跳至主要内容
临床试验/NCT00435734
NCT00435734进行中(未招募)不适用

Evaluation of the Intervention Program "Obeldicks" for Obese Children and Adolescents

University of Witten/Herdecke1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 1999年7月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
4,000
试验地点
1
主要终点
change of BMI-SDS

研究概览

简要总结

The intervention program "Obeldicks" was developed for obese children aged 6 to 16 years. This intervention is gender- and age specific. The 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. The evaluation compromised quality of structure, process and results of the intervention. Primary outcome measure is change of weight status as standard deviation score of BMI. Furthermore, cardiovascular risk factor profile, hormones (e.g. iGF-I, thyroid hormones, vitamin D status)adipocytokines, GI- hormones, intima media thickness are measured prior to and after the one-year intervention. The changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. Additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
是

入选标准

  • •percentile for age and gender

排除标准

  • •Psychiatric disorders
  • •Endocrine disorders

结局指标

主要结局

change of BMI-SDS

时间窗: 20 years

次要结局

  • change of GI hormones(10 years)
  • change of adipocytokines(10 years)
  • change of cardiovascualr risk factors(10 years)
  • change of metabolomics(10 years)
  • change of psychological variables(10 years)

研究者

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

Thomas Reinehr

Head of Department of Pediatric Endocrinology Diabetes and Nutrition Medicine

University of Witten/Herdecke

研究点 (1)

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