Cardiovascular DiseasesNCT00153400
The California WISEWOMAN Project:Cardiovascular(CVD) Health for Hispanic Women
A study testing Enhanced Lifestyle Intervention in people with Cardiovascular Diseases and Chronic Diseases, run by Centers for Disease Control and Prevention.
Trial summary
The purpose of this trial is to provide low-income, under- or un-insured 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
- Cardiovascular Diseases, Chronic Diseases
- What is being tested?
- Enhanced Lifestyle Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Jun 2007
- 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
- National Breast and Cervical Cancer Early Detection Program (NBCCEDP)participants without cancer
- Income < 200 percent of federal poverty level
- Under or uninsured for the health care coverage
- Blood pressure >= 120 mm Hg systolic or >=80 mm Hg diastolic or currently taking medication to lower cholesterol
Who cannot join
- >180 mm Hg systolic or >110 mm Hg diastolic
- > 400 cholesterol
- pregnant women
- had past or current CVD events
About this study
Official title: The California Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Project: Improving Cardiovascular Risk Factors for Underserved Hispanic Women
The purpose of this trial is to provide low-income, under- or un-insured 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 the detailed description
This study is based on a single group. Evaluated how effectively culturally appropriate lifestyle intervention was in improving, over a relatively short-term period (~12 months) on health behaviors and the CVD risk profile.
- Conditions
- Cardiovascular Diseases, Chronic Diseases
- Being tested
- Enhanced Lifestyle Intervention
- Keywords
- CVD risk
- Medical subject headings
- Cardiovascular Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Lifestyle InterventionBehavioural
Also called YWCA Health Coaching and Walk with Ease
Three face-to-face counseling sessions for nutrition and physical activity. Used a Spanish culturally tailored materials. These interventions were delivered by community health workers (CHWs) who are trained.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Lifestyle Intervention | Experimental | Three health coaching sessions or Lifestyle Programs on physical activity and nutrition are delivered to each woman. Support is offered by community health workers. Receives: Behavioral: Enhanced Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
CVD risk (10 year estimated risk)
Combines a number of risk factors into one metric. Lower score means lower risk. Higher score means higher risk. Low risk (0 to <5, borderline risk (5 to <7.5), intermediate risk (7.5 to < 20), and high risk (>20). Range 0 to 20.
Measured: baseline, one-year
Secondary outcomes (2)
Physical Activity
Number of minutes of physical activity per week. American Heart Association recommendation of 150 mins per week for good health. Self-recorded daily and self-reported weekly.
Measured: baseline, one-year
Dietary Behavior
Numbers of fruits and vegetables on a weekly basis. The NHLBI standard of measurement is 5-a-day. Self-recorded daily and self-reported weekly.
Measured: baseline, 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 startJan 2006
- Primary completionJun 2007
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Provide Health coaching and Lifestyle programs
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centers for Disease Control and Prevention
- Sponsor type
- US federal agency
- Collaborators
- University of California, San Francisco, California Department of Health Services
- Responsible party
- Sponsor
- Investigators
- Julie Will, Study chair, Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00153400
- Sponsor's protocol ID
- CDC-NCCDPHP-3898
- Other IDs
- U58/CCU922827-01
- Status last verified
- Aug 2024
- First submitted
- 8 Sep 2005
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Silverstein RP, VanderVos M, Welch H, Long A, Kabore CD, Hootman JM. Self-Directed Walk With Ease Workplace Wellness Program - Montana, 2015-2017. MMWR Morb Mortal Wkly Rep. 2018 Nov 23;67(46):1295-1299. doi: 10.15585/mmwr.mm6746a3.
PubMed 30462629Ahmann E, Saviet M, Conboy L, Smith K, Iachini B, DeMartin R. Health and Wellness Coaching and Sustained Gains: A Rapid Systematic Review. Am J Lifestyle Med. 2023 Jun 20;18(2):162-180. doi: 10.1177/15598276231180117. eCollection 2024 Mar-Apr.
PubMed 38559782
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The California Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Project: Improving Cardiovascular Risk Factors for Underserved Hispanic Women
- ClinicalTrials.gov ID
- NCT00153400
- Acronym / sponsor ID
- CDC-NCCDPHP-3898
- Conditions
- Cardiovascular Diseases, Chronic Diseases
- Keywords
- CVD risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Centers for Disease Control and PreventionUS federal agency
- Collaborators
- University of California, San Francisco, California Department of Health Services
- Study start
- Jan 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (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.
The purpose of this trial is to provide low-income, under- or un-insured 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.
Detailed description
This study is based on a single group. Evaluated how effectively culturally appropriate lifestyle intervention was in improving, over a relatively short-term period (~12 months) on health behaviors and the CVD risk profile.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Provide Health coaching and Lifestyle programs
| Arm | Type | Receives |
|---|---|---|
| Enhanced Lifestyle Intervention | Experimental | Behavioral: Enhanced Lifestyle InterventionThree health coaching sessions or Lifestyle Programs on physical activity and nutrition are delivered to each woman. Support is offered by community health workers. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- National Breast and Cervical Cancer Early Detection Program (NBCCEDP)participants without cancer
- Income < 200 percent of federal poverty level
- Under or uninsured for the health care coverage
- Blood pressure >= 120 mm Hg systolic or >=80 mm Hg diastolic or currently taking medication to lower cholesterol
Key exclusion criteria (4 listed)
- >180 mm Hg systolic or >110 mm Hg diastolic
- > 400 cholesterol
- pregnant women
- had past or current CVD events
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 |
|---|---|---|
| Enhanced Lifestyle InterventionAlso: YWCA Health Coaching and Walk with EaseThree face-to-face counseling sessions for nutrition and physical activity. Used a Spanish culturally tailored materials. These interventions were delivered by community health workers (CHWs) who are trained. | Behavioural | Enhanced Lifestyle Intervention |
Primary outcome
CVD risk (10 year estimated risk)
Time frame: baseline, one-year
Combines a number of risk factors into one metric. Lower score means lower risk. Higher score means higher risk. Low risk (0 to <5, borderline risk (5 to <7.5), intermediate risk (7.5 to < 20), and high risk (>20). Range 0 to 20.
2 secondary outcomes
Physical Activity
Time frame: baseline, one-year
Dietary Behavior
Time frame: baseline, 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 5 Aug 2024.
- Background: PubMed 30462629Silverstein RP, VanderVos M, Welch H, Long A, Kabore CD, Hootman JM. Self-Directed Walk With Ease Workplace Wellness Program - Montana, 2015-2017. MMWR Morb Mortal Wkly Rep. 2018 Nov 23;67(46):1295-1299. doi: 10.15585/mmwr.mm6746a3.
- Results publication: PubMed 38559782Ahmann E, Saviet M, Conboy L, Smith K, Iachini B, DeMartin R. Health and Wellness Coaching and Sustained Gains: A Rapid Systematic Review. Am J Lifestyle Med. 2023 Jun 20;18(2):162-180. doi: 10.1177/15598276231180117. eCollection 2024 Mar-Apr.
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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 Enhanced Lifestyle Intervention in people with Cardiovascular Diseases and Chronic Diseases, run by Centers for Disease Control and Prevention.
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 4 inclusion and 4 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 5 Aug 2024. 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?
CVD risk (10 year estimated risk) (time frame: baseline, one-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00153400, which also lists 2 linked publications.
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 5 Aug 2024.