Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

NCT05986617 | Terminated Results FDA Device

• 1 other identifier: 202207288
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity, namely at body mass index (BMI) levels exceeding 40kg/m2 (class III obesity), is a risk factor for many diseases including osteoarthritis (OA). In arthroplasty, patients in this population frequently present for and are turned away from surgical intervention. Subsequently, efforts are made to decrease BMI through simple weight loss, yet these have been suggested as ineffective and counterproductive. Furthermore, simple weight loss may include muscle mass loss, which is an additional risk factor for surgery. At the University of Iowa Hospitals and Clinics Orthopedics Department, efforts have been made to encourage muscle mass gain and body fat loss over simple weight loss where progress has been tracked through stationary, multi-frequency bioimpedance analysis (BIA). BIA is a readily available technology offered to industry and consumers, and BIA has recently been incorporated into wearable devices. In the UIHC Orthopedics department, a novel clinic aimed at holistically serving the osteoarthritic-class III obese population for controlled and monitored weight loss through BIA. This study, a randomized controlled trial, aims to recruit adult patients with class III obesity presenting to the arthroplasty-obesity clinic. While all patients will receive individual body composition coaching to increase muscle mass and decrease body fat mass, they will be randomized to one of two cohorts: the study group will receive a wearable BIA wristband (InBody BAND 2) and instruction on its use in addition to the standard coaching, and the control group will only receive the standard coaching. This study aims to identify if the use of a wearable BIA wristband aids in the desired body composition changes. In addition, this study aims to quantify the body composition changes exhibited by each cohort. Finally, this study aims to track surgical outcomes for those patients that are indicated for total joint arthroplasty.

Conditions

Obesity; Knee Osteoarthritis

Keywords

total knee replacement; obesity; total joint replacement; bioimpedance; orthopedics; body composition; fitness tracker

Study Arms (2)

Wearable Device Group

EXPERIMENTAL

Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.

Device: InBody Band 2

Control Group

NO INTERVENTION

Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.

Interventions

InBody Band 2 DEVICE

Wearable bioimpediance monitor similar to a fitness watch.

Wearable Device Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults \>/= 18 years
• BMI \> 40kg/m2
• Presenting to bariatric arthroplasty clinic with desire for total joint arthroplasty procedure
• Owns a smartphone capable of handling iOS or Google Play apps
• Has a wrist circumference less than or equal to 7.7"

You may not qualify if:

• Has a pacemaker or other electronic pacemaker placement
• Inability to complete study protocols
• Inability to stand unsupported for 60-90 seconds
• Does not own a smart phone capable of handling iOS or Google Play apps
• Has a wrist circumference greater than 7.7"

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hospitals & Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (13)

• Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

  PMID: 11234459 BACKGROUND

• Workgroup of the American Association of Hip and Knee Surgeons Evidence Based Committee. Obesity and total joint arthroplasty: a literature based review. J Arthroplasty. 2013 May;28(5):714-21. doi: 10.1016/j.arth.2013.02.011. Epub 2013 Mar 19.

  PMID: 23518425 BACKGROUND

• Andrew JG, Palan J, Kurup HV, Gibson P, Murray DW, Beard DJ. Obesity in total hip replacement. J Bone Joint Surg Br. 2008 Apr;90(4):424-9. doi: 10.1302/0301-620X.90B4.20522.

  PMID: 18378913 BACKGROUND

• DeMik DE, Bedard NA, Dowdle SB, Elkins JM, Brown TS, Gao Y, Callaghan JJ. Complications and Obesity in Arthroplasty-A Hip is Not a Knee. J Arthroplasty. 2018 Oct;33(10):3281-3287. doi: 10.1016/j.arth.2018.02.073. Epub 2018 Feb 26.

  PMID: 29631859 BACKGROUND

• Foreman CW, Callaghan JJ, Brown TS, Elkins JM, Otero JE. Total Joint Arthroplasty in the Morbidly Obese: How Body Mass Index >/=40 Influences Patient Retention, Treatment Decisions, and Treatment Outcomes. J Arthroplasty. 2020 Jan;35(1):39-44. doi: 10.1016/j.arth.2019.08.019. Epub 2019 Aug 17.

  PMID: 31530460 BACKGROUND

• Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The impact of pre-operative weight loss on incidence of surgical site infection and readmission rates after total joint arthroplasty. J Arthroplasty. 2014 Mar;29(3):458-64.e1. doi: 10.1016/j.arth.2013.07.030. Epub 2013 Sep 7.

  PMID: 24018161 BACKGROUND

• Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The risk of surgical site infection and re-admission in obese patients undergoing total joint replacement who lose weight before surgery and keep it off post-operatively. Bone Joint J. 2014 May;96-B(5):629-35. doi: 10.1302/0301-620X.96B5.33136.

  PMID: 24788497 BACKGROUND

• Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee arthroplasty in morbidly obese patients. Clin Orthop Relat Res. 2013 Oct;471(10):3358-66. doi: 10.1007/s11999-013-3049-9. Epub 2013 May 14.

  PMID: 23670675 BACKGROUND

• Ward LC, Dyer JM, Byrne NM, Sharpe KK, Hills AP. Validation of a three-frequency bioimpedance spectroscopic method for body composition analysis. Nutrition. 2007 Sep;23(9):657-64. doi: 10.1016/j.nut.2007.06.009.

  PMID: 17679047 BACKGROUND

• Milone MT, Shenoy K, Pham H, Jazrawi LM, Strauss EJ. MRI analysis of peripheral soft tissue composition, not body mass index, correlates with outcomes following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2018 Dec;26(12):3711-3716. doi: 10.1007/s00167-018-4966-7. Epub 2018 May 3.

  PMID: 29725746 BACKGROUND

• Muller M, Tohtz S, Winkler T, Dewey M, Springer I, Perka C. MRI findings of gluteus minimus muscle damage in primary total hip arthroplasty and the influence on clinical outcome. Arch Orthop Trauma Surg. 2010 Jul;130(7):927-35. doi: 10.1007/s00402-010-1085-4. Epub 2010 Mar 11.

  PMID: 20221834 BACKGROUND

• Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27.

  PMID: 23188719 BACKGROUND

• Qin ES, Bowen MJ, James SL, Chen WF. Multi-segment bioimpedance can assess patients with bilateral lymphedema. J Plast Reconstr Aesthet Surg. 2020 Feb;73(2):328-336. doi: 10.1016/j.bjps.2019.06.041. Epub 2019 Aug 7.

  PMID: 31515193 BACKGROUND

MeSH Terms

Conditions

Obesity; Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Jacob Elkins, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Orthopedics and Rehabilitation

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: August 14, 2023
• Study Start: July 14, 2023
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: June 30, 2026
• Results First Posted: December 17, 2024

Record last verified: 2026-04

Locations

US (1)