Validation of the Stayhealthy BC1 Body Comp Analyzer

NCT ID: NCT01209923

Last Updated: 2022-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 362 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-08-31

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.

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.

Conditions

Body Composition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Body composition testing

Body composition tested using bioelectrical impedance (BC1) and the DEXA or hydrostatic weighing methods.

Group Type: EXPERIMENTAL

BC1

Intervention Type: DEVICE

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

Interventions

BC1

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

Intervention Type: DEVICE

Other Intervention Names

BIA, underwater weighing, DEXA scanning, BC1

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• acute illness
• pregnancy
• pacemaker or defibrillator

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Todd Schroeder

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Edward T Schroeder, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

USC Clinical Exercise Research Center

Los Angeles, California, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 20579521 (View on PubMed)

Other Identifiers

Stayhealthy 01

Identifier Type: -

Identifier Source: org_study_id