Women's Health Habits Study

NCT ID: NCT00846638

Last Updated: 2010-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

611 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-05-31

Brief Summary

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The purpose of this randomized trial is to test the effectiveness of screening and brief intervention for risk drinking by nonpregnant women with specific medical problems exacerbated by excessive alcohol consumption. The medical problems are female factor infertility, hypertension, diabetes, and osteoporosis, conditions that are costly to treat and difficult to manage. Just as pregnant women are thought to be highly motivated to modify their alcohol consumption, so women with specific medical problems worsened by alcohol intake are an appropriate group to receive a brief intervention.

Detailed Description

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Conditions

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Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Diagnostic assessment with brief intervention and 3, 6, and 12 month follow-up

Group Type EXPERIMENTAL

Brief Intervention

Intervention Type BEHAVIORAL

Diagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up

2

Diagnostic assessment with 12 month follow-up

Group Type ACTIVE_COMPARATOR

Diagnostic assessment

Intervention Type BEHAVIORAL

Single session diagnostic assessment with 12 month followup

Interventions

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Brief Intervention

Diagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up

Intervention Type BEHAVIORAL

Diagnostic assessment

Single session diagnostic assessment with 12 month followup

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

\- 1. has diabetes, hypertension, osteoporosis, or infertility 2. Not currently receiving treatment for alcohol or drug problems or substance related medical illness 3. Not currently experiencing physical dependence on alcohol, requiring medically supervised detoxification 4. Not currently abusing or physically dependent on opiates, cocaine, or other illicit drugs 5. Not currently pregnant. Subjects with infertility may become pregnant during the course of the study.

6\. Not currently nursing. 7. Able to complete study measures.

Exclusion Criteria

1. Alcohol screen negative or drinks within NIAAA sensible drinking limits for women
2. Does not agree to randomization and study terms
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role collaborator

Office of Research on Women's Health (ORWH)

NIH

Sponsor Role collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01AA014678

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIH Grant R01AA014678

Identifier Type: -

Identifier Source: secondary_id

NIAAA-Chang-AA014678

Identifier Type: -

Identifier Source: org_study_id

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