- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00460135
The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
March 3, 2009 updated by: McGill University Health Centre/Research Institute of the McGill University Health Centre
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.
Study Overview
Status
Completed
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3H 1P3
- Montreal Children's Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between 8-12y
- Prepubertal
- Not on medications with known impact on weight loss
Exclusion Criteria:
- Pubertal
- Uncontrolled thyroid condition
- Type 2 diabetes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: RT
resistance training
|
2 times a week resistance training
|
|
No Intervention: Routine care
General counseling on increasing physical exercise
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in body composition as per DEXA scans
Time Frame: 12 weeks
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Changes in insulin resistance as per HOMA score
Time Frame: 12 weeks
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laurent Legault, MD, Montreal Children's Hospital of the MUHC
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2006
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
April 11, 2007
First Submitted That Met QC Criteria
April 12, 2007
First Posted (Estimate)
April 13, 2007
Study Record Updates
Last Update Posted (Estimate)
March 4, 2009
Last Update Submitted That Met QC Criteria
March 3, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PED-06-004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.