Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-03-01 @ 8:57 PM
Study NCT ID:
NCT06026059
Status:
COMPLETED
Last Update Posted:
2023-09-06
First Post:
2023-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-29', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Evaluation of the SEFI scale as a screening tool for child's nutritional risk.", 'timeFrame': 'Day 1', 'description': 'The correlation between the self evaluation of food intake (SEFI) scale, with scores from 0 to 10, indicating the presence of malnutrition score if score is inferior to 7 or absence of malnutrition if score superior to 7/10, and the STRONGkids score will be evaluated'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['undernutrition', 'diagnostic', 'screening'], 'conditions': ['Undernutrition']}, 'descriptionModule': {'briefSummary': "In current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings,however, in some cases, these tools cannot be used due to lack of data.\n\nThat's why a tool that doesn't require any anthropometric parameters, such as a visual food intake scale, could be useful to for medical and paramedical staff. In this way, a larger proportion of the paediatric population could benefit from nutritional screening.", 'detailedDescription': "HAS defines undernutrition as a state of nutritional imbalance, characterized by a negative energy and/or protein balance. This negative balance may be linked to a deficit in isolated intake and/or an increase in energy and/or protein expenditure.\n\nIn current practice, there are various nutritional risk scores and diagnostic tools which are used in both inpatient and outpatient settings. Practitioners can use discs to quickly and easily determine BMI, which corresponds to the ratio of Weight (Kg) / Height² (m). However, in some cases, these tools cannot be used due to lack of data.\n\nThat's why a tool that doesn't require any anthropometric parameters could be useful to for medical and paramedical staff. In this way, a larger proportion of the paediatric population could benefit from nutritional screening.\n\nIn adults, a visual food intake scale exists and has been validated for screening for nutritional risk. The hypothesis of this study is that the visual food intake scale could be a good tool for screening for nutritional risk in paediatrics"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a scheduled hospitalization, according to the day hospital scheduling list, will be proposed to participate in the study', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Child able to be weighed and measured\n* Family with Internet access and telephone number\n* Child and at least one parent present during day hospitalization,\n* Child able to respond to the SEFI® scale and having completed the 3-day food intake at home\n\nExclusion Criteria:\n\n* Children and/or parents with comprehension and/or communication difficulties\n* Children with any pathological condition making interpretation of results difficult from the investigator's point of view\n* Children receiving nutritional support: enteral and parenteral nutrition.\n* Child with nutritional follow-up"}, 'identificationModule': {'nctId': 'NCT06026059', 'acronym': 'EFImôme', 'briefTitle': 'Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Interest of a Visual Scale for Evaluating Food Portions as a Screening Tool for Nutritional Risk in Pediatrics', 'orgStudyIdInfo': {'id': 'RC31/20/0059'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'interview with the dietician', 'description': 'Initially, parent(s) and child will be interviewed together, details of the dietary record, as well as the data needed to calculate the nutritional risk score will be obtained.\n\nThe interview will then be only with the child, he will be asked to determine, on his/her own, the portion of food he/she thinks he/she ate the previous evening, using the SEFI score.\n\nFinally, one of the two parents will determine, on their own, the portion of food they think their child ate the previous evening, using the SEFI score.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Céline BARDE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}