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Completed

NCT Number: NCT03443635

Cooking for Health Optimization With Patients

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.

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Key information

Age range

7 year–115 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

New Orleans, Louisiana, 70119, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. High or Medium (Versus Low) Mediterranean Diet Adherence

    Time frame: 6 months

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Acronym: CHOP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 23, 2018
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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