Food is Medicine Prospective Study

NCT ID: NCT07169448

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-09-30

Brief Summary

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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

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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.

Conditions

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Wounds and Injuries

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Orthopaedic trauma surgical patients with inpatient stay

Discharged home from hospital, skilled nursing facility, or acute rehab

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Carol A. Lin, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Milton Little, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Central Contacts

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Program Manager

Role: CONTACT

424-314-0536

Program Manager

Role: CONTACT

310-423-4295

Facility Contacts

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Program Manager

Role: primary

424-314-0536

Program Manager

Role: backup

310-423-4295

References

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Firoozabadi R, Hamilton B, O'Donnell C, Agel J, Benirschke S, Kramer P, Henley MB. Prospective Study Investigating the Prevalence and Evolution of Malnourishment in the Acute Orthopaedic Trauma Patient. Arch Bone Jt Surg. 2022 Jul;10(7):592-600. doi: 10.22038/ABJS.2021.47718.2341.

Reference Type BACKGROUND
PMID: 36032641 (View on PubMed)

George A, Holderread BM, Lambert BS, Harris JD, McCulloch PC. Post-operative protein supplementation following orthopaedic surgery: A systematic review. Sports Med Health Sci. 2023 Sep 7;6(1):16-24. doi: 10.1016/j.smhs.2023.08.002. eCollection 2024 Mar.

Reference Type BACKGROUND
PMID: 38463662 (View on PubMed)

Lawson RM, Doshi MK, Barton JR, Cobden I. The effect of unselected post-operative nutritional supplementation on nutritional status and clinical outcome of orthopaedic patients. Clin Nutr. 2003 Feb;22(1):39-46. doi: 10.1054/clnu.2002.0588.

Reference Type BACKGROUND
PMID: 12553948 (View on PubMed)

Yeung SE, Hilkewich L, Gillis C, Heine JA, Fenton TR. Protein intakes are associated with reduced length of stay: a comparison between Enhanced Recovery After Surgery (ERAS) and conventional care after elective colorectal surgery. Am J Clin Nutr. 2017 Jul;106(1):44-51. doi: 10.3945/ajcn.116.148619. Epub 2017 May 3.

Reference Type BACKGROUND
PMID: 28468890 (View on PubMed)

Mosquera C, Koutlas NJ, Edwards KC, Strickland A, Vohra NA, Zervos EE, Fitzgerald TL. Impact of malnutrition on gastrointestinal surgical patients. J Surg Res. 2016 Sep;205(1):95-101. doi: 10.1016/j.jss.2016.05.030. Epub 2016 May 26.

Reference Type BACKGROUND
PMID: 27621004 (View on PubMed)

Handcox JE, Gutierrez-Naranjo JM, Salazar LM, Bullock TS, Griffin LP, Zelle BA. Nutrition and Vitamin Deficiencies Are Common in Orthopaedic Trauma Patients. J Clin Med. 2021 Oct 28;10(21):5012. doi: 10.3390/jcm10215012.

Reference Type BACKGROUND
PMID: 34768533 (View on PubMed)

Ernst A, Wilson JM, Ahn J, Shapiro M, Schenker ML. Malnutrition and the Orthopaedic Trauma Patient: A Systematic Review of the Literature. J Orthop Trauma. 2018 Oct;32(10):491-499. doi: 10.1097/BOT.0000000000001254.

Reference Type BACKGROUND
PMID: 30247276 (View on PubMed)

Leandro-Merhi VA, de Aquino JL. Determinants of malnutrition and post-operative complications in hospitalized surgical patients. J Health Popul Nutr. 2014 Sep;32(3):400-10.

Reference Type BACKGROUND
PMID: 25395903 (View on PubMed)

Bonilla-Palomas JL, Gamez-Lopez AL, Castillo-Dominguez JC, Moreno-Conde M, Lopez Ibanez MC, Alhambra Exposito R, Ramiro Ortega E, Anguita-Sanchez MP, Villar-Raez A. Nutritional Intervention in Malnourished Hospitalized Patients with Heart Failure. Arch Med Res. 2016 Oct;47(7):535-540. doi: 10.1016/j.arcmed.2016.11.005.

Reference Type BACKGROUND
PMID: 28262195 (View on PubMed)

Ponsford J, Hill B, Karamitsios M, Bahar-Fuchs A. Factors influencing outcome after orthopedic trauma. J Trauma. 2008 Apr;64(4):1001-9. doi: 10.1097/TA.0b013e31809fec16.

Reference Type BACKGROUND
PMID: 18404068 (View on PubMed)

Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016/s0002-9610(02)00866-8.

Reference Type BACKGROUND
PMID: 12095591 (View on PubMed)

Other Identifiers

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STUDY00004008

Identifier Type: -

Identifier Source: org_study_id

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