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Fat Reduction Intervention Trial in African-Americans
This study has been completed.
Study NCT00005700   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: June 23, 2005   History of Changes

May 25, 2000
June 23, 2005
September 1993
 
 
 
Complete list of historical versions of study NCT00005700 on ClinicalTrials.gov Archive Site
 
 
 
Fat Reduction Intervention Trial in African-Americans
 

To conduct a randomized controlled trial to evaluate the effectiveness of an intervention to reduce dietary fat.

BACKGROUND:

The African-American population of the United States continues to experience high rates of mortality from cardiovascular (CV) disease, including coronary heart disease, stroke and renal failure. The major syndromes which determine CV risk, including obesity, hypercholesterolemia, glucose intolerance, and hypertension, all occur more frequently among African Americans. Nutritional factors underlie many forms of CV disease and are an important focus of current prevention efforts. Very little is currently known, however, about specific nutritional patterns among African Americans that might lead to CV risk, or the applicability of structured interventions.

The study was conducted in response to an initiative on "Collaborative Projects on Minority Health" which was released in October 1992 after review and approval at the September 1992 National Heart, Lung, and Blood Advisory Council.

DESIGN NARRATIVE:

Given the growing recognition of the importance of total fat, from the point of view of both disease risk and eating patterns, the primary focus of the intervention was to reduce the percentage of calories in the diet from fat. Four hundred households were recruited and randomly assigned to either an active intervention or observation group for a period of 18 months. Dietary change consistent with specific recommendations made to the American public for reducing cardiovascular (CV) risk was encouraged, namely, reduction in total fat, saturated fat (SFA), and cholesterol (Chol). A practical, community-based program was developed which could be taken into households. Nutrition education and enhancement of skills helpful in making behavioral change formed the basis of the intervention. Lay educators, recruited from the target neighborhoods, worked under the close supervision of a community nutritionist. Changes in reported dietary intake, serum lipids/lipoproteins and body weights were measured. In addition to the formal evaluation of the trial outcome, an important secondary goal was to obtain detailed information about eating patterns in this community and characterize behavior associated with the achievement and maintenance of target nutrient goals.

The study was part of a collaborative project on minority health. Dr. Prewitt collaborated with Dr. Marian Fitzgibbon who was the principal investigator on R01HL51532.

 
Observational
Natural History
  • Cardiovascular Diseases
  • Coronary Heart Disease Risk Reduction
  • Heart Diseases
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
August 1998
 

No eligibility criteria

Male
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005700
 
4281
National Heart, Lung, and Blood Institute (NHLBI)
 
 
National Heart, Lung, and Blood Institute (NHLBI)
May 2001

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