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

Cardiovascular Diseases Clinical Trial

— HHER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00860444
• Other study ID #: 622
• Secondary ID: R01HL073001
• Status: Completed
• Phase: Phase 3
• First received: March 10, 2009
• Last updated: January 6, 2014
• Start date: May 2005
• Est. completion date: April 2008

Study information

• Verified date: January 2014
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 266
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 35 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (3)

Parra-Medina D, Wilcox S, Salinas J, Addy C, Fore E, Poston M, Wilson DK. Results of the Heart Healthy and Ethnically Relevant Lifestyle trial: a cardiovascular risk reduction intervention for African American women attending community health centers. Am — View Citation

Parra-Medina D, Wilcox S, Wilson DK, Addy CL, Felton G, Poston MB. Heart Healthy and Ethnically Relevant (HHER) Lifestyle trial for improving diet and physical activity in underserved African American women. Contemp Clin Trials. 2010 Jan;31(1):92-104. doi: 10.1016/j.cct.2009.09.006. Epub 2009 Sep 22. — View Citation

Wilcox S, Parra-Medina D, Felton GM, Poston MB, McClain A. Adoption and implementation of physical activity and dietary counseling by community health center providers and nurses. J Phys Act Health. 2010 Sep;7(5):602-12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Measured at baseline and Months 6 and 12	No
Primary	Weekly consumption frequency of dietary fat and cholesterol, as measured by the New Leaf Dietary Risk Assessment (DRA)		Measured at baseline and Months 6 and 12	No
Secondary	Body mass index (weight [kg]/height [m2])		Measured at baseline and Months 6 and 12	No
Secondary	Central adiposity (i.e., waist circumference in inches)		Measured at baseline and Months 6 and 12	No
Secondary	Total cholesterol (mg/dL)		Measured at baseline and Months 6 and 12	No