, in the past 7 days? Denominator is all randomized participants.
Time frame: 7 months post enrollment
Population: All randomized participants (intent-to-treat analysis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| This is Quitting | Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT) | 440 Participants |
| Assessment Only Control | Number of Participants With Self-reported 7-day Point Prevalence Abstinence (ITT) | 385 Participants |
Secondary
Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only)
Number of participants who responded No to the question Have you used any vape, even one puff, in the past 7 days? Denominator is those who responded to the question only.
Time frame: 7 months post enrollment
Population: Only 7-month survey responders (responder only analysis)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| This is Quitting | Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only) | 440 Participants |
| Assessment Only Control | Number of Participants With Self-reported 7-day Point Prevalence Abstinence (Responder Only) | 385 Participants |