NCT01209923

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 27, 2010

Completed
11.3 years until next milestone

Results Posted

Study results publicly available

January 13, 2022

Completed
Last Updated

January 13, 2022

Status Verified

December 1, 2021

Enrollment Period

2.3 years

First QC Date

July 16, 2010

Results QC Date

March 30, 2017

Last Update Submit

December 14, 2021

Conditions

Keywords

Percent body fatBody CompositionStayhealthy

Outcome Measures

Primary Outcomes (1)

  • Percent Body Fat

    Percent body was compared between devices

    2 measures were assessed during a single visit

Study Arms (1)

Body composition testing

EXPERIMENTAL

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

Device: BC1

Interventions

BC1DEVICE

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

Also known as: BIA, underwater weighing, DEXA scanning, BC1
Body composition testing

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • acute illness
  • pregnancy
  • pacemaker or defibrillator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USC Clinical Exercise Research Center

Los Angeles, California, 90033, United States

Location

Related Publications (1)

  • 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.

Results Point of Contact

Title
Edward Schroeder
Organization
University of Southern California

Study Officials

  • Edward T Schroeder, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 16, 2010

First Posted

September 27, 2010

Study Start

May 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

January 13, 2022

Results First Posted

January 13, 2022

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations