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Food is Medicine Prospective Study

Impact of A Postoperative Meal Delivery Program on Malnutrition in Orthopaedic Trauma Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07169448
Acronym
FIM
Enrollment
75
Registered
2025-09-11
Start date
2025-09-01
Completion date
2027-09-01
Last updated
2026-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wounds and Injuries

Keywords

Food is medicine

Brief summary

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.

Detailed description

This project addresses critical gaps in our understanding of how malnutrition affects recovery in orthopaedic trauma patients by focusing on three key outcomes: (1) the incidence of acute wound complications, (2) metabolic biomarker changes over time, and (3) patient-reported outcomes (PROMIS scores) and impact (qualitative survey) during the recovery period. By systematically investigating these outcomes, the project aims to understand how post-operative meal supplementation can be optimized to reduce complications and improve recovery. The findings will have significant implications for clinical practice, particularly in developing nutritional programs and guidelines that can be integrated into post-operative care protocols to improve outcomes and reduce healthcare costs for orthopaedic trauma patients.

Interventions

None listed

Sponsors

Cedars-Sinai Medical Center
Lead SponsorOTHER

Study design

Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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 * Orthopaedic trauma surgical patients that have had an operation and inpatient stay at Cedars-Sinai Medical Center

Exclusion criteria

* 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 * Any patients with mental illness the prevents them from giving consent. * Patients with dementia or cognitive impairment. * Patients who are homeless and/or unreliable to follow up

Design outcomes

Primary

MeasureTime frameDescription
Metabolic biomarker changes over timeFrom enrollment to 6-weeks postopEvaluation of biomarkers
Incidence of acute wound complicationsFrom enrollment to end of treatment at 1-year postopWound compliaction

Countries

United States

Contacts

CONTACTProgram Manager
joel.arnold@cshs.org424-314-0536
PRINCIPAL_INVESTIGATORCarol Lin, MD

Cedars-Sinai Medical Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 21, 2026