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

Study Overview
=================
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.

Detailed Description
-----------------
Secondary objectives To assess the feasibility of the Chalaxie tool use during a medical visit; To assess the relevance of the Chalaxie tool for the pediatrician; To describe the characteristics of the patients followed at the Réseau ODE; 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.

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

Conditions
-----------------
Pediatric Obesity

Intervention / Treatment
-----------------
* Procedure: Use of the Chalaxie pedagogical evaluation tool


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Overweight or obese minors with intellectual disability<br> | Procedure: Use of the Chalaxie pedagogical evaluation tool<br>* Use of the Chalaxie pedagogical evaluation tool during two visits<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intellectual disability, patient therapeutic education, pedagogical evaluation