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

August 2, 2024 updated by: Centers for Disease Control and Prevention

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Lifestyle Intervention
Three health coaching sessions or Lifestyle Programs on physical activity and nutrition are delivered to each woman. Support is offered by community health workers.
Behavioral: Enhanced Lifestyle Intervention
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, one-year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline, one-year
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.
baseline, one-year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centers for Disease Control and Prevention

Collaborators

University of California, San Francisco
California Department of Health Services

Investigators

  • Study Chair: Julie Will, Centers for Disease Control and Prevention

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2006

Primary Completion (Actual)

June 1, 2007

Study Completion (Actual)

June 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 8, 2005

First Posted (Estimated)

September 12, 2005

Study Record Updates

Last Update Posted (Actual)

August 5, 2024

Last Update Submitted That Met QC Criteria

August 2, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-NCCDPHP-3898
  • U58/CCU922827-01 (Other Grant/Funding Number: Centers for Disease Control and Prevention)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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