Obesity, ChildhoodLettura_evOBNCT06295406
Reading Ability in Childhood Obesity
An observational study of Obesity, Childhood and Obesity, Adolescent, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial summary
There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success. In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and… Read more about this study
- Who is it for?
- Ages 11 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Childhood, Obesity, Adolescent
- What is being tested?
- Neuropsychological assessment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Dec 2023to 30 Dec 2024
- Phase
- Observational
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).
Who may be able to join
- diagnosis of overweight or obesity
Who cannot join
- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
Italy1 site
IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
Piancavallo, VCO, 28824
About this study
There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.
In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory.
- Conditions
- Obesity, Childhood, Obesity, Adolescent
- Being tested
- Neuropsychological assessment
- Keywords
- Reading abilities, Cognitive functioning, Neuropsychological assessment, Motor abilities
- Medical subject headings
- Pediatric Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological assessmentOther
Neuropsychological tests assessing reading abilities, skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time will be performed
| Study group | Role | What they receive |
|---|---|---|
| Cases | Participants with age range between 11 and 16 years, with overweight (BMI>85° ) or obesity (BMI>95°) Receives: Other: Neuropsychological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Raw score at the neuropsychological assessment
For each neuropsychological test, the raw score reported by the participants will be computed according to the validation norms. There are different levels of minumun and maximum scores for each neuropsychological tests.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Dec 2023
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06295406
- Sponsor's protocol ID
- 21C310
- Acronym
- Lettura_evOB
- Status last verified
- Aug 2025
- First submitted
- 28 Feb 2024
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reading Ability in Childhood Obesity
- ClinicalTrials.gov ID
- NCT06295406
- Acronym / sponsor ID
- Lettura_evOB / 21C310
- Conditions
- Obesity, Childhood, Obesity, Adolescent
- Keywords
- Reading abilities, Cognitive functioning, Neuropsychological assessment, Motor abilities
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 6 Mar 2024 (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.
There is some evidence about the negative impact of overweight and obesity on reading ability, with negative consequences on quality of life and school success.
In this neuropsychological research, the relationship between the characteristics of reading abilities in individuals with obesity (age range between 11 and 16 years) and the skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time is investigated according to the cerebellar deficit theory.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Other: Neuropsychological assessmentParticipants with age range between 11 and 16 years, with overweight (BMI>85° ) or obesity (BMI>95°) |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).
Key inclusion criteria (1 listed)
- diagnosis of overweight or obesity
Key exclusion criteria (1 listed)
- concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.
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 |
|---|---|---|
| Neuropsychological assessmentNeuropsychological tests assessing reading abilities, skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time will be performed | Other | Cases |
Primary outcome
Raw score at the neuropsychological assessment
Time frame: baseline
For each neuropsychological test, the raw score reported by the participants will be computed according to the validation norms. There are different levels of minumun and maximum scores for each neuropsychological tests.
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 26 Aug 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Childhood and Obesity, Adolescent, run by Istituto Auxologico Italiano at 1 site in Italy.
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 1 inclusion and 1 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 26 Aug 2025. 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 Italy. 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?
Raw score at the neuropsychological assessment (time frame: baseline). 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 26 Aug 2025; AzTrials last refreshed its copy on 30 Oct 2026.