Exercise Training and Family-based Behavioural Treatment in Pre-pubertal Obese Children and Their Mother
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Change from baseline in Body Mass Index at 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Childhood obesity (>97 percentile WHO references)
排除标准
- •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;
结局指标
主要结局
Change from baseline in Body Mass Index at 6 months
时间窗: 6 months
Body Mass Index (weight/height 2) expressed in Standard Deviation Score
次要结局
- Change from baseline in total body and abdominal fat at 6 months(6 months)
- Change from baseline in waist circumference at 6 months(6 months)
- Change from baseline in blood pressure at 6 months(6 months)
- Change from baseline in arterial intima-media thickness at 6 months(6 months)
- Change from baseline in arterial flow-mediated dilation at 6 months(6 months)
- Change from baseline in arterial stiffness at 6 months(6 months)
- Change from baseline in cardiorespiratory fitness at 6 months(6 months)
- Change from baseline in physical activity at 6 months(6 months)
- Change from baseline in biological markers at 6 months(6 months)
- Change from baseline in quality of life at 6 months(6 months)
- Change from baseline in child's behavior at 6 months(6 months)
- Change from baseline in parental psychological health at 6 months(6 months)
研究者
Nathalie Farpour-Lambert
Head of the Obesity Care Program
University Hospital, Geneva