Women's Health Habits Study (WHHS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00846638
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : May 7, 2010
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Office of Research on Women's Health (ORWH)
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility Behavioral: Brief Intervention Behavioral: Diagnostic assessment Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 611 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Screening and Brief Intervention for Problem Drinking Women
Study Start Date : January 2005
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Drinking outcome [ Time Frame: 12 months post enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Senior)
Sexes 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:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00846638

United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Office of Research on Women's Health (ORWH)

Responsible Party: Grace Chang, MD, MPH, Brigham and Women's Hospital Identifier: NCT00846638     History of Changes
Other Study ID Numbers: NIAAA-Chang-AA014678
R01AA014678 ( U.S. NIH Grant/Contract )
NIH Grant R01AA014678
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: May 7, 2010
Last Verified: May 2010

Keywords provided by Brigham and Women's Hospital:
Risk drinking
Medical problems

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases
Genital Diseases, Male
Genital Diseases, Female