Clinical trial NCT05007249: Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.
Official title: Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatric Obesity
Keywords: intellectual disability
patient therapeutic education
pedagogical evaluation
Lead sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 29
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

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

Primary outcomes:
measure: Self-report patient perception questionnaire
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
measure: Duration of the visit
timeFrame: on enrollment day only
measure: Duration of the use of the self-esteem assessment module
timeFrame: on enrollment day only
measure: Clinician perception questionnaire
timeFrame: Through study completion, on enrollment day to the final visit, an average of 2 months
measure: Self-esteem
timeFrame: on enrollment day only
Other outcomes:
Locations:
city: Mulhouse
country: France
facility: Hôpital Emile Muller (GHRMSA)
Study officials:
affiliation: Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace
name: fatiha Guemazi-Kheffi, MD
role: PRINCIPAL_INVESTIGATOR
References: