Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

257 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Investigators will examine whether adding financial incentives to current best practices for smoking cessation during pregnancy (i.e., referral to pregnancy-specific counseling using a telephone quit line) increases cessation rates and improves infant health. While more expensive upfront compared to best practices alone, the investigators hypothesize that this treatment approach will be economically justified by the later cost savings associated with more women quitting, having healthier babies, and needing less healthcare. It should also help to reduce the greater risk for health problems often seen among those who less well off economically.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Smartphone-based Financial Incentives

NCT03922360

Tobacco Use Disorder

UNKNOWN NA

Financial Incentives for Smoking Cessation Among Mothers

NCT05740098

Cigarette Smoking

COMPLETED NA

Voucher Based Incentives to Treat Pregnant Smokers

NCT01801384

Efficacy of Financial Incentives

COMPLETED NA

Smoking Cessation Intervention in Pregnant Women

NCT03024606

Smoking Cessation

COMPLETED NA

Smoking Cessation for Low-Income Pregnant Women

NCT02211430

Pregnancy Smoking

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Smoking during pregnancy is the leading preventable cause of poor pregnancy outcomes in the U.S. Most pregnant smokers continue smoking through pregnancy producing serious immediate and longer-term adverse health consequences for the infant. Smoking during pregnancy is highly associated with economic disadvantage and a substantive contributor to health disparities.

Efficacious interventions are available, but cessation rates are low (\<20%) and improvements in birth outcomes often modest or absent. Current treatments usually entail relatively brief, lower-cost interventions (e.g., pregnancy specific quit lines). There is broad consensus that more effective interventions are sorely needed. This team of investigators has developed a novel behavioral economic intervention in which women earn financial incentives contingent on smoking abstinence. In a metaanalysis of treatments for smoking during pregnancy, effect sizes achieved with financial incentives were several fold larger than those achieved with lower intensity approaches or medications. The intervention also appears to improve birth outcomes and increase breastfeeding duration. While highly promising, further research is needed in at least three areas. (1) The evidence on birth outcomes and breastfeeding is from studies that combined data across trials rather than a single prospective trial, (2) whether the intervention produces other postpartum improvements in health has not been investigated, and (3) the overall cost-effectiveness of this approach has not been examined.

To examine these unanswered questions, the investigators are proposing a randomized, controlled clinical trial comparing the efficacy and cost effectiveness through one year postpartum of current best practices for smoking cessation during pregnancy vs. best practices plus financial incentives among 230 pregnant, Medicaid recipients. A third condition of 115 pregnant nonsmokers matched to the smokers on sociodemographic and health conditions will be included as well to compare the extent to which the treatments reduce the burden of smoking and to estimate how much more might be accomplished by further improvements in this incentives intervention without exceeding cost-effectiveness.

The investigators hypothesize that best practices plus financial incentives will be more effective than usual care practices alone, that the incentives intervention will be cost effective, and that while adding the incentives reduces a greater proportion of the health and economic burden of smoking than best practices alone, more can be done while remaining cost effective.

Overall, the proposed study has the potential to substantially advance knowledge on cost-effective smoking cessation for pregnant women. Importantly, because of the strong association between smoking during pregnancy and economic disadvantage, the proposed study also has the potential to contribute new knowledge relevant to reducing the serious challenges of health disparities.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cigarette Smoking

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Best practices for pregnant smokers

Five As plus referral to pregnancy-specific tobacco quit line

Group Type EXPERIMENTAL

Best practices

Intervention Type BEHAVIORAL

Best practices plus financial incentives

Best practices plus providing financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.

Group Type EXPERIMENTAL

Best practices

Intervention Type BEHAVIORAL

financial incentives

Intervention Type BEHAVIORAL

financial incentives provided contingent on biochemically confirmed smoking abstinence

Never-smoker comparison condition

We will follow a group of never-smoker pregnant women matched to smokers on key sociodemographic and obstetrical characteristics for purposes of comparisons in birth/health outcomes at delivery and through 1 year postpartum

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Best practices

Intervention Type BEHAVIORAL

financial incentives

financial incentives provided contingent on biochemically confirmed smoking abstinence

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Five As plus referral to pregnancy-specific quit line contingency management

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* report being smokers at the time that they learned of the current pregnancy;
* report smoking in the 7 days prior to the first prenatal care visit with biochemical verification;
* \< 25 weeks gestation;
* English speaking;
* plan on remaining in the geographical area through 12months postpartum.

* report being nonsmokers at the time they learned of the current pregnancy;
* report no smoking in the past 6 month;
* Biochemical verification of non-smoker status;
* report smoking \< 100 cigarettes in their lifetime;

Exclusion Criteria

* \> 25 weeks gestation;
* unavailable for routine assessments through 1 year postpartum;
* opioid substitution therapy;
* untreated/unstable serious mental illness

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No