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

October 9, 2018 updated by: University of Wisconsin, Madison

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

185

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53711
        • University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: First Breath
brief pre-natal smoking cessation counseling
Behavioral: brief pre-delivery smoking cessation counseling
Experimental: Striving to Quit
Additional pre-natal counseling (in-person and telephonic); post delivery counseling (in-person and telephonic) and incentives
Behavioral: additional pre-delivery smoking cessation counseling
Behavioral: post- delivery smoking cessation counseling
Behavioral: incentives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biochemically verified smoking abstinence
Time Frame: 6 months post intervention
Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm
6 months post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motivation to quit/remain quit
Time Frame: 6 months post intervention
Motivation to quit/remain quit measured on a 5 point Likert scale
6 months post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

May 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

October 31, 2016

First Submitted That Met QC Criteria

October 31, 2016

First Posted (Estimate)

November 2, 2016

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-1046

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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