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NCT Number: NCT07840118

Smartphone-based Incentives Intervention to Increase Smoking Cessation During Pregnancy

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.

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Key information

Conditions

Smoking During Pregnancy and Postpartum Behavior Health Behavior Perinatal Cigarette Smoking Smoking Smoking Cessation

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Vermont

Burlington, Vermont, 05464, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Best Practices

Behavioral

Participants receive the 5As including a staff referral to the state tobacco quitline.

Financial Incentives

Behavioral

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.

Primary outcomes

  1. Antepartum smoking abstinence

    Time frame: 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 outcomes

  1. Postpartum smoking abstinence

    Time frame: 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.

Other outcomes

  1. Birth Outcomes

    Time frame: Birth record at time of delivery

    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.

  2. Treatment Acceptability Questionnaire

    Time frame: 24 weeks following delivery

    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.

  3. Smoking abstinence at 24-weeks postpartum

    Time frame: 24 weeks after delivery

    Participants report no smoking in the past 7 days that is confirmed with a negative salivary cotinine test

  4. Cost effectiveness

    Time frame: 24-weeks postpartum

    A cost-effectiveness analysis of adding financial incentives to the Best-Practices intervention will be conducted.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

University of Vermont

Other

Collaborators

  • DynamiCare Health
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Examining a Digital Perinatal Smoking-Cessation Intervention

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 24, 2026
Registry last updated
Sep 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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