The aim of this study is to compare the effects of exercise training and family-based behavioral treatment, either in individual or in group setting, in pre-pubertal children and their mother.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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.
University Hospital of Geneva
Geneva, Canton of Geneva, Switzerland
Change from baseline in Body Mass Index at 6 months
Body Mass Index (weight/height 2) expressed in Standard Deviation Score
Time frame: 6 months
Change from baseline in total body and abdominal fat at 6 months
Body fat mass and percentage assessed using DXA
Time frame: 6 months
Change from baseline in waist circumference at 6 months
Time frame: 6 months
Change from baseline in blood pressure at 6 months
Resting and ambulatory (24 hours) systolic and diastolic blood pressure
Time frame: 6 months
Change from baseline in arterial intima-media thickness at 6 months
Measure of the arterial intima-media thickness using high-resolution ultrasound
Time frame: 6 months
Change from baseline in arterial flow-mediated dilation at 6 months
Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
Time frame: 6 months
Change from baseline in arterial stiffness at 6 months
Measure of mechanical indices using tonometry of applanation
Time frame: 6 months
Change from baseline in cardiorespiratory fitness at 6 months
Time frame: 6 months
Change from baseline in physical activity at 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Physical activity pattern using accelerometer
Time frame: 6 months
Change from baseline in biological markers at 6 months
Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
Time frame: 6 months
Change from baseline in quality of life at 6 months
Quality of life assessed using the Kidsscreen 52 questionnaire
Time frame: 6 months
Change from baseline in child's behavior at 6 months
Child Behavior Checklist filled by parents
Time frame: 6 months
Change from baseline in parental psychological health at 6 months
Global Health Questionnaire filled by parents
Time frame: 6 months