Ignite Creation Date:
2025-12-24 @ 6:51 PM
Ignite Modification Date:
2026-02-28 @ 9:53 AM
Study NCT ID:
NCT03963557
Status:
UNKNOWN
Last Update Posted:
2020-02-12
First Post:
2019-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Function and Body Mass Index in Children and Adolescents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D063766', 'term': 'Pediatric Obesity'}, {'id': 'D000072458', 'term': 'Orientation, Spatial'}], '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'}, {'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceptual organization index- Matrix reasoning subtest', 'timeFrame': '10-15 minutes', 'description': 'The examinee views an incomplete matrix or series and selects the response option that completes the matrix or series. Scoring is based on whether the response is right or wrong.'}, {'measure': 'Perceptual organization index- Block design subtest', 'timeFrame': '15-20 minutes', 'description': 'The Block Design subtest is designed to measure the ability to analyze and synthesize abstract visual stimuli. While viewing a constructed model or a picture in the Stimulus Book, the examinee uses red- and-white blocks to re-create the design within a specified time limit. Scoring is based on how quickly the participant completes.'}, {'measure': 'Processing speed index- Coding subtest', 'timeFrame': '2-3 minutes', 'description': "The processing speed index measures a child's ability efficiently to scan and understand visual information and complete a task with the data. Scoring is based on how many can the participant finish in 120 seconds."}, {'measure': 'Working memory index- Digit span subtest', 'timeFrame': '5-10 minutes', 'description': 'The task digit span uses numbers. Memory span is a common measure of short-term memory. It is also a component of cognitive ability. Scoring is based on how many correct answers (recall) are achieved'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity, Childhood', 'Obesity, Adolescent', 'Cognitive Orientation']}, 'descriptionModule': {'briefSummary': 'The child will complete computerized tasks and paper-pencil test, and will be presented with symbols, letters, or numbers on a computer screen and asked to respond by pressing a button on the computer. Before each task a researcher will explain the instructions of the task and assess if the child needs a break before completing the next task. While the child is completing computerized tasks, the parent/guardian will be asked to fill out paper-pencil questionnaires about the child and to sign a release of medical information form so that we can study how physical markers of health effect cognition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Local population; children and adolescents', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Local population (based on ethnicity)\n* Healthy or overweight/obese\n\nExclusion Criteria:\n\n* History of developmental delay or disorders\n* History of any medical conditions ( that may impact the development)'}, 'identificationModule': {'nctId': 'NCT03963557', 'briefTitle': 'Cognitive Function and Body Mass Index in Children and Adolescents', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London Diabetes Centre'}, 'officialTitle': 'Cognitive Function and Body Mass Index in Children and Adolescents', 'orgStudyIdInfo': {'id': 'IREC035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy participants', 'description': 'BMI 5th percentile to less than the 85th percentile'}, {'label': 'Overweight/Obese participants', 'description': 'BMI 85th percentile or more'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Abu Dhabi', 'status': 'RECRUITING', 'country': 'United Arab Emirates', 'contacts': [{'name': 'Dr Nader Lessan, MD FRCP CCST', 'role': 'CONTACT'}], 'facility': 'Imperial College London Diabetes Centre', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'centralContacts': [{'name': 'Dr Nader Lessan, MD FRCP CCST', 'role': 'CONTACT', 'email': 'nlessan@icldc.ae', 'phone': '+97124040800', 'phoneExt': '970'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London Diabetes Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Georgetown University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}