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临床试验/NCT00554645
NCT00554645已完成2 期

Multi-Disciplinary Group Intervention Versus Traditional Information Towards Severely Overweight Children and Their Families -

Forskningspuljen2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2004年1月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
45
试验地点
2
主要终点
Body Mass Index

研究概览

简要总结

The difficulties in loosing weight may not stem from lack og knowledge about nutrition, as implied by the standard treatment but from difficulties in following the advice. The hypothesis is, that revealing and addressing these difficulties psychotherapeutically may be more efficient in obtaining weight reduction. The effect of psychological group treatment of severely overweight children and their parents is compared with traditional nutritional information. In other words: Which is better: back-up or enlightenment?

详细描述

At on-set the children get a medical examination, blood-tests, measurement of height, weight, skin-fold, waist and hip. Children and parents fill out questionnaires on social and educational background as well as motivation and expectations to the treatment. All Children are thereafter randomised into two groups:multi-disciplinary group intervention versus traditional information. The randomisation is stratified according to gender and degree of overweight (135%-145% and >145%) supposing that the degree of overweight may mirror the difficulties in loosing weight. The experimental intervention consists of one lecture of general nutrition, weekly psychological group sessions for the children followed by physical exercise, and separate bi-monthly group sessions for the parents. After six months children and parents go to separate group sessions once a month for six months. The control group is offered nutritional advice once with a brief follow-up after one month. The height and weight of the children is measured every month, and the fat % is measured with DEXA-scanning at on-set, after six months, and after twelve months

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
10 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Weight compared to hight over 135% of the Danish norms (www.peadiatri.dk)

排除标准

  • None of the parents wants to participate
  • Diagnosed somatic course of overweight
  • Parents or children do not speak danish
  • Sever physical handicap
  • Psychiatric illness or mental retardation in children or parents
  • Severe child abuse
  • Siblings participation in the trail.

结局指标

主要结局

Body Mass Index

时间窗: Baseline, 6 months, 12 months

次要结局

  • fat% measured by DEXA scan, Hip/waist ratio, skinfold(Baseline, 6 months, 12 months)

研究者

发起方
Forskningspuljen
申办方类型
Other Gov

研究点 (2)

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