Back to resultsWomen's Health Habits Study (WHHS)
Primary Purpose
Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Brief Intervention
Diagnostic assessment
Sponsored by
About this trial
This is an interventional prevention trial for Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility focused on measuring Risk drinking, Women, Medical problems
Eligibility 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:
- Alcohol screen negative or drinks within NIAAA sensible drinking limits for women
- Does not agree to randomization and study terms
Sites / Locations
- Brigham and Women's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Diagnostic assessment with brief intervention and 3, 6, and 12 month follow-up
Diagnostic assessment with 12 month follow-up
Outcomes
Primary Outcome Measures
Drinking outcome
Secondary Outcome Measures
Full Information
NCT ID
NCT00846638
First Posted
February 18, 2009
Last Updated
May 6, 2010
Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Office of Research on Women's Health (ORWH)
1. Study Identification
Unique Protocol Identification Number
NCT00846638
Brief Title
Women's Health Habits Study
Acronym
WHHS
Official Title
Screening and Brief Intervention for Problem Drinking Women
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Office of Research on Women's Health (ORWH)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility
Keywords
Risk drinking, Women, Medical problems
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
611 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Diagnostic assessment with brief intervention and 3, 6, and 12 month follow-up
Arm Title
2
Arm Type
Active Comparator
Arm Description
Diagnostic assessment with 12 month follow-up
Intervention Type
Behavioral
Intervention Name(s)
Brief Intervention
Intervention Description
Diagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up
Intervention Type
Behavioral
Intervention Name(s)
Diagnostic assessment
Intervention Description
Single session diagnostic assessment with 12 month followup
Primary Outcome Measure Information:
Title
Drinking outcome
Time Frame
12 months post enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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:
Alcohol screen negative or drinks within NIAAA sensible drinking limits for women
Does not agree to randomization and study terms
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
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Women's Health Habits Study
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