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临床试验/NCT00860444
NCT00860444
已完成
3 期

The Heart Healthy and Ethnically Relevant (HHER) Lifestyle Program for Cardiovascular Risk Reduction

The University of Texas Health Science Center at San Antonio0 个研究点目标入组 266 人2005年5月

概览

阶段
3 期
干预措施
未指定
疾病 / 适应症
Cardiovascular Diseases
发起方
The University of Texas Health Science Center at San Antonio
入组人数
266
主要终点
Hours per week in moderate and vigorous intensity physical activities (MVPA), as measured by the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire
状态
已完成
最后更新
12年前

概览

简要总结

Cardiovascular disease (CVD) is a serious health problem among African American women. This study will evaluate a health care center-based program that aims to encourage African American women to eat a low fat diet and increase their physical activity levels to reduce the risk of developing CVD.

详细描述

CVD is the leading cause of death for women in the United States. It affects African American women at a higher rate than it does white women. People at risk for CVD are encouraged to maintain a healthy weight, eat a healthy diet that is low in fat and cholesterol, and increase their physical activity. Heath care centers are excellent places to provide counseling to people on ways to reduce their risk of CVD. In this study, researchers will evaluate the effectiveness of a community health care center-based counseling program aimed at reducing CVD risk factors among African American women from financially disadvantaged backgrounds. This study will enroll African American women. Participants will be randomly assigned to one of two groups-either a basic program or a comprehensive program. During a routine, scheduled visit with their health care providers, all participants will learn about the importance of increasing physical activity and eating a low fat diet. All participants will also receive educational materials and a community resource guide. In addition to this, participants in the comprehensive program will receive a pedometer and will be asked to keep a daily log of their physical activity and eating habits. Once a month, these same participants will receive telephone calls from a health counselor and a newsletter by mail that encourages them to maintain a healthy lifestyle. All participants will receive home visits from study staff at baseline and Months 6 and 12. During these visits, participants will undergo blood pressure, weight, height, and waist measurements and a blood collection. Participants will complete questionnaires to assess their medical history, diet, and physical activity habits. For 1 week after each visit, participants will wear a physical activity monitor and keep an activity diary.

注册库
clinicaltrials.gov
开始日期
2005年5月
结束日期
2008年4月
最后更新
12年前
研究类型
Interventional
研究设计
Parallel
性别
Female

研究者

责任方
Principal Investigator
主要研究者

Deborah Parra-Medina

Professor, Epidemiology and Biostatistics

The University of Texas Health Science Center at San Antonio

入排标准

入选标准

  • African American women
  • Able and willing to complete survey instruments and assessment procedures

排除标准

  • Physical disability or orthopedic problem that limits physical activity
  • Elevated blood pressure (i.e., greater than 160/95 mm Hg)
  • Insulin-dependent diabetes
  • Pregnant or planning to become pregnant during the study period

结局指标

主要结局

Hours per week in moderate and vigorous intensity physical activities (MVPA), as measured by the Community Healthy Activities Model Program for Seniors (CHAMPS) Physical Activity Questionnaire

时间窗: Measured at baseline and Months 6 and 12

Weekly consumption frequency of dietary fat and cholesterol, as measured by the New Leaf Dietary Risk Assessment (DRA)

时间窗: Measured at baseline and Months 6 and 12

次要结局

  • Body mass index (weight [kg]/height [m2])(Measured at baseline and Months 6 and 12)
  • Central adiposity (i.e., waist circumference in inches)(Measured at baseline and Months 6 and 12)
  • Total cholesterol (mg/dL)(Measured at baseline and Months 6 and 12)

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