Cooking for Health Optimization With Patients

Study Overview
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Brief Summary
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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.

Official Title
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Cooking for Health Optimization With Patients

Conditions
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Cardiovascular Diseases, Cardiovascular Risk Factor, Nutrition Disorders, Diabetes, Hypertension, Cancer, Depression, Obesity, Physical Activity

Intervention / Treatment
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* Behavioral: Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 7 to 115 years of age (patients), and currently a medical trainee or professional (including for physicians, nurses, physician assistants, and dieticians) Exclusion Criteria: Inability to complete at least 2 intervention classes

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 115 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Subjects receiving hands-on cooking and nutrition education classes | Behavioral: Treatment<br>* 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.<br>|
| No Intervention: Control<br>Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High or Medium (Versus Low) Mediterranean Diet Adherence | Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Readmissions | Re-presenting to the hospital for similar presenting diagnosis (for patients) | 30 days | 
| Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event | (For patients) | 6 months | 
| Competencies | Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees) | 6 months | 
| Healthcare Costs | Direct and indirect (for patients) | 6 months | 
| Healthcare Costs | Direct and indirect (for health systems caring for the patients in the trial) | 6 months | 
| Food Costs | Grocery and restaurant costs (for patients) | 6 months |