NCT Number: NCT00181909
Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
Female
Study type
Interventional
Phase
Phase 3
Primary location
Massachusetts General Hospital, Boston, Massachusetts, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
Biochemically-validated 7-day point prevalence tobacco abstinence at end of pregnancy
Secondary outcomes
-
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
Sponsors and collaborators
Lead sponsor
Massachusetts General Hospital
Other
Collaborators
- Robert Wood Johnson Foundation
Registry information
Important dates
- Study start
- 2001
- Study completion
- 2005
- First posted
- Sep 16, 2005
- Registry last updated
- Nov 28, 2006
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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