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Completed

NCT Number: NCT00846638

Women's Health Habits Study

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.

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Key information

Conditions

Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility Bone Diseases Bone Diseases, Metabolic Cardiovascular Diseases Diabetes Mellitus Endocrine System Diseases Genital Diseases Glucose Metabolism Disorders Hypertension Infertility Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Urogenital Diseases Vascular Diseases

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Brief intervention

Behavioral

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

Diagnostic assessment

Behavioral

Single session diagnostic assessment with 12 month followup

Primary outcomes

  1. Drinking outcome

    Time frame: 12 months post enrollment

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)
  • Office of Research on Women's Health (ORWH)

Registry information

Official study title

Screening and Brief Intervention for Problem Drinking Women

Acronym: WHHS

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Feb 19, 2009
Registry last updated
May 7, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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