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

This study has been completed.
Sponsor:
Collaborator:
The University of Texas Health Science Center at San Antonio
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00860444
First received: March 10, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted

March 10, 2009
March 10, 2009
May 2005
April 2008   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Body mass index (weight [kg]/height [m2]) [ Time Frame: Measured at baseline and Months 6 and 12 ] [ Designated as safety issue: No ]
  • Central adiposity (i.e., waist circumference in inches) [ Time Frame: Measured at baseline and Months 6 and 12 ] [ Designated as safety issue: No ]
  • Total cholesterol (mg/dL) [ Time Frame: Measured at baseline and Months 6 and 12 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Cardiovascular Risk Reduction Program Aimed at African American Women (The HHER Lifestyle Program)
The Heart Healthy and Ethnically Relevant (HHER) Lifestyle Program for Cardiovascular Risk Reduction

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Cardiovascular Diseases
  • Behavioral: Basic 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.
  • 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. They will also receive 12 months of telephone counseling and a monthly newsletter.
  • Active Comparator: 1
    Participants will take part in the basic educational and counseling program through their community health care center.
    Intervention: Behavioral: Basic Educational and Counseling Program
  • Experimental: 2
    Participants will take part in the comprehensive educational and counseling program through their community health care center.
    Intervention: Behavioral: Comprehensive Educational and Counseling Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
April 2008
April 2008   (final data collection date for primary outcome measure)

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
Female
35 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00860444
622, R01 HL073001
Yes
Deborah Parra-Medina, PhD, Professor, University of Texas Health Sciences Center at San Antonio
National Heart, Lung, and Blood Institute (NHLBI)
The University of Texas Health Science Center at San Antonio
Principal Investigator: Deborah Parra-Medina, PhD The University of Texas Health Science Center, Houston
National Heart, Lung, and Blood Institute (NHLBI)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP