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Wearable Bioimpedance Analyzer for Obesity in Osteoarthritis
N/A
Waitlist Available
Research Sponsored by University of Iowa
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months postoperatively
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to see if a wearable BIA wristband can help obese patients with osteoarthritis, who are seeking joint surgery, to safely lose body fat and gain muscle mass.
Who is the study for?
This trial is for adults with class III obesity (BMI > 40kg/m2) who are seeking joint replacement surgery and own a smartphone. It's not suitable for those unable to stand unsupported, have a pacemaker, or can't follow the study procedures.
What is being tested?
The trial tests if wearing the InBody Band 2, a bioimpedance analyzer that tracks body composition changes, helps in gaining muscle mass and losing fat when combined with standard coaching compared to coaching alone.
What are the potential side effects?
There are no direct side effects from using the InBody Band 2 itself as it is non-invasive. However, participants should be aware of general risks associated with changing diet and exercise routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months postoperatively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Rate of body composition changes
Secondary study objectives
Body composition changes quantified
Surgical Outcomes
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Wearable Device GroupExperimental Treatment1 Intervention
Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
Group II: Control GroupActive Control1 Intervention
Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
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Who is running the clinical trial?
University of IowaLead Sponsor
467 Previous Clinical Trials
893,381 Total Patients Enrolled
8 Trials studying Obesity
7,659 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I want a joint replacement and am visiting a clinic for it.I am unable to follow the study's required procedures.I cannot stand by myself for 1 to 1.5 minutes.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Wearable Device Group
- Group 2: Control Group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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