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OpenTrials
Completed

NCT Number: NCT00181909

Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization

The principal objective is to test whether offering pregnant smokers a proactive telephone counseling program throughout pregnancy and for 2 months postpartum increases the rate of smoking cessation at end of pregnancy and 3 months postpartum, compared to a "best practice" control condition.

Completed

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Massachusetts General Hospital, Boston, Massachusetts, United States

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About this study

A randomized controlled trial compared the efficacy of a proactive pregnancy-tailored telephone-delivered smoking cessation counseling program with a "best practice" brief counseling control condition among pregnant women referred by prenatal care providers and a managed care plan in Massachusetts. Intervention group patients received up to 105 min of cognitive-behavioral counseling delivered in a motivational interviewing style by trained counselors throughout pregnancy and for 2 months postpartum. Control group patients received 5 minutes of brief counseling at 1 telephone call. All participants were mailed written self-help smoking cessation material tailored to pregnancy. The primary outcome measure was cotinine-validated tobacco abstinence at the end of pregnancy. Secondary outcomes were cotinine-validated abstinence at 3 months postpartum and self-reported significant (>50%) reduction in daily cigarette use.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Pregnant women
  • current cigarette smoker (smoked >1 cigarette in the past 7 days)
  • 18 years old or older
  • Willing to consider altering their smoking behavior during their pregnancy

Exclusion criteria

  • More than 26 weeks' gestation at study entry
  • No telephone access
  • Not planning to live in New England for 1 year
  • Unable to read and speak English

Treatment and study plan

Smoking cessation counseling delivered by telephone

Behavioral

Primary outcomes

  1. Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy

Secondary outcomes

  1. Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum

  2. Self-reported significant (>50%) reduction in tobacco use

  3. Quit attempt of >24 hours duration from enrollment to end of pregnancy

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Robert Wood Johnson Foundation

Registry information

Important dates

Study start
2001
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Nov 28, 2006

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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