Women's Health Habits Study (WHHS)

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00846638
First received: February 18, 2009
Last updated: May 6, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846638

Locations
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Brigham and Women's Hospital
  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 July 29, 2014