Women's Health Habits Study (WHHS)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility |
Behavioral: Brief Intervention Behavioral: Diagnostic assessment |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Screening and Brief Intervention for Problem Drinking Women |
- Drinking outcome [ Time Frame: 12 months post enrollment ] [ Designated as safety issue: No ]
| Enrollment: | 611 |
| Study Start Date: | January 2005 |
| Study Completion Date: | May 2009 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Diagnostic assessment with brief intervention and 3, 6, and 12 month follow-up
|
Behavioral: Brief Intervention
Diagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up
|
|
Active Comparator: 2
Diagnostic assessment with 12 month follow-up
|
Behavioral: Diagnostic assessment
Single session diagnostic assessment with 12 month followup
|
Eligibility| Ages Eligible for Study: | 21 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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:
- Alcohol screen negative or drinks within NIAAA sensible drinking limits for women
- Does not agree to randomization and study terms
Contacts and Locations More Information
No publications provided
| Responsible Party: | Grace Chang, MD, MPH, Brigham and Women's Hospital |
| ClinicalTrials.gov Identifier: | NCT00846638 History of Changes |
| Other Study ID Numbers: | NIAAA-Chang-AA014678, R01AA014678, NIH Grant R01AA014678 |
| Study First Received: | February 18, 2009 |
| Last Updated: | May 6, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Brigham and Women's Hospital:
|
Risk drinking Women Medical problems |
Additional relevant MeSH terms:
|
Hypertension Infertility Osteoporosis Vascular Diseases Cardiovascular Diseases |
Genital Diseases, Male Genital Diseases, Female Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on September 26, 2012
