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APEX: Adiposity Prevention by Exercise in Black Girls

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00006405
First Posted: October 13, 2000
Last Update Posted: January 21, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  Purpose
To determine whether a one year afternoon exercise program will reduce adiposity in African American girls, ages 8 to 10.

Condition Intervention
Cardiovascular Diseases Heart Diseases Obesity Behavioral: Exercise

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 2002
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006405


Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
OverallOfficial: Paule Barbeau Augusta University
  More Information