Validation of the Stayhealthy BC1 Body Comp Analyzer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01209923
Recruitment Status : Completed
First Posted : September 27, 2010
Last Update Posted : September 27, 2010
Information provided by:
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Body Composition Device: BC1 Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Validation of the BC1 Bioelectrical Impedance Body Comp Analyzer
Study Start Date : May 2007
Actual Primary Completion Date : August 2009
Actual Study Completion Date : August 2009

Arm Intervention/treatment
Experimental: Body composition testing
Body composition tested using bioelectrical impedance and the DEXA or hydrostatic weighing methods.
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

Primary Outcome Measures :
  1. Percent body fat [ Time Frame: 2 years ]
    Percent body was compared between devices

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01209923

United States, California
USC Clinical Exercise Research Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: Edward T Schroeder, PhD University of Southern California

Publications of Results:
Responsible Party: E. Todd Schroeder Assistant Professor, University of Southern California Identifier: NCT01209923     History of Changes
Other Study ID Numbers: Stayhealthy 01
First Posted: September 27, 2010    Key Record Dates
Last Update Posted: September 27, 2010
Last Verified: July 2010

Keywords provided by University of Southern California:
Percent body fat
Body Composition