Women's Health Habits Study (WHHS)

Mass General Brigham

Status and phase: Completed; Phase 3

Conditions: Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility

Treatments: Behavioral: Diagnostic assessment; Behavioral: Brief Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00846638

NIH Grant R01AA014678

R01AA014678 (U.S. NIH Grant/Contract)

NIAAA-Chang-AA014678

Details and patient eligibility

About

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.

Enrollment: 611 patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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611 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Behavioral: Brief Intervention

2

Active Comparator group

Description:

Diagnostic assessment with 12 month follow-up

Treatment:

Behavioral: Diagnostic assessment