Healthy Moms Alcohol Intervention
October 1, 2015 updated by: University of Wisconsin, Madison
"Brief Alcohol Intervention: The Healthy Moms Project."
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
250
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael Fleming, MD, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2001
Study Completion (Actual)
June 1, 2007
Study Registration Dates
First Submitted
October 21, 2005
First Submitted That Met QC Criteria
October 21, 2005
First Posted (Estimate)
October 25, 2005
Study Record Updates
Last Update Posted (Estimate)
October 5, 2015
Last Update Submitted That Met QC Criteria
October 1, 2015
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 5R01AA012522-03 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.