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CompletedNCT01041820Updated Nov 25, 2019

Critical Periods of Exercise

An interventional study of Exercise in Metabolism, sponsored by University of Alabama at Birmingham. Completed at 2 sites in United States. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-25.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
3 Years to 7 Years
Sex
All
01

Study summary

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.

  1. Hypothesis 1.1: There is a positive association between physical activity and bone mass.
  2. 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.

  3. Hypothesis 2.1: There is an inverse association between physical activity and bone marrow adipose tissue.
  4. Hypothesis 2.2: There is a positive association between sedentary behavior and bone marrow adipose tissue.
02

Conditions studied

  • Metabolism

Keywords

  • exercise
  • bone marrow adipose tissue
  • bone mineral density
  • 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.
03

In context

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Exercise group

    Children will participate in a 10-week moderate to vigorous exercise program

    Behavioral: Exercise

  • No intervention
    non-exercising

    Participants will receive no intervention

Interventions

  • BehavioralExercise

    Children will be exposed to a 10-week exercise intervention

06

What researchers measure

Primary outcomes

  1. Association between exercise and bone marrow adipose tissue in children 3-7 years

    Time frame: 10 weeks of exercise

07

Study locations

2 sites
  • Family Care Center
    Birmingham, Alabama 35210, United States
  • University of Alabama at Birmingham
    Birmingham, Alabama 35294, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01041820
Lead sponsor
University of Alabama at Birmingham
Responsible party
Krista Casazza (Krista R. Casazza PhD, RD/Assistant Professor, UAB, University of Alabama at Birmingham) — Principal investigator
First posted
Jan 1, 2010
Start date
Dec 2009
Primary completion
Dec 2010
Completion
Jun 2011
Last update
Nov 25, 2019

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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