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临床试验/NCT05424094
NCT05424094Unknown不适用

Health-related Quality of Life in Overweight and Obese Children/Adolescents - a Pilot Project in the 'Kinderleicht' Group Programme

Frank Wieber · Zurich University of Applied Sciences0 个研究点入组 16 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
16
主要终点
health related quality of life (HRQoL) over 11 months

研究概览

简要总结

The primary aim of the present study is to record changes in the health-related quality of life (HRQoL) of children/adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. In addition, these data will be examined for correlation with changes in BMI, waist and hip circumference, and motor performance.

Secondarily, the study addresses the questions of whether the recording of HROoL by means of the KINDL questionnaire is practicable for the programme leaders and what benefit can be gained from the analysed data for future cohorts.

详细描述

According to the 2021 publication of the WHO European Childhood Obesity Surveillance Initiative (COSI), overweight and obesity in children and adolescents remains one of the most serious health problems facing the European population in the 21st century. The WHO responded to this problem in 2019 with a review paper on the propagated intervention approaches. With its developed national guidelines, Switzerland relies on multiprofessional group programmes. One of the eleven currently tested and certified programmes is 'kinderleicht' in Chur. The nationwide KIDSSTEP study from 2014 - on which the nationwide guidelines for multiprofessional group programmes are based - shows that it is imperative to record the health-related quality of life (HRQoL) of the children and adolescents as well as their families. In practice, however, this evidence is still too little implemented. Using the example of 'kinderleicht', it is to show that the recording and documentation of HRQoL is practicable and can provide valuable insights for both programme participants and programme managers. The primary goal is to record the health-related quality of life of children and adolescents participating in the multi-professional group programme 'kinderleicht' in 2022 over the course of the eleven-month active phase. At the same time, these data are to be correlated and interpreted with changes in BMI, waist and hip circumference and motor performance. Secondarily, possible sensitive/difficult phases of a participant during the active phase of the intervention will be identified in order to provide the best possible coaching to the families of future cohorts.

研究设计

研究类型
干预性
分配方式
不适用
干预模型
单组
主要目的
治疗
盲法
开放(无盲法)

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • girls/boys aged 7-17 years.
  • participation with children
  • age-adjusted BMI: P > 97th percentile or 90th-97th percentile + diseases whose prognosis is worsened by the overweight or are the result of the overweight
  • medical examination unobjectionable
  • motivation to participate in the programme is given
  • written informed consent of the participant, 6.1. for children up to 14 years of age, verbal consent of the child is sufficient, plus written consent of the parents or a legal representative 6.2. for adolescents aged 14 and over, written consent from the adolescent is sufficient.

排除标准

  • BMI < 90 percentile
  • not part of 'easy for children
  • medical examination questionable
  • no motivation to participate in the programme
  • no verbal and/or written consent of the children and their parents/legal representatives

研究组 & 干预措施

'kinderleicht' programme

Experimental

Children receive coaching in the areas of behaviour, exercise, nutrition and medicine from qualified professionals.

干预措施: multi-professional group programme 'kinderleicht' (Behavioral)

结局指标

主要结局

health related quality of life (HRQoL) over 11 months

时间窗: 11 months

measured with the 'KINDL'-questionair; linkert scaled with a maximum value of 100 and a minimum value of 0 (points); the higher the score the better

次要结局

  • hip-waist ratio(11 months)
  • motor performance(11 months)
  • Rate of Body Mass Index (BMI) over 11 months(11 months)

研究者

发起方
Frank WieberZurich University of Applied Sciences
申办方类型
其他
责任方
申办者-研究者
主要研究者

Frank Wieber

professor doctor Frank Wieber

Zurich University of Applied Sciences

标识符

NCT 编号
NCT05424094
其他研究编号
HRQoL_29.12.21

日期

首次提交
(4年前)
首次发布
(4年前)
主要完成日期
(3年前)
研究完成日期
(3年前)
最近核实
(4年前)
最近更新
(4年前)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
否
是否有结果
否

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