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

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ClinicalTrials.gov Identifier: NCT02952703
Recruitment Status : Completed
First Posted : November 2, 2016
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment Phase
Smoking Tobacco Use Disorder Behavioral: brief pre-delivery smoking cessation counseling Behavioral: additional pre-delivery smoking cessation counseling Behavioral: post- delivery smoking cessation counseling Behavioral: incentives Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 185 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Disseminating and Implementing a Smoking Cessation Program Fro Pregnant and Postpartum Women
Study Start Date : November 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Biochemically verified smoking abstinence [ Time Frame: 6 months post intervention ]
    Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm


Secondary Outcome Measures :
  1. Motivation to quit/remain quit [ Time Frame: 6 months post intervention ]
    Motivation to quit/remain quit measured on a 5 point Likert scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02952703


Locations
United States, Wisconsin
University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health
Madison, Wisconsin, United States, 53711
Sponsors and Collaborators
University of Wisconsin, Madison
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02952703     History of Changes
Other Study ID Numbers: 2016-1046
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders