An interventional study of Cooking class and Standard of care in Cardiovascular Diseases, sponsored by Tulane University. Recruiting at 2 sites in United States. Open to participants aged 55 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by Tulane University · Not applicable, Interventional, and Prevention
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.
The study is designed as a two-arm parallel-group randomized controlled trial (RCT). The interventions in the two groups are described as below:
i) Culinary intervention group (n=48): The interventions include the teaching-kitchen based structured, hands-on culinary education classes.
ii) 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).
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's planned enrollment of 96 is close to the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Tulane University is the lead sponsor of 98 studies on the registry; 30 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The interventions include the teaching-kitchen based structured, hands-on culinary education classes.
Behavioral: Cooking class
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).
Other: Standard of care
3-month community teaching kitchen-based culinary education of MedDiet
Participants will continue to receive clinical care recommendations from their physicians
Change in blood pressure measurements
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.
Time frame: Baseline, 3 months
Change in blood glucose measurements
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.
Time frame: Baseline, 3 months
Change in blood lipid profile measurements
The investigators will measure the change in blood lipid profile. The blood lipid profile will be measured at baseline and at 3 months visit.
Time frame: Baseline, 3 months
Change in cognitive function measured using the Montreal Cognitive Assessment (MoCA)
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: 0-9: Severe cognitive impairment 10-17: Moderate cognitive impairment 18-25: Mild cognitive impairment 26-30: Normal cognitive function This will be measured at baseline visit and at 3 months visit.
Time frame: Baseline, 3 months
Depression severity assessment using the PHQ-9 (Patient Health Questionnaire)
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. 0-4 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. This will be measured at baseline visit and at 3 months visit.
Time frame: Baseline, 3 months
Loneliness severity assessment using the UCLA Loneliness Scale Version 3 (UCLA-LS)
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. Low Loneliness: Total score \< 28. Moderate Loneliness: Total score 28-43. High Loneliness: Total score \> 43. This will be measured at baseline visit and at 3 months visit.
Time frame: Baseline, 3 months
Social Anxiety Disorder assessment using the Severity Measure for Social Anxiety Disorder (Social Phobia Scale for Adults) questionnaire
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. Total Score Range: 0-40. Interpretation: Higher scores correlate with more severe social phobia symptoms. Cut-off Score: 24 or above may indicate a presence of non-generalized social phobia. This will be measured at baseline visit and at 3 months visit.
Time frame: Baseline, 3 months
Mediterranean eating pattern assessment using the Mediterranean Diet Adherence Screener (MEDAS) questionnaire
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. 0-4 points: Generally considered low adherence. 5-9 points: Considered moderate to fair adherence. 10-14 points: Indicates good or very good adherence. This will be measured at baseline visit and at 3 months visit.
Time frame: Baseline, 3 months
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tulane University