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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
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Smoking

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

First Posted
October 31, 2016
Last Updated
October 9, 2018
Sponsor
University of Wisconsin, Madison
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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

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Disseminating and Implementing a Smoking Cessation Program for Pregnant and Postpartum Women

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