Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women
Primary Purpose
Smoking, Tobacco Use Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
brief pre-delivery smoking cessation counseling
additional pre-delivery smoking cessation counseling
post- delivery smoking cessation counseling
incentives
Sponsored by
About this trial
This is an interventional treatment trial for Smoking
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.
Sites / Locations
- University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
First Breath
Striving to Quit
Arm Description
brief pre-natal smoking cessation counseling
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
Outcomes
Primary Outcome Measures
Biochemically verified smoking abstinence
Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm
Secondary Outcome Measures
Motivation to quit/remain quit
Motivation to quit/remain quit measured on a 5 point Likert scale
Full Information
NCT ID
NCT02952703
First Posted
October 31, 2016
Last Updated
October 9, 2018
Sponsor
University of Wisconsin, Madison
1. Study Identification
Unique Protocol Identification Number
NCT02952703
Brief Title
Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women
Official Title
Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Tobacco Use Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
First Breath
Arm Type
Active Comparator
Arm Description
brief pre-natal smoking cessation counseling
Arm Title
Striving to Quit
Arm Type
Experimental
Arm Description
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
Intervention Type
Behavioral
Intervention Name(s)
brief pre-delivery smoking cessation counseling
Intervention Type
Behavioral
Intervention Name(s)
additional pre-delivery smoking cessation counseling
Intervention Type
Behavioral
Intervention Name(s)
post- delivery smoking cessation counseling
Intervention Type
Behavioral
Intervention Name(s)
incentives
Primary Outcome Measure Information:
Title
Biochemically verified smoking abstinence
Description
Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm
Time Frame
6 months post intervention
Secondary Outcome Measure Information:
Title
Motivation to quit/remain quit
Description
Motivation to quit/remain quit measured on a 5 point Likert scale
Time Frame
6 months post intervention
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53711
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women
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