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Fat Reduction Intervention Trial in African-Americans

Primary Purpose

Cardiovascular Diseases, Coronary Heart Disease Risk Reduction, Heart Diseases

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Cardiovascular Diseases

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    February 17, 2016
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00005700
    Brief Title
    Fat Reduction Intervention Trial in African-Americans
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    May 2001
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1993 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 1998 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Coronary Heart Disease Risk Reduction, Heart Diseases

    7. Study Design

    10. Eligibility

    Sex
    Male
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9216572
    Citation
    Prewitt TE, Durazo-Arvizu R, McGee DL, Luke A, Cooper RS. One size fits all: implications for assessing dietary behavior. J Am Diet Assoc. 1997 Jul;97(7 Suppl):S70-2. doi: 10.1016/s0002-8223(97)00734-7.
    Results Reference
    background
    PubMed Identifier
    9098179
    Citation
    Luke A, Durazo-Arvizu R, Rotimi C, Prewitt TE, Forrester T, Wilks R, Ogunbiyi OJ, Schoeller DA, McGee D, Cooper RS. Relation between body mass index and body fat in black population samples from Nigeria, Jamaica, and the United States. Am J Epidemiol. 1997 Apr 1;145(7):620-8. doi: 10.1093/oxfordjournals.aje.a009159.
    Results Reference
    background
    PubMed Identifier
    9922066
    Citation
    Fitzgibbon ML, Prewitt TE, Blackman LR, Simon P, Luke A, Keys LC, Avellone ME, Singh V. Quantitative assessment of recruitment efforts for prevention trials in two diverse black populations. Prev Med. 1998 Nov-Dec;27(6):838-45. doi: 10.1006/pmed.1998.0367.
    Results Reference
    background

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    Fat Reduction Intervention Trial in African-Americans

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