The Role of Exercise and/or Diet in Weight Loss, and Weight Maintenance in Obese Preadolescent Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- BMI
研究概览
简要总结
A 3-arms randomized prospective intervention study to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. Children were randomly allocated into three groups. The first group underwent an exercise program, the second one underwent both an exercise program and a diet program and the third underwent a diet program alone.
The total duration of the intervention is 12 weeks followed by a period of 9 months of follow-up. The effects of the different intervention on weight loss and weight maintenance,body composition, on hormonal components that regulate the caloric balance, on metabolic profile and cardiovascular risk factors and on psychological parameters were also determined.
详细描述
A 3-arms randomized prospective intervention study including 161 patients in order to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender. The study recruited patients from 2 endocrine clinics.
Objectives:
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The main aim was to determine the roles of exercise and/or diet on weight loss and weight maintenance in obese children.
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Secondary goals were:
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To determine the effects of exercise and/or diet on body composition.
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To determine the effects of exercise and/or diet on leptin and ghrelin that play a role in the regulation of energy balance.
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To determine the effects of exercise and/or diet on metabolic profile, cardiovascular risk factors, and inflammatory markers as fasting glucose,insulin and lipid profile,homocysteine ,adiponectin levels,CRP,and IL-6.
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To determine the role of exercise and/or diet on psychological parameters of obese children.
Study Population
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
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obese preadolescent children 6-11 year-old with BMI> 95th percentile for age and gender.
- •A signed informed consent will be taken from patients and their parents.
- •Agreement to a follow-up of one year.
排除标准
- •Cardiac problems (arrhythmia, Congestive heart disease)
- •Uncontrolled hypertension
- •Severe hepatic impairment (liver enzymes above 3 folds the upper normal values)
- •Renal failure
- •Genetic syndromes associated with obesity
- •Presence of untreated hypothyroidism
- •Participation in a clinical study during the last month
结局指标
主要结局
BMI
BMI-SDS
BODY FAT PERCENTAGE
WAIST AND HIP CIRCUMFERENCES
次要结局
- BLOOD INFLAMATORY MARKERS
- GHRELIN AND LEPTIN LEVELS
- RESTING ENERGY EXPENDITURE
- BLOOD METABOLIC PROFILE
- PSYCHOLOGICAL PARAMETERS