A Phase 3 interventional study of Basic Educational and Counseling Program and Comprehensive Educational and Counseling Program in Cardiovascular Diseases, sponsored by The University of Texas Health Science Center at San Antonio. Completed. Open to female participants aged 35 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-01-07.
Sponsored by The University of Texas Health Science Center at San Antonio · Phase 3, Interventional, and Prevention
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.
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.
4,902 studies on the registry are indexed under Cardiovascular Diseases; 920 are open to participants now.
This study's enrollment of 266 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 31 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will take part in the basic educational and counseling program through their community health care center.
Behavioral: Basic Educational and Counseling Program
Participants will take part in the comprehensive educational and counseling program through their community health care center.
Behavioral: Comprehensive Educational and Counseling Program
Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting.
Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting. They will also receive 12 months of telephone counseling and a monthly newsletter.
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
Time frame: 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)
Time frame: Measured at baseline and Months 6 and 12
Body mass index (weight [kg]/height [m2])
Time frame: Measured at baseline and Months 6 and 12
Central adiposity (i.e., waist circumference in inches)
Time frame: Measured at baseline and Months 6 and 12
Total cholesterol (mg/dL)
Time frame: Measured at baseline and Months 6 and 12
No study locations are listed for this record.
This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio