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Cardiovascular Risk Reduction Program Aimed at African American Women (The HHER Lifestyle Program)
This study has been completed.
First Received: March 10, 2009   No Changes Posted
Sponsors and Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
The University of Texas Health Science Center at San Antonio
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00860444
  Purpose

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.


Condition Intervention Phase
Cardiovascular Diseases
Behavioral: Basic Educational and Counseling Program
Behavioral: Comprehensive Educational and Counseling Program
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Official Title: The Heart Healthy and Ethnically Relevant (HHER) Lifestyle Program for Cardiovascular Risk Reduction

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 266
Study Start Date: May 2005
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
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 receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting.
2: Experimental
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. They will also receive 12 months of telephone counseling and a monthly newsletter.

Detailed 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.

  Eligibility

Ages Eligible for Study:   35 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00860444

Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Deborah Parra-Medina, PhD The University of Texas Health Science Center, Houston
  More Information

No publications provided

Responsible Party: University of Texas Health Sciences Center at San Antonio ( Deborah Parra-Medina, PhD, Professor )
Study ID Numbers: 622, R01 HL073001
Study First Received: March 10, 2009
Last Updated: March 10, 2009
ClinicalTrials.gov Identifier: NCT00860444     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):
Primary Care
Diet
Physical Activity

Study placed in the following topic categories:
Healthy

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 10, 2009