Trial Outcomes & Findings for Wearable Bioimpedance Analyzer for Tracking Body Composition Changes (NCT NCT05986617)

NCT ID: NCT05986617

Last Updated: 2026-06-30

Results Overview

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

Recruitment status

TERMINATED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

Maximum 12 months prior to TJA

Results posted on

2026-06-30

Participant Flow

Recruitment period dates: 07/14/2023 - 05/31/2024 Types of location: medical clinic

Participant milestones

Participant milestones
Measure	Wearable Device Group Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. InBody Band 2: Wearable bioimpediance monitor similar to a fitness watch.	Control Group Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
Overall Study STARTED	30	30
Overall Study COMPLETED	1	5
Overall Study NOT COMPLETED	29	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Wearable Device Group n=30 Participants Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. InBody Band 2: Wearable bioimpediance monitor similar to a fitness watch.	Control Group n=30 Participants Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=30 Participants	0 Participants n=60 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=30 Participants	15 Participants n=30 Participants	45 Participants n=60 Participants
Age, Categorical >=65 years	0 Participants n=30 Participants	15 Participants n=30 Participants	15 Participants n=60 Participants
Age, Continuous	57.6 years n=30 Participants	58.1 years n=30 Participants	57.9 years n=60 Participants
Sex: Female, Male Female	25 Participants n=30 Participants	23 Participants n=30 Participants	48 Participants n=60 Participants
Sex: Female, Male Male	5 Participants n=30 Participants	7 Participants n=30 Participants	12 Participants n=60 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	30 participants n=30 Participants	30 participants n=30 Participants	60 participants n=60 Participants
Body mass index (BMI)	49.8 units on a scale (kg/m^2) n=30 Participants	50.9 units on a scale (kg/m^2) n=30 Participants	50.3 units on a scale (kg/m^2) n=60 Participants

PRIMARY outcome

Timeframe: Maximum 12 months prior to TJA

Population: 6 total subjects were indicated for surgery. 3 per group.

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

Outcome measures

Outcome measures
Measure	Control Group n=3 Participants Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.	Wearable Device Group n=3 Participants Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. InBody Band 2: Wearable bioimpediance monitor similar to a fitness watch.
Device Impact on Length of Time Until Surgical Indication	8.7 months Interval 7.0 to 10.0	3.7 months Interval 3.0 to 7.0

SECONDARY outcome

Timeframe: 24 months postoperatively

Population: Surgical outcomes were not collected due to study termination. At the time of study closure only 2 participants had had surgery, and they did not complete a follow-up period long enough to warrant surgical outcomes analysis. The research team can't compliantly access the medical records of these study participants anymore due to study termination. This information was never extracted, and therefore an analysis cannot be provided.

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

Outcome measures

Outcome measures
Measure	Control Group Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.	Wearable Device Group Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. InBody Band 2: Wearable bioimpediance monitor similar to a fitness watch.
Surgical Outcomes	0 Participants	0 Participants

SECONDARY outcome

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

Population: 3 participants from each group graduated, meaning they were indicated for surgery upon achieving their goals.

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).

Outcome measures

Outcome measures
Measure	Control Group n=3 Participants Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.	Wearable Device Group n=3 Participants Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. InBody Band 2: Wearable bioimpediance monitor similar to a fitness watch.
Body Composition Changes Quantified change in body mass (lbs)	-37.1 lbs Standard Deviation 15.8	-16.2 lbs Standard Deviation 13.8
Body Composition Changes Quantified change in fat mass (lbs)	-28.4 lbs Standard Deviation 12.9	-11.4 lbs Standard Deviation 9.9
Body Composition Changes Quantified change in skeletal muscle mass (lbs)	-5.1 lbs Standard Deviation 2.0	-3.1 lbs Standard Deviation 2.3

Adverse Events

Wearable Device Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Wearable Device Group n=30 participants at risk Will be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty. InBody Band 2: Wearable bioimpediance monitor similar to a fitness watch.	Control Group n=30 participants at risk Will not be given InBody Band 2 to use while trying to achieve weight loss goal prior to total joint arthroplasty.
Skin and subcutaneous tissue disorders Band Tightness Resulting in Wrist Pain and Ball on Wrist	0.00% 0/30 • 1 year	0.00% 0/30 • 1 year

Additional Information

Victoria Tappa

University of Iowa

Phone: 3193846136

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place