ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Fat Reduction Intervention Trial in African-Americans

This study has been completed.

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00005700
  Purpose

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


Condition
Cardiovascular Diseases
Coronary Heart Disease Risk Reduction
Heart Diseases

MedlinePlus related topics:   Heart Diseases   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Natural History

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

Study Start Date:   September 1993
Estimated Study Completion Date:   August 1998

Detailed Description:

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.

  Eligibility
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Criteria

No eligibility criteria

  Contacts and Locations

No Contacts or Locations Provided
  More Information


Publications:

Study ID Numbers:   4281
First Received:   May 25, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00005700
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Coronary Disease
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on December 03, 2008




Links to all studies - primarily for crawlers