Ultrasound and Motivational Enhancement for Prenatal Smoking Cessation
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Primary Purpose: Treatment
|Official Title:||Ultrasound and Motivational Enhancement for Prenatal Smoking Cessation|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00013793
|United States, Texas|
|University of Texas Medical School|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Janet Y. Groff, M.D., Ph.D.|