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

Phase 3

Completed

• Conditions: Pregnancy; Smoking Cessation

• Registration Number: NCT00181909
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

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.

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.

Study Timeline

• Study Start: 2001-09
• Study Completion: 2005-06
• Status Verified: 2005-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Last Update Submitted: 2006-11-27
• Last Update Posted: 2006-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 434

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Tufts Health Plan; 🇺🇸 Waltham, Massachusetts, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States