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临床试验/NCT02013843
NCT02013843已完成不适用

Treatment of Overweight and Obese Children - the "Holbaek-Method" in a Municipality Based Treatment Program.

Holbaek Sygehus2 个研究点 分布在 1 个国家目标入组 1,007 人开始时间: 2013年3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
1,007
试验地点
2
主要终点
Body mass index standard deviation score

研究概览

简要总结

In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek. The effect is evaluated by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life and concentration of fasting blood lipids and glucose during one year of treatment.

详细描述

In the present study the effect of a community-based treatment of overweight and obese children is analyzed. The treatment-method is based on the principals and the method used in the Children Obesity Clinic in the Pediatric department i Holbaek and the care providers in each of the eight municipalities included are thought thoroughly to use this method.

The treatment effect is evaluated after one year, and the effect is assessed by the change in body mass index standard deviation score, change in blood pressure standard deviation score, quality of life (PedsQL), body composition and concentration of fasting blood lipids and glucose.

研究设计

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

入排标准

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

入选标准

  • Body mass index above 90-percentile for age and gender

排除标准

  • 未提供

结局指标

主要结局

Body mass index standard deviation score

时间窗: 1 year

primary outcome is the change in body mass index standard deviation score during 12 month treatment of overweight and obesity.

次要结局

  • Change in blood pressure standard deviation score(1 year)
  • Change in the concentration of blood lipids(1 year)
  • change in the concentration of fasting blood-glucose, HBA1C and insulin(1 year)
  • Change in body composition measured by Tanita BC 418(1 year)
  • Change in quality of life assessed by PedsQL(1 year)

研究者

发起方
Holbaek Sygehus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pernille Maria Mollerup

MD

Holbaek Sygehus

研究点 (2)

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