NCT01041820

Brief 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. 1.Hypothesis 1.1: There is a positive association between physical activity and bone mass.
  2. 2.Hypothesis 1.2: There is a positive association between sedentary behavior and total fat mass.
  3. 3.Hypothesis 2.1: There is an inverse association between physical activity and bone marrow adipose tissue.
  4. 4.Hypothesis 2.2: There is a positive association between sedentary behavior and bone marrow adipose tissue.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

December 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

November 25, 2019

Status Verified

November 1, 2019

Enrollment Period

1 year

First QC Date

December 30, 2009

Last Update Submit

November 21, 2019

Conditions

Metabolism

Keywords

exercisebone marrow adipose tissuebone mineral densityChildren in the intervention condition will complete a supervised physical activity program 3 days/wk for 10 weeksControl treatment will be provided no interventionAll participants will be instructed not to change their current dietary habits during the study period.

Outcome Measures

Primary Outcomes (1)

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

    10 weeks of exercise

Study Arms (2)

Exercise group

EXPERIMENTAL

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

Behavioral: Exercise

non-exercising

NO INTERVENTION

Participants will receive no intervention

Interventions

ExerciseBEHAVIORAL

Children will be exposed to a 10-week exercise intervention

Exercise group

Eligibility Criteria

Age3 Years - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • children aged 3 to 7 years
  • healthy, not under the care of a doctor
  • not taking medications known to alter body composition or metabolism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Family Care Center

Birmingham, Alabama, 35210, United States

Location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Krista R. Casazza PhD, RD/Assistant Professor, UAB

Study Record Dates

First Submitted

December 30, 2009

First Posted

January 1, 2010

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

November 25, 2019

Record last verified: 2019-11

Locations

US(2)