NC Enhanced WISEWOMAN Project
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cardiovascular Disease |
Behavioral: Lifestyle behavior change program Behavioral: Pamphlets |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Testing Lifestyle Interventions for CVD Risk Reduction in Older, Underserved Women; Enhanced WISEWOMAN Project |
- physical activity
- fruit intake
- vegetable intake
- fat intake
- Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);
- CVD risk factors (total and HDL cholesterol, blood pressure);
- Psychosocial variables
| Enrollment: | 258 |
| Study Start Date: | March 2003 |
| Study Completion Date: | January 2005 |
| Primary Completion Date: | December 2004 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Enhanced New Leaf Intervention
|
Behavioral: Lifestyle behavior change program
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.
|
|
2
Minimum Intervention
|
Behavioral: Pamphlets
Nutritional and physical activity pamphlets from American Heart Association
|
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.
Eligibility| Ages Eligible for Study: | 40 Years to 64 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations| United States, North Carolina | |
| New Hanover Community Health Center | |
| Wilmington, North Carolina, United States, 28401 | |
| Principal Investigator: | Alice S Ammerman, DrPH, RD | University of North Carolina, Chapel Hill |
More Information
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Alice Ammerman, DrPH, RD/Director, Center for Health Promotion and Disease Prevention |
| ClinicalTrials.gov Identifier: | NCT00288327 History of Changes |
| Other Study ID Numbers: | U48/CCU409660 |
| Study First Received: | February 6, 2006 |
| Last Updated: | March 12, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of North Carolina, Chapel Hill:
|
diet physical activity smoking cessation |
Additional relevant MeSH terms:
|
Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 17, 2013