search
Back to results

APEX: Adiposity Prevention by Exercise in Black Girls

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Obesity

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Exercise
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

8 Years - 10 Years (Child)FemaleDoes 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)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00006405
    Brief Title
    APEX: Adiposity Prevention by Exercise in Black Girls
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2002 (undefined)
    Primary Completion Date
    March 2007 (Actual)
    Study Completion Date
    March 2007 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    5. Study Description

    Brief Summary
    To determine whether a one year afternoon exercise program will reduce adiposity in African American girls, ages 8 to 10.
    Detailed Description
    BACKGROUND: Obese children who engage in vigorous exercise programs show beneficial effects on total body percent fat (percent BF) and visceral adipose tissue (VAT); however, little is known about how to prevent accretion of total body or visceral adiposity in high risk youths, such as African-American (AA) females.The project has important health implications for two reasons, as follows. There is a dearth of information concerning the effects of exercise interventions in school and community settings. If the study shows that an afternoon exercise program reduces accretion of general and visceral adiposity and has a favorable impact on fitness and health in a population that is at high risk of obesity, then schools may be encouraged to implement similar interventions to prevent juvenile obesity and associated health problems. The study was awarded in response to a Program Announcement on Physical Activity and Cardiopulmonary Health released in October 1994 jointly by the NHLBI, the National Institute of Diabetes and Digestive and Kidney Diseases, and the National Institute of Nursing Research. DESIGN NARRATIVE: The design involves randomization of 200 African American girls, eight to 10 years of age into intervention or control groups. After one year, the groups are compared to test the primary hypothesis that a one year afternoon exercise program will reduce accretion of general and visceral adiposity in these girls. Then the girls will switch group assignments for the next year. The pattern of data over the three time points will show what happens over a two year period in which the youths are, or are not, involved in the exercise program. The measurements will include: (1) percent body fat with dual-energy x-ray absorptiometry; (2) visceral adipose tissue (VAT) with magnetic resonance imaging; (3) cardiovascular fitness with a multi-stage treadmill test; (4) cardiovascular disease (CVD) risk factors (i.e., the ratio of total to high density lipoprotein cholesterol, insulin, systolic blood pressure, and fibrinogen); (5) free-living exercise and diet; (6) psychosocial variables (i.e., self-efficacy and self-concept); (7) sexual maturation; (8) anthropometric measures. The exercise program will be implemented in neighborhood schools for 90 minutes each weekday afternoon. Transportation will be provided if needed. Sessions will include motor skill instruction and aerobic exercises.

    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

    8. Arms, Groups, and Interventions

    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    10 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
    15580193
    Citation
    Gutin B, Yin Z, Humphries MC, Hoffman WH, Gower B, Barbeau P. Relations of fatness and fitness to fasting insulin in black and white adolescents. J Pediatr. 2004 Dec;145(6):737-43. doi: 10.1016/j.jpeds.2004.07.016.
    Results Reference
    background
    PubMed Identifier
    15879296
    Citation
    Gutin B, Yin Z, Humphries MC, Bassali R, Le NA, Daniels S, Barbeau P. Relations of body fatness and cardiovascular fitness to lipid profile in black and white adolescents. Pediatr Res. 2005 Jul;58(1):78-82. doi: 10.1203/01.PDR.0000163386.32348.90. Epub 2005 May 5.
    Results Reference
    background

    Learn more about this trial

    APEX: Adiposity Prevention by Exercise in Black Girls

    We'll reach out to this number within 24 hrs