Food is Medicine Prospective Study

Not yet recruiting

• Conditions: Wounds and Injuries

• Registration Number: NCT07169448
• Lead Sponsor: Cedars-Sinai Medical Center

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.

Study Timeline

• Study First Submitted: 2025-08-25
• Status Verified: 2025-09
• Study Start: 2025-09-01
• Study First Submitted QC: 2025-09-09
• Last Update Submitted: 2025-09-09
• Study First Posted: 2025-09-11
• Last Update Posted: 2025-09-11
• Primary Completion: 2027-09
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Metabolic biomarker changes over time	From enrollment to 6-weeks postop	Evaluation of biomarkers
Incidence of acute wound complications	From enrollment to end of treatment at 1-year postop	Wound compliaction

Trial Locations

Locations (1)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States