Exercise and Behavioral Therapy in Obese Children
|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|
|Childhood Obesity||Behavioral: Family-based behavioral therapy|
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
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|