NCT05415371

Persistent Poverty Counties Pregnant Women With Medicaid

Monetary Incentives to Promote Engagement With the Oklahoma Tobacco Helpline Among Pregnant Women With Medicaid

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Female
• Age: 18 Years – 105 Years
• Healthy volunteers: Accepted

Summary

Although many women initially quit smoking during pregnancy, most will return to smoking by the end of pregnancy or during the first 6 months postpartum. The proposed pilot project is designed to evaluate the feasibility and potential efficacy of offering small financial incentives for the completion of smoking cessation coaching and biochemically-verified smoking abstinence at follow-up among pregnant women with Medicaid insurance who contact the Oklahoma Tobacco Helpline (OTH). The study will enroll 100 pregnant women who will be randomly assigned to OTH care or OTH plus escalating incentives (OTH+I) for completing up to 5 coaching calls over the first 8 weeks after enrolling (prepartum) and for biochemically-verified smoking abstinence at 9 weeks post-enrollment (assessed remotely via smartphone). In addition, participants will be incentivized for completing a postpartum coaching call by 8 weeks postpartum. Feasibility outcomes for the incentives based intervention will focus on coaching call completion, rates of prepartum and postpartum follow-up, biochemically-verified smoking cessation, and perceptions of the intervention. Potential effectiveness will be evaluated by comparing biochemically-verified smoking abstinence rates in OTH+I relative to OTH alone at 12 weeks post-enrollment (prepartum) and 12 weeks postpartum.

Conditions

• Tobacco Cessation
• Tobacco Use
• Tobacco Smoking
• Smoking Cessation Financial Incentives
• Socioeconomic Status
• Contingency Management
• Pregnancy

Interventions

Type	Name	Description
BEHAVIORAL	Standard Care + Financial Incentives	Financial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence.
OTHER	Standard Care	Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.

Timeline

• Start date: 2022-09-30
• Primary completion: 2025-06-30
• Completion: 2025-12-31
• First posted: 2022-06-13
• Last updated: 2024-10-02

Locations

1 site across 1 country: United States