Women's Health Habits Study

NCT00846638 | Completed Phase 3

• 3 other identifiers: NIAAA-Chang-AA014678R01AA014678NIH Grant R01AA014678
• Study Type: interventional
• Target: 611
• Locations: 1 country
• Sites: 1

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.

Conditions

Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility

Keywords

Risk drinking; Women; Medical problems

Outcome Measures

Primary Outcomes (1)

• Drinking outcome

  12 months post enrollment

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: Brief Intervention

2

ACTIVE COMPARATOR

Diagnostic assessment with 12 month follow-up

Behavioral: Diagnostic assessment

Interventions

Brief Intervention BEHAVIORAL

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

1

Diagnostic assessment BEHAVIORAL

Single session diagnostic assessment with 12 month followup

2

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator
• Office of Research on Women's Health (ORWH): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Osteoporosis; Infertility

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: February 19, 2009
• Study Start: January 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: May 7, 2010

Record last verified: 2010-05

Locations

US (1)