Trial Outcomes & Findings for Validation of the Stayhealthy BC1 Body Comp Analyzer (NCT NCT01209923)

Results Overview

Percent body was compared between devices

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

362 participants

Primary outcome timeframe

2 measures were assessed during a single visit

Results posted on

2022-01-13

Participant milestones
Measure	Body Composition Testing Body composition tested using bioelectrical impedance (BC1) and the DEXA or hydrostatic weighing methods. BC1: Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.
Overall Study STARTED	362
Overall Study COMPLETED	362
Overall Study NOT COMPLETED	0

Withdrawal data not reported

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort
Measure	Body Composition Testing n=362 Participants Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods. BC1: Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.
Age, Categorical <=18 years	115 Participants n=362 Participants
Age, Categorical Between 18 and 65 years	237 Participants n=362 Participants
Age, Categorical >=65 years	10 Participants n=362 Participants
Age, Continuous	45.7 years STANDARD_DEVIATION 17.4 • n=362 Participants
Sex: Female, Male Female	192 Participants n=362 Participants
Sex: Female, Male Male	170 Participants n=362 Participants
Region of Enrollment United States	360 participants n=362 Participants

Timeframe: 2 measures were assessed during a single visit

Population: 247 adults and 115 children

Percent body was compared between devices

Outcome measures
Measure	Stayhealthy BC1 Bioelectric Impedance Analyzer n=362 Participants Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods. BC1: Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.	Reference Assessment n=362 Participants Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods. Dual-Energy X-Ray Absoptiometry assessment of body fat for adults or hydrostatic weighing assessment of body fat for children
Percent Body Fat Women	32.8 percent body fat Standard Deviation 9.1	33.4 percent body fat Standard Deviation 9.6
Percent Body Fat Men	20.3 percent body fat Standard Deviation 5.3	20.4 percent body fat Standard Deviation 5.6
Percent Body Fat Children	18.4 percent body fat Standard Deviation 8.4	18.8 percent body fat Standard Deviation 8.3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

University of Southern California

Phone: 323-442-2498