Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT07011459
Status:
RECRUITING
Last Update Posted:
2025-09-11
First Post:
2025-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Cooking for Health Optimization and Disease Prevention (CHOP) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 96}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-10', 'studyFirstSubmitDate': '2025-05-16', 'studyFirstSubmitQcDate': '2025-05-30', 'lastUpdatePostDateStruct': {'date': '2025-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood pressure measurements', 'timeFrame': 'Baseline, 3 months', 'description': 'The investigators will measure the change in blood pressure from baseline visit 1 to visit 3. The average of 3 blood pressure readings will be taken. They will be measured at baseline visit and at 3 months visit.'}, {'measure': 'Change in blood glucose measurements', 'timeFrame': 'Baseline, 3 months', 'description': 'The investigators will measure the change in blood glucose. The fasting blood glucose will be measured at baseline and at 3 months visit. A continuous glucose monitoring (CGM) device will be used as well to measure the change in blood glucose.'}, {'measure': 'Change in blood lipid profile measurements', 'timeFrame': 'Baseline, 3 months', 'description': 'The investigators will measure the change in blood lipid profile. The blood lipid profile will be measured at baseline and at 3 months visit.'}], 'secondaryOutcomes': [{'measure': 'Change in cognitive function measured using the Montreal Cognitive Assessment (MoCA)', 'timeFrame': 'Baseline, 3 months', 'description': 'The investigators will measure the change in cognitive function using the Montreal Cognitive Assessment. It is a screening tool used to assess cognitive function. A higher score indicates less severe cognitive impairment. The grading scale for the MoCA is as follows:\n\n0-9: Severe cognitive impairment 10-17: Moderate cognitive impairment 18-25: Mild cognitive impairment 26-30: Normal cognitive function\n\nThis will be measured at baseline visit and at 3 months visit.'}, {'measure': 'Depression severity assessment using the PHQ-9 (Patient Health Questionnaire)', 'timeFrame': 'Baseline, 3 months', 'description': 'The investigators will assess the depression severity using the PHQ-9 (Patient Health Questionnaire) It is a self-reporting scoring system which assigns points to each question based on the frequency of reported symptoms, with a total score ranging from 0 to 27. The total score can then be used to determine the possible level of depression severity. The higher the score, the more severe depression level will be.\n\n0-4 points: None to minimal depression. 5-9 points: Mild depression. 10-14 points: Moderate depression. 15-19 points: Moderately severe depression. 20-27 points: Severe depression.\n\nThis will be measured at baseline visit and at 3 months visit.'}, {'measure': 'Loneliness severity assessment using the UCLA Loneliness Scale Version 3 (UCLA-LS)', 'timeFrame': 'Baseline, 3 months', 'description': "The investigators will assess the loneliness severity using the UCLA Loneliness Scale Version 3 (UCLA-LS). It is a self-reporting questionnaire used to measure an individual's feelings of loneliness. It's scored by combining the total of responses to 20 questions, where higher scores generally indicate greater feelings of loneliness. The interpretation of scores often uses a categorization based on the total score, with scores above 43 generally indicating a high degree of loneliness.\n\nLow Loneliness: Total score \\< 28. Moderate Loneliness: Total score 28-43. High Loneliness: Total score \\> 43.\n\nThis will be measured at baseline visit and at 3 months visit."}, {'measure': 'Social Anxiety Disorder assessment using the Severity Measure for Social Anxiety Disorder (Social Phobia Scale for Adults) questionnaire', 'timeFrame': 'Baseline, 3 months', 'description': 'The investigators will assess Social Anxiety Disorder using the Severity Measure for Social Anxiety Disorder (Social Phobia Scale for Adults). It is a 10-item questionnaire, used to assess social anxiety (social phobia) in adults.\n\nTotal Score Range: 0-40. Interpretation: Higher scores correlate with more severe social phobia symptoms.\n\nCut-off Score: 24 or above may indicate a presence of non-generalized social phobia.\n\nThis will be measured at baseline visit and at 3 months visit.'}, {'measure': 'Mediterranean eating pattern assessment using the Mediterranean Diet Adherence Screener (MEDAS) questionnaire', 'timeFrame': 'Baseline, 3 months', 'description': "The investigators will assess the Mediterranean eating pattern using the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. It is used to assess how someone's diet aligns with a traditional Mediterranean eating pattern. A higher score means better adherence.\n\n0-4 points: Generally considered low adherence. 5-9 points: Considered moderate to fair adherence. 10-14 points: Indicates good or very good adherence.\n\nThis will be measured at baseline visit and at 3 months visit."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Culinary', 'Cardiometabolic health', 'Mental health', 'Mediterranean Diet', 'Nutrition'], 'conditions': ['Cardiovascular Diseases']}, 'descriptionModule': {'briefSummary': "Poor nutrition-related diseases disproportionately impact seniors and racial/ethnic minorities who are more likely to experience disparities in proper nutrition. Culinary medicine is a new evidence-based educational approach that blends the art of food and cooking with the science of medicine. Recently, culinary medicine is proposed by the 2020-2030 Strategic Plan for NIH Nutrition Research and national 'Food is Medicine (FIM)' Movement as potential solutions for improving healthy eating, creating social and emotional connections, and nutrition-related health equity. Built upon the well-established community teaching kitchen at The Goldring Center for Culinary Medicine (GCCM) at Tulane University and nearly 10 years of experience in delivering culinary education of Mediterranean diet (MedDiet), the investigators will conduct a randomized controlled trial (RCT) to test the feasibility and effectiveness of 3-month community teaching kitchen-based culinary education of MedDiet on improving cardiometabolic and mental health among racially and ethnically diverse seniors.", 'detailedDescription': 'The study is designed as a two-arm parallel-group randomized controlled trial (RCT). The interventions in the two groups are described as below:\n\ni) Culinary intervention group (n=48): The interventions include the teaching-kitchen based structured, hands-on culinary education classes.\n\nii) Usual diet control group (n=48): Participants randomized to the usual diet group will not receive culinary education classes, while they will continue to receive clinical care recommendations from their physician(s).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 55 years or older\n* English speaking\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Medical history of cardiovascular disease (CVD) or cancer.\n* Food allergies including, but not limited to, milk, eggs, shellfish, nuts, wheat or gluten, and soy.\n* Special diets including, but not limited to, Mediterranean, veganism, vegetarianism, gluten-free, and the ketogenic diet.\n* Current use of medications that could affect blood glucose and lipids levels including, but not limited to, insulins (Humalog, Novolog, insulin detemir, etc.), anti-diabetic medications (metformin, sulfonylureas, meglitinides, etc.), Ozempic. HAART, and beta blockers.\n* No children are involved.\n* No other vulnerable subjects will be involved.'}, 'identificationModule': {'nctId': 'NCT07011459', 'briefTitle': 'The Cooking for Health Optimization and Disease Prevention (CHOP) Trial', 'organization': {'class': 'OTHER', 'fullName': 'Tulane University'}, 'officialTitle': "Community Teaching Kitchen-based Culinary Education as a 'Food is Medicine' Solution for Improving Health Equity Among Racially/Ethnically Diverse Seniors", 'orgStudyIdInfo': {'id': '2024-1940'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Culinary intervention group', 'description': 'The interventions include the teaching-kitchen based structured, hands-on culinary education classes.', 'interventionNames': ['Behavioral: Cooking class']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Usual diet control group', 'description': 'Participants randomized to the usual diet group will not receive culinary education classes, while they will continue to receive clinical care recommendations from their physician(s).', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Cooking class', 'type': 'BEHAVIORAL', 'description': '3-month community teaching kitchen-based culinary education of MedDiet', 'armGroupLabels': ['Culinary intervention group']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Participants will continue to receive clinical care recommendations from their physicians', 'armGroupLabels': ['Usual diet control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Heather Nace', 'role': 'CONTACT', 'email': 'hnace@tulane.edu', 'phone': '504-988-9108'}, {'name': 'Vivian Fonseca, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Goldring Center for Culinary Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Cristina Miller, MPH', 'role': 'CONTACT', 'email': 'cmiller17@tulane.edu', 'phone': '504-988-2166'}, {'name': 'Marquita Canatella, RN', 'role': 'CONTACT', 'email': 'mcanatella@tulane.edu', 'phone': '504-988-1809'}, {'name': 'Lu Qi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tulane Weatherhead School of Public Health and Tropical Medicine', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}], 'centralContacts': [{'name': 'Cristina Miller, MPH', 'role': 'CONTACT', 'email': 'cmiller17@tulane.edu', 'phone': '504-988-2166'}, {'name': 'Marquita Canatella, RN', 'role': 'CONTACT', 'email': 'mcanatella@tulane.edu', 'phone': '504-988-1809'}], 'overallOfficials': [{'name': 'Lu Qi, PhD, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tulane University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tulane University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Humana Foundation', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}