Healthy Moms Alcohol Intervention

This study has been completed.
Information provided by:
University of Wisconsin, Madison Identifier:
First received: October 21, 2005
Last updated: April 20, 2011
Last verified: April 2011

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.

Condition Intervention
Fetal Alcohol Syndrome
Behavioral: counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: "Brief Alcohol Intervention: The Healthy Moms Project."

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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;

Estimated Enrollment: 250
Study Start Date: April 2001
Study Completion Date: June 2007

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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:

  • N/A
  Contacts and Locations
Please refer to this study by its identifier: NCT00244062

Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Michael Fleming, MD University of Wisconsin, Madison
  More Information

No publications provided Identifier: NCT00244062     History of Changes
Other Study ID Numbers: 5R01AA012522-03, #5R01AA012522-03
Study First Received: October 21, 2005
Last Updated: April 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Fetal Alcohol Syndrome
Alcohol-Related Disorders
Substance-Related Disorders
Mental Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders processed this record on April 16, 2014