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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | ||
| Family-based behavioral therapy | Experimental | Family-based behavioural therapy either in group or in individual setting. Parents can choose between the 2 types of therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Family-based behavioral therapy | Behavioral | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nathalie Farpour-Lambert, MD | University of Geneva, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Geneva | Geneva | Canton of Geneva | 1205 | Switzerland |
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| ID | Term |
|---|---|
| D063766 | Pediatric Obesity |
| D009765 | Obesity |
| D001519 | Behavior |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |