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Clinical Trials/NCT02952703
NCT02952703
Completed
Not Applicable

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

University of Wisconsin, Madison1 site in 1 country185 target enrollmentNovember 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Smoking
Sponsor
University of Wisconsin, Madison
Enrollment
185
Locations
1
Primary Endpoint
Biochemically verified smoking abstinence
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
May 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Biochemically verified smoking abstinence

Time Frame: 6 months post intervention

Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)\<9ppm

Secondary Outcomes

  • Motivation to quit/remain quit(6 months post intervention)

Study Sites (1)

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