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

Not Applicable

Completed

• Conditions: Tobacco Use Disorder; Smoking
• Interventions: Behavioral: additional pre-delivery smoking cessation counseling; Behavioral: brief pre-delivery smoking cessation counseling; Behavioral: post- delivery smoking cessation counseling; Behavioral: incentives

• Registration Number: NCT02952703
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-31
• Study First Submitted QC: 2016-10-31
• Study Start: 2016-11
• Study First Posted: 2016-11-02
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-09
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 185

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Striving to Quit	incentives	Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
Striving to Quit	additional pre-delivery smoking cessation counseling	Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
Striving to Quit	post- delivery smoking cessation counseling	Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
First Breath	brief pre-delivery smoking cessation counseling	brief pre-natal smoking cessation counseling

Primary Outcome Measures

Name	Time	Method
Biochemically verified smoking abstinence	6 months post intervention	Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)\<9ppm

Secondary Outcome Measures

Name	Time	Method
Motivation to quit/remain quit	6 months post intervention	Motivation to quit/remain quit measured on a 5 point Likert scale

Trial Locations

Locations (1)

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States