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Wearable Bioimpedance Analyzer for Tracking Body Composition Changes
NA trial testing InBody Band 2 in Obesity in 60 participants. Terminated before completion.
| Lead sponsor | University of Iowa |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | other |
| Enrollment | 60 |
| Start date | 14 July 2023 |
| Primary completion | 8 October 2024 |
| Estimated completion | 8 October 2024 |
| Sites | 1 location across United States |
University of Iowa
Adults 18 to 99, any sex, with Obesity or Knee Osteoarthritis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
In this RCT, we analyzed the impact of the wearable device (band) on length of time until surgical indication
| Group | Value | 95% CI |
|---|---|---|
| Wearable Device Group | 3.7 | 3 – 7 |
| Control Group | 8.7 | 7 – 10 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Wearable Device Group | Control Group |
|---|---|---|---|
| Band Tightness Resulting in Wrist Pain and Ball on Wrist | Skin and subcutaneous tissue disorders | — | — |
Data from ClinicalTrials.gov NCT05986617 adverse events section.
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.
No peer-reviewed publications indexed yet for this trial.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing