AzTrials
AzTrials

ObesityNCT05986617

Wearable Bioimpedance Analyzer for Tracking Body Composition Changes

A study testing InBody Band 2 in people with Obesity and Knee Osteoarthritis, run by University of Iowa at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Obesity, Knee Osteoarthritis
What is being tested?
InBody Band 2
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
14 Jul 2023to 8 Oct 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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"

Who cannot join

  • 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"

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Iowa Hospitals & Clinics

    Iowa City, Iowa, 52242

Other trials in United States

About this study

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.

Being tested
InBody Band 2
Keywords
total knee replacement, obesity, total joint replacement, bioimpedance, orthopedics, body composition, fitness tracker
Medical subject headings
Obesity, Osteoarthritis, Knee

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InBody Band 2Device

    Wearable bioimpediance monitor similar to a fitness watch.

Study groups in NCT05986617
Study groupRoleWhat they receive
Wearable Device GroupExperimentalWill be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
Receives: Device: InBody Band 2
Control GroupNo interventionWill not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Device Impact on Length of Time Until Surgical Indication

    In this RCT, we analyzed the impact of the wearable device (band) on length of time until surgical indication

    Measured: Maximum 12 months prior to TJA

Secondary outcomes (2)

  1. Surgical Outcomes

    Incidence of complications in surgical outcomes for patients across both groups that achieve obtaining surgical indication.

    Measured: 24 months postoperatively

  2. Body Composition Changes Quantified

    Body mass change, fat mass change, skeletal muscle mass change, from the first evaluation visit to the surgery indication visit (when participants are deemed optimized for surgery).

    Measured: Baseline (first visit) and at surgery indication visit.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start14 Jul 2023
  3. Primary completion8 Oct 2024
  4. Study completion8 Oct 2024

Why it stopped: Lack of feasibility due to study device issues.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05986617
Sponsor's protocol ID
202207288
Status last verified
Apr 2026
First submitted
3 May 2023
Last updated
30 Jun 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Obesity: preventing and managing the global epidemic. Report of a WHO consultation. World Health Organ Tech Rep Ser. 2000;894:i-xii, 1-253.

    PubMed 11234459

  • Workgroup of the American Association of Hip and Knee Surgeons Evidence Based Committee. Obesity and total joint arthroplasty: a literature based review. J Arthroplasty. 2013 May;28(5):714-21. doi: 10.1016/j.arth.2013.02.011. Epub 2013 Mar 19.

    PubMed 23518425

  • Andrew JG, Palan J, Kurup HV, Gibson P, Murray DW, Beard DJ. Obesity in total hip replacement. J Bone Joint Surg Br. 2008 Apr;90(4):424-9. doi: 10.1302/0301-620X.90B4.20522.

    PubMed 18378913

  • DeMik DE, Bedard NA, Dowdle SB, Elkins JM, Brown TS, Gao Y, Callaghan JJ. Complications and Obesity in Arthroplasty-A Hip is Not a Knee. J Arthroplasty. 2018 Oct;33(10):3281-3287. doi: 10.1016/j.arth.2018.02.073. Epub 2018 Feb 26.

    PubMed 29631859

  • Foreman CW, Callaghan JJ, Brown TS, Elkins JM, Otero JE. Total Joint Arthroplasty in the Morbidly Obese: How Body Mass Index >/=40 Influences Patient Retention, Treatment Decisions, and Treatment Outcomes. J Arthroplasty. 2020 Jan;35(1):39-44. doi: 10.1016/j.arth.2019.08.019. Epub 2019 Aug 17.

    PubMed 31530460

  • Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The impact of pre-operative weight loss on incidence of surgical site infection and readmission rates after total joint arthroplasty. J Arthroplasty. 2014 Mar;29(3):458-64.e1. doi: 10.1016/j.arth.2013.07.030. Epub 2013 Sep 7.

    PubMed 24018161

  • Inacio MC, Kritz-Silverstein D, Raman R, Macera CA, Nichols JF, Shaffer RA, Fithian DC. The risk of surgical site infection and re-admission in obese patients undergoing total joint replacement who lose weight before surgery and keep it off post-operatively. Bone Joint J. 2014 May;96-B(5):629-35. doi: 10.1302/0301-620X.96B5.33136.

    PubMed 24788497

  • Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee arthroplasty in morbidly obese patients. Clin Orthop Relat Res. 2013 Oct;471(10):3358-66. doi: 10.1007/s11999-013-3049-9. Epub 2013 May 14.

    PubMed 23670675

  • Ward LC, Dyer JM, Byrne NM, Sharpe KK, Hills AP. Validation of a three-frequency bioimpedance spectroscopic method for body composition analysis. Nutrition. 2007 Sep;23(9):657-64. doi: 10.1016/j.nut.2007.06.009.

    PubMed 17679047

  • Milone MT, Shenoy K, Pham H, Jazrawi LM, Strauss EJ. MRI analysis of peripheral soft tissue composition, not body mass index, correlates with outcomes following anterior cruciate ligament reconstruction. Knee Surg Sports Traumatol Arthrosc. 2018 Dec;26(12):3711-3716. doi: 10.1007/s00167-018-4966-7. Epub 2018 May 3.

    PubMed 29725746

  • Muller M, Tohtz S, Winkler T, Dewey M, Springer I, Perka C. MRI findings of gluteus minimus muscle damage in primary total hip arthroplasty and the influence on clinical outcome. Arch Orthop Trauma Surg. 2010 Jul;130(7):927-35. doi: 10.1007/s00402-010-1085-4. Epub 2010 Mar 11.

    PubMed 20221834

  • Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema evaluation after total knee arthroplasty. Physiother Res Int. 2013 Sep;18(3):140-7. doi: 10.1002/pri.1540. Epub 2012 Nov 27.

    PubMed 23188719

  • Qin ES, Bowen MJ, James SL, Chen WF. Multi-segment bioimpedance can assess patients with bilateral lymphedema. J Plast Reconstr Aesthet Surg. 2020 Feb;73(2):328-336. doi: 10.1016/j.bjps.2019.06.041. Epub 2019 Aug 7.

    PubMed 31515193

Questions about this trial

What is this clinical trial studying?

A study testing InBody Band 2 in people with Obesity and Knee Osteoarthritis, run by University of Iowa at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Device Impact on Length of Time Until Surgical Indication (time frame: Maximum 12 months prior to TJA). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05986617, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.

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