Cooking for Health Optimization With Patients

Phase 1

Completed

• Conditions: Cardiovascular Risk Factor; Depression; Physical Activity; Hypertension; Nutrition Disorders; Cardiovascular Diseases; Diabetes; Cancer; Obesity
• Interventions: Behavioral: Treatment

• Registration Number: NCT03443635
• Lead Sponsor: Tulane University

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 available

Study Timeline

• Study Start: 2018-02-01
• Study First Submitted: 2018-02-10
• Study First Submitted QC: 2018-02-17
• Study First Posted: 2018-02-23
• Primary Completion: 2020-12-18
• Study Completion: 2020-12-18
• Results First Submitted: 2021-12-07
• Results First Submitted QC: 2021-12-07
• Results First Posted: 2022-02-25
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7192

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Treatment	Subjects receiving hands-on cooking and nutrition education classes

Primary Outcome Measures

Name	Time	Method
High or Medium (Versus Low) Mediterranean Diet Adherence	6 months	Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)

Secondary Outcome Measures

Name	Time	Method
Hospital Readmissions	30 days	Re-presenting to the hospital for similar presenting diagnosis (for patients)
Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event	6 months	(For patients)
Competencies	6 months	Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
Healthcare Costs	6 months	Direct and indirect (for health systems caring for the patients in the trial)
Food Costs	6 months	Grocery and restaurant costs (for patients)

Trial Locations

Locations (1)

The Goldring Center for Culinary Medicine at Tulane University School of Medicine; 🇺🇸 New Orleans, Louisiana, United States