NCT05026697

Brief Summary

The purpose of this data collection is to establish the validity and reliability of several different commercially available bioelectrical impedance analysis devices that are used to estimate body composition.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

June 3, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

June 9, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2021

Completed
Last Updated

August 9, 2022

Status Verified

August 1, 2022

Enrollment Period

6 months

First QC Date

June 3, 2021

Last Update Submit

August 8, 2022

Conditions

Keywords

body compositionfat massfat-free massbody fat percentage

Outcome Measures

Primary Outcomes (3)

  • Body fat percentage

    Percentage of body mass that is attributable to fat mass. This value is provided by each body composition assessment device being tested (see list of devices in Study Description).

    1 day

  • Fat-free mass

    Calculated as body mass minus fat mass. Fat mass is equal to body mass multiplied by body fat percentage. Body fat percentage is provided by each body composition assessment device being tested (see list of devices in Study Description).

    1 day

  • Fat mass

    Body mass multiplied by body fat percentage. Body fat percentage is provided by each body composition assessment device being tested (see list of devices in Study Description).

    1 day

Secondary Outcomes (3)

  • Segmental body fat percentage

    1 day

  • Segmental fat-free mass

    1 day

  • Segmental fat mass

    1 day

Other Outcomes (4)

  • Body mass

    1 day

  • Total body water

    1 day

  • Visceral fat

    1 day

  • +1 more other outcomes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of generally healthy, weight-stable adults located in or near the community of Lubbock, Texas (or willing to travel to Lubbock, Texas).

You may qualify if:

  • Between the ages of 18 and 50
  • Generally healthy (defined as an absence of any disease or medical condition which could potentially result in abnormal body composition, including but not limited to musculoskeletal or metabolic diseases)
  • Weight-stable (defined as no change in body mass \>5 pounds in the past month)

You may not qualify if:

  • Height greater than 75.5 inches (due to height limitation of DXA scanner)
  • Weight greater than 330 pounds (due to weight limitation of some of the devices used)
  • Presence of facial hair longer than 1/2 inch (and unwillingness to shave) or self-report of large amounts of body hair due to the impact of hair on Bod Pod body volume estimates
  • Presence of pacemaker or any electrical device (due to electrical currents administered by bioimpedance devices)
  • Amputation of limb, implantation of a meaningful amount metal (e.g., full joint replacement), or physical deformity large enough to invalidate traditional body composition assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

Location

Study Officials

  • Grant Tinsley, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2021

First Posted

August 30, 2021

Study Start

June 9, 2021

Primary Completion

December 10, 2021

Study Completion

December 10, 2021

Last Updated

August 9, 2022

Record last verified: 2022-08

Locations