Healthy Moms Alcohol Intervention

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00244062
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : October 5, 2015
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief 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.

Condition or disease Intervention/treatment Phase
Fetal Alcohol Syndrome Pregnancy Alcoholism Behavioral: counseling Not Applicable

Study Type : Interventional  (Clinical Trial)
Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: "Brief Alcohol Intervention: The Healthy Moms Project."
Study Start Date : April 2001
Actual Study Completion Date : June 2007

Primary Outcome Measures :
  1. 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 :
  1. 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;

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00244062

Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
Principal Investigator: Michael Fleming, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison Identifier: NCT00244062     History of Changes
Other Study ID Numbers: 5R01AA012522-03 ( U.S. NIH Grant/Contract )
5R01AA012522-03 ( U.S. NIH Grant/Contract )
First Posted: October 25, 2005    Key Record Dates
Last Update Posted: October 5, 2015
Last Verified: April 2011

Additional relevant MeSH terms:
Fetal Alcohol Spectrum Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders