Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women
NCT ID: NCT02952703
Last Updated: 2018-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
185 participants
INTERVENTIONAL
2016-11-30
2018-05-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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First Breath
brief pre-natal smoking cessation counseling
brief pre-delivery smoking cessation counseling
Striving to Quit
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
additional pre-delivery smoking cessation counseling
post- delivery smoking cessation counseling
incentives
Interventions
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brief pre-delivery smoking cessation counseling
additional pre-delivery smoking cessation counseling
post- delivery smoking cessation counseling
incentives
Eligibility Criteria
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Inclusion Criteria
* 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 smoking in past 6 months;
* involved in another smoking research study.
18 Years
65 Years
FEMALE
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Locations
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University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2016-1046
Identifier Type: -
Identifier Source: org_study_id
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