Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT06295406
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2024-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reading Ability in Childhood Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-20', 'studyFirstSubmitDate': '2024-02-28', 'studyFirstSubmitQcDate': '2024-02-28', 'lastUpdatePostDateStruct': {'date': '2025-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Raw score at the neuropsychological assessment', 'timeFrame': 'baseline', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reading abilities', 'Cognitive functioning', 'Neuropsychological assessment', 'Motor abilities'], 'conditions': ['Obesity, Childhood', 'Obesity, Adolescent']}, 'descriptionModule': {'briefSummary': '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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '16 Years', 'minimumAge': '11 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants with obesity will be recruited at the beginning of a rehabilitative treatment at the Istituto Auxologico Italiano, IRCCS, San Giuseppe Hospital (Italy).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria\n\n• diagnosis of overweight or obesity\n\nExclusion criteria:\n\n• concurrent neurological, neurodevelopmental (e.g., autism), motor, somatosensory and/or psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT06295406', 'acronym': 'Lettura_evOB', 'briefTitle': 'Reading Ability in Childhood Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Reading Ability in Childhood Obesity', 'orgStudyIdInfo': {'id': '21C310'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases', 'description': 'Participants with age range between 11 and 16 years, with overweight (BMI\\>85° ) or obesity (BMI\\>95°)', 'interventionNames': ['Other: Neuropsychological assessment']}], 'interventions': [{'name': 'Neuropsychological assessment', 'type': 'OTHER', 'description': 'Neuropsychological tests assessing reading abilities, skills of motor coordination, postural stability, manual dexterity, including graphomotor skills, and estimation of time will be performed', 'armGroupLabels': ['Cases']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28824', 'city': 'Piancavallo', 'state': 'VCO', 'country': 'Italy', 'facility': 'IRCCS Istituto Auxologico Italiano - Ospedale San Giuseppe', 'geoPoint': {'lat': 46.00932, 'lon': 8.62916}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}