A Phase 1/2 interventional study of Treatment in Cardiovascular Diseases, Cardiovascular Risk Factor and Nutrition Disorders, sponsored by Tulane University. Completed at 1 site in United States. Open to participants aged 7 Years to 115 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Tulane University · Phase 1/2, Interventional, and Treatment
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.
Exclusion Criteria:
Subjects receiving hands-on cooking and nutrition education classes
Behavioral: Treatment
Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)
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.
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
Hospital Readmissions
Re-presenting to the hospital for similar presenting diagnosis (for patients)
Time frame: 30 days
Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event
(For patients)
Time frame: 6 months
Competencies
Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
Time frame: 6 months
Healthcare Costs
Direct and indirect (for patients)
Time frame: 6 months
Healthcare Costs
Direct and indirect (for health systems caring for the patients in the trial)
Time frame: 6 months
Food Costs
Grocery and restaurant costs (for patients)
Time frame: 6 months
| Milestone | Treatment | Control |
|---|---|---|
| Started | 2616 | 4576 |
| Completed | 2127 | 3720 |
| Not completed | 489 | 856 |
Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)
| percentage of arm | Treatment | Control |
|---|---|---|
| High or Medium (Versus Low) Mediterranean Diet Adherence | 55.99 | 50.53 |
Re-presenting to the hospital for similar presenting diagnosis (for patients)
Results for this outcome have not been posted.
(For patients)
Results for this outcome have not been posted.
Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
Results for this outcome have not been posted.
Direct and indirect (for patients)
Results for this outcome have not been posted.
Direct and indirect (for health systems caring for the patients in the trial)
Results for this outcome have not been posted.
Grocery and restaurant costs (for patients)
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/2,616 (0%) | 0/2,616 (0%) | 0/2,616 (0%) |
| Control | 0/4,576 (0%) | 0/4,576 (0%) | 0/4,576 (0%) |
| Age, Categorical(Participants) | Treatment | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1870 | 3571 | 5441 |
| >=65 years | 746 | 1005 | 1751 |
| Age, Continuous(years) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 32.02 ± 12.69 | 28.16 ± 8.48 | 29.49 ± 10.30 |
| Sex: Female, Male(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Female | 1700 | 2725 | 4425 |
| Male | 916 | 1851 | 2767 |
| Race (NIH/OMB)(Participants) | Treatment | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 39 | 14 | 53 |
| Asian | 376 | 709 | 1085 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 556 | 507 | 1063 |
| White | 1262 | 2601 | 3863 |
| More than one race | 383 | 745 | 1128 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment | Control | Total |
|---|---|---|---|
| United States | 2616 | 4576 | 7192 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get 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