Exercise and Behavioral Therapy in Obese Children
Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Geneva, Suisse, 1205
- University Hospital of Geneva
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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;
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Aucune intervention: Contrôler
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Expérimental: Family-based behavioral therapy
Family-based behavioural therapy either in group or in individual setting.
Parents can choose between the 2 types of therapy.
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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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in Body Mass Index at 6 months
Délai: 6 months
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Body Mass Index (weight/height 2) expressed in Standard Deviation Score
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6 months
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change from baseline in total body and abdominal fat at 6 months
Délai: 6 months
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Body fat mass and percentage assessed using DXA
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6 months
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Change from baseline in waist circumference at 6 months
Délai: 6 months
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6 months
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Change from baseline in blood pressure at 6 months
Délai: 6 months
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Resting and ambulatory (24 hours) systolic and diastolic blood pressure
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6 months
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Change from baseline in arterial intima-media thickness at 6 months
Délai: 6 months
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Measure of the arterial intima-media thickness using high-resolution ultrasound
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6 months
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Change from baseline in arterial flow-mediated dilation at 6 months
Délai: 6 months
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Measure of the flow-mediated dilation of the brachial artery using high-resolution ultrasound
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6 months
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Change from baseline in arterial stiffness at 6 months
Délai: 6 months
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Measure of mechanical indices using tonometry of applanation
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6 months
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Change from baseline in cardiorespiratory fitness at 6 months
Délai: 6 months
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6 months
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Change from baseline in physical activity at 6 months
Délai: 6 months
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Physical activity pattern using accelerometer
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6 months
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Change from baseline in biological markers at 6 months
Délai: 6 months
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Fasting glucose, insulin, total-, LDL-, HDL-cholesterol, high-sensitive C-reactive protein.
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6 months
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Change from baseline in quality of life at 6 months
Délai: 6 months
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Quality of life assessed using the Kidsscreen 52 questionnaire
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6 months
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Change from baseline in child's behavior at 6 months
Délai: 6 months
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Child Behavior Checklist filled by parents
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6 months
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Change from baseline in parental psychological health at 6 months
Délai: 6 months
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Global Health Questionnaire filled by parents
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6 months
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Nathalie Farpour-Lambert, MD, University of Geneva
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SNF 3200B0-120437
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