Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

Sponsor

University of Iowa (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05986617

Collaborator

(none)

Enrollment

Location

Arms

21.6

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity Knee Osteoarthritis	Device: InBody Band 2	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

Actual Study Start Date :

Jul 14, 2023

Anticipated Primary Completion Date :

Apr 1, 2025

Anticipated Study Completion Date :

May 1, 2025

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Rate of body composition changes [Maximum 12 months prior to TJA]
To identify if the use of a wearable BIA wristband has any effect on the rate of desired body composition changes.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.