NCT07169448

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
16mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

August 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 11, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 20, 2026

Status Verified

March 1, 2026

Enrollment Period

2 years

First QC Date

August 25, 2025

Last Update Submit

March 18, 2026

Conditions

Wounds and Injuries

Keywords

Food is medicine

Outcome Measures

Primary Outcomes (2)

  • Metabolic biomarker changes over time

    Evaluation of biomarkers

    From enrollment to 6-weeks postop

  • Incidence of acute wound complications

    Wound compliaction

    From enrollment to end of treatment at 1-year postop

Other Outcomes (4)

  • Patient-reported outcomes Depression

    From enrollment to end of study period at 1-year postop

  • Patient-reported outcomes Anxiety

    From enrollment to end of study period at 1-year postop

  • Patient-reported outcomes Physical Function

    From enrollment to end of study period at 1-year postop

  • +1 more other outcomes

Study Arms (1)

Orthopaedic trauma surgical patients with inpatient stay

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Publications (11)

  • 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.

    PMID: 36032641BACKGROUND

  • 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.

    PMID: 38463662BACKGROUND

  • 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.

    PMID: 12553948BACKGROUND

  • 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.

    PMID: 28468890BACKGROUND

  • 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.

    PMID: 27621004BACKGROUND

  • 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.

    PMID: 34768533BACKGROUND

  • 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.

    PMID: 30247276BACKGROUND

  • 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.

    PMID: 25395903BACKGROUND

  • 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.

    PMID: 28262195BACKGROUND

  • 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.

    PMID: 18404068BACKGROUND

  • 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.

    PMID: 12095591BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Carol Lin, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Program Manager

CONTACT

424-314-0536joel.arnold@cshs.org

Program Manager

CONTACT

310-423-4295laura.sarmiento@cshs.org

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 25, 2025

First Posted

September 11, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 20, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)