Clinical trial NCT05986617: Wearable Bioimpedance Analyzer for Tracking Body Composition Changes
Official title: Wearable Bioimpedance Analyzer for Tracking Body Composition Changes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Knee Osteoarthritis
Keywords: total knee replacement
obesity
total joint replacement
bioimpedance
orthopedics
body composition
fitness tracker
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: Inclusion Criteria:

* 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"

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 capable of handling iOS or Google Play apps
* Has a wrist circumference greater than 7.7"

Primary outcomes:
measure: Device Impact on Length of Time Until Surgical Indication
timeFrame: Maximum 12 months prior to TJA
Secondary outcomes:
measure: Surgical Outcomes
timeFrame: 24 months postoperatively
measure: Body Composition Changes Quantified
timeFrame: Maximum 12 months prior to TJA
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Jacob Elkins, MD
role: PRINCIPAL_INVESTIGATOR
References:
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