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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Body composition testing | Experimental | Body composition tested using bioelectrical impedance (BC1) and the DEXA or hydrostatic weighing methods. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BC1 | Device | Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Body Fat | Percent body was compared between devices | 2 measures were assessed during a single visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward T Schroeder, PhD | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Clinical Exercise Research Center | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20579521 | Result | Erceg DN, Dieli-Conwright CM, Rossuello AE, Jensky NE, Sun S, Schroeder ET. The Stayhealthy bioelectrical impedance analyzer predicts body fat in children and adults. Nutr Res. 2010 May;30(5):297-304. doi: 10.1016/j.nutres.2010.04.009. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | adults 18-80yrs and children 10-17yrs |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent Body Fat | Percent body was compared between devices | 247 adults and 115 children | Posted | Mean | Standard Deviation | percent body fat | 2 measures were assessed during a single visit |
|
Adverse events were monitored over the study but no adverse events were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Schroeder | University of Southern California | 323-442-2498 | eschroed@usc.edu |
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| Count of Participants |
| Participants |
| No |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
|
| 0 |
| 362 |
| 0 |
| 362 |
| 0 |
| 362 |
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