Healthy Moms Alcohol Intervention

Pregnancy Clinical Trial

Official title:

"Brief Alcohol Intervention: The Healthy Moms Project."

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00244062
• Other study ID #: 5R01AA012522-03
• Secondary ID: 5R01AA012522-03
• Status: Completed
• Phase: N/A
• First received: October 21, 2005
• Last updated: October 1, 2015
• Start date: April 2001
• Est. completion date: June 2007

Study information

• Verified date: April 2011
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The study proposes to test the efficacy of a primary care-based brief intervention with women who resumed heavy drinking during the post-partum period and who used alcohol during a previous pregnancy. The trial will also examine the effects of tobacco use, illicit drug use, depression and domestic violence on alcohol use.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women of childbearing age (18-40) who drank alcohol during their previous pregnancy and who report drinking above recommended limits in the post partum period.

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Alcoholism
• Fetal Alcohol Spectrum Disorders
• Fetal Alcohol Syndrome
• Pregnancy

Intervention

Behavioral:
• counseling

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The aim is to conduct a randomized test of the efficacy of brief physician/nurse advice in reducing alcohol use, alcohol-related harm, and fetal alcohol exposure in subsequent pregnancies in a sample of high-risk post partum pts.
Secondary	To est. the prevalence of drinking in ethnic div. pop. post partum women who are pts in 60 practices in Dane, Waukesha, and Milwaukee counties;the effect of age, race, tobacco use, marital status, partner alcohol use, and readiness-to-change;