Risk Reduction BehaviorNCT00153426
West Virginia WISEWOMAN Project
A study testing West Virginia WISEWOMAN in people with Risk Reduction Behavior, run by West Virginia University.
Trial summary
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases. Read more about this study
- Who is it for?
- Ages 40 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Risk Reduction Behavior
- What is being tested?
- West Virginia WISEWOMAN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 733 participants
- Where
- No sites listed yet
- Study dates
- Jul 2003to Mar 2008
- Phase
- Interventional
- 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 40 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- NBCCEDP
Who cannot join
- -
About this study
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.
- Conditions
- Risk Reduction Behavior
- Being tested
- West Virginia WISEWOMAN
- Medical subject headings
- Risk Reduction Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
West Virginia WISEWOMANBehavioural
Print-based tailored health communications and computer-based interactive nutrition program
| Study group | Role | What they receive |
|---|---|---|
| lifestyle counseling | Experimental | Women assigned to lifestyle change intervention arm for nutrition and physical activity with print-based tailored health communications and a computer-based interactive nutrition program targeting health behaviors of diet and physical activity. Women in a control group did not receive the intervention. Receives: Behavioral: West Virginia WISEWOMAN |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in physical activity and nutrition lifestyle behaviors
Measured: baseline and one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startJul 2003
- Primary completionMar 2008
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Risk Reduction BehaviorStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 733 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robin Seabury, West Virginia University
- Investigators
- Julie Will, Study chair, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153426
- Sponsor's protocol ID
- CDC-NCCDPHP-4234
- Other IDs
- U58/CCU322798-01
- Status last verified
- Jun 2012
- First submitted
- 8 Sep 2005
- Last updated
- 28 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- West Virginia WISEWOMAN Project
- ClinicalTrials.gov ID
- NCT00153426
- Acronym / sponsor ID
- CDC-NCCDPHP-4234
- Conditions
- Risk Reduction Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 733 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jul 2003
- Primary completion
- Mar 2008 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 12 Sep 2005 (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.
To provide low-income, under- or uninsured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lifestyle counseling | Experimental | Behavioral: West Virginia WISEWOMANWomen assigned to lifestyle change intervention arm for nutrition and physical activity with print-based tailored health communications and a computer-based interactive nutrition program targeting health behaviors of diet and physical activity. Women in a control group did not receive the intervention. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- NBCCEDP
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| West Virginia WISEWOMANPrint-based tailored health communications and computer-based interactive nutrition program | Behavioural | lifestyle counseling |
Primary outcome
change in physical activity and nutrition lifestyle behaviors
Time frame: baseline and one year
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 28 Jun 2012.
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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.
Julie Will study chair
Centers for Disease Control and Prevention
Questions about this trial
What is this clinical trial studying?
A study testing West Virginia WISEWOMAN in people with Risk Reduction Behavior, run by West Virginia University.
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 1 inclusion and 1 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 28 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
change in physical activity and nutrition lifestyle behaviors (time frame: baseline and one year). 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 28 Jun 2012.