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

University of Wisconsin (UW)

Status: Completed

Conditions: Tobacco Use Disorder; Smoking

Treatments: Behavioral: brief pre-delivery smoking cessation counseling; Behavioral: post- delivery smoking cessation counseling; Behavioral: additional pre-delivery smoking cessation counseling; Behavioral: incentives

Study type: Interventional

Funder types: Other

Identifiers

NCT02952703

2016-1046

Details and patient eligibility

About

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.

Enrollment: 185 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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185 participants in 2 patient groups

First Breath

Active Comparator group

Description:

brief pre-natal smoking cessation counseling

Treatment:

Behavioral: brief pre-delivery smoking cessation counseling

Striving to Quit

Experimental group

Description:

Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives

Treatment:

Behavioral: incentives

Behavioral: post- delivery smoking cessation counseling

Behavioral: additional pre-delivery smoking cessation counseling