Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant Women
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Best practices for pregnant smokers Five As plus referral to pregnancy-specific tobacco quit line |
Behavioral: Best practices
Other Names:
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| Experimental: 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. |
Behavioral: Best practices
Other Names:
Behavioral: financial incentives
financial incentives provided contingent on biochemically confirmed smoking abstinence
Other Names:
|
| No Intervention: 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 |
Outcome Measures
Primary Outcome Measures
- 7-day point prevalence abstinence levels at final antepartum assessment [collected once per women at approximately 28 weeks gestation in each of the two smoking arms]
Women reports that she has not smoked, not even a puff, in the pst 7 days and self-report is biochemically verified via urine cotinine testing
Secondary Outcome Measures
- 7-day point prevalence abstinence postpartum [assessments at 4, 8, 12, 24, and 52 weeks postpartum]
7-day point-prevalence abstinence will be assessed at weeks 4, 8, 12, 24 and 48 through the 1st year postpartum. Abstinence will be defined as self-report of no smoking in past 7 days, not even a puff, with biochemical verification of self-report using urine cotinine testing
Other Outcome Measures
- birth outcomes (mean birth weight, % of infants meeting criteria for small for gestational age, mean gestational age, % of infants < 37 weeks gestation weeks, % of infants admitted to the Neonatal Intensive Care Unit) [delivery]
birth outcomes will be compared between the three study arms
- Breastfeeding in the two treatment arms [All postpartum assessments]
Compare the two treatment arms on overall percentage of women breastfeeding and percentage breastfeeding and abstinent from smoking
- Infant growth and developmental status in first year of life [24- and 50-weeks postpartum assessments]
Infant growth (length & weight) will be assessed at 24- and 50-weeks assessments; mothers complete the Ages and Stages Questionnaire at those same assessments
- maternal and infant health care utilization during infants first year of life [1 year postpartum]
Investigators will compare maternal and infant healthcare utilization (outpatient and inpatient visits to health care provider, use of prescription medications) between the three study arms during infants 1st year of life
- cost-effectiveness analysis [study entry through 1 year postpartum]
Investigators will compare the cost-effectiveness of the two treatment arms
Eligibility Criteria
Criteria
Inclusion Criteria for two intervention arms:
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report being smokers at the time that they learned of the current pregnancy;
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report smoking in the 7 days prior to the first prenatal care visit with biochemical verification;
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< 25 weeks gestation;
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English speaking;
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plan on remaining in the geographical area through 12months postpartum.
Inclusion Criteria for never-smoker comparison condition:
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report being nonsmokers at the time they learned of the current pregnancy;
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report no smoking in the past 6 month;
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Biochemical verification of non-smoker status;
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report smoking < 100 cigarettes in their lifetime;
Exclusion criteria:
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25 weeks gestation;
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unavailable for routine assessments through 1 year postpartum;
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opioid substitution therapy;
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untreated/unstable serious mental illness
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Vermont, University Health Center Campus | Burlington | Vermont | United States | 05401 |
Sponsors and Collaborators
- University of Vermont
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Centers for Disease Control and Prevention
Investigators
- Principal Investigator: Stephen T Higgins, PhD, University of Vermont
Study Documents (Full-Text)
None provided.More Information
Publications
- 1R01HD075669-01
- R01HD075669-01