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

NCT ID: NCT00181909

Last Updated: 2006-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

434 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-09-30

Study Completion Date

2005-06-30

Brief Summary

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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

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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.

Conditions

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Pregnancy Smoking Cessation

Keywords

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Pregnancy Smoking cessation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Smoking cessation counseling delivered by telephone

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Robert Wood Johnson Foundation

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Nancy A Rigotti, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Elyse R Park, PhD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Tufts Health Plan

Waltham, Massachusetts, United States

Site Status

Countries

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United States

References

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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. doi: 10.1097/01.AOG.0000218100.05601.f8.

Reference Type RESULT
PMID: 16816060 (View on PubMed)

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. doi: 10.1016/j.ypmed.2006.10.008. Epub 2007 Jan 3.

Reference Type DERIVED
PMID: 17204318 (View on PubMed)

Other Identifiers

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2000-P-002438

Identifier Type: -

Identifier Source: org_study_id