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

About this trial
This is an observational trial for Cardiovascular Diseases
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006405
First Posted
October 12, 2000
Last Updated
January 18, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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
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APEX: Adiposity Prevention by Exercise in Black Girls
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