NCT00801645

Brief Summary

The main purpose of this project is to investigate the effects of an exercise program on arterial function and cardiovascular diseases risk factors in obese and lean pre-pubertal children. This information will be used to underpin prevention strategies to reduce cardiovascular diseases in overweight youth.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Aug 2004

Longer than P75 for not_applicable obesity

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 3, 2008

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
Last Updated

January 5, 2012

Status Verified

January 1, 2012

Enrollment Period

4.2 years

First QC Date

December 2, 2008

Last Update Submit

January 4, 2012

Conditions

Obesity

Keywords

ObesityCardiovascular diseaseEndothelial functionBlood pressureExercisePhysical activityMetabolic syndromeChildrenPediatric

Outcome Measures

Primary Outcomes (1)

  • Arterial function

    0-3-6-24 months

Secondary Outcomes (9)

  • Body composition

    0-3-6-24 months

  • Body mass index

    0-3-6-24 months

  • Cardiorespiratory fitness

    0-3-6-24 months

  • Physical activity

    0-3-6-24 months

  • Insulin resistance

    0-3-6-24 months

  • +4 more secondary outcomes

Study Arms (4)

Obese exercise

EXPERIMENTAL
Behavioral: Exercise

Obese Control

NO INTERVENTION

Lean Exercise

EXPERIMENTAL
Behavioral: Exercise

Lean Control

NO INTERVENTION

Interventions

ExerciseBEHAVIORAL

The exercise groups engage in aerobic exercise training three 60-minute sessions per week for 12 weeks, in addition of school physical education. Training sessions consist of 30 minutes of aerobic exercise (walking, running, games, swimming), followed by strength training and stretching.

Also known as: Physical activity
Lean ExerciseObese exercise

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • obese children: Pre-pubertal (Tanner stage 1), BMI \> 97th age- and gender-specific percentile (Kromeyer-Hauschild et al. 2001).
  • lean subjects: Pre-pubertal (Tanner stage 1), BMI \> 10th and \< 90th age- and gender-specific percentile.

You may not qualify if:

  • being involved in any weight control, physical activity, or behavioral therapy
  • familial history of dyslipidemia or essential hypertension
  • medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism
  • orthopedic affection limiting physical activity
  • genetic disorder or a chronic disease
  • following a therapy for psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Child and Adolescent, University Hospital of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Location

Related Publications (2)

  • Maggio AB, Aggoun Y, Martin XE, Marchand LM, Beghetti M, Farpour-Lambert NJ. Long-term follow-up of cardiovascular risk factors after exercise training in obese children. Int J Pediatr Obes. 2011 Jun;6(2-2):e603-10. doi: 10.3109/17477166.2010.530665. Epub 2010 Dec 10.

    PMID: 21142752DERIVED

  • Farpour-Lambert NJ, Aggoun Y, Marchand LM, Martin XE, Herrmann FR, Beghetti M. Physical activity reduces systemic blood pressure and improves early markers of atherosclerosis in pre-pubertal obese children. J Am Coll Cardiol. 2009 Dec 15;54(25):2396-406. doi: 10.1016/j.jacc.2009.08.030.

    PMID: 20082930DERIVED

MeSH Terms

Conditions

ObesityCardiovascular DiseasesMotor ActivityMetabolic Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Maurice Beghetti, PD

    Pediatric Cardiology Unit, Departement of Child and Adolescent, University Hospital, Geneva

    STUDY DIRECTOR

  • Nathalie J Farpour-Lambert, MD

    Pediatric Cardiology Unit, Department of Child and Adolescent, University Hospital, Geneva

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of the Obesity Care Program

Study Record Dates

First Submitted

December 2, 2008

First Posted

December 3, 2008

Study Start

August 1, 2004

Primary Completion

October 1, 2008

Study Completion

June 1, 2010

Last Updated

January 5, 2012

Record last verified: 2012-01

Locations

CH(1)