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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. (CHALAXIE)

Primary Purpose

Pediatric Obesity

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Use of the Chalaxie pedagogical evaluation tool
Sponsored by
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pediatric Obesity focused on measuring intellectual disability, patient therapeutic education, pedagogical evaluation

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

  • Hôpital Emile Muller (GHRMSA)

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Overweight or obese minors with intellectual disability

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Duration of the visit
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
Duration will be measured from the moment the investigator clicks on the module until the completion of the last question.
Clinician perception questionnaire
Clinician perception questionnaire consists of 12 single choice questions.
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.

Full Information

First Posted
August 2, 2021
Last Updated
June 10, 2022
Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
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1. Study Identification

Unique Protocol Identification Number
NCT05007249
Brief Title
Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
July 28, 2021 (Actual)
Primary Completion Date
February 17, 2022 (Actual)
Study Completion Date
February 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Obesity
Keywords
intellectual disability, patient therapeutic education, pedagogical evaluation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Overweight or obese minors with intellectual disability
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Use of the Chalaxie pedagogical evaluation tool
Intervention Description
Use of the Chalaxie pedagogical evaluation tool during two visits
Primary Outcome Measure Information:
Title
Self-report patient perception questionnaire
Description
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.
Time Frame
through study completion, an average of 2 months
Secondary Outcome Measure Information:
Title
Duration of the visit
Description
Duration will be measured from the moment the written consent is obtained until the end of the visit
Time Frame
on enrollment day only
Title
Duration of the use of the self-esteem assessment module
Description
Duration will be measured from the moment the investigator clicks on the module until the completion of the last question.
Time Frame
on enrollment day only
Title
Clinician perception questionnaire
Description
Clinician perception questionnaire consists of 12 single choice questions.
Time Frame
Through study completion, on enrollment day to the final visit, an average of 2 months
Title
Self-esteem
Description
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.
Time Frame
on enrollment day only

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fatiha Guemazi-Kheffi, MD
Organizational Affiliation
Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Emile Muller (GHRMSA)
City
Mulhouse
ZIP/Postal Code
68100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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