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Lifestyle, Adiposity and Cardiovascular Health in Youths

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Obesity

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

15 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2000
    Last Updated
    January 18, 2008
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00006402
    Brief Title
    Lifestyle, Adiposity and Cardiovascular Health in Youths
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2000 (undefined)
    Primary Completion Date
    July 2004 (Actual)
    Study Completion Date
    July 2004 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To determine the influences of diet and physical activity (PA) on total body fatness and regional fat distribution and the relationship of these to risk factors of cardiovascular disease during adolescence.
    Detailed Description
    BACKGROUND: Adult studies have shown that adiposity, especially visceral adipose tissue, and cardiovascular (CV) fitness are key links between lifestyle factors like diet and exercise on one hand, and CV disease on the other. However, very little is known about these links during the juvenile years, when the processes leading to CV disease are at an early stage of development. The study is in response to a Program Announcement issued in March 1998 on Diet and Cardiovascular Disease Risk in Children and Adolescents. The Program Announcement, jointly issued by the National Institute of Nursing Research and the NHLBI, sought to encourage research relevant to the development and/or testing of dietary interventions to improve the cardiovascular disease (CVD) risk profiles in children and adolescents, especially those at increased risk for CVD or for development of CVD risk factors because of genetics, family history, socioeconomic status (SES), race/ethnicity, levels of blood cholesterol or blood pressure, or other factors. DESIGN NARRATIVE: The study determines the relations of free-living diet and exercise to total body percent fat ( percent BF), visceral adipose tissue and CV fitness in black and white boys and girls of varying socioeconomic status (SES). The study also determines the relations of fatness and fitness to different CVD risk factors. A total of 800 15 to 18 year olds, 200 in each ethnic and gender subgroup will be recruited. Diet will be assessed with seven 24-hour recalls, and exercise with two seven-day recalls and heart rate monitoring. Percent body fat will be measured with dual-energy x-ray absorptiometry, visceral adipose tissue with magnetic resonance imaging and CV fitness with a multi-stage treadmill test. Measurements will be made of major fatness- and fitness-related CV disease risk factors (e.g., total cholesterol:HDL cholesterol ratio, insulin, systolic blood pressure, left ventricular mass indexed to height, fibrinogen). Multivariate and univariate analyses will be conducted to determine relationships.

    6. Conditions and Keywords

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

    7. Study Design

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    No eligibility criteria
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Paule Barbeau
    Organizational Affiliation
    Augusta University

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    14694220
    Citation
    Litaker MS, Barbeau P, Humphries MC, Gutin B. Comparison of Hologic QDR-1000/W and 4500W DXA Scanners in 13- to 18-Year Olds. Obes Res. 2003 Dec;11(12):1545-52. doi: 10.1038/oby.2003.206.
    Results Reference
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    Lifestyle, Adiposity and Cardiovascular Health in Youths

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