A Phase 1/2 interventional study of Treatment in Cardiovascular Diseases, Cardiovascular Risk Factor and Nutrition Disorders, sponsored by Tulane University. Completed at 1 site in United States. Open to participants aged 7 Years to 115 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Tulane University · Phase 1/2, Interventional, and Treatment
Among 17 studies in Hypertension by Tulane University — 2 open to participants now, 7 under way, none of them phase 3. Hypertension · Tulane University.
Among the 17 studies in Hypertension by Tulane University, this one is the 2nd largest by enrollment of the 15 interventional ones that give a count, is one of 3 that started in 2018, is the only one in phase 1/2, and was the 7th registered.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
Browse Hypertension studies →2 of the 17 studies in Hypertension by Tulane University are open now, in 1 country. Recruiting first, the newest first:
Tulane University · Sites in United States
Ages 18+
Tulane University · Sites in United States
Ages 18–75
By country, each count listing its studies:
Of the 564 Hypertension studies recruiting now, 266 (47%) set no upper age limit and 200 (35%) stop at 75 or younger; 40 take children under 18; 138 take healthy volunteers.
This study: 7 Years to 115 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
17 studies; the count open now beside each. This study's row is marked.
First in 1973; this study’s year is marked. 3 started in 2018.
This study's enrollment of 7,192 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Median enrollment 1,176 across the 15 interventional studies, 5,874 across the 2 observational. Of the 10 that completed or were terminated, 5 (50%) have results posted.
This tab as a report to print or save as PDF → With an account.
Tulane University is the lead sponsor of 96 studies on the registry; 23 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
3 of the studies in Hypertension by Tulane University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05183763Tulane UniversityMedication Adherence Program | 2027-04-30 |
| NCT06133322Tulane UniversityBlood Pressure Lowering Strategies to Eliminate Hypertension Disparities (BLESSED) | 2027-06-30 |
| NCT06065098Tulane UniversityChurch-based Health Intervention to Eliminate Racial Inequalities in Cardiovascular Health | 2027-08-31 |
Among the 17 studies in Hypertension by Tulane University, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 7,192 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Tulane University is the lead sponsor of 96 studies on the registry; 23 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 5 (56%) have results posted.
Compared within Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiovascular Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Subjects receiving hands-on cooking and nutrition education classes
Behavioral: Treatment
Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)
The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.
High or Medium (Versus Low) Mediterranean Diet Adherence
Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)
Time frame: 6 months
Hospital Readmissions
Re-presenting to the hospital for similar presenting diagnosis (for patients)
Time frame: 30 days
Composite Rate of All Cause-mortality, Myocardial Infarction, and Cerebrovascular Event
(For patients)
Time frame: 6 months
Competencies
Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
Time frame: 6 months
Healthcare Costs
Direct and indirect (for patients)
Time frame: 6 months
Healthcare Costs
Direct and indirect (for health systems caring for the patients in the trial)
Time frame: 6 months
Food Costs
Grocery and restaurant costs (for patients)
Time frame: 6 months
| Milestone | Treatment | Control |
|---|---|---|
| Started | 2616 | 4576 |
| Completed | 2127 | 3720 |
| Not completed | 489 | 856 |
Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)
| percentage of arm | Treatment | Control |
|---|---|---|
| High or Medium (Versus Low) Mediterranean Diet Adherence | 55.99 | 50.53 |
Re-presenting to the hospital for similar presenting diagnosis (for patients)
Results for this outcome have not been posted.
(For patients)
Results for this outcome have not been posted.
Educating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
Results for this outcome have not been posted.
Direct and indirect (for patients)
Results for this outcome have not been posted.
Direct and indirect (for health systems caring for the patients in the trial)
Results for this outcome have not been posted.
Grocery and restaurant costs (for patients)
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment | 0/2,616 (0%) | 0/2,616 (0%) | 0/2,616 (0%) |
| Control | 0/4,576 (0%) | 0/4,576 (0%) | 0/4,576 (0%) |
| Age, Categorical(Participants) | Treatment | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1870 | 3571 | 5441 |
| >=65 years | 746 | 1005 | 1751 |
| Age, Continuous(years) | Treatment | Control | Total |
|---|---|---|---|
| Mean | 32.02 ± 12.69 | 28.16 ± 8.48 | 29.49 ± 10.30 |
| Sex: Female, Male(Participants) | Treatment | Control | Total |
|---|---|---|---|
| Female | 1700 | 2725 | 4425 |
| Male | 916 | 1851 | 2767 |
| Race (NIH/OMB)(Participants) | Treatment | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 39 | 14 | 53 |
| Asian | 376 | 709 | 1085 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 556 | 507 | 1063 |
| White | 1262 | 2601 | 3863 |
| More than one race | 383 | 745 | 1128 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Treatment | Control | Total |
|---|---|---|---|
| United States | 2616 | 4576 | 7192 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Dec 2020, 34 months.
Results were first posted in Feb 2022, 1 year 2 months after primary completion.
Of 20 phase 1/2 interventional studies under Hypertension, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 60. This study's 34 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tulane University