Validation of the Stayhealthy BC1 Body Comp Analyzer

This study has been completed.
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01209923
First received: July 16, 2010
Last updated: September 24, 2010
Last verified: July 2010

July 16, 2010
September 24, 2010
May 2007
August 2009   (final data collection date for primary outcome measure)
Percent body fat [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Percent body was compared between devices
Same as current
Complete list of historical versions of study NCT01209923 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Validation of the Stayhealthy BC1 Body Comp Analyzer
Validation of the BC1 Bioelectrical Impedance 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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Body Composition
Device: BC1
Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.
Other Name: BIA, underwater weighing, DEXA scanning, BC1
Experimental: Body composition testing
Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods.
Intervention: Device: BC1
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
180
August 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • acute illness
  • pregnancy
  • pacemaker or defibrillator
Both
10 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01209923
Stayhealthy 01
No
E. Todd Schroeder Assistant Professor, University of Southern California
University of Southern California
Not Provided
Principal Investigator: Edward T Schroeder, PhD University of Southern California
University of Southern California
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP