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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952703
• Other study ID #: 2016-1046
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: May 2018

Study information

• Verified date: October 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Disorder

Intervention

Behavioral:
• brief pre-delivery smoking cessation counseling

• additional pre-delivery smoking cessation counseling

• post- delivery smoking cessation counseling

• incentives

Locations

Country	Name	City	State
United States	University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically verified smoking abstinence	Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm	6 months post intervention
Secondary	Motivation to quit/remain quit	Motivation to quit/remain quit measured on a 5 point Likert scale	6 months post intervention