Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cooking for Health Optimization With Patients (CHOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 10, 2018
First Posted Date  ICMJE February 23, 2018
Last Update Posted Date December 3, 2018
Actual Study Start Date  ICMJE February 1, 2018
Estimated Primary Completion Date February 1, 2028   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2018)
Mediterranean diet adherence [ Time Frame: 6 months ]
9-point scale (for patients and medical trainees)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2018)
  • Hospital readmissions [ Time Frame: 30 days ]
    Re-presenting to the hospital for similar presenting diagnosis (for patients)
  • Composite rate of all cause-mortality, myocardial infarction, and cerebrovascular event [ Time Frame: 6 months ]
    (For patients)
  • Competencies [ Time Frame: 6 months ]
    Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
  • Healthcare costs [ Time Frame: 6 months ]
    Direct and indirect (for patients)
  • Healthcare costs [ Time Frame: 6 months ]
    Direct and indirect (for health systems caring for the patients in the trial)
  • Food costs [ Time Frame: 6 months ]
    Grocery and restaurant costs (for patients)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cooking for Health Optimization With Patients
Official Title  ICMJE Cooking for Health Optimization With Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiovascular Diseases
  • Cardiovascular Risk Factor
  • Nutrition Disorders
  • Diabetes
  • Hypertension
  • Cancer
  • Depression
  • Obesity
  • Physical Activity
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Treatment
    Subjects receiving hands-on cooking and nutrition education classes
    Intervention: Behavioral: Treatment
  • No Intervention: Control
    Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 17, 2018)
19500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2028
Estimated Primary Completion Date February 1, 2028   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 115 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Dominique Monlezun, MD, PhD, MPH (504) 988-9108 dmonlezu@tulane.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03443635
Other Study ID Numbers  ICMJE CHOP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dominique J Monlezun, Tulane University
Study Sponsor  ICMJE Tulane University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dominique Monlezun, MD, PhD, MPH The Goldring Center for Culinary Medicine at Tulane University School of Medicine
PRS Account Tulane University
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP