Skip to main content
OpenTrials
Completed

NCT Number: NCT00860444

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

35 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Basic Educational and Counseling Program

Behavioral

Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting.

Comprehensive Educational and Counseling Program

Behavioral

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.

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. Body mass index (weight [kg]/height [m2])

    Time frame: Measured at baseline and Months 6 and 12

  2. Central adiposity (i.e., waist circumference in inches)

    Time frame: Measured at baseline and Months 6 and 12

  3. Total cholesterol (mg/dL)

    Time frame: Measured at baseline and Months 6 and 12

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Acronym: HHER

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Mar 12, 2009
Registry last updated
Jan 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.