Trial Outcomes & Findings for A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults (NCT NCT05897242)
NCT ID: NCT05897242
Last Updated: 2025-06-24
Results Overview
We calculated descriptive statistics (mean, standard deviation) for the primary acceptability benchmark of overall satisfaction averaging at least 3.5 on a 1-5 Likert-type scale within the ACT on Vaping arm only. Overall satisfaction was assessed with a 5-point Likert-type item on the 3-month follow-up survey, with response options ranging from (1) "not at all" to (5) "very much." The ACT on Vaping benchmark average of 3.5 falls between ratings of 3="somewhat" and 4="mostly." Higher values are associated with a higher level of satisfaction.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
61 participants
Primary outcome timeframe
At 3 months post-randomization
Results posted on
2025-06-24
Participant Flow
Participants were recruited via the Facebook/Instagram advertising platform. Two hundred individuals were eligible. The final sample comprised 61 participants who were randomized in January 2024.
Participant milestones
| Measure |
Arm I (Act on Vaping App)
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Smartphone app: Use ACT on Vaping smartphone app
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Arm II (Incentivized Text Message Check-ins)
Participants receive incentivized text messages check-ins assessing their vaping status.
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
31
|
30
|
|
Overall Study
COMPLETED
|
23
|
29
|
|
Overall Study
NOT COMPLETED
|
8
|
1
|
Reasons for withdrawal
| Measure |
Arm I (Act on Vaping App)
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Smartphone app: Use ACT on Vaping smartphone app
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Arm II (Incentivized Text Message Check-ins)
Participants receive incentivized text messages check-ins assessing their vaping status.
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
|
Overall Study
Incomplete
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults
Baseline characteristics by cohort
| Measure |
Arm I (Act on Vaping App)
n=31 Participants
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Smartphone app: Use ACT on Vaping smartphone app
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Arm II (Incentivized Text Message Check-ins)
n=30 Participants
Participants receive incentivized text messages check-ins assessing their vaping status.
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.5 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
22 years
STANDARD_DEVIATION 3.6 • n=7 Participants
|
21.8 years
STANDARD_DEVIATION 3.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
30 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Vaping frequency (past 30 days)
Once a week or more but not daily
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Vaping frequency (past 30 days)
At least daily
|
25 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Vaping intensity (past 30 days)
0-4 times/day
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Vaping intensity (past 30 days)
5-9 times/day
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Vaping intensity (past 30 days)
10-14 times/day
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Vaping intensity (past 30 days)
15-19 times/day
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Vaping intensity (past 30 days)
20-29 times/day
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Vaping intensity (past 30 days)
30+ times/day
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Other tobacco product use (past 30 days)
Not at all
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Other tobacco product use (past 30 days)
Less than once a month
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Other tobacco product use (past 30 days)
Once a month or more, but less than once a week
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Other tobacco product use (past 30 days)
Once a week or more, but not daily
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Other tobacco product use (past 30 days)
At least daily
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
24-hour quit attempts (past 12 months)
At least 1 attempt
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
24-hour quit attempts (past 12 months)
No attempts
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Contemplation Ladder Score
High quit readiness (>5)
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Contemplation Ladder Score
Low quit readiness (≤ 5)
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
e-cigarette Fagerström Test for Nicotine Dependence (e-FTND)
|
5 units on a scale
STANDARD_DEVIATION 2.2 • n=5 Participants
|
5.4 units on a scale
STANDARD_DEVIATION 2.5 • n=7 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 2.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: At 3 months post-randomizationPopulation: We calculated descriptive statistics (e.g., means, proportions) for the ACT on Vaping treatment group to evaluate the go/no-go criteria and to compare the two arms on other indicators of treatment acceptability and efficacy. Given that pilot and feasibility trials are not appropriate designs for testing hypotheses regarding the efficacy of interventions, we focused on descriptive differences as an alternative to hypothesis testing.
We calculated descriptive statistics (mean, standard deviation) for the primary acceptability benchmark of overall satisfaction averaging at least 3.5 on a 1-5 Likert-type scale within the ACT on Vaping arm only. Overall satisfaction was assessed with a 5-point Likert-type item on the 3-month follow-up survey, with response options ranging from (1) "not at all" to (5) "very much." The ACT on Vaping benchmark average of 3.5 falls between ratings of 3="somewhat" and 4="mostly." Higher values are associated with a higher level of satisfaction.
Outcome measures
| Measure |
Arm I (Act on Vaping App)
n=21 Participants
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Smartphone app: Use ACT on Vaping smartphone app
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Arm II (Incentivized Text Message Check-ins)
Participants receive incentivized text messages check-ins assessing their vaping status.
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
|---|---|---|
|
Overall Treatment Satisfaction Rating
|
3.8 units on a scale
Standard Deviation 1.3
|
—
|
PRIMARY outcome
Timeframe: From baseline to 3 months post-randomizationPopulation: We calculated descriptive statistics (e.g., means, proportions) for the ACT on Vaping treatment group to evaluate the go/no-go criteria and to compare the two arms on other indicators of treatment acceptability and efficacy.
Will evaluate differences of Contemplation Ladder scores. The 1-item Contemplation Ladder, scores range from 0-10, was used to assess readiness to quit using e-cigarettes. The higher the score, the more ready the person is to make a change. The anchor for the cut-off score of 5, indicating high vs. low quit readiness, is "Think I should quit but not quite ready."
Outcome measures
| Measure |
Arm I (Act on Vaping App)
n=24 Participants
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Smartphone app: Use ACT on Vaping smartphone app
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Arm II (Incentivized Text Message Check-ins)
n=29 Participants
Participants receive incentivized text messages check-ins assessing their vaping status.
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
|---|---|---|
|
Change in Readiness to Quit
|
0.96 units on a scale
Standard Deviation 2.0
|
0.72 units on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: At 3 months post-randomizationMaking a 24-hour quit attempt between baseline and 3-month follow-up was assessed via self-report at the 3-month follow-up survey. The percentage of participants with self-reported 24-hour quit attempts is evaluated descriptively.
Outcome measures
| Measure |
Arm I (Act on Vaping App)
n=24 Participants
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Smartphone app: Use ACT on Vaping smartphone app
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Arm II (Incentivized Text Message Check-ins)
n=29 Participants
Participants receive incentivized text messages check-ins assessing their vaping status.
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
|---|---|---|
|
Percentage of Participants With a 24-hour Quit Attempt
|
21 Participants
|
22 Participants
|
PRIMARY outcome
Timeframe: At 3 months post-randomizationComplete case, self-reported 30-day abstinence from all nicotine and tobacco products at 3 months, confirmed via saliva cotinine testing. Differences were evaluated descriptively.
Outcome measures
| Measure |
Arm I (Act on Vaping App)
n=24 Participants
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Smartphone app: Use ACT on Vaping smartphone app
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Arm II (Incentivized Text Message Check-ins)
n=29 Participants
Participants receive incentivized text messages check-ins assessing their vaping status.
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
|---|---|---|
|
Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco
|
1 Participants
|
0 Participants
|
Adverse Events
Arm I (Act on Vaping App)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm II (Incentivized Text Message Check-ins)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Act on Vaping App)
n=31 participants at risk
Participants receive supportive messages and use the ACT on Vaping smartphone app. They also receive incentivized text message check-ins assessing their vaping status.
Smartphone app: Use ACT on Vaping smartphone app
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
Arm II (Incentivized Text Message Check-ins)
n=30 participants at risk
Participants receive incentivized text messages check-ins assessing their vaping status.
Text Message: Receive text messages
Survey Administration: Ancillary studies
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COVID-19 infection
|
0.00%
0/31 • Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
|
|
Psychiatric disorders
Worsening of pre-existing mental health condition
|
0.00%
0/31 • Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
|
|
Cardiac disorders
Lowered resting heart rate
|
3.2%
1/31 • Number of events 1 • Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
|
0.00%
0/30 • Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
|
|
Skin and subcutaneous tissue disorders
Burn on inner thigh.
|
0.00%
0/31 • Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
|
3.3%
1/30 • Number of events 1 • Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).
Adverse events were collected by a web-based survey, and their relationship to the intervention was adjudicated by an independent medical monitor.
|
Additional Information
Jaimee Heffner, Associate Professor
Fred Hutchinson Cancer Center
Phone: 2066677314
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place