Cooking for Health Optimization With Patients

NCT03443635 | Completed Phase 1 Results

• 1 other identifier: CHOP
• Study Type: interventional
• Target: 7,192
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiovascular Diseases; Cardiovascular Risk Factor; Nutrition Disorders; Diabetes; Hypertension; Cancer; Depression; Obesity; Physical Activity

Outcome Measures

Primary Outcomes (1)

• High or Medium (Versus Low) Mediterranean Diet Adherence

  Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)

  6 months

Secondary Outcomes (6)

• Hospital Readmissions

  30 days

• Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event

  6 months

• Competencies

  6 months

• Healthcare Costs

  6 months

• Healthcare Costs

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Subjects receiving hands-on cooking and nutrition education classes

Behavioral: Treatment

Control

NO INTERVENTION

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

Interventions

Treatment BEHAVIORAL

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.

Treatment

Eligibility Criteria

• Age: 7 Years - 115 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• to 115 years of age (patients), and currently a medical trainee or professional (including for physicians, nurses, physician assistants, and dieticians)

You may not qualify if:

• Inability to complete at least 2 intervention classes

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

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

New Orleans, Louisiana, 70119, United States

Location

Related Publications (11)

• 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.

  PMID: 26002686 BACKGROUND

• 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.

  PMID: 26435851 BACKGROUND

• 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.

  PMID: 34176552 BACKGROUND

• 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.

  PMID: 32744215 BACKGROUND

• 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.

  PMID: 34457749 BACKGROUND

• 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.

  PMID: 32231488 BACKGROUND

• 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.

  PMID: 33281513 BACKGROUND

• 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.

  PMID: 34457464 BACKGROUND

• 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.

  PMID: 29850526 BACKGROUND

• 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.

  PMID: 24803593 BACKGROUND

• 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.

  PMID: 24512876 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Cardiovascular Diseases; Nutrition Disorders; Diabetes Mellitus; Hypertension; Neoplasms; Depression; Obesity; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Behavioral Symptoms; Behavior; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Principal Investigator
• Organization: Tulane University Goldring Center for Culinary Medicine

dominique.monlezun@gmail.com

3373290724

Study Officials

• Dominique Monlezun, MD, PhD, MPH

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2018
• First Posted: February 23, 2018
• Study Start: February 1, 2018
• Primary Completion: December 18, 2020
• Study Completion: December 18, 2020
• Last Updated: April 29, 2022
• Results First Posted: February 25, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)