NCT06295406

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 28, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 6, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

1.1 years

First QC Date

February 28, 2024

Last Update Submit

August 20, 2025

Conditions

Keywords

Reading abilitiesCognitive functioningNeuropsychological assessmentMotor abilities

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Study Arms (1)

Cases

Participants with age range between 11 and 16 years, with overweight (BMI\>85° ) or obesity (BMI\>95°)

Other: Neuropsychological assessment

Interventions

Neuropsychological tests assessing reading abilities, skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time will be performed

Cases

Eligibility Criteria

Age11 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • diagnosis of overweight or obesity

You may not qualify if:

  • concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe

Piancavallo, VCO, 28824, Italy

Location

MeSH Terms

Conditions

Pediatric Obesity

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2024

First Posted

March 6, 2024

Study Start

December 1, 2023

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

August 26, 2025

Record last verified: 2025-08

Locations