Food is Medicine Prospective Study
ConditionWounds and Injuries
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCedars-Sinai Medical Center
About this trial
The purpose of this study is to examine the impact of a medically tailored post-operative meal delivery program on surgical outcomes and metabolic lab markers in orthopaedic trauma patients. Patients will have 12 days of meals and shakes delivered to their house through our partnership with Meals on Wheels. Metabolic lab values will be drawn at the 2 week and 6 week post-op visits. All patients will be followed for up to 1 year postoperatively.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals 18 years old or older are included.
English or Spanish speaking
Reside in the following zip codes: 90001, 90002, 90003, 90004, 90005, 90006, 90007, 90008, 90009, 90010, 90011, 90012, 90013, 90014, 90015, 90016, 90017, 90018, 90019, 90020, 90021, 90023, 90026, 90027, 90028, 90029, 90031, 90035, 90036, 90037, 90038, 90039, 90043, 90044, 90046, 90047, 90048, 90052, 90057, 90059, 90061, 90062, 90065, 90068, 90069
Discharged home, either directly from Cedars-Sinai Medical Center or after time in a skilled nursing facility or acute rehab
Disqualifiers
Any records flagged "break the glass" or "research opt out."
Any pregnant patients.
Patients with any congenital metabolic conditions
Patients with dietary restrictions (ex. Kosher, Halal, vegan, gluten free, etc.) that are unable to be reasonably accommodated by St. Vincent Meals on Wheels
Trial population
Orthopaedic trauma surgical patients that have had an operation and inpatient stay at Cedars-Sinai Medical Center
Trial design
Design model
Ecologic or community
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
75 Participants
are grouped into 1 trial groupGroup A: Orthopaedic trauma surgical patients with inpatient stay
Trial outcomes
Primary outcomes
1
Metabolic biomarker changes over time
Evaluation of biomarkers
Time frame
From enrollment to 6-weeks postop2
Incidence of acute wound complications
Wound compliaction
Time frame
From enrollment to end of treatment at 1-year postopOther outcomes
1
Patient-reported outcomes Depression
The PROMIS Depression scale is a self-reported measure used to assess negative mood, views of self, and social cognition associated with depressive symptoms. Scores are reported on a T-score metric, standardized with a mean of 50 and standard deviation of 10, based on the U.S. general population. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning more severe depressive symptoms. A T-score of 50 represents the average level of depressive symptoms in the general population.
Time frame
From enrollment to end of study period at 1-year postop2
Patient-reported outcomes Anxiety
The PROMIS Anxiety scale measures fear, anxious misery, hyperarousal, and somatic symptoms related to anxiety. Like other PROMIS instruments, it uses a T-score metric with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning greater severity of anxiety symptoms. A T-score of 50 reflects the average level of anxiety symptoms in the general population.
Time frame
From enrollment to end of study period at 1-year postop3
Patient-reported outcomes Physical Function
The PROMIS Physical Function scale evaluates an individual's capability to perform physical activities such as mobility, dexterity, and self-care. Scores are reported using a T-score, standardized with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate better outcomes, meaning greater physical functioning. A T-score of 50 reflects the average physical function in the general population.
Time frame
From enrollment to end of study period at 1-year postop4
Patient-reported outcomes Pain Interference
The PROMIS Pain Interference scale assesses the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. It is scored on the T-score metric, with a mean of 50 and standard deviation of 10. Scale Range: 0 to 100 (T-score) Interpretation: Higher scores indicate worse outcomes, meaning pain is interfering more with daily life. A T-score of 50 indicates average pain interference relative to the general population.
Time frame
From enrollment to end of study period at 1-year postopSponsors and contacts
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Source ClinicalTrials.gov