Exercise and Behavioral Therapy in Obese Children
Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Anticipado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Geneva, Suiza, 1205
- University Hospital of Geneva
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Sin intervención: Control
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Experimental: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in Body Mass Index at 6 months
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change from baseline in total body and abdominal fat at 6 months
Periodo de tiempo: 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
Periodo de tiempo: 6 months
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6 months
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Change from baseline in blood pressure at 6 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months
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6 months
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Change from baseline in physical activity at 6 months
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 6 months
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Global Health Questionnaire filled by parents
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Nathalie Farpour-Lambert, MD, University of Geneva
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SNF 3200B0-120437
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