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CompletedNCT05007249CHALAXIEUpdated Jun 13, 2022

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

An interventional study of Use of the Chalaxie pedagogical evaluation tool in Pediatric Obesity, sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace. Completed at 1 site in France. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2022-06-13.

Sponsored by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Not applicable
Ages
11 Years to 17 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pediatric Obesity

Keywords

  • intellectual disability
  • patient therapeutic education
  • pedagogical evaluation
03

In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's enrollment of 29 is below the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace is the lead sponsor of 27 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
29 participants (actual)

Study arms

  • Other
    Overweight or obese minors with intellectual disability

    Procedure: Use of the Chalaxie pedagogical evaluation tool

Interventions

  • ProcedureUse of the Chalaxie pedagogical evaluation tool

    Use of the Chalaxie pedagogical evaluation tool during two visits

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through study completion, an average of 2 months

Secondary outcomes

  1. Duration of the visit

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

    Time frame: on enrollment day only

  2. 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.

    Time frame: on enrollment day only

  3. Clinician perception questionnaire

    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

  4. 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.

    Time frame: on enrollment day only

07

Study locations

1 site
  • Hôpital Emile Muller (GHRMSA)
    Mulhouse, 68100, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05007249
Lead sponsor
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Responsible party
Sponsor
First posted
Aug 16, 2021
Start date
Jul 28, 2021
Primary completion
Feb 17, 2022
Completion
Feb 17, 2022
Last update
Jun 13, 2022

Study contacts

fatiha Guemazi-Kheffi, MD
principal investigator · Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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