NC Enhanced WISEWOMAN Project

Cardiovascular Disease Clinical Trial

Official title:

Testing Lifestyle Interventions for CVD Risk Reduction in Older, Underserved Women; Enhanced WISEWOMAN Project

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00288327
• Other study ID #: U48/CCU409660
• Status: Completed
• Phase: N/A
• First received: February 6, 2006
• Last updated: March 12, 2009
• Start date: March 2003
• Est. completion date: January 2005

Study information

• Verified date: March 2009
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 258
• Est. completion date: January 2005
• Est. primary completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 64 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

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.
• Pamphlets
Nutritional and physical activity pamphlets from American Heart Association

Locations

Country	Name	City	State
United States	New Hanover Community Health Center	Wilmington	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Centers for Disease Control and Prevention, North Carolina Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	physical activity
Primary	fruit intake
Primary	vegetable intake
Primary	fat intake
Secondary	Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);
Secondary	CVD risk factors (total and HDL cholesterol, blood pressure);
Secondary	Psychosocial variables