Pediatric ObesityCHALAXIENCT05007249
Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.
A study testing Use of the Chalaxie pedagogical evaluation tool in people with Pediatric Obesity, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Pediatric Obesity
- What is being tested?
- Use of the Chalaxie pedagogical evaluation tool
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jul 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
Read the detailed description
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.
- Conditions
- Pediatric Obesity
- Being tested
- Use of the Chalaxie pedagogical evaluation tool
- Keywords
- intellectual disability, patient therapeutic education, pedagogical evaluation
- Medical subject headings
- Pediatric Obesity, Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of the Chalaxie pedagogical evaluation toolProcedure or surgery
Use of the Chalaxie pedagogical evaluation tool during two visits
| Study group | Role | What they receive |
|---|---|---|
| Overweight or obese minors with intellectual disability | Other | Not described Receives: Procedure: Use of the Chalaxie pedagogical evaluation tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 months
Secondary outcomes (4)
Duration of the visit
Duration will be measured from the moment the written consent is obtained until the end of the visit
Measured: 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.
Measured: on enrollment day only
Clinician perception questionnaire
Clinician perception questionnaire consists of 12 single choice questions.
Measured: 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.
Measured: on enrollment day only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start28 Jul 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud Alsace
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fatiha Guemazi-Kheffi, MD, Principal investigator, Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05007249
- Sponsor's protocol ID
- GHR 1169
- Acronym
- CHALAXIE
- Status last verified
- Aug 2021
- First submitted
- 2 Aug 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of the Chalaxie Pedagogical Tool in the Management of Overweight or Obese Children With Intellectual Disability : a Pilot Monocentric Prospective Study.
- ClinicalTrials.gov ID
- NCT05007249
- Acronym / sponsor ID
- CHALAXIE / GHR 1169
- Conditions
- Pediatric Obesity
- Keywords
- intellectual disability, patient therapeutic education, pedagogical evaluation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Groupe Hospitalier de la Region de Mulhouse et Sud AlsaceUniversity, hospital or other
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overweight or obese minors with intellectual disability | Other | Procedure: Use of the Chalaxie pedagogical evaluation tool |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of the Chalaxie pedagogical evaluation toolUse of the Chalaxie pedagogical evaluation tool during two visits | Procedure or surgery | Overweight or obese minors with intellectual disability |
Primary outcome
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.
4 secondary outcomes
Duration of the visit
Time frame: on enrollment day only
Duration of the use of the self-esteem assessment module
Time frame: on enrollment day only
Clinician perception questionnaire
Time frame: Through study completion, on enrollment day to the final visit, an average of 2 months
Self-esteem
Time frame: on enrollment day only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fatiha Guemazi-Kheffi, MD principal investigator
Groupe Hospitalier de la Région de Mulhouse et Sud-Alsace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of the Chalaxie pedagogical evaluation tool in people with Pediatric Obesity, run by Groupe Hospitalier de la Region de Mulhouse et Sud Alsace at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-report patient perception questionnaire (time frame: through study completion, an average of 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.