Women's Health Habits Study

Phase 3

Completed

• Conditions: Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility
• Interventions: Behavioral: Brief Intervention; Behavioral: Diagnostic assessment

• Registration Number: NCT00846638
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-02-18
• Study First Posted: 2009-02-19
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-05
• Last Update Submitted: 2010-05-06
• Last Update Posted: 2010-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 611

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Brief Intervention	Diagnostic assessment with brief intervention and 3, 6, and 12 month follow-up
2	Diagnostic assessment	Diagnostic assessment with 12 month follow-up

Primary Outcome Measures

Name	Time	Method
Drinking outcome	12 months post enrollment

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States