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

Not Applicable
Completed
Conditions
Pediatric Obesity
Interventions
Procedure: Use of the Chalaxie pedagogical evaluation tool
Registration Number
NCT05007249
Lead Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
29
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Overweight or obese minors with intellectual disabilityUse of the Chalaxie pedagogical evaluation tool-
Primary Outcome Measures
NameTimeMethod
Self-report patient perception questionnairethrough 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.

Secondary Outcome Measures
NameTimeMethod
Self-esteemon enrollment day only

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.

Duration of the use of the self-esteem assessment moduleon enrollment day only

Duration will be measured from the moment the investigator clicks on the module until the completion of the last question.

Clinician perception questionnaireThrough study completion, on enrollment day to the final visit, an average of 2 months

Clinician perception questionnaire consists of 12 single choice questions.

Duration of the visiton enrollment day only

Duration will be measured from the moment the written consent is obtained until the end of the visit

Trial Locations

Locations (1)

Hôpital Emile Muller (GHRMSA)

🇫🇷

Mulhouse, France

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