CHALAXIE: 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 (Other)

Overall Status

Completed

CT.gov ID

NCT05007249

Collaborator

(none)

Enrollment

Location

Arm

6.7

Actual Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Obesity	Procedure: Use of the Chalaxie pedagogical evaluation tool	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 28, 2021

Actual Primary Completion Date :

Feb 17, 2022

Actual Study Completion Date :

Feb 17, 2022

Arms and Interventions

Arm	Intervention/Treatment
Other: Overweight or obese minors with intellectual disability	Procedure: Use of the Chalaxie pedagogical evaluation tool Use of the Chalaxie pedagogical evaluation tool during two visits

Arm

Intervention/Treatment

Other: Overweight or obese minors with intellectual disability

Procedure: Use of the Chalaxie pedagogical evaluation tool

Use of the Chalaxie pedagogical evaluation tool during two visits

Outcome Measures

Primary Outcome Measures

Self-report patient perception questionnaire [through 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

Duration of the visit [on enrollment day only]
Duration will be measured from the moment the written consent is obtained until the end of the visit
Duration of the use of the self-esteem assessment module [on 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 questionnaire [Through study completion, on enrollment day to the final visit, an average of 2 months]
Clinician perception questionnaire consists of 12 single choice questions.
Self-esteem [on 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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