Cardiovascular Risk Reduction Program Aimed at African American Women (The HHER Lifestyle Program)

The University of Texas System (UT)

Status and phase: Completed; Phase 3

Conditions: Cardiovascular Diseases

Treatments: Behavioral: Basic Educational and Counseling Program; Behavioral: Comprehensive Educational and Counseling Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00860444

622

R01HL073001 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 266 patients

Sex: Female

Ages: 35+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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266 participants in 2 patient groups

1

Active Comparator group

Description:

Participants will take part in the basic educational and counseling program through their community health care center.

Treatment:

Behavioral: Basic Educational and Counseling Program

2

Experimental group

Description:

Participants will take part in the comprehensive educational and counseling program through their community health care center.

Treatment:

Behavioral: Comprehensive Educational and Counseling Program