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Cooking for Health Optimization With Patients (CHOP)

Primary Purpose

Cardiovascular Diseases, Cardiovascular Risk Factor, Nutrition Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Treatment
Sponsored by
Tulane University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiovascular Diseases

Eligibility Criteria

7 Years - 115 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • The Goldring Center for Culinary Medicine at Tulane University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

Subjects receiving hands-on cooking and nutrition education classes

Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)

Outcomes

Primary Outcome Measures

High or Medium (Versus Low) Mediterranean Diet Adherence
Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)

Secondary Outcome Measures

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

Full Information

First Posted
February 10, 2018
Last Updated
April 4, 2022
Sponsor
Tulane University
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1. Study Identification

Unique Protocol Identification Number
NCT03443635
Brief Title
Cooking for Health Optimization With Patients
Acronym
CHOP
Official Title
Cooking for Health Optimization With Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
December 18, 2020 (Actual)
Study Completion Date
December 18, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tulane University

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Cardiovascular Risk Factor, Nutrition Disorders, Diabetes, Hypertension, Cancer, Depression, Obesity, Physical Activity

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7192 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Subjects receiving hands-on cooking and nutrition education classes
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)
Intervention Type
Behavioral
Intervention Name(s)
Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
High or Medium (Versus Low) Mediterranean Diet Adherence
Description
Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Hospital Readmissions
Description
Re-presenting to the hospital for similar presenting diagnosis (for patients)
Time Frame
30 days
Title
Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event
Description
(For patients)
Time Frame
6 months
Title
Competencies
Description
Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
Time Frame
6 months
Title
Healthcare Costs
Description
Direct and indirect (for patients)
Time Frame
6 months
Title
Healthcare Costs
Description
Direct and indirect (for health systems caring for the patients in the trial)
Time Frame
6 months
Title
Food Costs
Description
Grocery and restaurant costs (for patients)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
115 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique Monlezun, MD, PhD, MPH
Organizational Affiliation
The Goldring Center for Culinary Medicine at Tulane University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Goldring Center for Culinary Medicine at Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26002686
Citation
Monlezun DJ, Kasprowicz E, Tosh KW, Nix J, Urday P, Tice D, Sarris L, Harlan TS. Medical school-based teaching kitchen improves HbA1c, blood pressure, and cholesterol for patients with type 2 diabetes: Results from a novel randomized controlled trial. Diabetes Res Clin Pract. 2015 Aug;109(2):420-6. doi: 10.1016/j.diabres.2015.05.007. Epub 2015 May 12.
Results Reference
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PubMed Identifier
26435851
Citation
Monlezun DJ, Leong B, Joo E, Birkhead AG, Sarris L, Harlan TS. Novel Longitudinal and Propensity Score Matched Analysis of Hands-On Cooking and Nutrition Education versus Traditional Clinical Education among 627 Medical Students. Adv Prev Med. 2015;2015:656780. doi: 10.1155/2015/656780. Epub 2015 Sep 8.
Results Reference
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PubMed Identifier
34176552
Citation
Monlezun DJ, Carr C, Niu T, Nordio F, DeValle N, Sarris L, Harlan T. Meta-analysis and machine learning-augmented mixed effects cohort analysis of improved diets among 5847 medical trainees, providers and patients. Public Health Nutr. 2022 Feb;25(2):281-289. doi: 10.1017/S1368980021002809. Epub 2021 Jun 28.
Results Reference
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PubMed Identifier
32744215
Citation
Razavi AC, Sapin A, Monlezun DJ, McCormack IG, Latoff A, Pedroza K, McCullough C, Sarris L, Schlag E, Dyer A, Harlan TS. Effect of culinary education curriculum on Mediterranean diet adherence and food cost savings in families: a randomised controlled trial. Public Health Nutr. 2021 Jun;24(8):2297-2303. doi: 10.1017/S1368980020002256. Epub 2020 Aug 3.
Results Reference
background
PubMed Identifier
34457749
Citation
Patnaik A, Tran J, McWhorter JW, Burks H, Ngo A, Nguyen TD, Mody A, Moore L, Hoelscher DM, Dyer A, Sarris L, Harlan T, Chassay CM, Monlezun D. Regional variations in medical trainee diet and nutrition counseling competencies: Machine learning-augmented propensity score analysis of a prospective multi-site cohort study. Med Sci Educ. 2020 May 20;30(2):911-915. doi: 10.1007/s40670-020-00973-6. eCollection 2020 Jun.
Results Reference
background
PubMed Identifier
32231488
Citation
Razavi AC, Monlezun DJ, Sapin A, Stauber Z, Schradle K, Schlag E, Dyer A, Gagen B, McCormack IG, Akhiwu O, Sarris L, Dotson K, Harlan TS. Multisite Culinary Medicine Curriculum Is Associated With Cardioprotective Dietary Patterns and Lifestyle Medicine Competencies Among Medical Trainees. Am J Lifestyle Med. 2020 Jan 24;14(2):225-233. doi: 10.1177/1559827619901104. eCollection 2020 Mar-Apr. Erratum In: Am J Lifestyle Med. 2020 Mar 11;14(2):234.
Results Reference
background
PubMed Identifier
33281513
Citation
Razavi AC, Monlezun DJ, Sapin A, Sarris L, Schlag E, Dyer A, Harlan T. Etiological Role of Diet in 30-Day Readmissions for Heart Failure: Implications for Reducing Heart Failure-Associated Costs via Culinary Medicine. Am J Lifestyle Med. 2019 Jul 14;14(4):351-360. doi: 10.1177/1559827619861933. eCollection 2020 Jul-Aug.
Results Reference
background
PubMed Identifier
34457464
Citation
Wetherill MS, Davis GC, Kezbers K, Carter V, Wells E, Williams MB, Ijams SD, Monlezun D, Harlan T, Whelan LJ. Development and Evaluation of a Nutrition-Centered Lifestyle Medicine Curriculum for Physician Assistant Students. Med Sci Educ. 2018 Dec 6;29(1):163-172. doi: 10.1007/s40670-018-00655-4. eCollection 2019 Mar.
Results Reference
background
PubMed Identifier
29850526
Citation
Monlezun DJ, Dart L, Vanbeber A, Smith-Barbaro P, Costilla V, Samuel C, Terregino CA, Abali EE, Dollinger B, Baumgartner N, Kramer N, Seelochan A, Taher S, Deutchman M, Evans M, Ellis RB, Oyola S, Maker-Clark G, Dreibelbis T, Budnick I, Tran D, DeValle N, Shepard R, Chow E, Petrin C, Razavi A, McGowan C, Grant A, Bird M, Carry C, McGowan G, McCullough C, Berman CM, Dotson K, Niu T, Sarris L, Harlan TS, Co-Investigators OBOTC. Machine Learning-Augmented Propensity Score-Adjusted Multilevel Mixed Effects Panel Analysis of Hands-On Cooking and Nutrition Education versus Traditional Curriculum for Medical Students as Preventive Cardiology: Multisite Cohort Study of 3,248 Trainees over 5 Years. Biomed Res Int. 2018 Apr 15;2018:5051289. doi: 10.1155/2018/5051289. eCollection 2018.
Results Reference
background
PubMed Identifier
24803593
Citation
Kasprowicz E, Monlezun DJ, Harlan TS. Letter by Kasprowicz et al regarding article, "reducing sodium intake to prevent stroke: time for action, not hesitation". Stroke. 2014 Jun;45(6):e108. doi: 10.1161/STROKEAHA.114.005157. Epub 2014 May 6. No abstract available.
Results Reference
background
PubMed Identifier
24512876
Citation
Birkhead AG, Foote S, Monlezun DJ, Loyd J, Joo E, Leong B, Sarris L, Harlan TS. Medical student-led community cooking classes: a novel preventive medicine model that's easy to swallow. Am J Prev Med. 2014 Mar;46(3):e41-2. doi: 10.1016/j.amepre.2013.11.006. No abstract available.
Results Reference
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Links:
URL
http://culinarymedicine.org/
Description
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