Reading Ability in Childhood Obesity (Lettura_evOB)

March 6, 2024 updated by: Federica Scarpina, Istituto Auxologico Italiano

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • VCO
      • Piancavallo, VCO, Italy, 28824
        • Recruiting
        • IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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).

Description

Inclusion criteria

• diagnosis of overweight or obesity

Exclusion criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Participants with age range between 11 and 16 years, with overweight (BMI>85° ) or obesity (BMI>95°)
Other: Neuropsychological assessment
Neuropsychological tests assessing reading abilities, skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time will be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

February 28, 2024

First Submitted That Met QC Criteria

February 28, 2024

First Posted (Actual)

March 6, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21C310

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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