Ignite Creation Date:
2025-12-26 @ 12:15 PM
Ignite Modification Date:
2025-12-31 @ 2:31 PM
Study NCT ID:
NCT00005700
Status:
COMPLETED
Last Update Posted:
2016-02-18
First Post:
2000-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fat Reduction Intervention Trial in African-Americans
Sponsor:
National Heart, Lung, and Blood Institute (NHLBI)
Organization:
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To conduct a randomized controlled trial to evaluate the effectiveness of an intervention to reduce dietary fat.
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
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.
The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| R01HL051508 | NIH | None | https://reporter.nih.gov/quic… | View |