Ignite Creation Date:
2024-05-06 @ 4:29 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT05007249
Status:
COMPLETED
Last Update Posted:
2022-06-13
First Post:
2021-08-02
Brief Title:
Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability a Pilot Monocentric Prospective Study
Sponsor:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Organization:
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Study Overview
Official Title:
Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability a Pilot Monocentric Prospective Study
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CHALAXIE
Brief Summary:
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
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
Detailed Description:
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 ie final visit which should take place between 3 weeks and 2 months after the first visit they will use a module of their choice
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 ie final visit which should take place between 3 weeks and 2 months after the first visit they will use a module of their choice
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None