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

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.

Study Overview

• Status: Completed
• Conditions: Pediatric Obesity
• Intervention / Treatment: Procedure: Use of the Chalaxie pedagogical evaluation tool

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Mulhouse, France, 68100
    • Hôpital Emile Muller (GHRMSA)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	through study completion, an average of 2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the visit	Duration will be measured from the moment the written consent is obtained until the end of the visit	on enrollment day only
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.	on enrollment day only
Clinician perception questionnaire	Clinician perception questionnaire consists of 12 single choice questions.	Through study completion, on enrollment day to the final visit, an average of 2 months
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.	on enrollment day only

Collaborators and Investigators

• Sponsor: Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
• Investigators: Principal Investigator: fatiha Guemazi-Kheffi, MD, Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): February 17, 2022
• Study Completion (Actual): February 17, 2022

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 10, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 10, 2022
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: intellectual disability; patient therapeutic education; pedagogical evaluation
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Overnutrition; Nutrition Disorders; Body Weight; Neurodevelopmental Disorders; Obesity; Pediatric Obesity; Overweight; Intellectual Disability
• Other Study ID Numbers: GHR 1169

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No