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

NCT ID: NCT05986617

Last Updated: 2024-12-17

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: NA
• Target enrollment: 60 participants
• Primary outcome timeframe: Maximum 12 months prior to TJA
• Results posted on: 2024-12-17

Participant Flow

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

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

Measure	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	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.
Age, Categorical <=18 years	0 Participants n=30 Participants	0 Participants n=60 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=30 Participants	45 Participants n=60 Participants	30 Participants n=30 Participants
Age, Categorical >=65 years	15 Participants n=30 Participants	15 Participants n=60 Participants	0 Participants n=30 Participants
Age, Continuous	58.1 years n=30 Participants	57.9 years n=60 Participants	57.6 years n=30 Participants
Sex: Female, Male Female	23 Participants n=30 Participants	48 Participants n=60 Participants	25 Participants n=30 Participants
Sex: Female, Male Male	7 Participants n=30 Participants	12 Participants n=60 Participants	5 Participants n=30 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	60 participants n=60 Participants	30 participants n=30 Participants
Body mass index (BMI)	50.9 units on a scale (kg/m^2) n=30 Participants	50.3 units on a scale (kg/m^2) n=60 Participants	49.8 units on a scale (kg/m^2) n=30 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

Measure	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.	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.
Device Impact on Length of Time Until Surgical Indication	3.7 months Interval 3.0 to 7.0	8.7 months Interval 7.0 to 10.0

SECONDARY outcome

Timeframe: 24 months postoperatively

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Maximum 12 months prior to TJA

Body mass change, fat mass change, skeletal muscle mass change

Outcome measures

Outcome data not reported

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

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: victoria-tappa@uiowa.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place