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Critical Periods of Exercise

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Krista Casazza, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01041820
First received: December 30, 2009
Last updated: April 18, 2012
Last verified: April 2012
History of Changes
  Purpose

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.

Condition Intervention
Metabolism
 Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Critical Periods of Exercise

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Association between exercise and bone marrow adipose tissue in children 3-7 years [ Time Frame: 10 weeks of exercise ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise group
Children will participate in a 10-week moderate to vigorous exercise program
 Behavioral: Exercise
Children will be exposed to a 10-week exercise intervention
No Intervention: non-exercising
Participants will receive no intervention

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041820

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Family Care Center
Birmingham, Alabama, United States, 35210
Sponsors and Collaborators
University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Krista Casazza, Krista R. Casazza PhD, RD/Assistant Professor, UAB, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01041820     History of Changes
Other Study ID Numbers: F090904001
Study First Received: December 30, 2009
Last Updated: April 18, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
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.

ClinicalTrials.gov processed this record on May 19, 2013