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

Not Applicable

Completed

• Conditions: Cardiovascular Diseases; Chronic Diseases
• Interventions: Behavioral: Enhanced Lifestyle Intervention

• Registration Number: NCT00153400
• Lead Sponsor: Centers for Disease Control and Prevention

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 Timeline

• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-12
• Study Start: 2006-01
• Primary Completion: 2007-06
• Study Completion: 2007-06
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-02
• Last Update Posted: 2024-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enhanced Lifestyle Intervention	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.

Primary Outcome Measures

Name	Time	Method
CVD risk (10 year estimated risk)	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 Outcome Measures

Name	Time	Method
Dietary Behavior	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.
Physical Activity	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.