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The Cooking for Health Optimization and Disease Prevention (CHOP) Trial

ConditionCardiovascular Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-120
SponsorTulane University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 55 years or older

English speaking

Ability to provide informed consent.

Disqualifiers

Medical history of cardiovascular disease (CVD) or cancer.

Food allergies including, but not limited to, milk, eggs, shellfish, nuts, wheat or gluten, and soy.

Special diets including, but not limited to, Mediterranean, veganism, vegetarianism, gluten-free, and the ketogenic diet.

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cooking class

    Behavioral

    3-month community teaching kitchen-based culinary education of MedDiet

  • Standard of care

    Other intervention

    Participants will continue to receive clinical care recommendations from their physicians

Treatment groups

96 Participants
are divided into 2 treatment groups
Group A: Culinary intervention groupActive comparator 1 intervention
Group B: Usual diet control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tulane University

Lead sponsor

Humana Foundation

Collaborator

Source ClinicalTrials.gov
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