Risk Drinking,Diabetes, Hypertension, Osteoporosis, InfertilityPhase 3WHHSNCT00846638
Women's Health Habits Study
A Phase 3 study testing Brief Intervention and Diagnostic assessment in people with Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility
- What is being tested?
- Brief Intervention and Diagnostic assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to May 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Alcohol screen negative or drinks within NIAAA sensible drinking limits for women
- Does not agree to randomization and study terms
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Screening and Brief Intervention for Problem Drinking Women
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.
- Being tested
- Brief Intervention, Diagnostic assessment
- Keywords
- Risk drinking, Women, Medical problems
- Medical subject headings
- Diabetes Mellitus, Hypertension, Osteoporosis, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief InterventionBehavioural
Diagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up
Diagnostic assessmentBehavioural
Single session diagnostic assessment with 12 month followup
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Diagnostic assessment with brief intervention and 3, 6, and 12 month follow-up Receives: Behavioral: Brief Intervention |
| 2 | Active comparator | Diagnostic assessment with 12 month follow-up Receives: Behavioral: Diagnostic assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinking outcome
Measured: 12 months post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2009 (estimated)
- Study startJan 2005
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Drinking,Diabetes, Hypertension, Osteoporosis, InfertilityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Office of Research on Women's Health (ORWH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00846638
- Sponsor's protocol ID
- NIAAA-Chang-AA014678
- Other IDs
- R01AA014678, NIH Grant R01AA014678
- Acronym
- WHHS
- Status last verified
- May 2010
- First submitted
- 18 Feb 2009
- Last updated
- 7 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening and Brief Intervention for Problem Drinking Women
- ClinicalTrials.gov ID
- NCT00846638
- Acronym / sponsor ID
- WHHS / NIAAA-Chang-AA014678
- Keywords
- Risk drinking, Women, Medical problems
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA), Office of Research on Women's Health (ORWH)
- Study start
- Jan 2005
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 19 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Brief InterventionDiagnostic assessment with brief intervention and 3, 6, and 12 month follow-up |
| 2 | Active comparator | Behavioral: Diagnostic assessmentDiagnostic assessment with 12 month follow-up |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Alcohol screen negative or drinks within NIAAA sensible drinking limits for women
- Does not agree to randomization and study terms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief InterventionDiagnostic assessment followed by a single session Brief Intervention with 3, 6, and 12 month follow-up | Behavioural | 1 |
| Diagnostic assessmentSingle session diagnostic assessment with 12 month followup | Behavioural | 2 |
Primary outcome
Drinking outcome
Time frame: 12 months post enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2010.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Brief Intervention and Diagnostic assessment in people with Risk Drinking,Diabetes, Hypertension, Osteoporosis, Infertility, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinking outcome (time frame: 12 months post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2010.