- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006405
APEX: Adiposity Prevention by Exercise in Black Girls
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Study Plan
How is the study designed?
Collaborators and Investigators
Investigators
- Paule Barbeau, Augusta University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 930
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Heart Diseases
-
Baker Heart and Diabetes InstitutePrincess Alexandra Hospital, Brisbane, Australia; Royal Perth Hospital; Alice... and other collaboratorsRecruitingHeart Failure | Valve Heart DiseaseAustralia
-
Medical University of ViennaUnknownHeart Diseases | Heart Failure | Valvular Heart DiseaseAustria
-
Centre Chirurgical Marie LannelongueActive, not recruitingValvular Heart Disease | Valve Disease, Heart
-
Abiomed Inc.RecruitingHeart Diseases | Acute Decompensated Heart Failure | Congestive Heart Failure | Acute Heart FailureUnited States
-
Aristotle University Of ThessalonikiRecruitingCardiovascular Diseases | Heart Failure | Valvular Heart Disease | Biochemical DysfunctionGreece
-
Wuerzburg University HospitalRecruitingHeart Failure | Chronic Heart Failure | Chronic Heart DiseaseGermany
-
Kathirvel SubramaniamUniversity of Maryland, Baltimore; CSL BehringRecruitingHeart Failure,Congestive | Heart Disease End StageUnited States
-
University of MichiganTerminatedDiastolic Heart Failure | Hypertensive Heart DiseaseUnited States
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
-
Yonsei UniversityCompletedMitral Valvular Heart Disease
Clinical Trials on Exercise
-
University of Kansas Medical CenterRecruiting
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
University of Texas, El PasoRecruitingKnee Osteoarthritis | Knee Pain Chronic | Central Pain SyndromeUnited States
-
Toronto Rehabilitation InstituteCompletedAcute Myeloid LeukemiaCanada
-
Sahmyook UniversityRecruitingChronic Nonspecific Neck PainKorea, Republic of
-
University of AlbertaWomen and Children's Health Research Institute, CanadaRecruitingType 1 Diabetes | Post-menopauseCanada
-
Uskudar UniversityCompleted
-
Yuksek Ihtisas UniversityCompletedDementia | Frailty | Cognitive Function | Reaction Time | Aerobic Exercise | Balance ExerciseTurkey
-
National Taiwan Normal UniversityCompletedAging | Cognitive DeclineTaiwan
-
Wayne State UniversityUnknown