Persistent Poverty Counties Pregnant Women With Medicaid

Not Applicable

• Conditions: Smoking Cessation Financial Incentives; Tobacco Smoking; Tobacco Use; Contingency Management; Pregnancy; Tobacco Cessation; Socioeconomic Status
• Interventions: Other: Standard Care; Behavioral: Standard Care + Financial Incentives

• Registration Number: NCT05415371
• Lead Sponsor: University of Oklahoma

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-25
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-13
• Study Start: 2022-09-30
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care	Standard Care	Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.
Standard Care + Financial Incentives	Standard Care + Financial Incentives	Financial Incentives participants will receive standard care plus incentives for completing counseling calls and abstinence.
Standard Care + Financial Incentives	Standard Care	Financial Incentives participants will receive standard care plus incentives for completing counseling calls and abstinence.

Primary Outcome Measures

Name	Time	Method
Self-reported abstinence 12 weeks postpartum	12 weeks postpartum	The outcome measure is biochemically verified abstinence over 7-day point prevalence at 12 weeks post-partum
Biochemically verified abstinence 12 weeks post enrollment	12 weeks post enrollment	The outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment.

Trial Locations

Locations (1)

TSET Health Promotion Research Center; 🇺🇸 Oklahoma City, Oklahoma, United States