Cardiovascular DiseaseNCT00288327
NC Enhanced WISEWOMAN Project
A study testing Lifestyle behavior change program and Pamphlets in people with Cardiovascular Disease, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The overall aim of the study was to test the feasibility and effectiveness of a cardiovascular disease risk reduction intervention program for midlife, low-income women. We enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices for Healthy Living, which was designed specifically… Read more about this study
- Who is it for?
- Ages 40 to 64 years, women only
- Conditions the study is for
- Cardiovascular Disease
- What is being tested?
- Lifestyle behavior change program and Pamphlets
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jan 2005
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Women 40-64 years old
- Patient at participating site who is considered an appropriate candidate by the primary care clinician
- Ability and willingness to provide informed consent
- Availability for follow-up--plan to reside within 50 miles of study site for 1 year
- Home phone or easy access to phone
Who cannot join
- Medical condition for which intervention may not be appropriate
- Pregnancy/lactation
- Severe chronic medical conditions such that interventions to improve diet and physical activity are not appropriate
Trial locations and contacts
1 site in 1 country.
United States1 site
New Hanover Community Health Center
Wilmington, North Carolina, 28401
About this study
Official title: Testing Lifestyle Interventions for CVD Risk Reduction in Older, Underserved Women; Enhanced WISEWOMAN Project
The overall aim of the study was to test the feasibility and effectiveness of a cardiovascular disease risk reduction intervention program for midlife, low-income women. We enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices for Healthy Living, which was designed specifically for this demographic group as part of the CDC's WISEWOMAN Program. The enhanced intervention was tested in a randomized controlled trial in a community health center setting.
Read the detailed description
We conducted a 2 year study to test the feasibility and effectiveness of a CVD risk reduction intervention program for older, under or uninsured women. We used an existing nutrition and physical activity (PA) intervention tool (New Leaf…Choices for Healthy Living) designed specifically for this demographic group as part of the WISEWOMAN program (A CDC-funded CVD risk factor screening and intervention program for older, low-income women). We enhanced this already tested intervention to include: 1) the latest recommendations regarding dietary fat and carbohydrate intake, 2) group education sessions and follow-up telephone contacts from lay health advisors (LHAs); and 3) a community resource linkage component delivered primarily by LHAs. We tested the enhanced intervention in a randomized controlled trial in a community health center setting.
A total of 240 women aged 40-64 were randomized to the enhanced New Leaf intervention or minimum intervention groups. Women in the enhanced New Leaf group received a 6 month intensive intervention consisting of 2 individual counseling sessions at the CHC, postcard mailings, 3 group sessions, and lay health advisor (LHA) guided linkages to community resources for diet and PA. This was followed by a 6 month maintenance period led by the LHA and including 6 phone contacts, and 3 tailored mailings along with continued community resource linkages. Primary outcome measures at 6 and 12 months included 1) PA measured by CSA accelerometer and 2) fruit, vegetable, and fat intake. Secondary outcomes included biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids), CVD risk factors (total and HDL cholesterol, blood pressure), and psychosocial variables.
- Conditions
- Cardiovascular Disease
- Being tested
- Lifestyle behavior change program, Pamphlets
- Keywords
- diet, physical activity, smoking cessation
- Medical subject headings
- Cardiovascular Diseases, Motor Activity, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle behavior change programBehavioural
Intervention included a six-month intensive intervention of 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls.
PamphletsBehavioural
Nutritional and physical activity pamphlets from American Heart Association
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Enhanced New Leaf Intervention Receives: Behavioral: Lifestyle behavior change program |
| 2 | Other | Minimum Intervention Receives: Behavioral: Pamphlets |
What is being measured
The primary outcome is the main question the study is designed to answer.
physical activity
fruit intake
vegetable intake
fat intake
Secondary outcomes (3)
Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);
CVD risk factors (total and HDL cholesterol, blood pressure);
Psychosocial variables
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startMar 2003
- Primary completionDec 2004
- Study completionJan 2005
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 DiseaseStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services
- Investigators
- Alice S Ammerman, DrPH, RD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00288327
- Sponsor's protocol ID
- U48/CCU409660
- Status last verified
- Mar 2009
- First submitted
- 6 Feb 2006
- Last updated
- 13 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosamond WD, Ammerman AS, Holliday JL, Tawney KW, Hunt KJ, Keyserling TC, Will JC, Mokdad AH. Cardiovascular disease risk factor intervention in low-income women: the North Carolina WISEWOMAN project. Prev Med. 2000 Oct;31(4):370-9. doi: 10.1006/pmed.2000.0726.
PubMed 11006062Keyserling TC, Samuel Hodge CD, Jilcott SB, Johnston LF, Garcia BA, Gizlice Z, Gross MD, Savinon CE, Bangdiwala SI, Will JC, Farris RP, Trost S, Ammerman AS. Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project. Prev Med. 2008 Jun;46(6):499-510. doi: 10.1016/j.ypmed.2008.02.011. Epub 2008 Feb 15.
PubMed 18394692
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Lifestyle Interventions for CVD Risk Reduction in Older, Underserved Women; Enhanced WISEWOMAN Project
- ClinicalTrials.gov ID
- NCT00288327
- Acronym / sponsor ID
- U48/CCU409660
- Conditions
- Cardiovascular Disease
- Keywords
- diet, physical activity, smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services
- Study start
- Mar 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 7 Feb 2006 (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 overall aim of the study was to test the feasibility and effectiveness of a cardiovascular disease risk reduction intervention program for midlife, low-income women. We enhanced an existing nutrition and physical activity intervention tool, A New Leaf...Choices for Healthy Living, which was designed specifically for this demographic group as part of the CDC's WISEWOMAN Program. The enhanced intervention was tested in a randomized controlled trial in a community health center setting.
Detailed description
We conducted a 2 year study to test the feasibility and effectiveness of a CVD risk reduction intervention program for older, under or uninsured women. We used an existing nutrition and physical activity (PA) intervention tool (New Leaf…Choices for Healthy Living) designed specifically for this demographic group as part of the WISEWOMAN program (A CDC-funded CVD risk factor screening and intervention program for older, low-income women). We enhanced this already tested intervention to include: 1) the latest recommendations regarding dietary fat and carbohydrate intake, 2) group education sessions and follow-up telephone contacts from lay health advisors (LHAs); and 3) a community resource linkage component delivered primarily by LHAs. We tested the enhanced intervention in a randomized controlled trial in a community health center setting.
A total of 240 women aged 40-64 were randomized to the enhanced New Leaf intervention or minimum intervention groups. Women in the enhanced New Leaf group received a 6 month intensive intervention consisting of 2 individual counseling sessions at the CHC, postcard mailings, 3 group sessions, and lay health advisor (LHA) guided linkages to community resources for diet and PA. This was followed by a 6 month maintenance period led by the LHA and including 6 phone contacts, and 3 tailored mailings along with continued community resource linkages. Primary outcome measures at 6 and 12 months included 1) PA measured by CSA accelerometer and 2) fruit, vegetable, and fat intake. Secondary outcomes included biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids), CVD risk factors (total and HDL cholesterol, blood pressure), and psychosocial variables.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Lifestyle behavior change programEnhanced New Leaf Intervention |
| 2 | Other | Behavioral: PamphletsMinimum Intervention |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women 40-64 years old
- Patient at participating site who is considered an appropriate candidate by the primary care clinician
- Ability and willingness to provide informed consent
- Availability for follow-up--plan to reside within 50 miles of study site for 1 year
- Home phone or easy access to phone
Key exclusion criteria (3 listed)
- Medical condition for which intervention may not be appropriate
- Pregnancy/lactation
- Severe chronic medical conditions such that interventions to improve diet and physical activity are not appropriate
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 |
|---|---|---|
| Lifestyle behavior change programIntervention included a six-month intensive intervention of 2 individual counseling sessions, 3 group sessions, and 3 phone calls from a peer counselor followed by a maintenance phase (6 months) including 1 individual counseling session and 7 monthly peer counselor calls. | Behavioural | 1 |
| PamphletsNutritional and physical activity pamphlets from American Heart Association | Behavioural | 2 |
Primary outcome
physical activity
fruit intake
vegetable intake
fat intake
3 secondary outcomes
Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);
CVD risk factors (total and HDL cholesterol, blood pressure);
Psychosocial variables
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 13 Mar 2009.
- Background: PubMed 11006062Rosamond WD, Ammerman AS, Holliday JL, Tawney KW, Hunt KJ, Keyserling TC, Will JC, Mokdad AH. Cardiovascular disease risk factor intervention in low-income women: the North Carolina WISEWOMAN project. Prev Med. 2000 Oct;31(4):370-9. doi: 10.1006/pmed.2000.0726.
- Derived from this study: PubMed 18394692Keyserling TC, Samuel Hodge CD, Jilcott SB, Johnston LF, Garcia BA, Gizlice Z, Gross MD, Savinon CE, Bangdiwala SI, Will JC, Farris RP, Trost S, Ammerman AS. Randomized trial of a clinic-based, community-supported, lifestyle intervention to improve physical activity and diet: the North Carolina enhanced WISEWOMAN project. Prev Med. 2008 Jun;46(6):499-510. doi: 10.1016/j.ypmed.2008.02.011. Epub 2008 Feb 15.
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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.
Alice S Ammerman, DrPH, RD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lifestyle behavior change program and Pamphlets in people with Cardiovascular Disease, run by University of North Carolina, Chapel Hill 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 5 inclusion and 3 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 13 Mar 2009. 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.
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?
physical activity. The study lists 4 primary outcomes in all. 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 NCT00288327, 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 13 Mar 2009.