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

NCT05007249 | Completed

• 1 other identifier: GHR 1169
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Obesity

Keywords

intellectual disability; patient therapeutic education; pedagogical evaluation

Outcome Measures

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.

  through study completion, an average of 2 months

Secondary Outcomes (4)

• Duration of the visit

  on enrollment day only

• Duration of the use of the self-esteem assessment module

  on enrollment day only

• Clinician perception questionnaire

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

• Self-esteem

  on enrollment day only

Study Arms (1)

Overweight or obese minors with intellectual disability

OTHER

Procedure: Use of the Chalaxie pedagogical evaluation tool

Interventions

Use of the Chalaxie pedagogical evaluation tool PROCEDURE

Use of the Chalaxie pedagogical evaluation tool during two visits

Overweight or obese minors with intellectual disability

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Groupe Hospitalier de la Region de Mulhouse et Sud Alsace: lead

Study Sites (1)

Hôpital Emile Muller (GHRMSA)

Mulhouse, 68100, France

Location

MeSH Terms

Conditions

Pediatric Obesity; Intellectual Disability

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• fatiha Guemazi-Kheffi, MD

  Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: August 16, 2021
• Study Start: July 28, 2021
• Primary Completion: February 17, 2022
• Study Completion: February 17, 2022
• Last Updated: June 13, 2022

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)