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CompletedNCT00846638WHHSUpdated May 7, 2010

Women's Health Habits Study

A Phase 3 interventional study of Brief Intervention and Diagnostic assessment in Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility, sponsored by Brigham and Women's Hospital. Completed at 1 site in United States. Open to female participants aged 21 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-05-07.

Sponsored by Brigham and Women's Hospital · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
611
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
Female
01

Study 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.

02

Conditions studied

  • Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility

Keywords

  • Risk drinking
  • Women
  • Medical problems
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 611 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,236 studies on the registry; 224 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 64 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
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.
  1. Not currently nursing. 7. Able to complete study measures.

Exclusion criteria

Exclusion Criteria:

  1. Alcohol screen negative or drinks within NIAAA sensible drinking limits for women
  2. Does not agree to randomization and study terms
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
611 participants (actual)

Study arms

  • Experimental
    1

    Diagnostic assessment with brief intervention and 3, 6, and 12 month follow-up

    Behavioral: Brief Intervention

  • Active comparator
    2

    Diagnostic assessment with 12 month follow-up

    Behavioral: Diagnostic assessment

Interventions

  • BehavioralBrief Intervention

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

  • BehavioralDiagnostic assessment

    Single session diagnostic assessment with 12 month followup

06

What researchers measure

Primary outcomes

  1. Drinking outcome

    Time frame: 12 months post enrollment

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00846638
Lead sponsor
Brigham and Women's Hospital
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA), Office of Research on Women's Health (ORWH)
First posted
Feb 19, 2009
Start date
Jan 2005
Primary completion
May 2009
Completion
May 2009
Last update
May 7, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2010. You cannot join it, but the record below documents what was studied.

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