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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.

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05007249
Acronym
CHALAXIE
Enrollment
29
Registered
2021-08-16
Start date
2021-07-28
Completion date
2022-02-17
Last updated
2022-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pediatric Obesity

Keywords

intellectual disability, patient therapeutic education, pedagogical evaluation

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.

Interventions

PROCEDUREUse of the Chalaxie pedagogical evaluation tool

Use of the Chalaxie pedagogical evaluation tool during two visits

Sponsors

Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
11 Years to 17 Years
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Self-report patient perception questionnairethrough study completion, an average of 2 monthsThe 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

MeasureTime frameDescription
Duration of the visiton enrollment day onlyDuration 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 moduleon enrollment day onlyDuration 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 monthsClinician perception questionnaire consists of 12 single choice questions.
Self-esteemon enrollment day onlySelf-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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026