NC Enhanced WISEWOMAN Project

Not Applicable

Completed

• Conditions: Cardiovascular Disease
• Interventions: Behavioral: Lifestyle behavior change program; Behavioral: Pamphlets

• Registration Number: NCT00288327
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief 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.

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 Timeline

• Study Start: 2003-03
• Primary Completion: 2004-12
• Study Completion: 2005-01
• Study First Submitted: 2006-02-06
• Study First Submitted QC: 2006-02-06
• Study First Posted: 2006-02-07
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-12
• Last Update Posted: 2009-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 258

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lifestyle behavior change program	Enhanced New Leaf Intervention
2	Pamphlets	Minimum Intervention

Primary Outcome Measures

Name	Time	Method
physical activity
fruit intake
vegetable intake
fat intake

Secondary Outcome Measures

Name	Time	Method
Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids);
CVD risk factors (total and HDL cholesterol, blood pressure);
Psychosocial variables

Trial Locations

Locations (1)

New Hanover Community Health Center; 🇺🇸 Wilmington, North Carolina, United States