Ignite Creation Date:
2024-05-05 @ 11:57 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00181909
Status:
COMPLETED
Last Update Posted:
2006-11-28
First Post:
2005-09-13
Brief Title:
Efficacy of Proactive Telephone Counseling for Pregnant Smokers Enrolled in a Managed Care Organization
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None