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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
434
Massachusetts General Hospital
Boston, Massachusetts, United States
Tufts Health Plan
Waltham, Massachusetts, United States
Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
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
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