MetabolismNCT01041820
Critical Periods of Exercise
A study testing Exercise in people with Metabolism, run by University of Alabama at Birmingham at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 3 to 7 years
- healthy, not under the care of a doctor
- not taking medications known to alter body composition or metabolism
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Family Care Center
Birmingham, Alabama, 35210
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
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.
Read more
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.
- Conditions
- Metabolism
- Being tested
- Exercise
- 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.
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Children will be exposed to a 10-week exercise intervention
| Study group | Role | What they receive |
|---|---|---|
| Exercise group | Experimental | Children will participate in a 10-week moderate to vigorous exercise program Receives: Behavioral: Exercise |
| non-exercising | No intervention | Participants will receive no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between exercise and bone marrow adipose tissue in children 3-7 years
Measured: 10 weeks of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MetabolismStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Krista Casazza, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041820
- Sponsor's protocol ID
- F090904001
- Status last verified
- Nov 2019
- First submitted
- 30 Dec 2009
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Critical Periods of Exercise
- ClinicalTrials.gov ID
- NCT01041820
- Acronym / sponsor ID
- F090904001
- Conditions
- 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.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 1 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise group | Experimental | Behavioral: ExerciseChildren will participate in a 10-week moderate to vigorous exercise program |
| non-exercising | No intervention | –Participants will receive no intervention |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children aged 3 to 7 years
- healthy, not under the care of a doctor
- not taking medications known to alter body composition or metabolism
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseChildren will be exposed to a 10-week exercise intervention | Behavioural | Exercise group |
Primary outcome
Association between exercise and bone marrow adipose tissue in children 3-7 years
Time frame: 10 weeks of exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Metabolism, run by University of Alabama at Birmingham at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between exercise and bone marrow adipose tissue in children 3-7 years (time frame: 10 weeks of exercise). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.