Ignite Creation Date:
2025-12-24 @ 11:05 PM
Ignite Modification Date:
2025-12-25 @ 8:36 PM
Study NCT ID:
NCT03588169
Status:
COMPLETED
Last Update Posted:
2019-10-16
First Post:
2018-07-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044342', 'term': 'Malnutrition'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-15', 'studyFirstSubmitDate': '2018-07-04', 'studyFirstSubmitQcDate': '2018-07-16', 'lastUpdatePostDateStruct': {'date': '2019-10-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semi-structured individual interviews', 'timeFrame': '1 day on inclusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malnutrition', 'Oral Nutritional Supplementation']}, 'descriptionModule': {'briefSummary': 'Over 30% of hospitalized patients are malnourished. These figures range from 20% to 60% in geriatric units. Undernutrition results either from a decrease in energy intake, an increase in needs, an increase in losses or a combination of these three causes. As a factor in mortality, morbidity and lengthening the time of hospital stays, undernutrition induces health costs 45 to 102% higher than a person who is not undernourished. The nutritional management of patients initially includes hygieno-dietary advice, then the implementation of an oral nutritional supplementation (ONS). A recent study conducted by our teams highlighted the low ONS consumption among women compared to men (39.48% vs 73.41%). Interviews with patients showed that 13 out of 17 had a negative opinion of ONS.\n\nThe aim of this study is to show, on a larger scale, whether ONS consumption differs according to sex and if so, to highlight the obstacles to this consumption through the implementation of semi-directive interviews with patients. Ultimately, this research will lead to the implementation of alternative strategies to improve ONS consumption and to a better understanding of the obstacles to ONS consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalised in the endocrinology, digestive surgery, pneumology and geriatrics departments of the Dijon University Hospital, with a prescription for ONS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient who has given oral consent\n* over 18 years\n* orally fed\n* with a prescription for ONS\n* speaks and understands French\n* hospital stay longer than 4 days\n\nExclusion Criteria:\n\n* adult under tutelage\n* pregnant or breastfeeding women\n* cognitive disorders\n* patient does not speak or understand French'}, 'identificationModule': {'nctId': 'NCT03588169', 'acronym': 'CNO_ALIMS', 'briefTitle': 'Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire Dijon'}, 'officialTitle': 'Representations of Oral Nutritional Supplementation (ONS) in Hospitals : Gender differences_observational Study', 'orgStudyIdInfo': {'id': 'BRINDISI 2018 CNO_ALIMS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients hospitalized at the Dijon University Hospital', 'description': 'Patients hospitalized in the endocrinology, digestive surgery, pneumology and geriatric units of the Dijon University Hospital with a prescription for ONS', 'interventionNames': ['Dietary Supplement: semi-structured interviews']}], 'interventions': [{'name': 'semi-structured interviews', 'type': 'DIETARY_SUPPLEMENT', 'description': 'About 30 minutes and touching on the following subjects:\n\n* perception of hospital meals\n* patient representation of ONS\n* taking ONS and feelings about it', 'armGroupLabels': ['patients hospitalized at the Dijon University Hospital']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'Chu Dijon Bourogne', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire Dijon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}