An interventional study of Best Practices and Financial Incentives in Smoking During Pregnancy and Postpartum and Perinatal Cigarette Smoking, sponsored by University of Vermont. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by University of Vermont · Not applicable, Interventional, and Treatment
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.
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).
1,509 studies on the registry are indexed under Smoking; 193 are open to participants now.
This study's planned enrollment of 137 is above the median of 115 across 1,164 interventional studies indexed under Smoking.
Browse Smoking studies →University of Vermont is the lead sponsor of 221 studies on the registry; 27 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 9 (53%) have results posted.
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Exclusion Criteria:
Best Practices (BP) entails the 5As including referral to the state tobacco Quitline and further referral for those continuing to smoke.
Behavioral: Best Practices
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 · Behavioral: Financial Incentives
Participants receive the 5As including a staff referral to the state tobacco quitline.
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.
Antepartum smoking abstinence
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.
Time frame: Antepartum period is from study entry through infant delivery which is typically about 24 weeks duration.
Postpartum smoking abstinence
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.
Time frame: 2-weeks, 6-weeks, 12-weeks following delivery.
Birth Outcomes
Birth outcomes calculated from data extracted from the birth delivery reports include mean birth weight, % low birth weight deliveries (\< 2500 g), mean gestational age at delivery, % premature deliveries (\< 37 weeks), incidence of Neonatal Intensive Care Unit (NICU) admissions, and mean length of stay per NICU admission.
Time frame: Birth record at time of delivery
Treatment Acceptability Questionnaire
Participants in both treatment conditions will complete the Treatment Acceptance Questionnaire (TAQ) at the 24-weeks postpartum assessment. The TAQ will query participants about the (1) ease of use of their assigned intervention; (2) helpfulness, and (3) convenience of the intervention; (4) whether the intervention facilitated engagement with smoking-cessation treatment; (5) whether the intervention was fair, (6) fun, (7) or helpful in abstaining from smoking during pregnancy, (8) after the baby was born, and (9) longer-term; and (10) whether they would recommend the treatment that they received to others. All responses will be made using a 100-point visual analogue scale with higher scores represent greater acceptance.
Time frame: 24 weeks following delivery
Smoking abstinence at 24-weeks postpartum
Participants report no smoking in the past 7 days that is confirmed with a negative salivary cotinine test
Time frame: 24 weeks after delivery
Cost effectiveness
A cost-effectiveness analysis of adding financial incentives to the Best-Practices intervention will be conducted.
Time frame: 24-weeks postpartum
Plan to share: Yes — Investigators are willing to share data once the study is completed and results are published in a peer-reviewed journal. Sharing is conditional on those requesting having a scientific rationale for their request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Upon study completion and publication of the primary trial outcomes in a peer-reviewed journal and planned secondary outcomes (e.g., birth outcomes, cost-effectiveness). Anticipated start date is 3 years after trial completion. Anticipated end date is 5 years after study completion.
Access criteria: Briefly, this trial will use the standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR). All shared data, metadata, and associated documentation will be deposited via the National Addiction \& HIV Data Archive Program (NAHDAP), which is hosted by ICPSR. The scientific data provided by our trial will be findable via a study digital object identifier (DOI) minted by ICPSR. Users of our shared scientific data must register with ICPSR and agree to the Terms of Use, which allows use only for scientific research purposes and aggregate statistical analyses. This is intended to protect research participants and prohibit attempts to identify individual participants. Users must also agree to not redistribute data downloads.
Data sharing details ↗ · www.icpsr.umich.edu
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