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临床试验/NCT05007249
NCT05007249已完成不适用

Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2021年7月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Self-report patient perception questionnaire

研究概览

简要总结

The main objective of this study is to determine the benefit of the Chalaxie pedagogical evaluation tool in the management of overweight or obese children with intellectual disability.

Chalaxie is a software developped as a pedagogical evaluation tool. It is used in the therapeutic education of overweight and obese children and allow the clinican to explore several skills of the child, such as self-esteem.

详细描述

Secondary objectives

  1. To assess the feasibility of the Chalaxie tool use during a medical visit;
  2. To assess the relevance of the Chalaxie tool for the pediatrician;
  3. To describe the characteristics of the patients followed at the "Réseau ODE";
  4. To evaluate patient self-esteem.

Conduct of research After receiving written consent from the study participant and parental authority, the patients will have two visits with the pediatrician during which they will use the Chalaxie pedagogical evaluation tool. At the first visit, they will use the self-esteem assessment module. At the second visit (i.e. final visit), which should take place between 3 weeks and 2 months after the first visit, they will use a module of their choice.

研究设计

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

入排标准

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

入选标准

  • Minor patient of 11 years of age or older
  • Overweight or obese patient respectively defined as a BMI ≥ IOTF 25 and ≥ IOTF 30
  • Mild intellectual disability defined as intelligence quotient (IQ) ≥ 55 and <70 or (if IQ unknown) patient in a special education institution (ULIS, IM-PRO)
  • Affiliated or beneficiary of a social security scheme
  • Written consent of the patient and one of the parental authority holder

排除标准

  • Patient with a severe autistic disorder
  • Patient who already used the Chalaxie tool during his/her follow-up
  • Difficulties in understanding the instructions for using the software and/or difficulties in using a computer

结局指标

主要结局

Self-report patient perception questionnaire

时间窗: through study completion, an average of 2 months

The benefit of the Chalaxie pedagogical evaluation tool will be measured with the patient perception questionnaire completed at the final visit. It consists of seven single choice questions and one open question.

次要结局

  • Self-esteem(on enrollment day only)
  • Duration of the use of the self-esteem assessment module(on enrollment day only)
  • Clinician perception questionnaire(Through study completion, on enrollment day to the final visit, an average of 2 months)
  • Duration of the visit(on enrollment day only)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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