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.

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.

Intervention(s) in this Clinical Trial

• Behavioral: Smoking cessation counseling delivered by telephone

Primary Measures

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

Secondary 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

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Massachusetts General Hospital Other

Overall Clinical Trial Officials and Contacts

Nancy A Rigotti, MD Principal Investigator Massachusetts General Hospital  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00181909

Study ID Number: 2000-P-002438

ClinicalTrials.gov Identifier: NCT00181909

Health Authority: United States: Institutional Review Board