The Cooking for Health Optimization and Disease Prevention (CHOP) Trial

NCT07011459 | Recruiting

• 1 other identifier: 2024-1940
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 2

Brief Summary

Poor nutrition-related diseases disproportionately impact seniors and racial/ethnic minorities who are more likely to experience disparities in proper nutrition. Culinary medicine is a new evidence-based educational approach that blends the art of food and cooking with the science of medicine. Recently, culinary medicine is proposed by the 2020-2030 Strategic Plan for NIH Nutrition Research and national 'Food is Medicine (FIM)' Movement as potential solutions for improving healthy eating, creating social and emotional connections, and nutrition-related health equity. Built upon the well-established community teaching kitchen at The Goldring Center for Culinary Medicine (GCCM) at Tulane University and nearly 10 years of experience in delivering culinary education of Mediterranean diet (MedDiet), the investigators will conduct a randomized controlled trial (RCT) to test the feasibility and effectiveness of 3-month community teaching kitchen-based culinary education of MedDiet on improving cardiometabolic and mental health among racially and ethnically diverse seniors.

Conditions

Cardiovascular Diseases

Keywords

Culinary; Cardiometabolic health; Mental health; Mediterranean Diet; Nutrition

Outcome Measures

Primary Outcomes (3)

• Change in blood pressure measurements

  The investigators will measure the change in blood pressure from baseline visit 1 to visit 3. The average of 3 blood pressure readings will be taken. They will be measured at baseline visit and at 3 months visit.

  Baseline, 3 months

• Change in blood glucose measurements

  The investigators will measure the change in blood glucose. The fasting blood glucose will be measured at baseline and at 3 months visit. A continuous glucose monitoring (CGM) device will be used as well to measure the change in blood glucose.

  Baseline, 3 months

• Change in blood lipid profile measurements

  The investigators will measure the change in blood lipid profile. The blood lipid profile will be measured at baseline and at 3 months visit.

  Baseline, 3 months

Secondary Outcomes (5)

• Change in cognitive function measured using the Montreal Cognitive Assessment (MoCA)

  Baseline, 3 months

• Depression severity assessment using the PHQ-9 (Patient Health Questionnaire)

  Baseline, 3 months

• Loneliness severity assessment using the UCLA Loneliness Scale Version 3 (UCLA-LS)

  Baseline, 3 months

• Social Anxiety Disorder assessment using the Severity Measure for Social Anxiety Disorder (Social Phobia Scale for Adults) questionnaire

  Baseline, 3 months

• Mediterranean eating pattern assessment using the Mediterranean Diet Adherence Screener (MEDAS) questionnaire

  Baseline, 3 months

Study Arms (2)

Culinary intervention group

ACTIVE COMPARATOR

The interventions include the teaching-kitchen based structured, hands-on culinary education classes.

Behavioral: Cooking class

Usual diet control group

PLACEBO COMPARATOR

Participants randomized to the usual diet group will not receive culinary education classes, while they will continue to receive clinical care recommendations from their physician(s).

Other: Standard of care

Interventions

Cooking class BEHAVIORAL

3-month community teaching kitchen-based culinary education of MedDiet

Culinary intervention group

Standard of care OTHER

Participants will continue to receive clinical care recommendations from their physicians

Usual diet control group

Eligibility Criteria

• Age: 55 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 55 years or older
• English speaking
• Ability to provide informed consent.

You may not qualify if:

• Medical history of cardiovascular disease (CVD) or cancer.
• Food allergies including, but not limited to, milk, eggs, shellfish, nuts, wheat or gluten, and soy.
• Special diets including, but not limited to, Mediterranean, veganism, vegetarianism, gluten-free, and the ketogenic diet.
• Current use of medications that could affect blood glucose and lipids levels including, but not limited to, insulins (Humalog, Novolog, insulin detemir, etc.), anti-diabetic medications (metformin, sulfonylureas, meglitinides, etc.), Ozempic. HAART, and beta blockers.
• No children are involved.
• No other vulnerable subjects will be involved.

Sponsors & Collaborators

• Tulane University: lead
• Humana Foundation: collaborator

Study Sites (2)

The Goldring Center for Culinary Medicine

New Orleans, Louisiana, 70112, United States

RECRUITING

Tulane Weatherhead School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

RECRUITING

MeSH Terms

Conditions

Cardiovascular Diseases; Psychological Well-Being

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Lu Qi, PhD, MD

  Tulane University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cristina Miller, MPH

CONTACT

504-988-2166; cmiller17@tulane.edu

Marquita Canatella, RN

CONTACT

504-988-1809; mcanatella@tulane.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2025
• First Posted: June 8, 2025
• Study Start: July 7, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 11, 2025

Record last verified: 2025-09

Locations

US (2)