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Healthy Moms Alcohol Intervention

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ClinicalTrials.gov Identifier: NCT00244062
Recruitment Status : Completed
First Posted : October 25, 2005
Last Update Posted : October 5, 2015
Sponsor:
Collaborator:
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
Fetal Alcohol Syndrome Pregnancy Alcoholism Behavioral: counseling

Study Type : Interventional  (Clinical Trial)
Estimated 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
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;


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


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 ClinicalTrials.gov identifier (NCT number): NCT00244062


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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00244062     History of Changes
Other Study ID Numbers: 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:
Alcoholism
Fetal Alcohol Spectrum Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Fetal Diseases
Pregnancy Complications
Alcohol-Induced Disorders