Trial Outcomes & Findings for Cooking for Health Optimization With Patients (NCT NCT03443635)
NCT ID: NCT03443635
Last Updated: 2022-04-29
Results Overview
Based on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
7192 participants
Primary outcome timeframe
6 months
Results posted on
2022-04-29
Participant Flow
Participant milestones
| Measure |
Treatment
Subjects receiving hands-on cooking and nutrition education classes
Treatment: 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.
|
Control
Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)
|
|---|---|---|
|
Overall Study
STARTED
|
2616
|
4576
|
|
Overall Study
COMPLETED
|
2127
|
3720
|
|
Overall Study
NOT COMPLETED
|
489
|
856
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cooking for Health Optimization With Patients
Baseline characteristics by cohort
| Measure |
Treatment
n=2616 Participants
Subjects receiving hands-on cooking and nutrition education classes
Treatment: 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.
|
Control
n=4576 Participants
Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees) or medical care (for patients)
|
Total
n=7192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1870 Participants
n=99 Participants
|
3571 Participants
n=107 Participants
|
5441 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
746 Participants
n=99 Participants
|
1005 Participants
n=107 Participants
|
1751 Participants
n=206 Participants
|
|
Age, Continuous
|
32.02 years
STANDARD_DEVIATION 12.69 • n=99 Participants
|
28.16 years
STANDARD_DEVIATION 8.48 • n=107 Participants
|
29.49 years
STANDARD_DEVIATION 10.30 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1700 Participants
n=99 Participants
|
2725 Participants
n=107 Participants
|
4425 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
916 Participants
n=99 Participants
|
1851 Participants
n=107 Participants
|
2767 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
39 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
376 Participants
n=99 Participants
|
709 Participants
n=107 Participants
|
1085 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
556 Participants
n=99 Participants
|
507 Participants
n=107 Participants
|
1063 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1262 Participants
n=99 Participants
|
2601 Participants
n=107 Participants
|
3863 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
383 Participants
n=99 Participants
|
745 Participants
n=107 Participants
|
1128 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
2616 participants
n=99 Participants
|
4576 participants
n=107 Participants
|
7192 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 monthsBased on 9-point Trichopoulou et al. 2003 NEJM scale (for patients, medical trainees, and providers)
Outcome measures
| Measure |
Treatment
n=2616 Participants
Subjects receiving hands-on cooking and nutrition education classes
Treatment: 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.
|
Control
n=4576 Participants
Subjects not receiving any additional nutrition education aside from that contained in their curricula (for trainees/providers) or medical care (for patients)
|
|---|---|---|
|
High or Medium (Versus Low) Mediterranean Diet Adherence
|
55.99 percentage of arm
|
50.53 percentage of arm
|
SECONDARY outcome
Timeframe: 30 daysRe-presenting to the hospital for similar presenting diagnosis (for patients)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 months(For patients)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsEducating patients on healthy diet and lifestyles according to 25 competency topics (for medical trainees)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsDirect and indirect (for patients)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsDirect and indirect (for health systems caring for the patients in the trial)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsGrocery and restaurant costs (for patients)
Outcome measures
Outcome data not reported
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Principal Investigator
Tulane University Goldring Center for Culinary Medicine
Phone: 3373290724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place