- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041820
Critical Periods of Exercise
Early childhood (~3-7 years of age) is an important window for determining body composition trajectory and may be a critical period for the development of tissue partitioning patterns that influence obesity risk. As adiposity accelerates during this critical period, deposition/ preservation of fat stores may be sustained at the 'expense' of other tissues; i.e. energy homeostasis may be inherently biased toward fat gain. The type and amount of tissue mass accrued in early childhood has implications for metabolic profile, glucose/insulin homeostasis, hormone profile and resting energy expenditure.
The interplay between fat and bone deposition represents a physiologic trait enabling the body to choose between shuttling 'energy' towards accrual of a particular tissue. Plausibly the phenotype underlying obesity and diabetes risk may be determined by the differentiation of cell type (adipocyte, osteocyte, etc.) during this early stage of growth and development. In vitro studies demonstrate transdifferentiation under the influence of specific external stimuli, which can switch phenotypes toward other cell lineages. Further, rodent models have demonstrated that exposure to stimuli (exercise) early in life may prevent excess fat mass accrual in adulthood, even when the stimulus is later removed (animals are no longer exercising). Children's early experiences (engagement in physical activity vs. sedentary behavior) may 'environmentally induce' alterations in body composition and predispose individuals to obesity throughout life.
Aim 1. To examine the associations between body composition via DXA and objectively-measured physical activity/inactivity.
- Hypothesis 1.1: There is a positive association between physical activity and bone mass.
Hypothesis 1.2: There is a positive association between sedentary behavior and total fat mass.
Aim2. To examine the associations between adipose tissue distribution via MRI and objectively-measured physical activity/inactivity.
- Hypothesis 2.1: There is an inverse association between physical activity and bone marrow adipose tissue.
- Hypothesis 2.2: There is a positive association between sedentary behavior and bone marrow adipose tissue.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham
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Birmingham, Alabama, United States, 35210
- Family Care Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children aged 3 to 7 years
- healthy, not under the care of a doctor
- not taking medications known to alter body composition or metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise group
Children will participate in a 10-week moderate to vigorous exercise program
|
Children will be exposed to a 10-week exercise intervention
|
|
No Intervention: non-exercising
Participants will receive no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Association between exercise and bone marrow adipose tissue in children 3-7 years
Time Frame: 10 weeks of exercise
|
10 weeks of exercise
|
Collaborators and Investigators
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 (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- exercise
- bone mineral density
- bone marrow adipose tissue
- Children in the intervention condition will complete a supervised physical activity program 3 days/wk for 10 weeks
- Control treatment will be provided no intervention
- All participants will be instructed not to change their current dietary habits during the study period.
Other Study ID Numbers
- F090904001
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.
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