Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 185
- Locations
- 1
- Primary Endpoint
- Biochemically verified smoking abstinence
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
First Breath
brief pre-natal smoking cessation counseling
Intervention: brief pre-delivery smoking cessation counseling (Behavioral)
Striving to Quit
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
Intervention: additional pre-delivery smoking cessation counseling (Behavioral)
Striving to Quit
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
Intervention: post- delivery smoking cessation counseling (Behavioral)
Striving to Quit
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
Intervention: incentives (Behavioral)
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)