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Cooking for Health Optimization With Patients (CHOP)

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ClinicalTrials.gov Identifier: NCT03443635
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
Dominique J Monlezun, Tulane University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Cardiovascular Risk Factor Nutrition Disorders Diabetes Hypertension Cancer Depression Obesity Physical Activity Behavioral: Treatment Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cooking for Health Optimization With Patients
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : February 1, 2028
Estimated Study Completion Date : February 1, 2028
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Subjects receiving hands-on cooking and nutrition education classes
 Behavioral: 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.
No Intervention: Control
Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)


Outcome Measures
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Primary Outcome Measures :
  1. Mediterranean diet adherence [ Time Frame: 6 months ]
    9-point scale (for patients and medical trainees)


Secondary Outcome Measures :
  1. Hospital readmissions [ Time Frame: 30 days ]
    Re-presenting to the hospital for similar presenting diagnosis (for patients)

  2. Composite rate of all cause-mortality, myocardial infarction, and cerebrovascular event [ Time Frame: 6 months ]
    (For patients)

  3. Competencies [ Time Frame: 6 months ]
    Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)

  4. Healthcare costs [ Time Frame: 6 months ]
    Direct and indirect (for patients)

  5. Healthcare costs [ Time Frame: 6 months ]
    Direct and indirect (for health systems caring for the patients in the trial)

  6. Food costs [ Time Frame: 6 months ]
    Grocery and restaurant costs (for patients)


Eligibility Criteria
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Ages Eligible for Study:   7 Years to 115 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443635


Contacts
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Contact: Dominique Monlezun, MD, PhD, MPH (504) 988-9108 dmonlezu@tulane.edu

Locations
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United States, Louisiana
The Goldring Center for Culinary Medicine at Tulane University School of Medicine Recruiting
New Orleans, Louisiana, United States, 70119
Contact: Leah Sarris, RD, LDN    504-988-9108    dmonlezu@tulane.edu   
Sponsors and Collaborators
Tulane University
Investigators
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Principal Investigator: Dominique Monlezun, MD, PhD, MPH The Goldring Center for Culinary Medicine at Tulane University School of Medicine
More Information
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Additional Information:

Publications:

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Responsible Party: Dominique J Monlezun, Principal Investigator, Senior Data Scientist & Biostatistician (Goldring Center for Culinary Medicine), Tulane University
ClinicalTrials.gov Identifier: NCT03443635    
Other Study ID Numbers: CHOP
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: December 3, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Nutrition Disorders