Smoking During Pregnancy and Postpartum, Perinatal Cigarette Smoking
Conditions
Keywords
cigarettes, smoking, smoking cessation, pregnancy, postpartum, women, financial incentives
Brief summary
Cigarette smoking is the leading preventable cause of poor pregnancy outcomes in the U.S. and a problem for which more effective and easy-to-access treatments are much needed. This study examines whether outcomes achieved with recommended clinical practices (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) can be improved by also offering financial incentives delivered through a smartphone for maternal smoking abstinence.
Detailed description
Pregnant women residing in the U.S. who currently smoke cigarettes and are interested in quitting will be recruited nationally and randomly assigned to what is considered clinical best practices (BP) (referral to state tobacco Quitline with follow-up and further referrals for those continuing to smoke) or best practices in combination with financial incentives (BP+FI). Women assigned to the BP+FI treatment will have opportunities to earn financial incentives by abstaining from smoking during pregnancy and for 3 months after delivering their baby (total possible incentives is $750.00). Women will demonstrate that they have abstained by taking brief salivary cotinine tests using a smartphone or equivalent device. Incentives for abstaining are electronically added to a study-provided debit card. Participation and all results are strictly confidential. Participants in both treatment conditions will be financially compensated for study participation with potential earnings of $525.00. Total potential earnings for those assigned to BP is $525.00 and for those assigned to BP+FI it is $1,275 ($525 for study participation and $750 in incentives for quitting smoking).
Interventions
BEHAVIORALBest Practices
Participants receive the 5As including a staff referral to the state tobacco quitline.
BEHAVIORALFinancial Incentives
Participants receive financial incentives contingent on biochemically verified abstinence. Incentives are in the form of vouchers exchangeable for retail items and available through 12-weeks postpartum.
Sponsors
University of Vermont
DynamiCare Health
National Institute on Drug Abuse (NIDA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The design is a two parallel groups randomized clinical trial to assess if combining financial incentives with Best Practices improves outcomes above treatment with Best Practices alone.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 18 yrs of age * Reports current pregnancy of \</= 25 weeks gestational age * Consents to allow us to confirm pregnancy with healthcare provider * Reports current smoking when learned of current pregnancy * Reports smoking in the 7 days prior to screening * Reports of smoking in past 7 days is confirmed by a salivary cotinine test * Owns a digital phone or tablet * Sufficiently fluent in English to complete study tasks
Exclusion criteria
* Reports current or prior mental or medical condition that may interfere with study participation * Reports current opioid agonist treatment for opioid use disorder * Current use of prescribed opioid, antipsychotic, or stimulant medications * Live with someone who is enrolled in the study * Reside in a group home * Currently participating in another study that provides financial incentives * Legal problems that may result in incarceration within the next year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antepartum smoking abstinence | Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration. | The primary outcome is whether women randomly assigned to the two treatment groups differ in the percentage who abstain from smoking across an early (\< 25 weeks gestation) and late (\> 25 weeks gestation) antepartum assessments defined by the percentage of participants assigned to each condition who report no smoking in the past 7 days and submit of a salivary cotinine sample that tests negative for recent smoking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postpartum smoking abstinence | 2-weeks, 6-weeks, 12-weeks following delivery. | Smoking abstinence at 2, 6, and 12 weeks postpartum defined as the percent of participants randomly assigned to each of the two treatment conditions who report no smoking in the past 7 days and submit of a salivary cotinine test sample that is negative for recent smoking. |
Countries
United States
Contacts
CONTACTStephen T Higgins, PhD
CONTACTKatya A Nolder, PhD
PRINCIPAL_INVESTIGATORStephen T Higgins, PhD
University of Vermont
Outcome results
None listed