Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Robert Wood Johnson Foundation
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00181909
First received: September 13, 2005
Last updated: November 27, 2006
Last verified: September 2005
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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.

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00181909

Locations
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
Investigators
Principal Investigator: Nancy A Rigotti, MD Massachusetts General Hospital
Study Director: Elyse R Park, PhD Massachusetts General Hospital
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00181909     History of Changes
Other Study ID Numbers: 2000-P-002438
Study First Received: September 13, 2005
Last Updated: November 27, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Pregnancy
Smoking cessation

ClinicalTrials.gov processed this record on March 03, 2015