Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT03443635
Status:
COMPLETED
Last Update Posted:
2022-04-29
First Post:
2018-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cooking for Health Optimization With Patients
Sponsor:
Organization:
Raw JSON
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{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dominique.monlezun@gmail.com', 'phone': '3373290724', 'title': 'Principal Investigator', 'organization': 'Tulane University Goldring Center for Culinary Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'Subjects receiving hands-on cooking and nutrition education classes\n\nTreatment: The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.', 'otherNumAtRisk': 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'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Food Costs', 'timeFrame': '6 months', 'description': 'Grocery and restaurant costs (for patients)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'Subjects receiving hands-on cooking and nutrition education classes\n\nTreatment: The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2616'}, {'groupId': 'FG001', 'numSubjects': '4576'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2127'}, {'groupId': 'FG001', 'numSubjects': '3720'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '489'}, {'groupId': 'FG001', 'numSubjects': '856'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2616', 'groupId': 'BG000'}, {'value': '4576', 'groupId': 'BG001'}, {'value': '7192', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'Subjects receiving hands-on cooking and nutrition education classes\n\nTreatment: The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.'}, 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[{'value': '32.02', 'spread': '12.69', 'groupId': 'BG000'}, {'value': '28.16', 'spread': '8.48', 'groupId': 'BG001'}, {'value': '29.49', 'spread': '10.30', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1700', 'groupId': 'BG000'}, {'value': '2725', 'groupId': 'BG001'}, {'value': '4425', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '916', 'groupId': 'BG000'}, {'value': '1851', 'groupId': 'BG001'}, {'value': '2767', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '376', 'groupId': 'BG000'}, {'value': '709', 'groupId': 'BG001'}, {'value': '1085', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '556', 'groupId': 'BG000'}, {'value': '507', 'groupId': 'BG001'}, {'value': '1063', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1262', 'groupId': 'BG000'}, {'value': '2601', 'groupId': 'BG001'}, {'value': '3863', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '745', 'groupId': 'BG001'}, {'value': '1128', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2616', 'groupId': 'BG000'}, {'value': '4576', 'groupId': 'BG001'}, {'value': '7192', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-26', 'size': 374671, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-12-07T22:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7192}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-04', 'studyFirstSubmitDate': '2018-02-10', 'resultsFirstSubmitDate': '2021-12-07', 'studyFirstSubmitQcDate': '2018-02-17', 'lastUpdatePostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-12-07', 'studyFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High or Medium (Versus Low) Mediterranean Diet Adherence', 'timeFrame': '6 months', 'description': 'Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)'}], 'secondaryOutcomes': [{'measure': 'Hospital Readmissions', 'timeFrame': '30 days', 'description': 'Re-presenting to the hospital for similar presenting diagnosis (for patients)'}, {'measure': 'Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event', 'timeFrame': '6 months', 'description': '(For patients)'}, {'measure': 'Competencies', 'timeFrame': '6 months', 'description': 'Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)'}, {'measure': 'Healthcare Costs', 'timeFrame': '6 months', 'description': 'Direct and indirect (for patients)'}, {'measure': 'Healthcare Costs', 'timeFrame': '6 months', 'description': 'Direct and indirect (for health systems caring for the patients in the trial)'}, {'measure': 'Food Costs', 'timeFrame': '6 months', 'description': 'Grocery and restaurant costs (for patients)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiovascular Diseases', 'Cardiovascular Risk Factor', 'Nutrition Disorders', 'Diabetes', 'Hypertension', 'Cancer', 'Depression', 'Obesity', 'Physical Activity']}, 'referencesModule': {'references': [{'pmid': '26002686', 'type': 'BACKGROUND', 'citation': 'Monlezun DJ, Kasprowicz E, Tosh KW, Nix J, Urday P, Tice D, Sarris L, Harlan TS. Medical school-based teaching kitchen improves HbA1c, blood pressure, and cholesterol for patients with type 2 diabetes: Results from a novel randomized controlled trial. Diabetes Res Clin Pract. 2015 Aug;109(2):420-6. doi: 10.1016/j.diabres.2015.05.007. Epub 2015 May 12.'}, {'pmid': '26435851', 'type': 'BACKGROUND', 'citation': 'Monlezun DJ, Leong B, Joo E, Birkhead AG, Sarris L, Harlan TS. Novel Longitudinal and Propensity Score Matched Analysis of Hands-On Cooking and Nutrition Education versus Traditional Clinical Education among 627 Medical Students. Adv Prev Med. 2015;2015:656780. doi: 10.1155/2015/656780. Epub 2015 Sep 8.'}, {'pmid': '34176552', 'type': 'BACKGROUND', 'citation': 'Monlezun DJ, Carr C, Niu T, Nordio F, DeValle N, Sarris L, Harlan T. Meta-analysis and machine learning-augmented mixed effects cohort analysis of improved diets among 5847 medical trainees, providers and patients. Public Health Nutr. 2022 Feb;25(2):281-289. doi: 10.1017/S1368980021002809. Epub 2021 Jun 28.'}, {'pmid': '32744215', 'type': 'BACKGROUND', 'citation': 'Razavi AC, Sapin A, Monlezun DJ, McCormack IG, Latoff A, Pedroza K, McCullough C, Sarris L, Schlag E, Dyer A, Harlan TS. Effect of culinary education curriculum on Mediterranean diet adherence and food cost savings in families: a randomised controlled trial. Public Health Nutr. 2021 Jun;24(8):2297-2303. doi: 10.1017/S1368980020002256. Epub 2020 Aug 3.'}, {'pmid': '34457749', 'type': 'BACKGROUND', 'citation': 'Patnaik A, Tran J, McWhorter JW, Burks H, Ngo A, Nguyen TD, Mody A, Moore L, Hoelscher DM, Dyer A, Sarris L, Harlan T, Chassay CM, Monlezun D. Regional variations in medical trainee diet and nutrition counseling competencies: Machine learning-augmented propensity score analysis of a prospective multi-site cohort study. Med Sci Educ. 2020 May 20;30(2):911-915. doi: 10.1007/s40670-020-00973-6. eCollection 2020 Jun.'}, {'pmid': '32231488', 'type': 'BACKGROUND', 'citation': 'Razavi AC, Monlezun DJ, Sapin A, Stauber Z, Schradle K, Schlag E, Dyer A, Gagen B, McCormack IG, Akhiwu O, Sarris L, Dotson K, Harlan TS. Multisite Culinary Medicine Curriculum Is Associated With Cardioprotective Dietary Patterns and Lifestyle Medicine Competencies Among Medical Trainees. Am J Lifestyle Med. 2020 Jan 24;14(2):225-233. doi: 10.1177/1559827619901104. eCollection 2020 Mar-Apr.'}, {'pmid': '33281513', 'type': 'BACKGROUND', 'citation': 'Razavi AC, Monlezun DJ, Sapin A, Sarris L, Schlag E, Dyer A, Harlan T. Etiological Role of Diet in 30-Day Readmissions for Heart Failure: Implications for Reducing Heart Failure-Associated Costs via Culinary Medicine. Am J Lifestyle Med. 2019 Jul 14;14(4):351-360. doi: 10.1177/1559827619861933. eCollection 2020 Jul-Aug.'}, {'pmid': '34457464', 'type': 'BACKGROUND', 'citation': 'Wetherill MS, Davis GC, Kezbers K, Carter V, Wells E, Williams MB, Ijams SD, Monlezun D, Harlan T, Whelan LJ. Development and Evaluation of a Nutrition-Centered Lifestyle Medicine Curriculum for Physician Assistant Students. Med Sci Educ. 2018 Dec 6;29(1):163-172. doi: 10.1007/s40670-018-00655-4. eCollection 2019 Mar.'}, {'pmid': '29850526', 'type': 'BACKGROUND', 'citation': 'Monlezun DJ, Dart L, Vanbeber A, Smith-Barbaro P, Costilla V, Samuel C, Terregino CA, Abali EE, Dollinger B, Baumgartner N, Kramer N, Seelochan A, Taher S, Deutchman M, Evans M, Ellis RB, Oyola S, Maker-Clark G, Dreibelbis T, Budnick I, Tran D, DeValle N, Shepard R, Chow E, Petrin C, Razavi A, McGowan C, Grant A, Bird M, Carry C, McGowan G, McCullough C, Berman CM, Dotson K, Niu T, Sarris L, Harlan TS, Co-Investigators OBOTC. Machine Learning-Augmented Propensity Score-Adjusted Multilevel Mixed Effects Panel Analysis of Hands-On Cooking and Nutrition Education versus Traditional Curriculum for Medical Students as Preventive Cardiology: Multisite Cohort Study of 3,248 Trainees over 5 Years. Biomed Res Int. 2018 Apr 15;2018:5051289. doi: 10.1155/2018/5051289. eCollection 2018.'}, {'pmid': '24803593', 'type': 'BACKGROUND', 'citation': 'Kasprowicz E, Monlezun DJ, Harlan TS. Letter by Kasprowicz et al regarding article, "reducing sodium intake to prevent stroke: time for action, not hesitation". Stroke. 2014 Jun;45(6):e108. doi: 10.1161/STROKEAHA.114.005157. Epub 2014 May 6. No abstract available.'}, {'pmid': '24512876', 'type': 'BACKGROUND', 'citation': "Birkhead AG, Foote S, Monlezun DJ, Loyd J, Joo E, Leong B, Sarris L, Harlan TS. Medical student-led community cooking classes: a novel preventive medicine model that's easy to swallow. Am J Prev Med. 2014 Mar;46(3):e41-2. doi: 10.1016/j.amepre.2013.11.006. No abstract available."}], 'seeAlsoLinks': [{'url': 'http://culinarymedicine.org/', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Cooking for Health Optimization with Patients (CHOP) is the first known multi-site prospective cohort study with a nested Bayesian adaptive randomized trial in the preventive cardiology field of culinary medicine. It is also the first known longitudinal study to assess the impact of hands-on cooking and nutrition education on patient outcomes, with those classes taught by medical students and other future and current medical professionals who have first been trained in those classes on how to integrate diet and lifestyle counseling of patients with their respective scopes of clinical practice. CHOP is the primary research study of the world's first known medical school based teaching kitchen, The Goldring Center for Culinary Medicine at Tulane University School of Medicine. Medical trainees and professionals are followed in this study long-term to understand how the classes impact their competencies in patient counseling, attitudes about the counseling, and their own diets. Patients who consent to being randomized to these classes compared to standard of care are studied within the nested Bayesian adaptive randomized trial to understand how the classes impact their health outcomes, clinical and food costs, and the costs of health systems caring for these patient populations. CHOP is designed as a pragmatic population health trial to hopefully improve healthcare effectiveness, equity, and cost by establishing an evidence-based, scalable, sustainable model of healthcare intervention targeting the social determinants of health, while complementing the pharmacological and/or surgical management of patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '115 Years', 'minimumAge': '7 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 7 to 115 years of age (patients), and currently a medical trainee or professional (including for physicians, nurses, physician assistants, and dieticians)\n\nExclusion Criteria:\n\n* Inability to complete at least 2 intervention classes'}, 'identificationModule': {'nctId': 'NCT03443635', 'acronym': 'CHOP', 'briefTitle': 'Cooking for Health Optimization With Patients', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': 'Cooking for Health Optimization With Patients', 'orgStudyIdInfo': {'id': 'CHOP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Subjects receiving hands-on cooking and nutrition education classes', 'interventionNames': ['Behavioral: Treatment']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)'}], 'interventions': [{'name': 'Treatment', 'type': 'BEHAVIORAL', 'description': 'The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70119', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'The Goldring Center for Culinary Medicine at Tulane University School of Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'overallOfficials': [{'name': 'Dominique Monlezun, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Goldring Center for Culinary Medicine at Tulane University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}