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Completed

NCT Number: NCT05007249

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of the Chalaxie pedagogical evaluation tool

Procedure

Use of the Chalaxie pedagogical evaluation tool during two visits

Primary outcomes

  1. Self-report patient perception questionnaire

    Time frame: 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 outcomes

  1. Duration of the visit

    Time frame: on enrollment day only

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

  2. Duration of the use of the self-esteem assessment module

    Time frame: on enrollment day only

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

  3. Clinician perception questionnaire

    Time frame: Through study completion, on enrollment day to the final visit, an average of 2 months

    Clinician perception questionnaire consists of 12 single choice questions.

  4. Self-esteem

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace

Other

Registry information

Acronym: CHALAXIE

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 16, 2021
Registry last updated
Jun 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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