AzTrials
AzTrials

Cardiovascular DiseasesNCT07011459

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

A study testing Cooking class in people with Cardiovascular Diseases, run by Tulane University at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 55 to 120 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Diseases
What is being tested?
Cooking class
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
97 participants
Where
2 sitesUnited States
Study dates
7 Jul 2025to Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 120 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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 locations and contacts

2 sites in 1 country.

United States2 sites

  • The Goldring Center for Culinary Medicine

    New Orleans, Louisiana, 70112

  • Tulane Weatherhead School of Public Health and Tropical Medicine

    New Orleans, Louisiana, 70112

Other trials in United States

About this study

Official title: Community Teaching Kitchen-based Culinary Education as a 'Food is Medicine' Solution for Improving Health Equity Among Racially/Ethnically Diverse Seniors

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.

Read the 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:

  1. 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).
Being tested
Cooking class, Standard of care
Keywords
Culinary, Cardiometabolic health, Mental health, Mediterranean Diet, Nutrition
Medical subject headings
Cardiovascular Diseases, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cooking classBehavioural

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

  • Standard of careOther

    Participants will continue to receive clinical care recommendations from their physicians

Study groups in NCT07011459
Study groupRoleWhat they receive
Culinary intervention groupActive comparatorThe interventions include the teaching-kitchen based structured, hands-on culinary education classes.
Receives: Behavioral: Cooking class
Usual diet control groupPlacebo comparatorParticipants 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).
Receives: Other: Standard of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 3 months

  2. 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.

    Measured: Baseline, 3 months

  3. 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.

    Measured: Baseline, 3 months

Secondary outcomes (5)

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

    The investigators will measure the change in cognitive function using the Montreal Cognitive Assessment. It is a screening tool used to assess cognitive function. A higher score indicates less severe cognitive impairment. The grading scale for the MoCA is as follows:

    0-9: Severe cognitive impairment 10-17: Moderate cognitive impairment 18-25: Mild cognitive impairment 26-30: Normal cognitive function

    This will be measured at baseline visit and at 3 months visit.

    Measured: Baseline, 3 months

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

    The investigators will assess the depression severity using the PHQ-9 (Patient Health Questionnaire) It is a self-reporting scoring system which assigns points to each question based on the frequency of reported symptoms, with a total score ranging from 0 to 27. The total score can then be used to determine the possible level of depression severity. The higher the score, the more severe depression level will be.

    0-4 points: None to minimal depression. 5-9 points: Mild depression. 10-14 points: Moderate depression. 15-19 points: Moderately severe depression. 20-27 points: Severe depression.

    This will be measured at baseline visit and at 3 months visit.

    Measured: Baseline, 3 months

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

    The investigators will assess the loneliness severity using the UCLA Loneliness Scale Version 3 (UCLA-LS). It is a self-reporting questionnaire used to measure an individual's feelings of loneliness. It's scored by combining the total of responses to 20 questions, where higher scores generally indicate greater feelings of loneliness. The interpretation of scores often uses a categorization based on the total score, with scores above 43 generally indicating a high degree of loneliness.

    Low Loneliness: Total score < 28. Moderate Loneliness: Total score 28-43. High Loneliness: Total score > 43.

    This will be measured at baseline visit and at 3 months visit.

    Measured: Baseline, 3 months

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

    The investigators will assess Social Anxiety Disorder using the Severity Measure for Social Anxiety Disorder (Social Phobia Scale for Adults). It is a 10-item questionnaire, used to assess social anxiety (social phobia) in adults.

    Total Score Range: 0-40. Interpretation: Higher scores correlate with more severe social phobia symptoms.

    Cut-off Score: 24 or above may indicate a presence of non-generalized social phobia.

    This will be measured at baseline visit and at 3 months visit.

    Measured: Baseline, 3 months

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

    The investigators will assess the Mediterranean eating pattern using the Mediterranean Diet Adherence Screener (MEDAS) questionnaire. It is used to assess how someone's diet aligns with a traditional Mediterranean eating pattern. A higher score means better adherence.

    0-4 points: Generally considered low adherence. 5-9 points: Considered moderate to fair adherence. 10-14 points: Indicates good or very good adherence.

    This will be measured at baseline visit and at 3 months visit.

    Measured: Baseline, 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start7 Jul 2025
  3. Primary completionNov 2026 (estimated)
  4. Study completionNov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
97 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07011459
Sponsor's protocol ID
2024-1940
Status last verified
Oct 2026
First submitted
16 May 2025
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cooking class in people with Cardiovascular Diseases, run by Tulane University at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood pressure measurements (time frame: Baseline, 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07011459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in