Exercise and Behavioral Therapy in Obese Children

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother

Conditions
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Childhood Obesity

Intervention / Treatment
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* Behavioral: Family-based behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Childhood obesity (>97 percentile WHO references) Exclusion Criteria: being involved in any weight control, physical activity, behavior therapy, or gastric surgery program; familial history of dyslipidemia or essential hypertension; medications or hormones, which may influence cardiovascular function, body composition, lipid or glucose metabolism in the preceding 6 months; orthopaedic affection limiting physical activity; genetic disorder or another chronic disease;

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Family-based behavioral therapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Body Mass Index at 6 months | Body Mass Index (weight/height 2) expressed in Standard Deviation Score | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total body and abdominal fat at 6 months | Body fat mass and percentage assessed using DXA | 6 months | 
| Change from baseline in waist circumference at 6 months |  | 6 months | 
| Change from baseline in blood pressure at 6 months | Resting and ambulatory (24 hours) systolic and diastolic blood pressure | 6 months | 
| Change from baseline in arterial intima-media thickness at 6 months | Measure of the arterial intima-media thickness using high-resolution ultrasound | 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 | 6 months | 
| Change from baseline in arterial stiffness at 6 months | Measure of mechanical indices using tonometry of applanation | 6 months | 
| Change from baseline in cardiorespiratory fitness at 6 months |  | 6 months | 
| Change from baseline in physical activity at 6 months | Physical activity pattern using accelerometer | 6 months | 
| Change from baseline in biological markers at 6 months | Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein. | 6 months | 
| Change from baseline in quality of life at 6 months | Quality of life assessed using the Kidsscreen 52 questionnaire | 6 months | 
| Change from baseline in child's behavior at 6 months | Child Behavior Checklist filled by parents | 6 months | 
| Change from baseline in parental psychological health at 6 months | Global Health Questionnaire filled by parents | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Obesity, Children, Behavior, Family, Exercise