Weight loss before total joint arthroplasty using a remote dietitian and mobile app: study protocol for a multicenter randomized, controlled trial

Michael W Seward, Brielle J Antonelli, Nancy Giunta, Richard Iorio, Wolfgang Fitz, Jeffrey K Lange, Vivek M Shah, Antonia F Chen, Michael W Seward, Brielle J Antonelli, Nancy Giunta, Richard Iorio, Wolfgang Fitz, Jeffrey K Lange, Vivek M Shah, Antonia F Chen

Abstract

Background: The months prior to elective surgery may present an opportunity for patients to initiate behavior changes that will simultaneously ready them for surgery and improve their overall health status. An upcoming elective total joint arthroplasty (TJA) may serve as motivation for patients with severe obesity (body mass index [BMI]> 40 kg/m2) to lose weight, as it may optimize clinical outcomes following TJA and help them become eligible for TJA since some surgeons use a BMI of 40 kg/m2 as a cut-off for offering surgery in an effort to optimize outcomes.

Methods: The purpose of this multicenter randomized, controlled trial is to assess the feasibility and efficacy of a 12-week remote dietitian (RD) supervised dietary and physical activity weight loss intervention and mobile app for 60 patients with severe obesity prior to undergoing TJA. Intervention participants will receive access to a smartphone app and connect with an RD who will contact these participants weekly or bi-weekly via video calls for up to nine video calls. Together, participants and RDs will set goals for lifestyle modifications, and RDs will check on progress towards achieving these goals using in-app tools such as food logs and text messages between video calls. All patients will be encouraged to lose at least 20 pounds with a goal BMI < 40 kg/m2 after 12 weeks. Individuals randomized to the control group will receive clinical standard of care, such as nutritionist and/or physical therapy referrals. Outcome and demographic data will be collected from blood serology, chart review, mobile app user data, pre- and postintervention surveys, and phone interviews. The primary outcome measure will be weight change from baseline. Secondary outcome measures will include percentage of patients eligible to undergo TJA, number of sessions completed with dietitians, self-reported global health status (PROMIS Global Health scale), self-reported joint-specific pain and function (Knee injury and Osteoarthritis Outcome Score (KOOS) or Hip disability and Osteoarthritis Outcome Score (HOOS)), and serologies such as hemoglobin A1c, total lymphocyte count, albumin, and transferrin. Qualitative responses transcribed from phone interviews about the intervention will also be analyzed.

Discussion: This will be the first study to assess pre-operative weight loss in patients with severe obesity anticipating orthopaedic surgery using an RD and mobile app intervention aimed at helping patients become eligible for TJA.

Trial registration: Registered on 1 April 2020 at Clincialtrials.gov. Trial number is NCT04330391 .

Keywords: Arthroplasty; Dietitian; Knee osteoarthritis; Mobile applications; Multicenter Study; Nutritionists; Obesity; Obesity, Morbid; Osteoarthritis, Hip; Preoperative Period; Randomized Controlled Trial; Smartphone; Telemedicine; Weight loss.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram. Randomized controlled trial design

References

    1. Warner DO. Surgery as a teachable moment: lost opportunities to improve public health. Arch Surg. 2009;144(12):1106–1107. doi: 10.1001/archsurg.2009.205.
    1. Robinson A, Slight R, Husband A, Slight S. The value of teachable moments in surgical patient care and the supportive role of digital technologies. Perioper Med (Lond). 2020;9:2. 10.1186/s13741-019-0133-z.
    1. Myers JN, Fonda H. The Impact of Fitness on Surgical Outcomes: The Case for Prehabilitation. Curr Sports Med Rep. 2016;15(4):282–289. doi: 10.1249/JSR.0000000000000274.
    1. Khullar D, Maa J. The impact of smoking on surgical outcomes. J Am Coll Surg. 2012;215(3):418–426. doi: 10.1016/j.jamcollsurg.2012.05.023.
    1. Choban PS, Flancbaum L. The impact of obesity on surgical outcomes: a review. J Am Coll Surg. 1997;185(6):593–603. doi: 10.1016/S1072-7515(97)00109-9.
    1. Grocott MPW, Plumb JOM, Edwards M, Fecher-Jones I, Levett DZH. Re-designing the pathway to surgery: better care and added value. Perioper Med (Lond). 2017;6:9. 10.1186/s13741-017-0065-4.
    1. Williams K, Beeken RJ, Fisher A, Wardle J. Health professionals’ provision of lifestyle advice in the oncology context in the United Kingdom. Eur J Cancer Care (Engl). 2015;24(4):522–530. doi: 10.1111/ecc.12305.
    1. Seward MW, Simon D, Richardson M, Oken E, Gillman MW, Hivert M-F. Supporting healthful lifestyles during pregnancy: a health coach intervention pilot study. BMC Pregnancy Childbirth. 2018;18(1):375. doi: 10.1186/s12884-018-2010-z.
    1. McElroy MJ, Pivec R, Issa K, Harwin SF, Mont MA. The effects of obesity and morbid obesity on outcomes in TKA. J Knee Surg. 2013;26(2):83–88. doi: 10.1055/s-0033-1341407.
    1. Keeney BJ, Austin DC, Jevsevar DS. Preoperative weight loss for morbidly obese patients undergoing total knee arthroplasty. J Bone Jt Surg. 2019;101(16):1440–1450. doi: 10.2106/JBJS.18.01136.
    1. Losina E, Smith KC, Paltiel AD, Collins JE, Suter LG, Hunter DJ, et al. Cost-effectiveness of diet and exercise for overweight and obese patients with knee osteoarthritis. Arthritis Care Res (Hoboken) 2019;71(7):855–864. doi: 10.1002/acr.23716.
    1. Liljensøe A, Laursen J, Bliddal H, et al. FRI0620-HPR Weight Loss Intervention Before Total Knee Arthroplasty – Feasibility and Safety. Ann Rheum Dis. 2015;74:1326.
    1. Gandler N, Simmance N, Keenan J, Choong PFM, Dowsey MM. A pilot study investigating dietetic weight loss interventions and 12 month functional outcomes of patients undergoing total joint replacement. Obes Res Clin Pract. 2016;10(2):220–223. doi: 10.1016/j.orcp.2016.03.006.
    1. Pellegrini CA, Chang RW, Dunlop DD, Conroy DE, Lee J, Van Horn L, et al. Comparison of a patient-centered weight loss program starting before versus after knee replacement: a pilot study. Obes Res Clin Pract. 2018;12(5):472–478. doi: 10.1016/j.orcp.2018.06.009.
    1. Lui M, Jones CA, Westby MD. Effect of non-surgical, non-pharmacological weight loss interventions in patients who are obese prior to hip and knee arthroplasty surgery: a rapid review. Syst Rev. 2015;4:121. 10.1186/s13643-015-0107-2.
    1. Pellegrini CA, Ledford G, Hoffman SA, Chang RW, Cameron KA. Preferences and motivation for weight loss among knee replacement patients: Implications for a patient-centered weight loss intervention. BMC Musculoskelet Disord. 2017;18(1):327. doi: 10.1186/s12891-017-1687-x.
    1. DiLillo V, West DS. Motivational interviewing for weight loss. Psychiatr Clin North Am. 2011;34(4):861–869. doi: 10.1016/j.psc.2011.08.003.
    1. Kelley CP, Sbrocco G, Sbrocco T. Behavioral modification for the management of obesity. Prim Care - Clin Off Pract. 2016;43(1):159–175. doi: 10.1016/j.pop.2015.10.004.
    1. Raynor HA, Champagne CM. Position of the Academy of Nutrition and Dietetics: Interventions for the Treatment of Overweight and Obesity in Adults. J Acad Nutr Diet. 2016;116(1):129–147. doi: 10.1016/j.jand.2015.10.031.
    1. Cleveland LP, Seward MW, Simon D, Rifas-Shiman SL, Lewis KH, Bennett-Rizzo C, Halperin F, McManus KD, Block JP. BWHealthy Weight Pilot Study: A randomized controlled trial to improve weight-loss maintenance using deposit contracts in the workplace. Prev Med Rep. 2020;17:101061. 10.1016/j.pmedr.2020.101061.
    1. Meyer AH, Weissen-Schelling S, Munsch S, Margraf J. Initial development and reliability of a motivation for weight loss scale. Obes Facts. 2010;3(3):205–211. doi: 10.1159/000315048.
    1. Frates B. Paving the path to wellness. Harvard Health Publications. 2017. Measuring your Overall Wellness Using the PAVING Wheel; pp. 1–2.
    1. Bush K, Kivlahan DR, McDonell MB, Fihn SD, Bradley KA. The AUDIT alcohol consumption questions (AUDIT-C): An effective brief screening test for problem drinking. Arch Intern Med. 1998;158(16):1789–1795. doi: 10.1001/archinte.158.16.1789.
    1. Global Adult Tobacco Survey Collaborative Group. Tobacco questions for surveys: a subset of key questions from the global adult tobacco survey (GATS), 2nd Edition [Internet]. Atlanta, GA; 2011. Available from: . Accessed 10 Dec 2019.
    1. Saleh KJ, Mulhall KJ, Bershadsky B, Ghomrawi HM, White LE, Buyea CM, et al. Development and validation of a lower-extremity activity scale: Use for patients treated with revision total knee arthroplasty. J Bone Jt Surg - Ser A. 2005;87(9):1985–1994. doi: 10.2106/00004623-200509000-00011.
    1. Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) - validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes. 2003;1(17).
    1. Nilsdotter AK, Lohmander LS, Klässbo M, Roos EM. Hip disability and osteoarthritis outcome score (HOOS) - Validity and responsiveness in total hip replacement. BMC Musculoskelet Disord. 2003;4(10).
    1. Cross MB, Yi PH, Thomas CF, Garcia J, Della Valle CJ. Evaluation of malnutrition in orthopaedic surgery. J Am Acad Orthop Surg. 2014;22(3):193–199. doi: 10.5435/JAAOS-22-03-193.
    1. Borkan J. Crystallization-Immersion. In: Crabtree BF, Miller WL, editors. Doing Qualitative Research [Internet] Thousand Oaks, California: Sage Publications; 1999. pp. 179–194.

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