Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization
November 27, 2006 updated by: Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment
434
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Waltham, Massachusetts, United States
- Tufts Health Plan
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
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Secondary Outcome Measures
Outcome Measure |
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Biochemically-validated 7-day point prevalence tobacco abstinence at 3 months postpartum
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Self-reported significant (>50%) reduction in tobacco use
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Quit attempt of >24 hours duration from enrollment to end of pregnancy
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Elyse R Park, PhD, Massachusetts General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2001
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (Estimate)
September 16, 2005
Study Record Updates
Last Update Posted (Estimate)
November 28, 2006
Last Update Submitted That Met QC Criteria
November 27, 2006
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2000-P-002438
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.