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Completed

NCT Number: NCT02952703

Disseminating and Implementing a Smoking Cessation Program for 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.

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Key information

Conditions

Smoking Behavior Chemically-Induced Disorders Mental Disorders Substance-Related Disorders Tobacco Use Disorder

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin Center for Tobacco Research and Intervention, School of Medicine and Public Health

Madison, Wisconsin, 53711, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

brief pre-delivery smoking cessation counseling

Behavioral

additional pre-delivery smoking cessation counseling

Behavioral

post- delivery smoking cessation counseling

Behavioral

Incentives

Behavioral

Primary outcomes

  1. Biochemically verified smoking abstinence

    Time frame: 6 months post intervention

    Biochemically verified smoking abstinence: Breath Carbon Monoxide (CO)<9ppm

Secondary outcomes

  1. Motivation to quit/remain quit

    Time frame: 6 months post intervention

    Motivation to quit/remain quit measured on a 5 point Likert scale

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 2, 2016
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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