Cancer, Cardiovascular Diseases, Cardiovascular Risk Factor, Depression, Diabetes, Hypertension, Nutrition Disorders, Obesity, Physical Activity
Conditions
Brief summary
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.
Interventions
BEHAVIORALTreatment
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.
Sponsors
Tulane University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 115 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High or Medium (Versus Low) Mediterranean Diet Adherence | 6 months | Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Readmissions | 30 days | Re-presenting to the hospital for similar presenting diagnosis (for patients) |
| Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event | 6 months | (For patients) |
| Competencies | 6 months | Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees) |
| Healthcare Costs | 6 months | Direct and indirect (for patients) |
| Food Costs | 6 months | Grocery and restaurant costs (for patients) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Subjects receiving hands-on cooking and nutrition education classes
Treatment: 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. | 2,616 |
| Control Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients) | 4,576 |
| Total | 7,192 |
Baseline characteristics
| Characteristic | Control | Total | Treatment |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1005 Participants | 1751 Participants | 746 Participants |
| Age, Categorical Between 18 and 65 years | 3571 Participants | 5441 Participants | 1870 Participants |
| Age, Continuous | 28.16 years STANDARD_DEVIATION 8.48 | 29.49 years STANDARD_DEVIATION 10.3 | 32.02 years STANDARD_DEVIATION 12.69 |
| Race (NIH/OMB) American Indian or Alaska Native | 14 Participants | 53 Participants | 39 Participants |
| Race (NIH/OMB) Asian | 709 Participants | 1085 Participants | 376 Participants |
| Race (NIH/OMB) Black or African American | 507 Participants | 1063 Participants | 556 Participants |
| Race (NIH/OMB) More than one race | 745 Participants | 1128 Participants | 383 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 2601 Participants | 3863 Participants | 1262 Participants |
| Region of Enrollment United States | 4576 participants | 7192 participants | 2616 participants |
| Sex: Female, Male Female | 2725 Participants | 4425 Participants | 1700 Participants |
| Sex: Female, Male Male | 1851 Participants | 2767 Participants | 916 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2,616 | 0 / 4,576 |
| other Total, other adverse events | 0 / 2,616 | 0 / 4,576 |
| serious Total, serious adverse events | 0 / 2,616 | 0 / 4,576 |
Outcome results
Primary
High or Medium (Versus Low) Mediterranean Diet Adherence
Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment | High or Medium (Versus Low) Mediterranean Diet Adherence | 55.99 percentage of arm |
| Control | High or Medium (Versus Low) Mediterranean Diet Adherence | 50.53 percentage of arm |
Secondary
Competencies
Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
Time frame: 6 months
Secondary
Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event
(For patients)
Time frame: 6 months
Secondary
Food Costs
Grocery and restaurant costs (for patients)
Time frame: 6 months
Secondary
Healthcare Costs
Direct and indirect (for patients)
Time frame: 6 months
Secondary
Healthcare Costs
Direct and indirect (for health systems caring for the patients in the trial)
Time frame: 6 months
Secondary
Hospital Readmissions
Re-presenting to the hospital for similar presenting diagnosis (for patients)
Time frame: 30 days