Childhood Obesity
Conditions
Keywords
Obesity, Children, Behavior, Family, Exercise
Brief summary
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
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.
Interventions
BEHAVIORALFamily-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.
Sponsors
Swiss National Science Foundation
University Hospital, Geneva
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 11 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Body Mass Index at 6 months | 6 months | Body Mass Index (weight/height 2) expressed in Standard Deviation Score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in waist circumference at 6 months | 6 months | — |
| Change from baseline in blood pressure at 6 months | 6 months | Resting and ambulatory (24 hours) systolic and diastolic blood pressure |
| Change from baseline in arterial intima-media thickness at 6 months | 6 months | Measure of the arterial intima-media thickness using high-resolution ultrasound |
| Change from baseline in arterial flow-mediated dilation at 6 months | 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 | 6 months | Measure of mechanical indices using tonometry of applanation |
| Change from baseline in total body and abdominal fat at 6 months | 6 months | Body fat mass and percentage assessed using DXA |
| Change from baseline in physical activity at 6 months | 6 months | Physical activity pattern using accelerometer |
| Change from baseline in biological markers at 6 months | 6 months | Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein. |
| Change from baseline in quality of life at 6 months | 6 months | Quality of life assessed using the Kidsscreen 52 questionnaire |
| Change from baseline in child's behavior at 6 months | 6 months | Child Behavior Checklist filled by parents |
| Change from baseline in parental psychological health at 6 months | 6 months | Global Health Questionnaire filled by parents |
| Change from baseline in cardiorespiratory fitness at 6 months | 6 months | — |
Countries
Switzerland
Outcome results
None listed