NCT00460135

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.

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 Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2006

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 11, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

March 4, 2009

Status Verified

March 1, 2009

Enrollment Period

2.3 years

First QC Date

April 11, 2007

Last Update Submit

March 3, 2009

Conditions

Childhood ObesityBody CompositionResistance TrainingInsulin Resistance

Keywords

ResistanceTrainingObesityChildren

Outcome Measures

Primary Outcomes (1)

  • Changes in body composition as per DEXA scans

    12 weeks

Secondary Outcomes (1)

  • Changes in insulin resistance as per HOMA score

    12 weeks

Study Arms (2)

RT

EXPERIMENTAL

resistance training

Behavioral: resistance training

Routine care

NO INTERVENTION

General counseling on increasing physical exercise

Interventions

resistance trainingBEHAVIORAL

2 times a week resistance training

RT

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Pubertal
  • Uncontrolled thyroid condition
  • Type 2 diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal Children's Hospital

Montreal, Quebec, H3H 1P3, Canada

Location

MeSH Terms

Conditions

Pediatric ObesityInsulin ResistanceObesity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Laurent Legault, MD

    Montreal Children's Hospital of the MUHC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 11, 2007

First Posted

April 13, 2007

Study Start

April 1, 2006

Primary Completion

July 1, 2008

Study Completion

July 1, 2008

Last Updated

March 4, 2009

Record last verified: 2009-03

Locations

CA(1)