Childhood ObesityNCT00460135
The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
A study testing resistance training in people with Childhood Obesity and Body Composition, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
Impact of resistance training in prepubertal children with obesity focusing mostly in changes in body composition and markers of insulin resistance. Hypothesis is that this will show positive changes in this randomized controlled trial. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Obesity, Body Composition, Resistance Training
- What is being tested?
- resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2006to Jul 2008
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 8-12y
- Prepubertal
- Not on medications with known impact on weight loss
Who cannot join
- Pubertal
- Uncontrolled thyroid condition
- Type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Impact of resistance training in prepubertal children with obesity focusing mostly in changes in body composition and markers of insulin resistance.
Hypothesis is that this will show positive changes in this randomized controlled trial.
Read the detailed description
24 obese prepubertal obese children randomized to either resistance training program or usual care for 12 weeks. Baseline blood profiles and DEXA scans done before and after 12 weeks of training with the help of kinesiology graduates from Concordia University kinesiology department.
- Being tested
- resistance training
- Keywords
- Resistance, Training, Obesity, Children
- Medical subject headings
- Pediatric Obesity, Insulin Resistance, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
resistance trainingBehavioural
2 times a week resistance training
| Study group | Role | What they receive |
|---|---|---|
| RT | Experimental | resistance training Receives: Behavioral: resistance training |
| Routine care | No intervention | General counseling on increasing physical exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body composition as per DEXA scans
Measured: 12 weeks
Secondary outcomes (1)
Changes in insulin resistance as per HOMA score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2007 (estimated)
- Study startApr 2006
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood ObesityStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Investigators
- Laurent Legault, MD, Principal investigator, Montreal Children's Hospital of the MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460135
- Sponsor's protocol ID
- PED-06-004
- Status last verified
- Mar 2009
- First submitted
- 11 Apr 2007
- Last updated
- 4 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
- ClinicalTrials.gov ID
- NCT00460135
- Acronym / sponsor ID
- PED-06-004
- Keywords
- Resistance, Training, Obesity, Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 13 Apr 2007 (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.
Impact of resistance training in prepubertal children with obesity focusing mostly in changes in body composition and markers of insulin resistance.
Hypothesis is that this will show positive changes in this randomized controlled trial.
Detailed description
24 obese prepubertal obese children randomized to either resistance training program or usual care for 12 weeks. Baseline blood profiles and DEXA scans done before and after 12 weeks of training with the help of kinesiology graduates from Concordia University kinesiology department.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RT | Experimental | Behavioral: resistance trainingresistance training |
| Routine care | No intervention | –General counseling on increasing physical exercise |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Between 8-12y
- Prepubertal
- Not on medications with known impact on weight loss
Key exclusion criteria (3 listed)
- Pubertal
- Uncontrolled thyroid condition
- Type 2 diabetes
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 |
|---|---|---|
| resistance training2 times a week resistance training | Behavioural | RT |
Primary outcome
Changes in body composition as per DEXA scans
Time frame: 12 weeks
1 secondary outcome
Changes in insulin resistance as per HOMA score
Time frame: 12 weeks
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 4 Mar 2009.
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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.
Laurent Legault, MD principal investigator
Montreal Children's Hospital of the MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing resistance training in people with Childhood Obesity and Body Composition, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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 3 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 4 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Changes in body composition as per DEXA scans (time frame: 12 weeks). 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 4 Mar 2009.