Wearable Bioimpedance Analyzer for Tracking Body Composition Changes
Phase: NA
Conditions: Obesity, Knee Osteoarthritis
Sponsor: University of Iowa

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Protocol Title: Wearable Bioimpedance Analyzer for Tracking Body Composition Changes: A 
Randomized Controlled Trial  
Protocol Version: 1.1 
Protocol Date: 8/1/22 
Principal Investigator: Jacob M. Elkins, MD, PhD 
Research Team: Michael Marinier, Ayobami Ogunsola, Lauren Keitel  
 
1) Abstract 
a) 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. In our 
clinic, 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 our 
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. 
2) Background and Significance/Preliminary Studies 
a) Obesity is a well-known epidemic in the US with prevalence nearing 40%. [1] Obesity is 
a risk factor for a myriad of disease states including osteoarthritis (OA) due to increased 
load on the weightbearing joints. Therefore, patients with obesity, and namely those with 
body mass index (BMI) approaching >40kg/m2 (class III obesity), suffer from OA 
disproportionately compared to their non-obese peers. [2] As this population frequently 
reports to arthroplasty clinics, studies have identified increased rates of post-operative 
complications following total joint arthroplasty (TJA) specifically in the class III obese 
population. [2-5] To combat this increased risk, arthroplasty surgeons traditionally have 
excluded this population from their surgical practice or encouraged their patients to lose 
weight in order for their BMI to drop below 40kg/m2; however, these practices have been 
recently questioned. [6-8] 
 
 
With the validity of lowering BMI to improve TJA outcomes being questioned, 
studies have made efforts to identify more patient-specific factors such as body 
composition. Body composition can be identified through several modalities including 
anthropomorphic measurements, DEXA, MRI, and CT. [9-11] In addition, bioimpedance 

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analysis (BIA) offers rapid, accurate, and non-invasive assessment without the use of 
ionizing radiation. [9, 12, 13] BIA can be completed through multiple devices including a 
stationary, scale-like device, a portable ECG-like device, or even wearable wristbands.  
 
 
Our group has conducted numerous studies focusing on body composition in 
arthroplasty patients, including changes they experience following surgery and pre-
operative risk identification. By employing both clinic-based and home-based 
assessments more frequently than patients would normally have, this study aims to 
identify any benefit, if any, a wearable BIA device serves in an obese-arthroplasty 
population.  
3) Study Aims 
a) Aims: 
i) To identify if the use of a wearable BIA wristband aids in the desired body 
composition changes (body mass loss, fat mass loss, skeletal muscle mass gain) 
ii) To quantify the body composition changes exhibited by each cohort 
iii) To track surgical outcomes for those patients that are indicated for total joint 
arthroplasty 
b) Hypotheses: 
i) The wearable group will exhibit the desired body composition changes more rapidly 
than the control group 
ii) The wearable group will exhibit greater desired body composition changes more 
rapidly than the control group 
iii) The wearable group will less post-operative complications than the control group 
4) Administrative Organization 
a) This study will solely be completed at the University of Iowa Healthcare and Clinics 
Department of Orthopaedics and Rehabilitation. 
5) Study Design 
a) Experimental design of the study: randomized controlled trial with single blinding 
b) Study population general description 
i) Specify total number of adult subjects, age range and percent by gender 
(1) 90 subjects (>18 years old) 
(2) 50% male, 50% female 
ii) Specify total number of minor subjects (less than 18 years of age), age range and 
percent by gender. 
(1) none 
c) Sample size determination and power analyses 
i)  A power analysis was performed by the orthopedic department statistician Natalie 
Glass. 
d) Study outcomes/endpoints 
i) Primary outcomes 
(1) Muscle mass, body mass, and fat mass changes from baseline at 3-, 6-, 9-, and 12-
months 
ii) Secondary outcomes 
(1) Time to achieve desired body composition changes 
(2) Time to TJA indication 
(3) Surgical outcomes for those that undergo TJA 
6) Study Procedures 

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a) Describe Subject selection procedures 
i) Describe the sampling plan including Inclusion/Exclusion criteria (subject and 
disease characteristics) 
(1) Inclusion Criteria 
(a) Adults > 18 years 
(b) BMI > 40kg/m2 
(c) Presenting to arthroplasty-obesity clinic with desire for total joint arthroplasty 
procedure 
(d) Owns a smartphone capable of handling iOS or Google Play apps 
(2) Exclusion Criteria 
(a) Has a pacemaker or other electronic pacemaker placement 
(b) Inability to complete study protocols 
(c) Inability to stand unsupported for 60-90 seconds 
ii) Indicate if the study plans to enroll non-English speaking subjects. If so, specify 
language(s), who will translate documents, who will serve as a translator. The IRB 
must review and approve all translated documents. 
(1) This group will not be enrolled 
iii) Indicate if the study will enroll subordinates of the PI or a member of the research 
team. 
(1) This group will not be enrolled 
iv) Indicate if the study will enroll pregnant women for research on fetuses and neonates 
(1) This group will not be enrolled 
v) Indicate if the study will enroll adult subjects who have cognitive impairment and are 
not able to provide legally effective informed consent. If so, specify how you will 
assess capacity to consent and whether you will enroll subjects who cannot consent 
for themselves. Describe the consent process with the Legally Authorized 
Representative. 
(1) This group will not be enrolled 
vi) Indicate if the study will enroll subjects whose capacity to consent may change during 
the study. If so, specify how you will assess capacity to consent and how you will 
obtain consent from subjects or their Legally Authorized Representative. 
(1) This group will not be enrolled 
b) Describe all possible recruitment procedures 
i) Describe all recruitment methods and materials. 
(1) Subjects reporting to arthroplasty-obesity will be recruited by the study team 
members using the informed consent form as materials 
ii) Specify if the researcher will use protected health information (PHI) to identify 
potential subjects – what data elements, why you couldn’t recruit without accessing 
PHI, why you couldn’t obtain patient permission, how you will protect identified PHI 
used for recruitment purposes, when you will remove identifiers OR justification for 
storing identifiers until the end of the recruitment period. You must agree to agree not 
to reuse or disclose this information. 
(1) The subjects will be identified by those reporting to arthroplasty-obesity clinic, 
which the PI has access to. The identifiable information used will be the patient’s 
name, age, BMI, and reason for reporting to clinic. 
iii) Describe screening prior to consent 

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(1) Patients’ medical record will be reviewed for their age, BMI, and reason for 
reporting to clinic. When they are approached, they will be asked if they have a 
smartphone and/or an electronic cardiac device. 
iv) What recruitment materials will be provided to the potential participant 
(brochures/information sheets/video presentation)? 
(1) The informed consent will be used. 
v) Specify if you are discussing study in person or by phone prior to consent.\ 
(1) This will be discussed in person.  
c) Indicate where and when consent be obtained 
i) State who will conduct the consent process 
(1) Any member of the study team will conduct the consent process 
ii) Describe the steps of the consent process in detail. 
(1) The patient will be identified on the clinic schedule, and they will be approached 
in their private clinic room. They will be asked if they are interested in 
participating in a study. If they agree, they will be asked the above screening 
questions. If they are eligible a study team member will orally review the consent 
form and have the participant review the written consent form. All questions will 
be answered. 
iii) Specify what documents will be used in the consent process (Informed Consent 
Document, Consent Letter or Information Sheet, Assent Document, Verbal/Phone 
Script, Exempt Information Sheet, Consent Summary, Other) 
(1) Informed consent form 
iv) Specify if the study requires a waiver of consent OR waiver of documentation of 
consent. If so, provide justification. 
(1) No waiver 
v) Specify how long subjects can consider whether to participate AND if they can 
consult with other people before deciding to participate. 
(1) They will be eligible until the end of their initial clinic visits to arthroplasty-
obesity clinic 
vi) Specify how long after subjects agree to participate before the study procedures 
begin. 
(1) Immediately  
d) Describe screening procedures 
i) Describe eligibility screening procedures before and/or after consent. 
(1) Subjects will be asked about owning a smartphone and if they have an electronic 
cardiac device prior to the consent process 
ii) Describe the screening schedule (number of visits, length of visits) 
(1) The screening visit will be at the enrollment visit 
iii) Indicate whether screening tests/procedures are part of standard care or done for 
research purposes only 
(1) These are done per research protocol 
iv) Specify what happens with screen failures (including any data gathered during 
screening) 
(1) They will not be eligible to enroll, and no information/PHI will be recorded. 
e) Describe randomization procedures (if applicable) – Specify the randomization scheme 
and process. 

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i) Block randomization in RedCap. Patients will be randomized at the conclusion of 
their clinic visit as to not influence the education they receive by the PI/provider 
f) Describe study intervention(s) 
i) For Other types of intervention studies, describe: 
(1) Active intervention description 
(a) Patients will be provided a BIA wearable (InBody BAND 2) and instructions 
regarding downloading smartphone app. Education regarding the device and 
app will be provided. In addition, they will receive the standard 
procedures/education provided in arthroplasty-obesity clinic 
(2) Control group 
(a) They will receive the standard procedures /education provided in arthroplasty-
obesity clinic 
g) Describe all study assessments and activities 
i) Provide a thorough, detailed description 
(1) Randomization  
(a) Once enrolled, patients will be randomized by a non-PI study member. 
Randomization will occur after the clinic standard education as to not be 
influenced based on randomization group.  
(2) All patients  
(a) All patients will experience a “coaching” period and be eligible for a “surgical 
period”. All patients (study and control) will undergo the clinic standard 
operating procedures of stationary BIA, hand-grip strength, and exercise and 
nutritional education (weight/resistance training, low carbohydrate/high 
protein diet) in the “coaching” period. All patients will also be advised of the 
goal to maintain or lose body mass, lose body fat, and gain muscle mass, 
which is also clinic standard operating procedure. Patients will follow-up in 
the clinic per standard protocol at approximately every 3 months (±1 month). 
At each visit, stationary BIA, hand-grip strength, and exercise and nutritional 
coaching will be repeated, as is standard in clinic. All patients will be eligible 
to be indicated for TJA at the PI’s discretion. Per clinic procedures, patients 
are indicated for TJA as they achieve their body composition goals (maintain 
or lose body mass, lose body fat, and gain muscle mass). All patients will be 
instructed to not discuss their study arm (wearable or control) with the PI. 
Patients are eligible to enter the surgical period at any point during the 
coaching period. If patients feel that they meet their goals prior to they are 
eligible to reschedule their appointment sooner than the next visit. All patients 
will receive a phone call from a study team member every 1 month to assess 
compliance with study arm and check in on perceived progress.  
(3) Wearable group 
(a) If patients are randomized the wearable group, they will be provided a 
wearable and instructions on installing the app and its features. They will be 
instructed to take BIA measurements at least weekly via the wearable. The 
wearable group will be instructed at the beginning of each visit to remove and 
keep their wearable out of sight of the PI during their visit. 
(4) Patients who enter “Surgical” period 

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(a) Patients who are indicated for TJA (at the PI’s discretion) will leave the 
coaching period and enter the surgical period. Patients’ medical record will be 
followed if they are indicated for TJA for post-operative outcomes such as 
infection, reoperation, implant failure. Surgical follow-up will occur for up to 
24 months following study enrollment.  
ii) Provide a schedule of all study assessments and subject activities, including a tabular 
representation or timeline as applicable 
(1) See Table I below 
h) Recontacting Subjects Lost to Follow Up – Indicate if the researcher will attempt to 
locate subjects if the research team is unable to reach them through the contact 
information they provided. Describe the procedures and justification for these efforts to 
locate subjects. 
i) Research members will not contact the patients lost to follow, as standard clinic 
procedures have nursing staff contact the patients. 
i) Subject Compensation 
i) Specify compensation method(s) 
(1) Patients will not be compensated monetarily. Those randomized to the study 
cohort will be able to keep their wearable device, if desired. 
ii) Describe the compensation plan, including amount per visit, total compensation 
amount, pro-rating for early withdrawal 
(1) N/A 
iii) Indicate whether the study will use the departmental cash handling plan or obtain 
approval from Accounting Services for a study-specific cash handling plan. 
(1) N/A 
7) Privacy and Confidentiality Protections 
a) Describe privacy protections – collecting data in a private space, collecting the amount 
and type of information you need to answer your research question(s) 
i) Only the minimum necessary data will be collected. The data collected will be done 
in a private clinic room.  
b) Describe plans and justification for collecting social security number (SSN) 
i) N/A 
c) Confidentiality / Data Security Plans – Refer to the Data Security Educational Tool and 
the Protecting Sensitive Data page of the UI ITS website. Specify plans for transmitting, 
transporting and/or storing: 
i) Paper records 
(1) Informed consent documents to be kept in PI’s locked office 
ii) Electronic records - Specify who is responsible for maintaining security. Researchers 
are advised to consult with the departmental IT representative to establish a data 
security plan that is appropriate to the level of security of the data being 
collected/stored for the project. 
(1) Standard protections on departmental server 
iii) Biospecimens - Specify who is responsible for maintaining security. 
(1) N/A 
d) Plans for sharing data or taking data outside the UI 
i) N/A 
8) Risks and Benefits 

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a) Describe all possible risks (physical, emotional or psychological, financial, legal or social 
risks). 
i) Risks include loss of information/privacy, falling off stationary BIA scanner, hand 
pain from hand grip strength testing.  
b) Describe all steps to minimize any possible risk to subjects. 
i) Data will only be accessed by need-to-know study members, a study team member 
will supervise and “spot” the subject on the stationary BIA scanner, patient will be 
advised to take rests in between hand grip strength testing to minimize pain. 
c) Describe all guaranteed direct benefits to subjects (do not include compensation or 
hypothesized results). 
i) None 
d) Describe potential benefits to society from the results of the research. 
i) Future patients will benefit from knowing if wearable technology has an effect or not. 
9) Safety Monitoring Plan 
a) N/A 
10) Data Analysis Plan 
a) Describe statistical analysis methods as appropriate. Consult with a biostatistician, if 
appropriate. The analysis plan should correspond with the data collection described in the 
Study Procedures section. Describe plans for intent-to-treat methodology and any sample 
stratification. 
i) Noninferiority comparison of the primary outcome and secondary outcome between 
the treatment groups at each time points. 
ii) Multivariate analysis to compare patient demographics between the two treatment 
arms.  
iii) Non-parametric tests such as ANOVA and ANCOVA will be utilized to determine if 
there is any difference between the two groups. 
b) Provide the rationale or power analysis to support the number of subjects proposed to 
complete the study.   
Group sample sizes of 44 in the treatment and control arm achieve 80% power to detect a 
difference of 1.676 in a design with 5 repeated measurements having a compound 
symmetry covariance structure when the standard deviation is 3.610, the correlation 
between observations on the same subject is 0.500, and the alpha level is 0.050 
 
           

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11) Tables and Figures 
 
Table I. Schedule of study procedures.  
Study Period 
Coachinga 
Surgicala 
Visit Number 
V1  
V2 
V3 
V4 
V5 
V6 
V7 
V8 
V9 
V10 
V11 
V12 
V13 
EMR follow-up 
Month 
0 
1 
2 
3 
3 
4 
6 
7 
8 
9 
10 
11 
12 
Until Month 24 
All Patients 
Screening 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Clinic Educationb 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Stationary BIAb 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Handgrip Strengthb 
X 
 
 
X 
 
 
X 
 
 
X 
 
 
X 
 
Phone Visit 
 
X 
X 
 
X 
X 
 
X 
X 
 
X 
X 
 
 
Wearable Group 
Wearable Distribution 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
Wearable Compliance Check 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Surgical Outcomes Checkc 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
aPatients may exit the Coaching period and enter the Surgical period at any time point 
bStandard protocol for all patients presenting to arthroplasty-obesity clinic 
cOnly for study group 
dOnly for subjects that undergo TJA. Will occur via EMR rather than direct patient contact. 
 
 

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12) Literature Citations 
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Health Organ Tech Rep Ser 894: i, 2000 
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replacement. J Bone Joint Surg Br 90(4): 424, 2008 
4. 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. The Journal of arthroplasty 
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5. 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 35(1): 39, 2020 
6. 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 29(3): 458, 2014 
7. 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 96-
b(5): 629, 2014 
8. Friedman RJ, Hess S, Berkowitz SD, Homering M. Complication rates after hip or knee 
arthroplasty in morbidly obese patients. Clinical orthopaedics and related research 471(10): 
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9. Ward LC, Dyer JM, Byrne NM, Sharpe KK, Hills AP. Validation of a three-frequency 
bioimpedance spectroscopic method for body composition analysis. Nutrition 23(9): 657, 2007 
10. 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 
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Arch Orthop Trauma Surg 130(7): 927, 2010 
12. Pichonnaz C, Bassin JP, Currat D, Martin E, Jolles BM. Bioimpedance for oedema 
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13. Qin ES, Bowen MJ, James SL, Chen WF. Multi-segment bioimpedance can assess patients 
with bilateral lymphedema. J Plast Reconstr Aesthet Surg 73(2): 328, 2020