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

Pregnancy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00181909
• Other study ID #: 2000-P-002438
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: November 27, 2006
• Start date: September 2001
• Est. completion date: June 2005

Study information

• Verified date: September 2005
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 434
• Est. completion date: June 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Pregnancy
• Smoking Cessation

Intervention

Behavioral:
• Smoking cessation counseling delivered by telephone

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts Health Plan	Waltham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Robert Wood Johnson Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rigotti NA, Park ER, Regan S, Chang Y, Perry K, Loudin B, Quinn V. Efficacy of telephone counseling for pregnant smokers: a randomized controlled trial. Obstet Gynecol. 2006 Jul;108(1):83-92. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
Secondary	Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum
Secondary	Self-reported significant (>50%) reduction in tobacco use
Secondary	Quit attempt of >24 hours duration from enrollment to end of pregnancy