Clinical trial NCT07011459: The Cooking for Health Optimization and Disease Prevention (CHOP) Trial
Official title: Community Teaching Kitchen-based Culinary Education as a 'Food is Medicine' Solution for Improving Health Equity Among Racially/Ethnically Diverse Seniors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Culinary
Cardiometabolic health
Mental health
Mediterranean Diet
Nutrition
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Humana Foundation
First posted: 2025-06-08
Enrollment: 96
Sex: ALL
Minimum age (years): 55
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The study is designed as a two-arm parallel-group randomized controlled trial (RCT). The interventions in the two groups are described as below:

i) Culinary intervention group (n=48): The interventions include the teaching-kitchen based structured, hands-on culinary education classes.

ii) Usual diet control group (n=48): 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in blood pressure measurements
timeFrame: Baseline, 3 months
measure: Change in blood glucose measurements
timeFrame: Baseline, 3 months
measure: Change in blood lipid profile measurements
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Change in cognitive function measured using the Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline, 3 months
measure: Depression severity assessment using the PHQ-9 (Patient Health Questionnaire)
timeFrame: Baseline, 3 months
measure: Loneliness severity assessment using the UCLA Loneliness Scale Version 3 (UCLA-LS)
timeFrame: Baseline, 3 months
measure: Social Anxiety Disorder assessment using the Severity Measure for Social Anxiety Disorder (Social Phobia Scale for Adults) questionnaire
timeFrame: Baseline, 3 months
measure: Mediterranean eating pattern assessment using the Mediterranean Diet Adherence Screener (MEDAS) questionnaire
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: The Goldring Center for Culinary Medicine
state: Louisiana
city: New Orleans
country: United States
facility: Tulane Weatherhead School of Public Health and Tropical Medicine
state: Louisiana
Study officials:
affiliation: Tulane University
name: Lu Qi, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: