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Completed

NCT Number: NCT01209923

Validation of the Stayhealthy BC1 Body Comp Analyzer

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.

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Key information

Conditions

Body Composition

Age range

10 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

USC Clinical Exercise Research Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • boys and girls 10-17 yrs and men and women 18-80 yrs

Exclusion criteria

  • acute illness
  • pregnancy
  • pacemaker or defibrillator

Treatment and study plan

BC1

Device

Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.

Other names: BIA, underwater weighing, DEXA scanning, BC1

Primary outcomes

  1. Percent Body Fat

    Time frame: 2 measures were assessed during a single visit

    Percent body was compared between devices

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

Validation of the BC1 Bioelectrical Impedance Body Comp Analyzer

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Sep 27, 2010
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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