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

Study Overview
=================
Brief 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.

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.

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

Conditions
-----------------
Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: Basic Educational and Counseling Program
* Behavioral: Comprehensive Educational and Counseling Program


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Participants will take part in the basic educational and counseling program through their community health care center. | Behavioral: Basic Educational and Counseling Program<br>* Participants will receive one session of brief patient-centered physician counseling, along with educational handouts and nurse-assisted guidance with goal-setting.<br>|
| Experimental: 2<br>Participants will take part in the comprehensive educational and counseling program through their community health care center. | Behavioral: Comprehensive Educational and Counseling Program<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (weight [kg]/height [m2]) |  | Measured at baseline and Months 6 and 12 | 
| Central adiposity (i.e., waist circumference in inches) |  | Measured at baseline and Months 6 and 12 | 
| Total cholesterol (mg/dL) |  | Measured at baseline and Months 6 and 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Care, Diet, Physical Activity