Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First Breath | Active Comparator | brief pre-natal smoking cessation counseling |
|
| Striving to Quit | Experimental | Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brief pre-delivery smoking cessation counseling | Behavioral |
| ||
| additional pre-delivery smoking cessation counseling |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically verified smoking abstinence | Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm | 6 months post intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Motivation to quit/remain quit | Motivation to quit/remain quit measured on a 5 point Likert scale | 6 months post intervention |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health | Madison | Wisconsin | 53711 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 24, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral |
|
| post- delivery smoking cessation counseling | Behavioral |
|
| incentives | Behavioral |
|
| Oct 9, 2018 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D012907 | Smoking |
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D005298 | Fertility |
| ID | Term |
|---|---|
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
Not provided
Not provided