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Healthy Moms Alcohol Intervention

This study has been completed.
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00244062
First received: October 21, 2005
Last updated: April 20, 2011
Last verified: April 2011
History of Changes
  Purpose

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
Pregnancy
Alcoholism
 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:

U.S. FDA Resources

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
  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00244062

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

No publications provided

ClinicalTrials.gov 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:
Alcoholism
Fetal Alcohol Syndrome
Alcohol-Related Disorders
Substance-Related Disorders
 Mental Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders

ClinicalTrials.gov processed this record on May 23, 2013