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临床试验/NCT01067157
NCT01067157已完成不适用

Long-term Effects of Lifestyle Intervention in Obesity and Genetic Influence in Children - LOGIC-Study

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,500
试验地点
2
主要终点
Influence of gene variants in FTO, MC4R and TMEM-18 on reduction of overweight and obesity measured by standard deviation score Body Mass Index (sds-BMI)

研究概览

简要总结

The purpose of the study is to determine the genetic influence on short-, middle- and longterm effects of an inpatient lifestyle therapy program in overweight and obese children and adolescents.

详细描述

In Germany, as in other countries, overweight and obesity affects a growing number of children and adolescents. Obesity-related diseases such as arterial hypertension, disorders of glucose and lipid metabolism and an increase in inflammation markers are associated with higher morbidity and mortality in early life, therefore effective therapy concepts are needed.

The aim of this study is to evaluate the effects of a 4-6 week inpatient obesity lifestyle therapy program over 10 years and the genetic influence on the short-, middle- and longterm outcome.

The lifestyle intervention consists of physical exercise, nutrition education and behaviour therapy based on the criterions developed by the German Obesity Group (degree of weight reduction, improvement of comorbidity and health behaviour, minimising of side effects).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Overweight or obese children (BMI >90th percentile for age and gender), who obtained an inpatient lifestyle intervention in the participating clinic.
  • Children with written consent from their parents and the acceptance of a 10-year follow-up.

排除标准

  • Children without written consent from their parents.
  • Children with monogenetic diseases with influence on obesity (e.g. Prader-Willi-Syndrome) or with secondary obesity.

结局指标

主要结局

Influence of gene variants in FTO, MC4R and TMEM-18 on reduction of overweight and obesity measured by standard deviation score Body Mass Index (sds-BMI)

时间窗: 16 years

次要结局

未报告次要终点

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Sponsor

研究点 (2)

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