Childhood Obesity Clinical Trial
Official title:
Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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