Smoking CessationNCT03670264
BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
A study testing Quitline Incentive, Tobacco Cessation Incentive and Way to Health (WTH) Platform in people with Smoking Cessation, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Quitline Incentive, Tobacco Cessation Incentive and Way to Health (WTH) Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2018to 19 Mar 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Subjects that do not meet all of the inclusion criteria will not be enrolled.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia, Care Network
Philadelphia, Pennsylvania, 19146
About this study
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.
Read the 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.
- Conditions
- Smoking Cessation
- Being tested
- Quitline Incentive, Tobacco Cessation Incentive, Way to Health (WTH) Platform, Quitline Delivered Treatment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quitline IncentiveBehavioural
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).
Tobacco Cessation IncentiveBehavioural
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).
Way to Health (WTH) PlatformBehavioural
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 TreatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Quitline Incentive | Experimental | 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. Receives: Behavioral: Quitline Incentive; Behavioral: Way to Health (WTH) Platform; Behavioral: Quitline Delivered Treatment |
| Tobacco Cessation Incentive | Experimental | 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. Receives: Behavioral: Tobacco Cessation Incentive; Behavioral: Way to Health (WTH) Platform; Behavioral: Quitline Delivered Treatment |
| No Financial Incentive | Placebo comparator | No financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform. Receives: Behavioral: Way to Health (WTH) Platform; Behavioral: Quitline Delivered Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 10 weeks
Secondary outcomes (1)
Confirmation of Tobacco Abstinence
Confirmation of abstinence will be measured by assessing if participants salivary cotinine concentration are <30 ng per milliliter
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2018
- Study start21 Sep 2018
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Why it stopped: Despite efforts to recruit and enroll adolescents, identifying cigarette and e-cigarette users proved challenging. The study team was unable to meet the recruitment goal of 60 adolescents.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Sponsor
- Investigators
- Brian Jenssen, MD, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03670264
- Sponsor's protocol ID
- 17-014620
- Other IDs
- UL1TR001878
- Status last verified
- Jul 2021
- First submitted
- 12 Sep 2018
- Last updated
- 13 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BE Smokefree: Behavioral Economics Incentives to Engage Adolescents in Smoking Cessation
- ClinicalTrials.gov ID
- NCT03670264
- Acronym / sponsor ID
- 17-014620
- Conditions
- Smoking Cessation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Despite efforts to recruit and enroll adolescents, identifying cigarette and e-cigarette users proved challenging. The study team was unable to meet the recruitment goal of 60 adolescents.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, National Center for Advancing Translational Sciences (NCATS)
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 13 Sep 2018 (actual)
- Results
- Posted 13 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Quitline Incentive | Experimental | Behavioral: Quitline Incentive, Behavioral: Way to Health (WTH) Platform, Behavioral: Quitline Delivered TreatmentThe 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 | Experimental | Behavioral: Tobacco Cessation Incentive, Behavioral: Way to Health (WTH) Platform, Behavioral: Quitline Delivered TreatmentThe 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 | Placebo comparator | Behavioral: Way to Health (WTH) Platform, Behavioral: Quitline Delivered TreatmentNo financial incentive to engage in Quitline Delivered Treatment or report abstinence. Study procedures and reminders are managed through the WTH platform. |
Who may qualify
- Ages
- 14 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Subjects that do not meet all of the inclusion criteria will not be enrolled.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quitline IncentiveThe 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). | Behavioural | Quitline Incentive |
| Tobacco Cessation IncentiveThe 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). | Behavioural | Tobacco Cessation Incentive |
| Way to Health (WTH) PlatformThe 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. | Behavioural | No Financial Incentive, Quitline Incentive, Tobacco Cessation Incentive |
| Quitline Delivered TreatmentThe 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. | Behavioural | No Financial Incentive, Quitline Incentive, Tobacco Cessation Incentive |
Primary outcome
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
1 secondary outcome
Confirmation of Tobacco Abstinence
Time frame: 10 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Smoking Cessation
Recruiting
Scalable TELeheaLth Cancer CARe: The STELLAR Program to Treat Cancer Risk Behaviors
Obesity, Smoking Cessation
Not yet recruiting
Smoking Cessation Program for Lao People With HIV
Smoking Cessation, HIV
RecruitingPhase 3
Studying NMDA and Sigma-1 in Smoking Cessation Treatment (SUMMIT)
Smoking Cessation
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Not yet recruitingObservational study
PROMETHEE: A Shared Interregional Tele-Tobacco Cessation Platform Embedded Within the IMPULSION Lung Cancer Screening Program
Smoking Cessation, Lung Cancer Screening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Jenssen, MD principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quitline Incentive, Tobacco Cessation Incentive and Way to Health (WTH) Platform in people with Smoking Cessation, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Program Completion (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.