NC Enhanced WISEWOMAN Project

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease

Intervention / Treatment
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* Behavioral: Lifestyle behavior change program
* Behavioral: Pamphlets


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Enhanced New Leaf Intervention | Behavioral: Lifestyle behavior change program<br>* 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.<br>|
| Other: 2<br>Minimum Intervention | Behavioral: Pamphlets<br>* Nutritional and physical activity pamphlets from American Heart Association<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| physical activity |  |  | 
| fruit intake |  |  | 
| vegetable intake |  |  | 
| fat intake |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of dietary intake (red blood cell membrane fatty acids, carotenoids); |  |  | 
| CVD risk factors (total and HDL cholesterol, blood pressure); |  |  | 
| Psychosocial variables |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet, physical activity, smoking cessation