Persistent Poverty Counties Pregnant Women With Medicaid

Study Overview
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Brief Summary
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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.

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

Conditions
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Tobacco Cessation, Tobacco Use, Tobacco Smoking, Smoking Cessation Financial Incentives, Socioeconomic Status, Contingency Management, Pregnancy

Intervention / Treatment
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* Behavioral: Standard Care + Financial Incentives
* Other: Standard Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria contact the Oklahoma Tobacco Helpline seeking smoking cessation treatment, and enroll in the multiple call program are a female ≤ 25 weeks pregnant report smoking ≥ 5 cigarettes per day are ≥ 18 years of age are able to provide a copy/photo of their ID/driver's license or other documentation of identity are able to read, speak, and understand English Exclusion Criteria • participants will be excluded if they do not meet the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care<br>Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy. | Other: Standard Care<br>* Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.<br>|
| Experimental: Standard Care + Financial Incentives<br>Financial Incentives participants will receive standard care plus incentives for completing counseling calls and abstinence. | Behavioral: Standard Care + Financial Incentives<br>* Financial incentive participants will receive standard care and receive incentives for completing counseling calls and for abstinence.<br>Other: Standard Care<br>* Participants randomized to Standard Care will be offered weekly counseling calls and pharmacotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified abstinence 12 weeks post enrollment | The outcome measure is biochemically verified over 7-day point prevalence at 12 weeks post-enrollment. | 12 weeks post enrollment | 
| Self-reported abstinence 12 weeks postpartum | The outcome measure is biochemically verified abstinence over 7-day point prevalence at 12 weeks post-partum | 12 weeks postpartum |