Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal