Smartphone-based Incentives Intervention to Increase Smoking Cessation During Pregnancy

University of Vermont

Status: Not yet enrolling

Conditions: Perinatal Cigarette Smoking; Smoking During Pregnancy and Postpartum

Treatments: Behavioral: Financial Incentives; Behavioral: Best Practices

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT07840118

UG3DA065232 (U.S. NIH Grant/Contract)

STUDY00004146

Details and patient eligibility

About

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.

Full 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).

Enrollment: 137 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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137 participants in 2 patient groups

Best Practices

Experimental group

Description:

Best Practices (BP) entails the 5As including referral to the state tobacco Quitline and further referral for those continuing to smoke.

Treatment:

Behavioral: Best Practices

Best Practices plus Financial Incentives

Experimental group

Description:

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.

Treatment:

Behavioral: Best Practices

Behavioral: Financial Incentives