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BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation

BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03670264
Enrollment
15
Registered
2018-09-13
Start date
2018-09-21
Completion date
2021-03-19
Last updated
2021-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Smoking Cessation

Brief summary

More than 90% of adult smokers initiate tobacco use before age 18, making prevention and treatment of adolescent smoking a critical health priority. Behavioral economic interventions utilizing financial incentives can promote smoking cessation in adult populations. No studies have evaluated financial incentives among adolescents to promote engagement in effective tobacco cessation programs through primary care settings. The goal of this study is to to compare, through a pilot, randomized controlled trial, an intervention incentivizing contact with a tobacco cessation program (the Quitline), an intervention incentivizing quitting, or no financial incentive intervention on adolescent smoker enrollment and depth of engagement in the tobacco cessation program.

Detailed description

Context: Cigarette smoking remains a leading preventable cause of death in the United States (U.S.) with substantial morbidity, mortality, and financial costs each year. More than 90% of adult smokers initiate tobacco use before age 18, making prevention and treatment of adolescent tobacco use a critical health priority. Further, e-cigarettes are now the most common tobacco product used by teenagers, and adolescent use of e-cigarettes is strongly associated with transition to cigarette use. Behavioral economic interventions utilizing financial incentives can promote smoking cessation in adult populations. No studies have evaluated financial incentives among adolescents to promote engagement in effective tobacco cessation programs through primary care settings. Objectives: Primary Objective: To compare, through a pilot, randomized controlled trial, an intervention incentivizing contact with the Quitline, an intervention incentivizing quitting, or no financial incentive intervention on adolescent enrollment and depth of engagement in a tobacco cessation program (Free Smoker Quitline). Secondary Objective: To compare cotinine-confirmed 2-month quit rates across the 3 groups, among users who report abstinence. Study Design: This is a randomized controlled trial of a Quitline incentive versus tobacco cessation incentive versus no financial incentive on adolescent engagement with a tobacco cessation program. Setting/Participants: Setting: Primary care sites within the Children's Hospital of Philadelphia (CHOP's) Pediatric Research Consortium along with other non-clinical community settings. 60 adolescent tobacco users will be recruited. Eligibility criteria include adolescents (aged 14-21 years), who speak English, screen positive for tobacco use during their routine well child or acute visit, are interested in quitting, and have a smart phone. Study Interventions and Measures: Adolescents will be randomized to 1 of 3 financial incentive groups: (1) Quitline Incentive: the payment structure emphasizes engaging with the Quitline, with an additional smaller payment for tobacco cessation; (2) Tobacco Cessation Incentive: the payment structure emphasizes quitting regardless of engagement with the quitline (though the quitline will be presented as a helpful tool); and (3) no financial incentive. The Quitline is funded by the Pennsylvania Department of Health and staffed by trained cessation counselors available 24 hours a day, 7 days a week. Outcomes Measures: Objective 1: The main outcome of interest is 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. Objective 2: The secondary outcome is to confirm abstinence, via salivary cotinine concentration of \<30 ng per milliliter at 10 weeks after the start of the study.

Interventions

BEHAVIORALQuitline Incentive

The incentive structure emphasizes engaging with the quitline, 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 (compensation per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative cotinine swab).

BEHAVIORALTobacco Cessation Incentive

The incentive payment structure emphasizes quitting regardless of engagement with the quitline (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, for submitting the cotinine swab and for confirmed quitting (negative cotinine swab).

BEHAVIORALWay 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.

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.

Sponsors

University of Pennsylvania
CollaboratorOTHER
National Center for Advancing Translational Sciences (NCATS)
CollaboratorNIH
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
14 Years to 21 Years
Healthy volunteers
Yes

Inclusion criteria

* Adolescents (aged 14-21 years), male or female, who speak English, screen positive for tobacco use (defined as having smoked cigarette(s) and/or used an e-cigarette product on at least 1 day during the 30 days before the clinical encounter) during their routine well child or acute visit, are interested in quitting, have a smart phone, and provide assent to participate.

Exclusion criteria

* Subjects that do not meet all of the inclusion criteria will not be enrolled.

Design outcomes

Primary

MeasureTime frameDescription
Program Completion10 weeksAdolescent 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

Secondary

MeasureTime frameDescription
Confirmation of Tobacco Abstinence10 weeksConfirmation of abstinence will be measured by assessing if participants salivary cotinine concentration are \<30 ng per milliliter

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
5
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.
5
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.
5
Total15

Baseline characteristics

CharacteristicQuitline IncentiveTobacco Cessation IncentiveNo Financial IncentiveTotal
Age, Continuous18.2 Years
STANDARD_DEVIATION 1.6
16.6 Years
STANDARD_DEVIATION 1.1
17.6 Years
STANDARD_DEVIATION 2.1
17.4 Years
STANDARD_DEVIATION 1.7
Number of participants enrolled in the Quitline1 Participants2 Participants3 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants1 Participants1 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants5 Participants4 Participants14 Participants
Region of Enrollment
United States
5 participants5 participants5 participants15 participants
Sex: Female, Male
Female
1 Participants3 Participants4 Participants8 Participants
Sex: Female, Male
Male
4 Participants2 Participants1 Participants7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 50 / 50 / 5
other
Total, other adverse events
0 / 50 / 50 / 5
serious
Total, serious adverse events
0 / 50 / 50 / 5

Outcome results

Primary

Program Completion

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

Time frame: 10 weeks

Population: The number of participants who enrolled in the Quitline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Quitline IncentiveProgram Completion1 Participants
Tobacco Cessation IncentiveProgram Completion2 Participants
No Financial IncentiveProgram Completion3 Participants
Secondary

Confirmation of Tobacco Abstinence

Confirmation of abstinence will be measured by assessing if participants salivary cotinine concentration are \<30 ng per milliliter

Time frame: 10 weeks

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026