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
  Purpose

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 Intervention
Body Composition
Device: BC1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Validation of the BC1 Bioelectrical Impedance Body Comp Analyzer

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Percent body fat [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Percent body was compared between devices


Enrollment: 180
Study Start Date: May 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • acute illness
  • pregnancy
  • pacemaker or defibrillator
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209923

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

Publications:
Responsible Party: E. Todd Schroeder Assistant Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT01209923     History of Changes
Other Study ID Numbers: Stayhealthy 01
Study First Received: July 16, 2010
Last Updated: September 24, 2010
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 27, 2014