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NCT05986617 · ClinicalTrials.gov registry record · NA
Wearable Bioimpedance Analyzer for Tracking Body Composition Changes
A NA study, sponsored by University of Iowa.
- Terminated
- Registry status
- NA
- Development phase
- 60
- Enrollment target
NCT05986617 is a NA study that was terminated before completion, run by University of Iowa. The registered enrollment target is 60 participants.
The verdict
NCT05986617, a NA study, was terminated before completion, sponsored by University of Iowa.
- TERMINATED
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
Study 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.
Interventions
- DEVICE InBody Band 2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2023-07-14 |
| Est. Completion | 2024-10-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05986617
The ClinicalTrials.gov registry entry for NCT05986617 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Iowa, which has 228 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which InBody Band 2 is the first listed.
NCT05986617 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05986617 about?
NCT05986617 is a clinical study titled "Wearable Bioimpedance Analyzer for Tracking Body Composition Changes". 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 ...
What is the current status of trial NCT05986617?
This trial is currently terminated. It is a NA study. The enrollment target is 60 participants. The study started on 2023-07-14. Estimated completion is 2024-10-08.
What interventions are being tested in trial NCT05986617?
The interventions under investigation include: InBody Band 2 (DEVICE).
Who is sponsoring clinical trial NCT05986617?
This trial is sponsored by University of Iowa, which has 228 total clinical trials registered on ClinicalTrials.gov.
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