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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Pregnancy; Smoking Cessation	Behavioral: Smoking cessation counseling delivered by telephone	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	434 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Study Start Date :	September 2001
Study Completion Date :	June 2005

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes 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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

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

Park ER, Quinn VP, Chang Y, Regan S, Loudin B, Cummins S, Perry K, Rigotti NA. Recruiting pregnant smokers into a clinical trial: using a network-model managed care organization versus community-based practices. Prev Med. 2007 Mar;44(3):223-9. Epub 2007 Jan 3.

ClinicalTrials.gov Identifier:	NCT00181909 History of Changes
Other Study ID Numbers:	2000-P-002438
First Posted:	September 16, 2005
Last Update Posted:	November 28, 2006
Last Verified:	September 2005

Keywords provided by Massachusetts General Hospital:

Pregnancy; Smoking cessation