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

Tulane University logo

Tulane University

Status

Not yet enrolling

Conditions

Cardiovascular Diseases

Treatments

Other: Standard of care
Behavioral: Cooking class

Study type

Interventional

Funder types

Other

Identifiers

NCT07011459
2024-1940

Details and patient eligibility

About

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.

Full 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).

Enrollment

96 estimated patients

Sex

All

Ages

55 to 120 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

96 participants in 2 patient groups, including a placebo group

Culinary intervention group
Active Comparator group
Description:
The interventions include the teaching-kitchen based structured, hands-on culinary education classes.
Treatment:
Behavioral: Cooking class
Usual diet control group
Placebo Comparator group
Description:
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).
Treatment:
Other: Standard of care

Trial contacts and locations

2

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Central trial contact

Marquita Canatella, RN; Cristina Miller, MPH

Data sourced from clinicaltrials.gov

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