Pregnancy, Smoking Cessation
Conditions
Keywords
Pregnancy, Smoking cessation
Brief summary
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
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.
Interventions
BEHAVIORALSmoking cessation counseling delivered by telephone
Sponsors
Robert Wood Johnson Foundation
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy | — |
Secondary
| Measure | 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 | — |
Countries
United States
Outcome results
None listed