Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

November 21, 2024 updated by: Jacob M. Elkins, University of Iowa

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Wearable Device Group
Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
Device: InBody Band 2
Wearable bioimpediance monitor similar to a fitness watch.
No Intervention: Control Group
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Impact on Length of Time Until Surgical Indication
Time Frame: Maximum 12 months prior to TJA
In this RCT, we analyzed the impact of the wearable device (band) on length of time until surgical indication
Maximum 12 months prior to TJA

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Iowa

Investigators

  • Principal Investigator: Jacob Elkins, MD, University of Iowa

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 14, 2023

Primary Completion (Actual)

October 8, 2024

Study Completion (Actual)

October 8, 2024

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

August 2, 2023

First Posted (Actual)

August 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202207288

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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