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Cardiovascular DiseasesPhase 1/2CHOPNCT03443635

Cooking for Health Optimization With Patients

A Phase 1/2 study testing Treatment in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Tulane University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 7 to 115 yearsHealthy volunteers can take part
What is being tested?
Treatment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,192 participants
Where
1 siteUnited States
Study dates
1 Feb 2018to 18 Dec 2020
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 to 115 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Inability to complete at least 2 intervention classes

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    New Orleans, Louisiana, 70119

Other trials in United States

About this study

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.

Being tested
Treatment
Medical subject headings
Cardiovascular Diseases, Nutrition Disorders, Diabetes Mellitus, Hypertension, Neoplasms, Depression, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TreatmentBehavioural

    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 groups in NCT03443635
Study groupRoleWhat they receive
TreatmentExperimentalSubjects receiving hands-on cooking and nutrition education classes
Receives: Behavioral: Treatment
ControlNo interventionSubjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 6 months

Secondary outcomes (6)

  1. Hospital Readmissions

    Re-presenting to the hospital for similar presenting diagnosis (for patients)

    Measured: 30 days

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

    (For patients)

    Measured: 6 months

  3. Competencies

    Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)

    Measured: 6 months

  4. Healthcare Costs

    Direct and indirect (for patients)

    Measured: 6 months

  5. Healthcare Costs

    Direct and indirect (for health systems caring for the patients in the trial)

    Measured: 6 months

  6. Food Costs

    Grocery and restaurant costs (for patients)

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2018
  2. Study start1 Feb 2018
  3. Primary completion18 Dec 2020
  4. Study completion18 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7,192 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03443635
Sponsor's protocol ID
CHOP
Acronym
CHOP
Status last verified
Apr 2022
First submitted
10 Feb 2018
Last updated
29 Apr 2022
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 26002686

  • 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.

    PubMed 26435851

  • 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.

    PubMed 34176552

  • 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.

    PubMed 32744215

  • 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.

    PubMed 34457749

  • 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.

    PubMed 32231488

  • 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.

    PubMed 33281513

  • 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.

    PubMed 34457464

  • 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.

    PubMed 29850526

  • 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.

    PubMed 24803593

  • 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.

    PubMed 24512876

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Treatment in people with Cardiovascular Diseases and Cardiovascular Risk Factor, run by Tulane University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

High or Medium (Versus Low) Mediterranean Diet Adherence (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03443635, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2022.

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Cooking for Health Optimization With Patients | AzTrials