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

This study has been completed.
Robert Wood Johnson Foundation
Information provided by:
Massachusetts General Hospital Identifier:
First received: September 13, 2005
Last updated: November 27, 2006
Last verified: September 2005
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.

Condition Intervention Phase
Pregnancy Smoking Cessation Behavioral: Smoking cessation counseling delivered by telephone Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy

Secondary Outcome Measures:
  • Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum
  • Self-reported significant (>50%) reduction in tobacco use
  • Quit attempt of >24 hours duration from enrollment to end of pregnancy

Estimated Enrollment: 434
Study Start Date: September 2001
Estimated Study Completion Date: June 2005
Detailed Description:
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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00181909

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Tufts Health Plan
Waltham, Massachusetts, United States
Sponsors and Collaborators
Massachusetts General Hospital
Robert Wood Johnson Foundation
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
Study Director: Elyse R Park, PhD Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00181909     History of Changes
Other Study ID Numbers: 2000-P-002438
Study First Received: September 13, 2005
Last Updated: November 27, 2006

Keywords provided by Massachusetts General Hospital:
Smoking cessation processed this record on September 21, 2017