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

• ClinicalTrials.gov Identifier: NCT03670264
• Recruitment Status: Terminated
• First Posted: September 13, 2018
• Results First Posted: July 13, 2021
• Last Update Posted: July 13, 2021
• Sponsor: Children's Hospital of Philadelphia
• Collaborators: University of Pennsylvania; National Center for Advancing Translational Science (NCATS)
• Information provided by (Responsible Party): Children's Hospital of Philadelphia

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Smoking Cessation	Behavioral: Quitline Incentive; Behavioral: Tobacco Cessation Incentive; Behavioral: Way to Health (WTH) Platform; Behavioral: Quitline Delivered Treatment	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
• Actual Study Start Date: September 21, 2018
• Actual Primary Completion Date: March 19, 2021
• Actual Study Completion Date: March 19, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: 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.	Behavioral: Quitline 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).; Behavioral: 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.; Behavioral: 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.
Experimental: 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.	Behavioral: Tobacco 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).; Behavioral: 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.; Behavioral: 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.
Placebo Comparator: 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.	Behavioral: 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.; Behavioral: 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.

Outcome Measures

Primary Outcome Measures :

1. Program Completion [ Time Frame: 10 weeks ]
   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

Secondary Outcome Measures :

1. Confirmation of Tobacco Abstinence [ Time Frame: 10 weeks ]
   Confirmation of abstinence will be measured by assessing if participants salivary cotinine concentration are <30 ng per milliliter

Eligibility Criteria

• Ages Eligible for Study: 14 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Pennsylvania

Children's Hospital of Philadelphia, Care Network

Philadelphia, Pennsylvania, United States, 19146

Sponsors and Collaborators

Children's Hospital of Philadelphia

University of Pennsylvania

National Center for Advancing Translational Science (NCATS)

Investigators

• Principal Investigator: Brian Jenssen, MD; Children's Hospital of Philadelphia

  Study Documents (Full-Text)

Documents provided by Children's Hospital of Philadelphia:

Study Protocol and Statistical Analysis Plan  [PDF] September 18, 2020

More Information

• Responsible Party: Children's Hospital of Philadelphia
• ClinicalTrials.gov Identifier: NCT03670264
• Other Study ID Numbers: 17-014620; UL1TR001878 ( U.S. NIH Grant/Contract )
• First Posted: September 13, 2018
• Results First Posted: July 13, 2021
• Last Update Posted: July 13, 2021
• Last Verified: July 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No