A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults

OUTLINE:

Participants are randomized to 1 of 2 arms.

ARM I: Participants use the ACT on Vaping smartphone app and text messaging program and receive incentivized text messages assessing their vaping status.

ARM II: Participants receive incentivized text messages check-ins assessing their vaping status.

• Smartphone app (Behavioral), also known as ACT on Vaping: Use ACT on Vaping smartphone app
• Text Message (Other), also known as SMS Text: Receive text messages
• Survey Administration (Other): Ancillary studies

Primary outcomes

• Overall Treatment Satisfaction Rating [At 3 months post-randomization]: 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.
• Change in Readiness to Quit [From baseline to 3 months post-randomization]: 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."
• Percentage of Participants With a 24-hour Quit Attempt [At 3 months post-randomization]: Making 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.
• Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco [At 3 months post-randomization]: Complete case, self-reported 30-day abstinence from all nicotine and tobacco products at 3 months, confirmed via saliva cotinine testing. Differences were evaluated descriptively.

Sex: All, ages: 18 Years to 30 Years, accepts healthy volunteers

Inclusion Criteria:

* Age 18-30.
* Current weekly user of e-cigarette product(s).
* Owns an Android phone or iPhone.
* Has an email address.
* United States (US) resident, with a US mailing address.
* Willing to complete all study procedures.

Exclusion Criteria:

* Currently using other tobacco cessation treatments at the time of screening, including pharmacotherapy or behavioral support (note: use of these treatments is allowable during trial participation).
* Member of the same household as another research participant.

Participant flow

Outcome results

• Overall Treatment Satisfaction Rating (Primary), Mean, units on a scale: Arm I (Act on Vaping App) 3.8 +/- 1.3
• Change in Readiness to Quit (Primary), Mean, units on a scale: Arm I (Act on Vaping App) 0.96 +/- 2.0; Arm II (Incentivized Text Message Check-ins) 0.72 +/- 1.7
• Percentage of Participants With a 24-hour Quit Attempt (Primary), Count of participants, Participants: Arm I (Act on Vaping App) 21; Arm II (Incentivized Text Message Check-ins) 22
• Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco (Primary), Count of participants, Participants: Arm I (Act on Vaping App) 1; Arm II (Incentivized Text Message Check-ins) 0

Adverse events

Time frame: Adverse events were collected by a web-based survey (on Day 21, 42, 63, and at the 3-month follow-up time point).

Other adverse events by term

Limitations and caveats: A limitation of this study is the small sample size, which, while appropriate for a pilot study, does not allow for a definitive evaluation of acceptability or efficacy and limits the generalizability of the findings. Additionally, the cotinine testing for biochemical verification of abstinence was not directly observed, leaving open the possibility that the test could have been completed by someone other than the participant.

• Results publication: Heffner JL, Baker K, Georgiou K, Graham AL, Kelly MM, Konstantinou P, Lamprou E, Lele C, Lok KZ, Orzechowski M, Ruiz RA, Serfozo E, Karekla M. ACT on Vaping: Pilot Randomized Controlled Trial of a Novel Digital Health App With Text Messaging for Young Adult Vaping Cessation. Nicotine Tob Res. 2026 Apr 22;28(5):720-730. doi: 10.1093/ntr/ntaf112. PMID 40411791

• Study Protocol and Statistical Analysis Plan (PDF, 2024-05-10)
• Informed Consent Form (PDF, 2023-12-20)

• Jaimee Heffner, Principal investigator, Fred Hutch/University of Washington Cancer Consortium

NIH grants: UG3DA057032