- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05897242
A Smartphone Application (ACT on Vaping) for Vaping Cessation in Young Adults
ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Washington
-
Seattle, Washington, United States, 98109
- Fred Hutch/University of Washington Cancer Consortium
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Ancillary studies
Receive text messages
Other Names:
Use ACT on Vaping smartphone app
Other Names:
|
|
Active Comparator: Arm II (Incentivized text message check-ins)
Participants receive incentivized text messages check-ins assessing their vaping status.
|
Ancillary studies
Receive text messages
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Treatment Satisfaction Rating
Time Frame: 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. |
At 3 months post-randomization
|
|
Change in Readiness to Quit
Time Frame: 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."
|
From baseline to 3 months post-randomization
|
|
Cotinine-confirmed 30-day Point Prevalence Abstinence From All Nicotine and Tobacco
Time Frame: 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.
|
At 3 months post-randomization
|
|
Percentage of Participants With a 24-hour Quit Attempt
Time Frame: 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.
|
At 3 months post-randomization
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jaimee Heffner, Fred Hutch/University of Washington Cancer Consortium
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG1122763
- NCI-2022-10010 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- UG3DA057032 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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