The long-term goal of this research is to reduce tobacco-related disparities in maternal and infant health outcomes by improving smoking cessation and relapse prevention interventions for minority pregnant and postpartum women, who have been significantly underrepresented in smoking cessation research. This study will examine the feasibility and efficacy of a prize-based contingency management approach for increasing smoking cessation and preventing relapse among socioeconomically disadvantaged minority pregnant smokers. First, the intervention will be pretested with 10 pregnant low-income minority smokers and then refined based on acceptability survey and focus group data. Next, a pilot study will be conducted. 60 highly disadvantaged minority women, recruited from the outpatient obstetric clinics at a large teaching hospital, who report daily smoking and who meet other eligibility criteria will be enrolled and randomized to one of two study conditions: 1) Standard Psychoeducational Intervention (6-week, individually-administered, pregnancy-specific Quit Smoking Now curriculum, as currently implemented in the clinic; QSN Only); 2) Standard Psychoeducational Intervention plus Contingency Management (provision of incentives contingent on biochemically-verified abstinence; QSN-CM). Abstinence monitoring via expired carbon monoxide and salivary cotinine levels will occur in both groups beginning on the first quit day and continuing through 3-months postpartum. Only participants in the QSN-CM group will be reinforced for biochemically-verified abstinence with chances to win prizes ranging in value from approximately $1 to $100 ('fishbowl' or 'prize bowl' method). Study outcomes will be assessed through follow-up research exams (delivery and 6-months postpartum) and hospital chart reviews. The primary hypothesis is that that women randomized to the QSN-CM condition will have higher rates of abstinence during pregnancy and postpartum compared to women receiving standard of care alone. Results should advance scientific knowledge regarding effective methods for promoting and maintaining smoking abstinence among pregnant disadvantaged women and provide preliminary feasibility and efficacy data needed to support a larger randomized controlled trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The Quit Smoking Now (QSN) program, offered by the Florida Area Health Education Center, was developed based on principles of the Centers for Disease Control and Prevention's "Best Practices for Comprehensive Tobacco Control", and the U.S. Department of Health and Human Services' "Treating Tobacco Use and Dependence Clinical Guidelines" with an emphasis on reaching medically-underserved populations. The QSN curriculum will be delivered in 6 one-hour sessions . Pregnancy-specific session goals and content cover the effects of smoking on the developing fetus, secondhand smoke exposure, the importance of social support, and postpartum relapse.
Women will earn chances to win prizes for biochemically verified abstinence from tobacco.
University of Miami Miller School of Medicine
Miami, Florida, United States
Abstinence Duration
-duration in days --measured by self-report, carbon monoxide, salivary and urine cotinine levels
Time frame: (from quit date through 6 months postpartum; assessed up to 52 weeks)
Abstinence rate (%)
* 7-day point prevalence abstinence at delivery and 6 months postpartum defined by no smoking in the 7 days prior to assessment. * measured by self-report, carbon monoxide and salivary cotinine levels.
Time frame: delivery and 6 months postpartum
QSN attendance
* cumulative attendance at QSN sessions (1-6 weeks) * QSN attendance logs
Time frame: (6 weeks)
Smoking reduction
-change in the number of cigarettes smoked daily by self-report
Time frame: Change (baseline and delivery; baseline and 6 months postpartum)
Gestational Age
* measured in weeks * documented through medical chart review
Time frame: delivery
Infant Respiratory Illnesses
* number of episodes * documented through medical chart review
Time frame: 6 months postpartum
Birth Weight
* birth weight measured in grams * documented through medical chart review
Time frame: delivery
Neonatal Admissions
* duration in days * documented through medical chart review
Time frame: delivery
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