Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women

Study Overview
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Brief Summary
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This study tests whether a smoking cessation intervention for pregnant women that extends postpartum (Striving to Quit (STQ)) can be implemented and disseminated outside of the research environment that established its effectiveness (40% maintained biochemically verified 6-month abstinence). The research aim is: Is Striving to Quit more effective in achieving postpartum smoking cessation than First Breath, the current standard of care for pregnant women in Wisconsin who smoke? 250 women will be randomized into one of two study groups. Pregnant women in Group A (n=125) will receive the existing First Breath prenatal intervention. Those in Group B (Striving to Quit (STQ), n=125) will receive all Group A interventions, plus 1 additional prenatal home visit, 3 postpartum in-home smoking cessation counseling visits, 3 postpartum phone calls, and up to an additional $100 in gift cards. The primary outcome will be biochemically confirmed smoking cessation at 6-months postpartum.

Official Title
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Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women

Conditions
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Smoking, Tobacco Use Disorder

Intervention / Treatment
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* Behavioral: brief pre-delivery smoking cessation counseling
* Behavioral: additional pre-delivery smoking cessation counseling
* Behavioral: post- delivery smoking cessation counseling
* Behavioral: incentives


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant; enrolled in First Breath; Resides in Wisconsin counties of Calumet, Fond Du Lac, Kewaunee, Menominee, Oconto, Shawno, Sheyboygan, Winnebago, Door, Brown, Outagamie, Manitowac, or Waupaca; English speaking; willingness to quit or reduce smoking in next 30 days or if already quit, desire to remain quit after delivery; daily smoking (at least 1 cigarette/day for at least 1 week in past 6 months; willing to provide updates in contact information Exclusion Criteria: not pregnant; not smoking in past 6 months; involved in another smoking research study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: First Breath<br>brief pre-natal smoking cessation counseling | Behavioral: brief pre-delivery smoking cessation counseling<br> <br> |
| Experimental: Striving to Quit<br>Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives | Behavioral: additional pre-delivery smoking cessation counseling<br> <br> Behavioral: post- delivery smoking cessation counseling<br> <br> Behavioral: incentives<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified smoking abstinence | Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm | 6 months post intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivation to quit/remain quit | Motivation to quit/remain quit measured on a 5 point Likert scale | 6 months post intervention |