Exercise and Behavioral Therapy in Obese Children
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|ClinicalTrials.gov Identifier: NCT01506245|
Recruitment Status : Unknown
Verified January 2012 by Nathalie Farpour-Lambert, University Hospital, Geneva.
Recruitment status was: Enrolling by invitation
First Posted : January 9, 2012
Last Update Posted : January 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Childhood Obesity||Behavioral: Family-based behavioral therapy||Not Applicable|
Introduction: The prevalence of childhood obesity is increasing rapidly in developing countries. The aim of this study is to determine the effects of exercise training and family-based behavioral treatment (FBBT), either in individual or in group setting,in pre-pubertal children and their mother.
Methods: This is a 6-month randomized controlled trial (RCT) including 75 pre-pubertal obese children (age 8-11 years) randomly assigned to an Intervention (I, n=50) or a Control group (C, n=25). The intervention consists of a family-based behavioural therapy in group (1 session/week with a dietician and a psychologist) or in individual setting (paediatrician or dietician 1x/month). The intervention includes exercise training sessions twice a week (60 minutes each).
Measures include: body mass index (BMI), waist and hip circumferences; whole body and abdominal fat mass by DXA; resting and ambulatory blood pressure; arterial intima-media thickness and vascular reactivity (flow-mediated dilation)using high resolution ultrasound; arterial stiffness by tonometry of applanation; cardiorespiratory fitness by a treadmill test; physical activity; fasting lipids, glucose, insulin, and C-reactive protein levels; health-related quality of life and psychological health using standardized questionnaires and a semi-structured interview. Measures are completed in children and their mother at baseline and 6 months post-randomization.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||December 2012|
|No Intervention: Control|
Experimental: Family-based behavioral therapy
Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy.
Behavioral: Family-based behavioral therapy
The intervention consist of a 6-month family-based behavioural therapy either in group (1 session/week, with a dietician and a psychologist) or in individual setting (with a paediatrician or a dietician in alternance 1x/month). Both therapies include exercise training twice per week (60 minutes each). Parents, or at at least the mother, must participate to the behavioral treatment.
- Change from baseline in Body Mass Index at 6 months [ Time Frame: 6 months ]Body Mass Index (weight/height 2) expressed in Standard Deviation Score
- Change from baseline in total body and abdominal fat at 6 months [ Time Frame: 6 months ]Body fat mass and percentage assessed using DXA
- Change from baseline in waist circumference at 6 months [ Time Frame: 6 months ]
- Change from baseline in blood pressure at 6 months [ Time Frame: 6 months ]Resting and ambulatory (24 hours) systolic and diastolic blood pressure
- Change from baseline in arterial intima-media thickness at 6 months [ Time Frame: 6 months ]Measure of the arterial intima-media thickness using high-resolution ultrasound
- Change from baseline in arterial flow-mediated dilation at 6 months [ Time Frame: 6 months ]Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
- Change from baseline in arterial stiffness at 6 months [ Time Frame: 6 months ]Measure of mechanical indices using tonometry of applanation
- Change from baseline in cardiorespiratory fitness at 6 months [ Time Frame: 6 months ]
- Change from baseline in physical activity at 6 months [ Time Frame: 6 months ]Physical activity pattern using accelerometer
- Change from baseline in biological markers at 6 months [ Time Frame: 6 months ]Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
- Change from baseline in quality of life at 6 months [ Time Frame: 6 months ]Quality of life assessed using the Kidsscreen 52 questionnaire
- Change from baseline in child's behavior at 6 months [ Time Frame: 6 months ]Child Behavior Checklist filled by parents
- Change from baseline in parental psychological health at 6 months [ Time Frame: 6 months ]Global Health Questionnaire filled by parents
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506245
|University Hospital of Geneva|
|Geneva, Switzerland, 1205|
|Principal Investigator:||Nathalie Farpour-Lambert, MD||University of Geneva|