Validation of the Stayhealthy BC1 Body Comp Analyzer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Validation of the BC1 Bioelectrical Impedance Body Comp Analyzer

Conditions
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Body Composition

Intervention / Treatment
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* Device: BC1


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: boys and girls 10-17 yrs and men and women 18-80 yrs Exclusion Criteria: acute illness pregnancy pacemaker or defibrillator

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Body composition testing<br>Body composition tested using bioelectrical impedance (BC1) and the DEXA or hydrostatic weighing methods. | Device: BC1<br>* Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.<br>* Other names: BIA, underwater weighing, DEXA scanning, BC1;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Body Fat | Percent body was compared between devices | 2 measures were assessed during a single visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Percent body fat, Body Composition, Stayhealthy