Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT05693506
Status:
RECRUITING
Last Update Posted:
2024-09-04
First Post:
2022-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impacts of Remote Cooking Workshops on Patients With Obesity (CuisTO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-10-20', 'size': 535557, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-12-22T08:41', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Stepped Wedge'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 420}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-31', 'studyFirstSubmitDate': '2022-12-22', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'daily diet', 'timeFrame': '3 months', 'description': 'the daily food balance, consumption of fruits and vegetables, the frequency of cooking and the reduction in the consumption of ultra-processed dishes already prepared.\n\nThese changes will be measured by the PNNS-GS2 score through a dietary survey and a frequency questionnaire (CHALTIEL et al, national health nutrition program\n\n\\- guidelines score 2 (PNNS-GS2): development and validation of a diet quality score reflecting the 2017 French dietary guidelines, British Journal of Nutrition, 2019, 122, 331-342)'}], 'secondaryOutcomes': [{'measure': 'Self-efficacy', 'timeFrame': '3 and 6 months', 'description': 'Increase in the feeling of self-efficacy measured by the SEPOB (Self-Efficacy of the Obese Patient) Obesity-specific Feeling of Self-Efficacy questionnaire (DESCAMPS J et al., 2010) , measures the specific feeling of self-efficacy related to weight management usable in obese, overweight or normal weight subjects'}, {'measure': 'Patient goals', 'timeFrame': '3 months', 'description': 'Achievement of the objectives set by the patient when he participates in a series of 6 cooking workshops such as "I would like to learn to cook vegetables" or "cook less fat". The patient completes a questionnaire (before-after) proposing different possible objectives that the patients would like to achieve by participating in a cooking workshop. When filling out the questionnaire, the patient will have to choose the 3 objectives (out of 12 proposed + 1 free) which seem important to him when he attends a cooking workshop. He will have to number from 1 to 3 the order of importance of his objectives and note on a scale of 1 to 10 the skills he thinks he has in this area. The result is given in terms of the percentage of patients who have reached their initial personalized objective(s) after the two stages of the intervention. The achievement of the objectives set will be considered as achieved if the mark between the two interventions has increased.'}, {'measure': 'BMI', 'timeFrame': '3 and 6 months', 'description': 'Patient weight and height (Body Mass Index)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Impact of Cooking Workshops on Obese Adults']}, 'descriptionModule': {'briefSummary': 'The implementation of therapeutic cooking workshops during the management of obesity in hospitals is now well accepted and recognized as of potential interest on the nutritional level but also cognitive and social (DESPORT, 2015; DAGONEAU, 2008). The literature shows that adults participating in cooking workshops are satisfied and acquire cooking skills potentially useful for improving their health (WOLFSON, BLEICH, 2015; CARAHER, 1999). REICKS (2014, 2018) and REES (2012) point out, however, the low methodological quality of most of the studies conducted and, in fact, the effectiveness of therapeutic cooking workshops has not been formally demonstrated by rigorous randomized studies.\n\nThe Care and Prevention Research Unit (CRESP) of the Manhès Hospital Center then built a multicenter research protocol to demonstrate the impact of cooking workshops in the care of patients with obesity. The protocol involves 6 hospitals: Georges Pompidou European Hospital (HEGP) University Hospital Center (department of Prof S. CZERNICHOW), PITIE SALPETRIERE University Hospital Center (department of Prof J.M. OPPERT), Cognacq Jay Hospital Center, Forcilles Hospital Center, Bligny Hospital Center and Manhes Hospital Center .\n\nThe CuisTO protocol was selected by the PHRIP Jury of the DGOS (General Direction of the Care Offer French Ministry of Health) in 2019 as a high priority project.\n\nThe main objective of this research is to evaluate the effectiveness of remote cooking workshops in the management of obesity, through two methods of setting up therapeutic cooking workshops (so-called "classic" workshops and workshops in the form of "culinary challenges") to improve dietary balance in the context of the care of adult patients living with obesity. Dietary balance will be estimated by compliance with the recommendations of the latest National Health Nutrition Program (PNNS-4 2019-2023), "judged" by the PNNS-GS2 score, the consumption of fruits and vegetables, the frequency of cooking and a reduction in the consumption of ultra-processed dishes that have already been prepared.\n\nThis is a multicentre, open-label, controlled, comparative intervention study with sequential randomization in clusters (clusters) of the "stepped wedge" type'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult able to cook at home,\n* BMI greater than or equal to 30 kg/m²,\n* Being affiliated or beneficiaries of a social security scheme,\n* can be followed on an outpatient basis,\n* with physical and mental autonomy to cook,\n* having a kitchen in their place of accommodation (home, household, etc.),\n* ability to understand French,\n* agreeing to answer the various questionnaires,\n* having signed the information and consent form\n* Patient having the necessary tools for a workshop by videoconference (smartphone, tablet or computer)\n* Patient with sufficient connectivity for a videoconference in their kitchen (wifi, 4G network etc.)\n\nExclusion Criteria:\n\n* patient undergoing bariatric surgery\n* patient planning to undergo bariatric surgery within 6 months\n* patient who is not affiliated or beneficiary of a social security scheme,\n* patient taking part in another experimental research that may interfere with his physical or mental state to cook for the duration of the study.\n* patient having treatments that could have an impact on the study criteria will be excluded (treatment with cortisone, neuroleptics, etc.) according to the judgment of the doctors of the departments concerned\n* patient with an unstabilized pathology (hyper or hypothyroidism, etc.) that could have an impact on the study criteria according to the judgment of the doctors in the departments concerned\n* patient having attended other programs or other cooking workshops (whether therapeutic or not, "chefs\' workshop" type) in the last 6 months\n* patient having planned to attend other programs or other cooking workshops (whether therapeutic or not, "chefs\' workshop" type) apart from those offered during the study'}, 'identificationModule': {'nctId': 'NCT05693506', 'acronym': 'CuisTO', 'briefTitle': 'Impacts of Remote Cooking Workshops on Patients With Obesity (CuisTO)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier FH Manhes'}, 'officialTitle': '"Impact of Remote Therapeutic Cooking Workshops in the Management of Adult Patients Living With Obesity on Dietary Balance: Randomized Interventional Study in Stepped Wedge Type Clusters"', 'orgStudyIdInfo': {'id': '2021-A00214-37'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group Arm A', 'description': 'Arm A: Usual care in the investigating hospitals + questionnaires on daily eating habits, feeling of self-efficacy, etc.'}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group Arm B', 'description': 'Arm B: Usual care in the investigating hospitals + Classic cooking workshops (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy, etc.', 'interventionNames': ['Other: Cooking workshops']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Group C', 'description': 'Arm C: Usual care in the investigating hospitals + Cooking workshops in the form of culinary challenges (number of 6) + questionnaires on daily eating habits, feeling of self-efficacy...', 'interventionNames': ['Other: Cooking workshops']}], 'interventions': [{'name': 'Cooking workshops', 'type': 'OTHER', 'description': 'Cooking workshop in classic form, i.e. with recipes imposed by the dietician on the participants, or cooking workshops in the form of culinary challenges, i.e. without imposed recipes but according to the creativity of the participants', 'armGroupLabels': ['Experimental Group Arm B', 'Experimental Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91640', 'city': 'Briis-sous-Forges', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Carole PILLIAS', 'role': 'CONTACT', 'email': 'carole.pillias.diet@gmail.com', 'phone': '01 69 26 30 00'}, {'name': 'Carole PILLIAS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Bligny', 'geoPoint': {'lat': 48.62399, 'lon': 2.12112}}, {'zip': '77150', 'city': 'Férolles-Attilly', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Cécile SERON', 'role': 'CONTACT', 'email': 'CSERON@cognacq-jay.fr', 'phone': '01.60.64.61.72'}, {'name': 'Cécile SERON', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital FORCILLES', 'geoPoint': {'lat': 48.73184, 'lon': 2.63088}}, {'zip': '91700', 'city': 'Fleury-Mérogis', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Chloé NEURY', 'role': 'CONTACT', 'email': 'chloe.neury@ch-manhes.fr', 'phone': '01.69.25.67.07'}, {'name': 'Chloé NEURY', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CH Manhès', 'geoPoint': {'lat': 48.6373, 'lon': 2.36378}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Mireille SCHAFFNER', 'role': 'CONTACT', 'email': 'mireille.schaffner@aphp.fr', 'phone': '01 42 16 19 13'}, {'name': 'Mireille SCHAFFNER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'La Pitié Salpêtrière AP-HP.Sorbonne Université', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aymie ZIMMER', 'role': 'CONTACT', 'email': 'aymie.zimmer@aphp.fr'}, {'role': 'CONTACT', 'phone': '01 56 09 55 79'}, {'name': 'Aymie ZIMMER', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HEGP', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Camille SUEL', 'role': 'CONTACT', 'email': 'camille.suel@cognacq-jay.fr', 'phone': '01.45.30.83.68'}, {'name': 'Camille SUEL', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hôpital Cognacq-Jay', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Damien GALTIER', 'role': 'CONTACT', 'email': 'damien.galtier@ch-manhes.fr', 'phone': '00 33 610105577'}], 'overallOfficials': [{'name': 'Damien GALTIER', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier FH Manhès'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier FH Manhes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'care and prevention research coordinator', 'investigatorFullName': 'Damien GALTIER', 'investigatorAffiliation': 'Centre Hospitalier FH Manhes'}}}}