Body Composition
Conditions
Keywords
Percent body fat, Body Composition, Stayhealthy
Brief summary
The purpose of this study was to validate the Stayhealthy BC1 bioelectrical impedance analyzer to assess percent body fat in children and adults. The BC1 was compared to dual-energy x-ray absorptiometry assessment of body fat for adults and to hydrostatic weighing assessment of body fat for children. We hypothesized that the BC1 would provide similar measures of body fat between devices with acceptable limits of agreement.
Detailed description
The BC1 body composition analyzer is manufactured by Stayhealthy. It is a handheld, noninvasive bioelectrical impedance device. When held, the BC1 sends an electrical impulse through the body to determine body fat, muscle mass, and body hydration. Bio-impedance devices measure the change in electrical resistance in body tissues by using a detectable electrical signal that passes through the body. The method is based on the principle that lean body mass contains virtually all the water and conducting electrolytes in the body and provides a good electrical pathway. In contrast, fat or fat-containing tissues produce a poor electrical pathway. By inducing a low-energy, high -frequency signal, a measurement of the baseline resistance to flow of electrical current can be assessed. The resistance measurement relates directly to the volume of the conductor. Through repeated measurements and identifying other parameters (i.e. gender, weight, age and height) proprietary equations were developed that determine total body water, fat free body mass, and total body fat.
Interventions
DEVICEBC1
Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.
Sponsors
University of Southern California
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* boys and girls 10-17 yrs and men and women 18-80 yrs
Exclusion criteria
* acute illness * pregnancy * pacemaker or defibrillator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent Body Fat | 2 measures were assessed during a single visit | Percent body was compared between devices |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Body Composition Testing 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. | 362 |
| Total | 362 |
Baseline characteristics
| Characteristic | Body Composition Testing | — |
|---|---|---|
| Age, Categorical <=18 years | 115 Participants | — |
| Age, Categorical >=65 years | 10 Participants | — |
| Age, Categorical Between 18 and 65 years | 237 Participants | — |
| Age, Continuous | 45.7 years STANDARD_DEVIATION 17.4 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 360 participants | — |
| Sex: Female, Male Female | 192 Participants | — |
| Sex: Female, Male Male | 170 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 362 |
| other Total, other adverse events | 0 / 362 |
| serious Total, serious adverse events | 0 / 362 |
Outcome results
Primary
Percent Body Fat
Percent body was compared between devices
Time frame: 2 measures were assessed during a single visit
Population: 247 adults and 115 children
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stayhealthy BC1 Bioelectric Impedance Analyzer | Percent Body Fat | Men | 20.3 percent body fat | Standard Deviation 5.3 |
| Stayhealthy BC1 Bioelectric Impedance Analyzer | Percent Body Fat | Women | 32.8 percent body fat | Standard Deviation 9.1 |
| Stayhealthy BC1 Bioelectric Impedance Analyzer | Percent Body Fat | Children | 18.4 percent body fat | Standard Deviation 8.4 |
| Reference Assessment | Percent Body Fat | Men | 20.4 percent body fat | Standard Deviation 5.6 |
| Reference Assessment | Percent Body Fat | Women | 33.4 percent body fat | Standard Deviation 9.6 |
| Reference Assessment | Percent Body Fat | Children | 18.8 percent body fat | Standard Deviation 8.3 |
Comparison: Children BIA was compared to hydrostatic weighing; adults were compared to DEXA.p-value: 0.001t-test, 2 sided