[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07169448":3,"trial-entities:NCT07169448":125,"trial-summary:NCT07169448":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":25,"interventions":28,"primary_outcomes":29,"secondary_outcomes":38,"sex":39,"minimum_age":40,"maximum_age":23,"healthy_volunteers":15,"eligibility_criteria":41,"std_ages":57,"locations":60,"central_contacts":84,"overall_officials":87,"references":89,"see_also_links":124},"NCT07169448","STUDY00004008","Food is Medicine Prospective Study","Impact of A Postoperative Meal Delivery Program on Malnutrition in Orthopaedic Trauma Patients","RECRUITING","2027-09","2026-03","2026-03-20","2025-09-01","Cedars-Sinai Medical Center","OTHER",false,"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.","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.",[19],"Wounds and Injuries",[21],"Food is medicine","OBSERVATIONAL",null,[],{"count":26,"type":27},75,"ESTIMATED",[],[30,34],{"measure":31,"description":32,"timeFrame":33},"Metabolic biomarker changes over time","Evaluation of biomarkers","From enrollment to 6-weeks postop",{"measure":35,"description":36,"timeFrame":37},"Incidence of acute wound complications","Wound compliaction","From enrollment to end of treatment at 1-year postop",[],"ALL","18 Years",{"inclusion":42,"exclusion":48,"raw_text":56},[43,44,45,46,47],"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",[49,50,51,52,53,54,55],"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\u002For unreliable to follow up","Inclusion Criteria:\n\n* Individuals 18 years old or older are included.\n* English or Spanish speaking\n* 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\n* Discharged home, either directly from Cedars-Sinai Medical Center or after time in a skilled nursing facility or acute rehab\n* Orthopaedic trauma surgical patients that have had an operation and inpatient stay at Cedars-Sinai Medical Center\n\nExclusion Criteria:\n\n* Any records flagged \"break the glass\" or \"research opt out.\"\n* Any pregnant patients.\n* Patients with any congenital metabolic conditions\n* Patients with dietary restrictions (ex. Kosher, Halal, vegan, gluten free, etc.) that are unable to be reasonably accommodated by St. Vincent Meals on Wheels\n* Any patients with mental illness the prevents them from giving consent.\n* Patients with dementia or cognitive impairment.\n* Patients who are homeless and\u002For unreliable to follow up",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":13,"status":8,"city":62,"state":63,"zip":64,"country":65,"contacts":66,"geoPoint":81},"Los Angeles","California","90048","United States",[67,72,75,78],{"name":68,"role":69,"phone":70,"email":71},"Program Manager","CONTACT","424-314-0536","joel.arnold@cshs.org",{"name":68,"role":69,"phone":73,"email":74},"310-423-4295","laura.sarmiento@cshs.org",{"name":76,"role":77},"Carol Lin, MD","PRINCIPAL_INVESTIGATOR",{"name":79,"role":80},"Caryn Lindsey, DSW","SUB_INVESTIGATOR",{"lat":82,"lon":83},34.05223,-118.24368,[85,86],{"name":68,"role":69,"phone":70,"email":71},{"name":68,"role":69,"phone":73,"email":74},[88],{"name":76,"affiliation":13,"role":77},[90,94,97,100,103,106,109,112,115,118,121],{"pmid":91,"type":92,"citation":93},"36032641","BACKGROUND","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\u002FABJS.2021.47718.2341.",{"pmid":95,"type":92,"citation":96},"38463662","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\u002Fj.smhs.2023.08.002. eCollection 2024 Mar.",{"pmid":98,"type":92,"citation":99},"12553948","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\u002Fclnu.2002.0588.",{"pmid":101,"type":92,"citation":102},"28468890","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\u002Fajcn.116.148619. Epub 2017 May 3.",{"pmid":104,"type":92,"citation":105},"27621004","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\u002Fj.jss.2016.05.030. Epub 2016 May 26.",{"pmid":107,"type":92,"citation":108},"34768533","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\u002Fjcm10215012.",{"pmid":110,"type":92,"citation":111},"30247276","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\u002FBOT.0000000000001254.",{"pmid":113,"type":92,"citation":114},"25395903","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":116,"type":92,"citation":117},"28262195","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\u002Fj.arcmed.2016.11.005.",{"pmid":119,"type":92,"citation":120},"18404068","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\u002FTA.0b013e31809fec16.",{"pmid":122,"type":92,"citation":123},"12095591","Kehlet H, Wilmore DW. Multimodal strategies to improve surgical outcome. Am J Surg. 2002 Jun;183(6):630-41. doi: 10.1016\u002Fs0002-9610(02)00866-8.",[],{"nct_id":4,"conditions":126,"biomarkers":127},[19],[],{"nct_id":4,"found":129,"summary":130,"prompt_version":140},true,{"design":131,"status":132,"heading":133,"summary":134,"follow_up":135,"word_count":136,"commitments":137,"compensation":138,"drugs_mentioned":139},"This is an observational study planning to enroll 75 participants. It is not specified if participants will be randomly assigned to groups.","completed","Food is Medicine Study for Orthopaedic Trauma Patients","This study is looking at how a special meal delivery program affects recovery for people who have had orthopaedic (bone and joint) injuries. You would receive 12 days of medically tailored meals and shakes delivered to your home through Meals on Wheels after surgery. Researchers will track changes in your metabolic (body's chemical processes) markers and look at how often wound complications happen. The goal is to see if this meal program can help improve healing and reduce problems after surgery. This study is for adults aged 18 and older who speak English or Spanish and live in specific zip codes in the Los Angeles area. The study's status is currently unclear.","All patients will be followed for up to 1 year after their surgery.",112,"You would receive 12 days of meals and shakes delivered to your home. Metabolic lab values will be drawn at your 2-week and 6-week post-operative visits.","Not stated in the trial record.",[],"v2"]