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NCT Number: NCT07169448

Food is Medicine Prospective Study

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.

Recruiting

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Key information

Conditions

Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location status: Recruiting

Location contact

Carol Lin, MD

PRINCIPAL_INVESTIGATOR

Caryn Lindsey, DSW

SUB_INVESTIGATOR

Program Manager

CONTACT

[email protected]

424-314-0536

Program Manager

CONTACT

[email protected]

310-423-4295

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Metabolic biomarker changes over time

    Time frame: From enrollment to 6-weeks postop

    Evaluation of biomarkers

  2. Incidence of acute wound complications

    Time frame: From enrollment to end of treatment at 1-year postop

    Wound compliaction

Other outcomes

  1. Patient-reported outcomes Depression

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

    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.

  2. Patient-reported outcomes Anxiety

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

    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.

  3. Patient-reported outcomes Physical Function

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

    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.

  4. Patient-reported outcomes Pain Interference

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Program Manager

CONTACT

[email protected]

424-314-0536

Program Manager

CONTACT

[email protected]

310-423-4295

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

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

Acronym: FIM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 11, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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