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

Pediatric Obesity Clinical Trial

— CHALAXIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05007249
• Other study ID #: GHR 1169
• Status: Completed
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: February 17, 2022

Study information

• Verified date: August 2021
• Source: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: February 17, 2022
• Est. primary completion date: February 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Intellectual Disability
• Overweight
• Pediatric Obesity

Intervention

Procedure:
• Use of the Chalaxie pedagogical evaluation tool
Use of the Chalaxie pedagogical evaluation tool during two visits

Locations

Country	Name	City	State
France	Hôpital Emile Muller (GHRMSA)	Mulhouse

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-report patient perception questionnaire	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.	through study completion, an average of 2 months
Secondary	Duration of the visit	Duration will be measured from the moment the written consent is obtained until the end of the visit	on enrollment day only
Secondary	Duration of the use of the self-esteem assessment module	Duration will be measured from the moment the investigator clicks on the module until the completion of the last question.	on enrollment day only
Secondary	Clinician perception questionnaire	Clinician perception questionnaire consists of 12 single choice questions.	Through study completion, on enrollment day to the final visit, an average of 2 months
Secondary	Self-esteem	Self-esteem will be evaluated with the self-esteem assessment module. It consists of 6 questions with a visual scale of 6 emoticons. It also includes a 4-modality question assessing overall self-esteem that is completed by the patient and pediatrician respectively.	on enrollment day only