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临床试验/NCT02779647
NCT02779647已完成不适用

Play as a Method to Reduce Overweight and Obesity in Children. Kids-Play Study.

Universidad de Granada0 个研究点目标入组 98 人开始时间: 2016年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
98
主要终点
Children's body composition

研究概览

简要总结

Introduction Overweight and obesity are characterised by excess fat, which results in weight gain and is identified by the Body Mass Index (BMI). Studies show that overweight and obesity are the result of a complex interaction between genetic and environmental factors, which begins prenatally. Various studies have shown that physical exercise is an important component of weight loss programmes and that it also benefits the metabolic profile. Other authors have reported that greater weight loss is achieved by a programme that includes both diet and exercise, rather than either of these alone.

Aim The aim of this study is to analyse an intervention based on play as a means of improving the body composition of children with overweight or obesity.

Design / Method The design of the Kids-Play study is based on cases and controls. The study was conducted in Granada (Spain) The analysis sample of 98 children was divided into two groups: cases, consisting of 49 children, who participated in an intervention programme based on physical activity, play and nutritional advice (to both the child and the parents); and controls, another 49 children, who received only nutritional advice.

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 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Obese children that want participate in a voluntary way in the research and sign the informed consent.

排除标准

  • Refused to participate
  • Hormonal problems
  • Age < 8 or >12 years
  • Orthopaedic, respiratory
  • Other problems

研究组 & 干预措施

Study group

Experimental

Consisting of 49 children who were recommended a programme of physical activity, play and nutritional advice, for both the children and their parents

干预措施: The intervention consisted of physical activity based on play (Behavioral)

Control group

No Intervention

49 children, who received only nutritional advice

结局指标

主要结局

Children's body composition

时间窗: 12 months

The children's body composition was measured before and after the intervention, by bioelectrical impedance and using the InBody 720 body composition analyser.

次要结局

  • The level of daily physical activity(1 month)
  • Sleep apnea(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

María José Aguilar Cordero

Professor

Universidad de Granada

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