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OpenTrials
Completed

NCT Number: NCT00153400

The California WISEWOMAN Project:Cardiovascular(CVD) Health for Hispanic Women

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.

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Key information

Conditions

Cardiovascular Diseases Chronic Disease Chronic Diseases Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–64 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Lifestyle Intervention

Behavioral

Three face-to-face counseling sessions for nutrition and physical activity. Used a Spanish culturally tailored materials. These interventions were delivered by community health workers (CHWs) who are trained.

Other names: YWCA Health Coaching and Walk with Ease

Primary outcomes

  1. 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

  1. Physical Activity

    Time frame: baseline, one-year

    Number of minutes of physical activity per week. American Heart Association recommendation of 150 mins per week for good health. Self-recorded daily and self-reported weekly.

  2. Dietary Behavior

    Time frame: baseline, one-year

    Numbers of fruits and vegetables on a weekly basis. The NHLBI standard of measurement is 5-a-day. Self-recorded daily and self-reported weekly.

Sponsors and collaborators

Lead sponsor

Centers for Disease Control and Prevention

Fed

Collaborators

  • California Department of Health Services
  • University of California, San Francisco

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Aug 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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