Smoking, Tobacco Use Disorder
Conditions
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.
Interventions
BEHAVIORALbrief pre-delivery smoking cessation counseling
BEHAVIORALadditional pre-delivery smoking cessation counseling
BEHAVIORALpost- delivery smoking cessation counseling
BEHAVIORALincentives
Sponsors
University of Wisconsin, Madison
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically verified smoking abstinence | 6 months post intervention | Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)\<9ppm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Motivation to quit/remain quit | 6 months post intervention | Motivation to quit/remain quit measured on a 5 point Likert scale |
Countries
United States
Outcome results
None listed