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

Study Overview
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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

Intervention / Treatment
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* Behavioral: Smoking cessation counseling delivered by telephone


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Smoking cessation counseling delivered by telephone|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Smoking cessation