Healthy Moms Alcohol Intervention

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT00244062
• Collaborator: National Institutes of Health (NIH) (NIH)
• Enrollment: 250
• Duration (Months): 74

Study Details

Study Description

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	N/A

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Official Title: "Brief Alcohol Intervention: The Healthy Moms Project."
• Study Start Date: Apr 1, 2001
• Actual Study Completion Date: Jun 1, 2007

Outcome Measures

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; []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• 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:

• N/A

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Wisconsin, Madison
• National Institutes of Health (NIH)

Investigators

• Principal Investigator: Michael Fleming, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT00244062
• Other Study ID Numbers: 5R01AA012522-03; 5R01AA012522-03
• First Posted: Oct 25, 2005
• Last Update Posted: Oct 5, 2015
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Fetal Alcohol Spectrum Disorders; Alcoholism

Study Results

No Results Posted as of Oct 5, 2015