Impact of a POPOP on Preoperative Health, Eligibility, and Clinical & Patient-Reported Outcomes in TJA
NCT ID: NCT04910048
Last Updated: 2024-09-19
Study Results
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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COMPLETED
NA
46 participants
INTERVENTIONAL
2022-01-17
2024-09-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard of Care
The first arm consists of UAMS standard of care (SOC), including providing a brochure with information (contact information, brief educational information) for the patient to consult with a nutritionist to help with self-directed weight loss.
SOC (standard of care)
Referral to a dietician for two months of self-directed weight loss
Intervention (POPOP)
The second arm is a specified 2-month POPOP focused on weight loss administered by the external partner, 20Lighter. The program includes customized meal plans; vitamin, mineral and nutritional supplementation; and daily engagement via a smartphone app with a 20Lighter health care provider. Video conferencing appointments will occur approximately every 3 weeks. The program does not require any exercise or physical engagement but does necessitate that patients have a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection. During the first 40 days the customized meal plans are adhered to, then from days 41-60 patients will transition back to a normal dietary lifestyle via a customized plan based on considerations including, food preferences, physical engagement and height. Patients who achieve a BMI below 40.0 before the end of the 60 day program may be seen sooner than 90d for follow-up appointment in the UAMS clinic.
POPOP (preoperative patient optimization program)
A 2 month structured program focused on reduction of BMI, body weight, visceral fat, body fat and improvement of lean body mass and intracellular fluid.
Interventions
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POPOP (preoperative patient optimization program)
A 2 month structured program focused on reduction of BMI, body weight, visceral fat, body fat and improvement of lean body mass and intracellular fluid.
SOC (standard of care)
Referral to a dietician for two months of self-directed weight loss
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI between 41.00-48.00 kg/m2 at time of enrollment
* Over the age of 18 years
* Would consider undergoing a total joint arthroplasty if eligible
* Owns a smartphone or tablet with Bluetooth capability, cell signal or WIFI connection
* Willing to comply with the requirements of the study and provide informed consent prior to enrollment.
Exclusion Criteria
* Pregnancy
* Breastfeeding
* History of a major organ transplant or other health issue requiring immunosuppressant drugs
* Strict vegetarian diet
* Diagnosis of and/or are taking medication for psychiatric conditions including schizophrenia, bipolar disorder or manic depression
* Patients scheduled for, or those who have previously undergone, bariatric surgery
* Patients unable to understand and speak English
* Patients requiring a revision or bilateral TJA
* Patients unwilling or unable to use a bluetooth-enabled smartphone with cell service or home internet access
* Incarceration
18 Years
80 Years
ALL
No
Sponsors
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University of Arkansas
OTHER
Responsible Party
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Principal Investigators
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Jeffrey B Stambough, MD
Role: PRINCIPAL_INVESTIGATOR
University of Arkansas
Locations
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UAMS Orthopaedic Clinic - Shackleford
Little Rock, Arkansas, United States
Countries
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References
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Bolognesi MP, Marchant MH Jr, Viens NA, Cook C, Pietrobon R, Vail TP. The impact of diabetes on perioperative patient outcomes after total hip and total knee arthroplasty in the United States. J Arthroplasty. 2008 Sep;23(6 Suppl 1):92-8. doi: 10.1016/j.arth.2008.05.012.
Boyce L, Prasad A, Barrett M, Dawson-Bowling S, Millington S, Hanna SA, Achan P. The outcomes of total knee arthroplasty in morbidly obese patients: a systematic review of the literature. Arch Orthop Trauma Surg. 2019 Apr;139(4):553-560. doi: 10.1007/s00402-019-03127-5. Epub 2019 Feb 16.
Gerlach E, Selley R, Johnson D, Nicolay R, Versteeg G, Plantz M, Tjong V, Terry M. Patient-Reported Outcomes Measurement Information System Validation in Hip Arthroscopy: A Shift Towards Reducing Survey Burden. Cureus. 2021 Feb 10;13(2):e13265. doi: 10.7759/cureus.13265.
Goodman SM, Mehta BY, Mandl LA, Szymonifka JD, Finik J, Figgie MP, Navarro-Millan IY, Bostrom MP, Parks ML, Padgett DE, McLawhorn AS, Antao VC, Yates AJ, Springer BD, Lyman SL, Singh JA. Validation of the Hip Disability and Osteoarthritis Outcome Score and Knee Injury and Osteoarthritis Outcome Score Pain and Function Subscales for Use in Total Hip Replacement and Total Knee Replacement Clinical Trials. J Arthroplasty. 2020 May;35(5):1200-1207.e4. doi: 10.1016/j.arth.2019.12.038. Epub 2019 Dec 27.
Harold RE, Butler BA, Delagrammaticas D, Sullivan R, Stover M, Manning DW. Patient-Reported Outcomes Measurement Information System Correlates With Modified Harris Hip Score in Total Hip Arthroplasty. Orthopedics. 2021 Jan 1;44(1):e19-e25. doi: 10.3928/01477447-20201202-02. Epub 2020 Dec 7.
Horn ME, Reinke EK, Couce LJ, Reeve BB, Ledbetter L, George SZ. Reporting and utilization of Patient-Reported Outcomes Measurement Information System(R) (PROMIS(R)) measures in orthopedic research and practice: a systematic review. J Orthop Surg Res. 2020 Nov 23;15(1):553. doi: 10.1186/s13018-020-02068-9.
Keeney BJ, Austin DC, Jevsevar DS. Preoperative Weight Loss for Morbidly Obese Patients Undergoing Total Knee Arthroplasty: Determining the Necessary Amount. J Bone Joint Surg Am. 2019 Aug 21;101(16):1440-1450. doi: 10.2106/JBJS.18.01136.
Lingamfelter M, Orozco FR, Beck CN, Harrer MF, Post ZD, Ong AC, Ponzio DY. Nutritional Counseling Program for Morbidly Obese Patients Enables Weight Optimization for Safe Total Joint Arthroplasty. Orthopedics. 2020 Jul 1;43(4):e316-e322. doi: 10.3928/01477447-20200521-08. Epub 2020 Jun 5.
Shaka H, Ojemolon PE. Impact of Obesity on Outcomes of Patients With Hip Osteoarthritis Who Underwent Hip Arthroplasty. Cureus. 2020 Oct 10;12(10):e10876. doi: 10.7759/cureus.10876.
Shapiro JA, Narayanan AS, Taylor PR, Olcott CW, Del Gaizo DJ. Fate of the Morbidly Obese Patient Who Is Denied Total Joint Arthroplasty. J Arthroplasty. 2020 Jun;35(6S):S124-S128. doi: 10.1016/j.arth.2020.01.071. Epub 2020 Feb 4.
Other Identifiers
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262790
Identifier Type: -
Identifier Source: org_study_id
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