Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

Study Overview
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Brief Summary
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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.

Official Title
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Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

Conditions
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Obesity, Knee Osteoarthritis

Intervention / Treatment
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* Device: InBody Band 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults >/= 18 years BMI > 40kg/m2 Presenting to arthroplasty-obesity clinic with desire for total joint arthroplasty procedure Owns a smartphone capable of handling iOS or Google Play apps. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Wearable Device Group<br>Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. | Device: InBody Band 2<br>* Wearable bioimpediance monitor similar to a fitness watch.<br>|
| No Intervention: Control Group<br>Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of body composition changes | To identify if the use of a wearable BIA wristband has any effect on the rate of desired body composition changes. | Maximum 12 months prior to TJA | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Outcomes | Incidence of complications in surgical outcomes for patients across both groups that achieve obtaining surgical indication. | 24 months postoperatively | 
| Body composition changes quantified | Body mass change, fat mass change, skeletal muscle mass change | Maximum 12 months prior to TJA | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orthopedics, total knee replacement, obesity, total joint replacement, bioimpedance, body composition, fitness tracker