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Home > "F" Clinical Trials Conditions > Fat Reduction Intervention Trial in African-Americans  Fat Reduction Intervention Trial in African-Americans
Fat Reduction Intervention Trial in African-Americans
For Condition: Heart Diseases,Coronary Heart Disease Risk Reduction,Cardiovascular Diseases
Status: Completed
Sponsor(s): National Heart, Lung, and Blood Institute (NHLBI) ,
Synopsis: To conduct a randomized controlled trial to evaluate the effectiveness of an intervention to reduce dietary fat.
Details: 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:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: No eligibility criteria
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: 4281;
Study Start Date: September 1993
Record last reviewed: May 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005700
Other Coronary Heart Disease Risk Reduction Studies:
1. Aspirin-Myocardial Infarction Study (AMIS)
2. Nurses' Health Study
3. Blood Pressure Tracking--Childhood to Young Adulthood
4. Gender Response To Coronary Risk
5. Urinary Kallikrein and Hypertension: A Prospective Study
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Other Coronary Heart Disease Risk Reduction Clinical Trials
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Fat Reduction Intervention Trial in African-Americans
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