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Clinical Trials/NCT02210832
NCT02210832CompletedNot Applicable

Financial Incentives for Smoking Cessation Among Disadvantaged Pregnant

University of Vermont1 site in 1 country257 target enrollmentStarted: January 31, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
257
Locations
1
Primary Endpoint
7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment

Study Overview

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.

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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •for two intervention arms:
  • •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.
  • •Inclusion Criteria for never-smoker comparison condition:
  • •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

Arms & Interventions

Best practices for pregnant smokers

Experimental

Five As plus referral to pregnancy-specific tobacco quit line

Intervention: Best practices (Behavioral)

Best practices plus financial incentives

Experimental

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.

Intervention: Best practices (Behavioral)

Best practices plus financial incentives

Experimental

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.

Intervention: financial incentives (Behavioral)

Never-smoker comparison condition

No Intervention

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

Outcomes

Primary Outcomes

7-day Point Prevalence Abstinence Levels at Final Antepartum Assessment

Time Frame: collected once per women at approximately 28-weeks gestation in each of the two smoking arms

Abstinence was defined as woman reports that she has not smoked, not even a puff, in the past 7 days and self-report is biochemically verified via urine cotinine testing

Secondary Outcomes

  • 7-day Point Prevalence Abstinence Postpartum(Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum)
  • Breastfeeding in the Three Trial Arms(Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum)
  • Breastfeeding While Abstinent From Smoking(Repeated assessments completed at 2-, 4-, 8-, 12-, 24-, and 48-weeks postpartum)
  • Craving Item From the Minnesota Nicotine Withdrawal Scale (MNWS).(Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.)
  • Nicotine Withdrawal Total Scores for the Two Smoking-cessation Trial Conditions.(Outcomes reported for 8 assessments (early pregnancy, late pregnancy, 2, 4, 8, 12, 24, 28 weeks postpartum.)
  • Birth Outcomes (NICU Admissions)(at delivery)
  • Ages & Stages Questionnaire (ASQ)(24- and 48-weeks postpartum)
  • Cost Per Participant(Trial entry through 24-weeks postpartum (approximately one year following smoking-cessation quit date).)
  • Incremental Cost Effectiveness Ratio (ICER)(24 weeks postpartum)
  • Infant Growth in First Year of Life(delivery, 24-week, and 50-week postpartum assessments)
  • Birth Outcomes (% Small for Gestational Age Deliveries)(delivery)
  • Birth Outcomes (Percent Preterm [<37 Weeks] Deliveries)(at delivery)
  • Birth Outcome: Gestational Age at Delivery(at delivery)
  • Quality of Life Years Gained (QALYs)(24 weeks postpartum)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Stephen T. Higgins, PhD

Professor of Psychiatry and Psychology

University of Vermont

Study Sites (1)

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