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The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.

Primary Purpose

Childhood Obesity, Body Composition, Resistance Training

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
resistance training
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Childhood Obesity focused on measuring Resistance, Training, Obesity, Children

Eligibility Criteria

8 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 8-12y
  • Prepubertal
  • Not on medications with known impact on weight loss

Exclusion Criteria:

  • Pubertal
  • Uncontrolled thyroid condition
  • Type 2 diabetes

Sites / Locations

  • Montreal Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RT

Routine care

Arm Description

resistance training

General counseling on increasing physical exercise

Outcomes

Primary Outcome Measures

Changes in body composition as per DEXA scans

Secondary Outcome Measures

Changes in insulin resistance as per HOMA score

Full Information

First Posted
April 11, 2007
Last Updated
March 3, 2009
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00460135
Brief Title
The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
Official Title
The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Obesity, Body Composition, Resistance Training, Insulin Resistance
Keywords
Resistance, Training, Obesity, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RT
Arm Type
Experimental
Arm Description
resistance training
Arm Title
Routine care
Arm Type
No Intervention
Arm Description
General counseling on increasing physical exercise
Intervention Type
Behavioral
Intervention Name(s)
resistance training
Intervention Description
2 times a week resistance training
Primary Outcome Measure Information:
Title
Changes in body composition as per DEXA scans
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Changes in insulin resistance as per HOMA score
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Between 8-12y Prepubertal Not on medications with known impact on weight loss Exclusion Criteria: Pubertal Uncontrolled thyroid condition Type 2 diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Legault, MD
Organizational Affiliation
Montreal Children's Hospital of the MUHC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal Children's Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada

12. IPD Sharing Statement

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The Impact of Resistance Exercise Training On Metabolic Dysregulation in Obese Children.

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