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Clinical Trials/NCT00153400
NCT00153400
Completed
Not Applicable

The California Well-Integrated Screening and Evaluation for Women Across the Nation (WISEWOMAN) Project: Improving Cardiovascular Risk Factors for Underserved Hispanic Women

Centers for Disease Control and Prevention0 sites100 target enrollmentStarted: January 2006Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
100
Primary Endpoint
CVD risk (10 year estimated risk)

Overview

Brief Summary

The purpose of this trial is to provide low-income, under- or un-insured 40- to 64-year-old women with the knowledge, skills, and opportunities to improve diet, physical activity, and other lifestyle behaviors to prevent, delay and control cardiovascular and other chronic diseases.

Detailed Description

This study is based on a single group. Evaluated how effectively culturally appropriate lifestyle intervention was in improving, over a relatively short-term period (~12 months) on health behaviors and the CVD risk profile.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Masking Description

Low income uninsured and underinsured participants.

Eligibility Criteria

Ages
40 Years to 64 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • National Breast and Cervical Cancer Early Detection Program (NBCCEDP)participants without cancer
  • Income \< 200 percent of federal poverty level
  • Under or uninsured for the health care coverage
  • Blood pressure \>= 120 mm Hg systolic or \>=80 mm Hg diastolic or currently taking medication to lower cholesterol

Exclusion Criteria

  • \>180 mm Hg systolic or \>110 mm Hg diastolic
  • \> 400 cholesterol
  • pregnant women
  • had past or current CVD events

Outcomes

Primary Outcomes

CVD risk (10 year estimated risk)

Time Frame: baseline, one-year

Combines a number of risk factors into one metric. Lower score means lower risk. Higher score means higher risk. Low risk (0 to \<5, borderline risk (5 to \<7.5), intermediate risk (7.5 to \< 20), and high risk (\>20). Range 0 to 20.

Secondary Outcomes

  • Dietary Behavior(baseline, one-year)
  • Physical Activity(baseline, one-year)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

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