Trial Outcomes & Findings for BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation (NCT NCT03670264)
NCT ID: NCT03670264
Last Updated: 2021-07-13
Results Overview
Adolescent completion of the tobacco cessation program, defined as the proportion of tobacco users identified in the clinic that enroll, use, and complete the Quitline program compared across the 3 groups
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
10 weeks
Results posted on
2021-07-13
Participant Flow
Participant milestones
| Measure |
Quitline Incentive
The incentive structure emphasizes engaging with the Quitline Delivered Treatment, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the Quitline, for maintaining involvement in the Quitline program (per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the Way to Health (WTH) platform.
|
Tobacco Cessation Incentive
The incentive structure emphasizes quitting regardless of engagement with the Quitline Delivered Treatment (though the Quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, compensation for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the WTH platform.
|
No Financial Incentive
No financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform.
Way to Health (WTH) Platform: The WTH platform is a web-based platform that sends reminder text messages to participants regarding study procedures and has has secure financial tracking and processing systems to manage participant payments, including the ability to track earnings and pay participants via a non-integrated payment system.
Quitline Delivered Treatment: The quitline provides tobacco cessation treatment to individuals who enroll in treatment. This treatment includes 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between proactive calls.
|
|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
Baseline characteristics by cohort
| Measure |
Quitline Incentive
n=5 Participants
The incentive structure emphasizes engaging with the Quitline Delivered Treatment, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the Quitline, for maintaining involvement in the Quitline program (per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the Way to Health (WTH) platform.
|
Tobacco Cessation Incentive
n=5 Participants
The incentive structure emphasizes quitting regardless of engagement with the Quitline Delivered Treatment (though the Quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, compensation for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the WTH platform.
|
No Financial Incentive
n=5 Participants
No financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform.
Way to Health (WTH) Platform: The WTH platform is a web-based platform that sends reminder text messages to participants regarding study procedures and has has secure financial tracking and processing systems to manage participant payments, including the ability to track earnings and pay participants via a non-integrated payment system.
Quitline Delivered Treatment: The quitline provides tobacco cessation treatment to individuals who enroll in treatment. This treatment includes 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between proactive calls.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
18.2 Years
STANDARD_DEVIATION 1.6 • n=5 Participants
|
16.6 Years
STANDARD_DEVIATION 1.1 • n=7 Participants
|
17.6 Years
STANDARD_DEVIATION 2.1 • n=5 Participants
|
17.4 Years
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 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
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
15 participants
n=4 Participants
|
|
Number of participants enrolled in the Quitline
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 10 weeksPopulation: The number of participants who enrolled in the Quitline
Adolescent completion of the tobacco cessation program, defined as the proportion of tobacco users identified in the clinic that enroll, use, and complete the Quitline program compared across the 3 groups
Outcome measures
| Measure |
Quitline Incentive
n=5 Participants
The incentive structure emphasizes engaging with the Quitline Delivered Treatment, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the Quitline, for maintaining involvement in the Quitline program (per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the Way to Health (WTH) platform.
|
Tobacco Cessation Incentive
n=5 Participants
The incentive structure emphasizes quitting regardless of engagement with the Quitline Delivered Treatment (though the Quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, compensation for submitting the cotinine swab and for confirmed quitting (negative salivary cotinine). Study procedures, payments and reminders are managed through the WTH platform.
|
No Financial Incentive
n=5 Participants
No financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform.
|
|---|---|---|---|
|
Program Completion
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 10 weeksConfirmation of abstinence will be measured by assessing if participants salivary cotinine concentration are \<30 ng per milliliter
Outcome measures
Outcome data not reported
Adverse Events
Quitline Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Tobacco Cessation Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
No Financial Incentive
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place