Cigarette SmokingNCT05740098
Financial Incentives for Smoking Cessation Among Mothers
A study testing Best Practices, Financial Incentives and Nicotine Replacement Therapy in people with Cigarette Smoking, run by University of Vermont at 1 site in United States.
Trial summary
Investigators will examine whether adding financial incentives and nicotine replacement dual therapy to current best practices for smoking cessation (i.e. referral to counseling using a telephone quit line) increases cessation rates in mothers and reduces second-hand smoke exposure in children. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cigarette Smoking
- What is being tested?
- Best Practices, Financial Incentives and Nicotine Replacement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Oct 2020
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Expresses interest in quitting smoking
- Express willingness to initiate NRT
- Mother is ≥ 18 years of age
- Self-reported smoking ≥ 10 cigarettes per day for ≥ 1 year, biochemically verified
- Mother has a child < 12 years of age
- Child resides with mother full-time
Show all 11Show fewer
- Not currently using any other tobacco cessation medications (e.g. Chantix) or NRT, or willing to stop use prior to participation in the study
- Lives in Chittenden County, Vermont or surrounding counties
- Plans on remaining in the geographical area for the next 12 months
- English-speaking
- Willing to let child participate in the study
Who cannot join
- Failing to meet any of the above criteria
- Has medical contraindications to NRT products
- Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for moderate or severe alcohol or drug dependence other than nicotine in the prior 12 months (those on opioid substitution therapy are allowed)
- Current/past psychotic disorder
- Being suicidal
- Currently pregnant or trying to become pregnant in the next 12 months
- Incarceration
- Refusal to participate in study
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Vermont Medical Center
Burlington, Vermont, 05401
About this study
Official title: Financial Incentives for Smoking Cessation Among Disadvantaged Mothers With Young Children
Investigators will examine whether adding financial incentives and nicotine replacement dual therapy to current best practices for smoking cessation (i.e. referral to counseling using a telephone quit line) increases cessation rates in mothers and reduces second-hand smoke exposure in children. While perhaps more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be a more cost-effective cessation intervention.
Read the detailed description
Smoking prevalence among disadvantaged mothers remains at strikingly high levels (40-60%). Disadvantaged women are more likely to begin smoking at an earlier age, be heavier smokers, be nicotine dependent, and fail in their efforts to quit smoking (Kandel et al., 2009). These women and their children also suffer higher rates of smoking-related adverse health consequences.
Despite widespread knowledge of the harmful effects of secondhand smoke exposure (SHSe), estimates are that 85% of children from low-income U.S. families experience chronic exposure. Children exposed to SHS are at increased risk for numerous serious health problems, including sudden infant death syndrome, more severe asthma, lower respiratory infections, and chronic middle ear disease, and maternal smoking is a particularly significant contributor to this increased morbidity and mortality. SHSe is also a substantial economic burden on the U.S. healthcare system, being estimated to increase direct medical and life-lost costs by > $5 billion annually.
Interventions developed to reduce children's SHSe have aimed to (1) decrease parental smoking around their children, (2) increase parental smoking cessation, or (3) both. Since smoking by a child's mother is a particularly significant contributor to SHSe, interventions have typically targeted smoking mothers. Regarding efforts to decrease smoking around children, studies testing relatively low-intensity interventions (e.g., written materials, brief advice) have failed to change exposure levels, while those testing more intensive interventions have had more success decreasing children's SHSe, with at least some instances of biochemically-verified changes.
Clearly, more effective smoking-cessation interventions for mothers are needed to meet the public health priority of reducing SHSe among children. The investigators recognize that maternal smoking cessation will not eliminate SHSe among children since many (~40%) live with more than one smoker. However, the evidence is clear that smoking mothers are the primary contributors to their children's SHSe, making them the obvious first target. The overarching goal of this project is to develop an efficacious, cost-effective incentive-based smoking cessation intervention that is combined with state-of-the-art smoking-cessation pharmacotherapy practices to optimize outcomes.
Participants will be 250 mothers (10 pilot and 80 per treatment condition) recruited from our university-affiliated hospital's pediatric practice, other pediatric and family medicine practices throughout the county in which our clinic is located, local offices for Women, Infants, and Children (WIC), and other recruitment strategies (e.g., ads on Facebook). Participants will be randomly assigned to one of three treatment conditions: (1) usual care for smoking cessation and protecting children from SHSe, (2) usual care combined with incentives for objectively verified smoking abstinence, and (3) usual care combined with incentives and pharmacotherapy using innovative procedures to enhance its efficacy.
The investigators believe combining pharmacotherapies with incentives could be an effective strategy for surmounting adherence problems in this population by assuring that women have regular contact with clinic staff and thereby providing staff opportunities to problem-solve obstacles that may have arisen around adherence or side effects and to regularly underscore the importance and potential benefits of using the medications as prescribed.
The investigators hypothesize that each of the interventions with incentives will increase smoking abstinence compared to usual care alone, but that the largest magnitude and most cost-effective treatment effects will be achieved by combining incentives with pharmacotherapy. They also hypothesize that (a) both incentives interventions will decrease child cotinine levels significantly more than usual care alone and (b) that SHSe levels will be significantly lower among children of abstainers than smokers.
Taken together, developing efficacious and cost-effective interventions to increase smoking cessation interventions among disadvantaged mothers and reducing SHSe among their children is an important U.S. public health priority. The financial incentives model is effective with other treatment-recalcitrant populations and we believe has the potential to meet this important public-health challenge. Behavioral-economic theory suggests that the efficacy of the cessation intervention is at least in part attributable to providing smaller, more immediate incentives for success that act to bridge the temporal delay to the larger naturalistic rewards of improved health outcomes for mother and child. The investigators will continue to investigate the behavioral-economic processes involved in smoking among disadvantaged women and in individual differences in treatment response. Lastly, there is rapidly growing interest in the use of incentives to promote healthy behavior change in disadvantaged populations. The proposed project and others like it will be important to assuring that the necessary scientific knowledge is available to support that effort.
- Conditions
- Cigarette Smoking
- Being tested
- Best Practices, Financial Incentives, Nicotine Replacement Therapy
- Keywords
- Cigarette Smoking, Quit Smoking, Mothers
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticesBehavioural
Also called Usual Care
Five As plus referral to a quit line
Financial IncentivesBehavioural
Also called Contingency Management
Financial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date.
Nicotine Replacement TherapyDrug
Also called NRT
Nicotine patches and gum/lozenge provided together for dual therapy
| Study group | Role | What they receive |
|---|---|---|
| Best practices | Experimental | Participants will receive the Five As plus a referral to a quit line. Receives: Behavioral: Best Practices |
| Best practices and financial incentives | Experimental | Participants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence Receives: Behavioral: Best Practices; Behavioral: Financial Incentives |
| Best practices, financial incentives, and NRT | Experimental | Participants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy. Receives: Behavioral: Best Practices; Behavioral: Financial Incentives; Drug: Nicotine Replacement Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day Point Prevalence Smoking Abstinence Levels
Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms.
Measured: Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms
Objective Measure of Child Secondhand Smoke Exposure (SHSe)
SHSe will be defined as the level of cotinine measured in the urine of the youngest child at baseline, 6-, 12-, and 24-weeks following the mother's quit date. SHSe outcomes will be compared between the three treatment arms and between children of abstainers versus smokers independent of treatment condition. We hypothesize being able to detect greater reductions from baseline levels in the incentives compared to Best Practices treatment conditions and among abstainers compared to smokers. We report main effects of treatment condition as geometric means (+/- SEM) collapsed across the three assessment times for each treatment condition controlling for baseline values.
Measured: Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit date
Secondary outcomes (4)
Continuous Abstinence
Continuous abstinence will be defined as self-report of no smoking in the past 7 days at each time point, not even a puff, with biochemical verification via breath CO and urine cotinine. Continuous abstinence from quit date through 24 week assessment will be compared between the three treatment arms.
Measured: 24 weeks following quit date
7-day Point Prevalence Abstinence at 48-week Follow-up Assessment
Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath CO and urine cotinine. We will use this data to estimate relapse rates across treatment arms and for use in comparing SHSe levels in children of abstainers versus smokers.
Measured: 48 weeks following quit date
Smoking Abstinence
Biochemically-verified 7-day point-prevalence smoking abstinence.
Measured: Assessed once per woman at 6-, 12-, 24-, and 48-weeks following quit date.
Smoking Abstinence
Biochemically-verified 7-day point-prevalence smoking abstinence.
Measured: Collected once per woman at baseline, 6-, 12-, 24-, and 48-weeks following quit date.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study startJun 2015
- Primary completionDec 2019
- Study completionOct 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Stephen T. Higgins, PhD, University of Vermont
- Investigators
- Stephen T Higgins, PhD, Study director, University of Vermont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740098
- Sponsor's protocol ID
- 5R01HD078332
- Other IDs
- R01HD078332
- Status last verified
- Feb 2023
- First submitted
- 7 Dec 2018
- Last updated
- 28 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Higgins ST, Plucinski S, Orr E, Nighbor TD, Coleman SRM, Skelly J, DeSarno M, Bunn J. Randomized clinical trial examining financial incentives for smoking cessation among mothers of young children and possible impacts on child secondhand smoke exposure. Prev Med. 2023 Nov;176:107651. doi: 10.1016/j.ypmed.2023.107651. Epub 2023 Jul 30.
PubMed 37527730
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives for Smoking Cessation Among Disadvantaged Mothers With Young Children
- ClinicalTrials.gov ID
- NCT05740098
- Acronym / sponsor ID
- 5R01HD078332
- Conditions
- Cigarette Smoking
- Keywords
- Cigarette Smoking, Quit Smoking, Mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- University of VermontUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 22 Feb 2023 (actual)
- Results
- Posted 28 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators will examine whether adding financial incentives and nicotine replacement dual therapy to current best practices for smoking cessation (i.e. referral to counseling using a telephone quit line) increases cessation rates in mothers and reduces second-hand smoke exposure in children. While perhaps more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be a more cost-effective cessation intervention.
Detailed description
Smoking prevalence among disadvantaged mothers remains at strikingly high levels (40-60%). Disadvantaged women are more likely to begin smoking at an earlier age, be heavier smokers, be nicotine dependent, and fail in their efforts to quit smoking (Kandel et al., 2009). These women and their children also suffer higher rates of smoking-related adverse health consequences.
Despite widespread knowledge of the harmful effects of secondhand smoke exposure (SHSe), estimates are that 85% of children from low-income U.S. families experience chronic exposure. Children exposed to SHS are at increased risk for numerous serious health problems, including sudden infant death syndrome, more severe asthma, lower respiratory infections, and chronic middle ear disease, and maternal smoking is a particularly significant contributor to this increased morbidity and mortality. SHSe is also a substantial economic burden on the U.S. healthcare system, being estimated to increase direct medical and life-lost costs by > $5 billion annually.
Interventions developed to reduce children's SHSe have aimed to (1) decrease parental smoking around their children, (2) increase parental smoking cessation, or (3) both. Since smoking by a child's mother is a particularly significant contributor to SHSe, interventions have typically targeted smoking mothers. Regarding efforts to decrease smoking around children, studies testing relatively low-intensity interventions (e.g., written materials, brief advice) have failed to change exposure levels, while those testing more intensive interventions have had more success decreasing children's SHSe, with at least some instances of biochemically-verified changes.
Clearly, more effective smoking-cessation interventions for mothers are needed to meet the public health priority of reducing SHSe among children. The investigators recognize that maternal smoking cessation will not eliminate SHSe among children since many (~40%) live with more than one smoker. However, the evidence is clear that smoking mothers are the primary contributors to their children's SHSe, making them the obvious first target. The overarching goal of this project is to develop an efficacious, cost-effective incentive-based smoking cessation intervention that is combined with state-of-the-art smoking-cessation pharmacotherapy practices to optimize outcomes.
Participants will be 250 mothers (10 pilot and 80 per treatment condition) recruited from our university-affiliated hospital's pediatric practice, other pediatric and family medicine practices throughout the county in which our clinic is located, local offices for Women, Infants, and Children (WIC), and other recruitment strategies (e.g., ads on Facebook). Participants will be randomly assigned to one of three treatment conditions: (1) usual care for smoking cessation and protecting children from SHSe, (2) usual care combined with incentives for objectively verified smoking abstinence, and (3) usual care combined with incentives and pharmacotherapy using innovative procedures to enhance its efficacy.
The investigators believe combining pharmacotherapies with incentives could be an effective strategy for surmounting adherence problems in this population by assuring that women have regular contact with clinic staff and thereby providing staff opportunities to problem-solve obstacles that may have arisen around adherence or side effects and to regularly underscore the importance and potential benefits of using the medications as prescribed.
The investigators hypothesize that each of the interventions with incentives will increase smoking abstinence compared to usual care alone, but that the largest magnitude and most cost-effective treatment effects will be achieved by combining incentives with pharmacotherapy. They also hypothesize that (a) both incentives interventions will decrease child cotinine levels significantly more than usual care alone and (b) that SHSe levels will be significantly lower among children of abstainers than smokers.
Taken together, developing efficacious and cost-effective interventions to increase smoking cessation interventions among disadvantaged mothers and reducing SHSe among their children is an important U.S. public health priority. The financial incentives model is effective with other treatment-recalcitrant populations and we believe has the potential to meet this important public-health challenge. Behavioral-economic theory suggests that the efficacy of the cessation intervention is at least in part attributable to providing smaller, more immediate incentives for success that act to bridge the temporal delay to the larger naturalistic rewards of improved health outcomes for mother and child. The investigators will continue to investigate the behavioral-economic processes involved in smoking among disadvantaged women and in individual differences in treatment response. Lastly, there is rapidly growing interest in the use of incentives to promote healthy behavior change in disadvantaged populations. The proposed project and others like it will be important to assuring that the necessary scientific knowledge is available to support that effort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Best practices | Experimental | Behavioral: Best PracticesParticipants will receive the Five As plus a referral to a quit line. |
| Best practices and financial incentives | Experimental | Behavioral: Best Practices, Behavioral: Financial IncentivesParticipants will receive the Five As, a referral to a quit line, and financial incentives contingent on biochemically confirmed smoking abstinence |
| Best practices, financial incentives, and NRT | Experimental | Behavioral: Best Practices, Behavioral: Financial Incentives, Drug: Nicotine Replacement TherapyParticipants will receive the Five As, a referral to a quit line, financial incentives contingent on biochemically confirmed smoking abstinence, and nicotine replacement therapy (NRT) provided in the form of both nicotine patches and gum/lozenge for dual therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Expresses interest in quitting smoking
- Express willingness to initiate NRT
- Mother is ≥ 18 years of age
- Self-reported smoking ≥ 10 cigarettes per day for ≥ 1 year, biochemically verified
- Mother has a child < 12 years of age
Key exclusion criteria (8 listed)
- Failing to meet any of the above criteria
- Has medical contraindications to NRT products
- Meeting Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for moderate or severe alcohol or drug dependence other than nicotine in the prior 12 months (those on opioid substitution therapy are allowed)
- Current/past psychotic disorder
- Being suicidal
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 |
|---|---|---|
| Best PracticesAlso: Usual CareFive As plus referral to a quit line | Behavioural | Best practices, Best practices and financial incentives, Best practices, financial incentives, and NRT |
| Financial IncentivesAlso: Contingency ManagementFinancial incentives provided contingent on biochemically confirmed smoking abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks following quit date. | Behavioural | Best practices and financial incentives, Best practices, financial incentives, and NRT |
| Nicotine Replacement TherapyAlso: NRTNicotine patches and gum/lozenge provided together for dual therapy | Drug | Best practices, financial incentives, and NRT |
Primary outcome
7-day Point Prevalence Smoking Abstinence Levels
Time frame: Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms
Point prevalence abstinence will be defined as self-report of no smoking in the past 7 days, not even a puff, with biochemical verification via breath carbon monoxide (CO) and urine cotinine. Abstinence at the 12-week (end of treatment) and 24-week assessment will be compared between the three treatment arms.
Objective Measure of Child Secondhand Smoke Exposure (SHSe)
Time frame: Collected twice per child at baseline, and once at approximately 6-, 12- and 24-weeks following quit date
SHSe will be defined as the level of cotinine measured in the urine of the youngest child at baseline, 6-, 12-, and 24-weeks following the mother's quit date. SHSe outcomes will be compared between the three treatment arms and between children of abstainers versus smokers independent of treatment condition. We hypothesize being able to detect greater reductions from baseline levels in the incentives compared to Best Practices treatment conditions and among abstainers compared to smokers. We report main effects of treatment condition as geometric means (+/- SEM) collapsed across the three assessment times for each treatment condition controlling for baseline values.
4 secondary outcomes
Continuous Abstinence
Time frame: 24 weeks following quit date
7-day Point Prevalence Abstinence at 48-week Follow-up Assessment
Time frame: 48 weeks following quit date
Smoking Abstinence
Time frame: Assessed once per woman at 6-, 12-, 24-, and 48-weeks following quit date.
Smoking Abstinence
Time frame: Collected once per woman at baseline, 6-, 12-, 24-, and 48-weeks following quit date.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37527730Higgins ST, Plucinski S, Orr E, Nighbor TD, Coleman SRM, Skelly J, DeSarno M, Bunn J. Randomized clinical trial examining financial incentives for smoking cessation among mothers of young children and possible impacts on child secondhand smoke exposure. Prev Med. 2023 Nov;176:107651. doi: 10.1016/j.ypmed.2023.107651. Epub 2023 Jul 30.
- Individual participant dataSharing planned: No
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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.
Stephen T Higgins, PhD study director
University of Vermont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practices, Financial Incentives and Nicotine Replacement Therapy in people with Cigarette Smoking, run by University of Vermont 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 11 inclusion and 8 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: finished, as of the sponsor's last update on 28 Jul 2023. 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. 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 28 Jul 2023). 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?
7-day Point Prevalence Smoking Abstinence Levels (time frame: Collected once per woman at approximately 12- and 24- weeks following quit date in each of the three smoking arms). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05740098, which also lists 1 linked publication.
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 28 Jul 2023.