Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2026-01-02 @ 9:21 AM
Study NCT ID:
NCT03203135
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2017-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-06', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-06-28', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Waist circumference', 'timeFrame': '14 months', 'description': 'in centimeters'}, {'measure': 'Weight', 'timeFrame': '14 months', 'description': 'in kg'}, {'measure': 'Blood pressure', 'timeFrame': '14 months', 'description': 'in mm Hg'}, {'measure': 'Metabolic parameters (Total cholesterol, HDL, LDL, Triglycerdies, glycemia)', 'timeFrame': '14 months', 'description': 'in g/l'}, {'measure': 'Food consumption behavior and food representations', 'timeFrame': '14 months', 'description': 'score'}, {'measure': 'Physical activity level', 'timeFrame': '14 months', 'description': 'Ricci and gagnon score'}, {'measure': 'Height', 'timeFrame': '14 months', 'description': 'in meters'}], 'secondaryOutcomes': [{'measure': 'Motivation to change habits', 'timeFrame': '14 months', 'description': 'scale of Prochaska'}, {'measure': 'Body Feeling', 'timeFrame': '14 months', 'description': 'Analog visual scales (AVS)'}, {'measure': 'Well-being', 'timeFrame': '14 months', 'description': 'AVS'}, {'measure': 'Stress', 'timeFrame': '14 months', 'description': 'AVS'}, {'measure': 'Sleep quality', 'timeFrame': '14 months', 'description': 'AVS'}, {'measure': 'Fatigue', 'timeFrame': '14 months', 'description': 'scale of Pichot'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shift-work', 'Eating Behavior']}, 'descriptionModule': {'briefSummary': 'Staggered work affects about 20% of French employees and its health risks are now well known. They concern physical health (sleep disorders, weight gain, cancer, cardiovascular disorders, nutritional problems, etc.) and psychological health. Faced with these "alarming" findings, it is necessary to find ways of improvement and levers of action to prevent them.\n\nThis project aims to set up and evaluate a nutritional health prevention programme for the benefit of employees in staggered hours from CITEO. CITEO is a company of social mediation.\n\nThe objectives of the project are twofold: to evaluate the impact of working conditions in shifted schedules on food behavior and on to improve their eating behaviors.\n\nHow? Focusing on the pleasure of eating through a nutritional prevention program in which various and varied actions will be proposed but always adapted to the life of the company (example: culinary demonstration, physical activity, provision of baskets of Fruits, etc.).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants working at CITEO in staggered hours\n\nExclusion Criteria:\n\n* Pregnant woman, person with severe pathology'}, 'identificationModule': {'nctId': 'NCT03203135', 'acronym': "PREV'HODE", 'briefTitle': 'Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.', 'organization': {'class': 'OTHER', 'fullName': 'Institut Pasteur de Lille'}, 'officialTitle': 'Assesment of the Impact of a Nutritional Prevention Programme for Employees in Staggered Hours.', 'orgStudyIdInfo': {'id': '2017-A00812-51'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'interventionNames': ['Behavioral: Nutritional prevention programme']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group'}], 'interventions': [{'name': 'Nutritional prevention programme', 'type': 'BEHAVIORAL', 'description': 'The nutritional prevention programme will offer a wide range of food and physical activity activities adapted to the life of the company (example: culinary demonstration, physical activity, provision of fruit baskets, etc.) .', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59019', 'city': 'Lille', 'state': 'Nord', 'country': 'France', 'facility': 'NutrInvest - Institut Pasteur de Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Jean-Michel LECERF, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IPL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Pasteur de Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Jean-Michel Lecerf', 'investigatorAffiliation': 'Institut Pasteur de Lille'}}}}