Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00013793
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2001-03-29
Brief Title:
Ultrasound and Motivational Enhancement for Prenatal Smoking Cessation
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
Ultrasound and Motivational Enhancement for Prenatal Smoking Cessation
Status:
COMPLETED
Status Verified Date:
2003-12
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 primary purpose of this randomized clinical trial is to test the efficacy of motivational enhancement ME therapy combined with biologic feedback fetal ultrasound for increasing smoking quit rates among low-income pregnant women considered resistant smokers We hypothesize that ME along with biofeedback will increase the rate of validated smoking cessation at 8 months gestation by at least 10 percentage points above that produced by Best Practice BP counseling alone This study will also examine reduction of smoking among non-quitters and maintenance of smoking cessation through 6 weeks postpartum among women who quit
Prenatal smoking is the leading preventable cause of low birth weight in the US Reduction in smoking during pregnancy could result in significant improvements in pregnancy outcomes and reducing the cost of health care There is evidence that low-intensity pregnancy smoking cessation programs may be inadequate for women who are more addicted and at educational and economic disadvantage Motivational enhancement strategies have shown considerable promise in the treatment of addictive behaviors Physiological feedback highlighting prenatal effects of smoking and benefits of cessation has been found to enhance prenatal smoking cessation counseling An intervention that combines motivational enhancement counseling and physiological feedback may have powerful effects beyond low-intensity interventions or usual counseling
Prenatal smoking is the leading preventable cause of low birth weight in the US Reduction in smoking during pregnancy could result in significant improvements in pregnancy outcomes and reducing the cost of health care There is evidence that low-intensity pregnancy smoking cessation programs may be inadequate for women who are more addicted and at educational and economic disadvantage Motivational enhancement strategies have shown considerable promise in the treatment of addictive behaviors Physiological feedback highlighting prenatal effects of smoking and benefits of cessation has been found to enhance prenatal smoking cessation counseling An intervention that combines motivational enhancement counseling and physiological feedback may have powerful effects beyond low-intensity interventions or usual counseling
Detailed Description:
Targeting women who deliver at one of the two UT-Houston teaching hospitals Lyndon B Johnson LBJ and Hermann Hospitals pregnant women between 18 and 28 weeks gestation will be recruited from University of TexasHarris County Hospital District-affiliated clinics including Acres Homes Aldine Settegast Baytown and Squatty Lyons LBJ and Hermann Hospital outpatient clinics private practice OBGYNs with patients who will deliver at Hermann Hospital and area WIC Women Infants and Children Program sites Participants will be randomized to one of three groups including 1 best practice BP counseling 2 BP plus ultrasound and 3 BP plus ultrasound plus motivational enhancement ME counseling Counseling and cotinine testing will be performed at the University Clinical Research Center UCRC initially at 34 weeks and at 6 weeks postpartum The primary outcome is the rate of smoking cessation among the women at 34 weeks gestation Based on previous reports projected quit rates for the 3 interventions BP BP ultrasound and BP ultrasound ME are 06 12 and 20 respectively A sample size of 360 will be necessary in order to observe these differences in quit rates The chi-square test for trend in proportions will be used to determine statistical significance for this primary outcome
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: