Body CompositionCBIANCT05026697
Validity and Reliability of Commercially Available Bioelectrical Impedance Analysis Devices
An observational study of Body Composition, run by Texas Tech University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2021to 10 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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).
Who may be able to join
- 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)
Who cannot join
- Failing to meet any of the aforementioned inclusion criteria or self-reporting a body composition abnormality (due to medical condition, lifestyle practices, etc.)
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology & Sport Management
Lubbock, Texas, 79409
About this study
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.
Read the detailed description
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.
This study will involve 1-2 total visits: one initial visit followed by an optional follow-up visit 12-16 weeks later. These visits will consist of body composition assessments after an overnight fast. Before the overnight fast, the individual will be asked to drink 1 liter (the equivalent of two 16.9-ounce water bottles) between the final meal of the day and the beginning of the 8-hour fasting period. At the first visit, participants will undergo dual x-ray absorptiometry (DXA; GE Lunar Prodigy), air displacement plethysmography (ADP; Cosmed Bod Pod), a 3D body scan (SizeStream SS20), and several multi- and single-frequency bioelectrical impedance analysis (BIA) assessments. The BIA assessment methods will be conducted twice. This will allow for test-retest reliability assessment of each of the BIA devices being assessed in our study. At the optional second visit, all assessment methods utilized in our laboratory will be conducted once. By comparing these values to the values from the first visit, we will be able to establish the cumulative error due to technical error and biological error (i.e. random biological differences in the participants between the two assessments). We will collect data in a similar fashion during this second visit in order to compare the changes over time between the measurements provided by the commercially available BIA devices against the changes detected by a validated 4-compartment model of body composition, which uses research-grade devices. Cumulatively, this information will provide essential data to consumers regarding both the immediate and long-term test-retest reliability as well as the validity of commercially available BIA devices such as home body fat scales.
The commercially available BIA devices being examined in the present study includes:
- Omron HBF-306
- RENPHO Smart Bathroom Scale (item number: ES-26BB-B)
- Hawanna Body Fat Scale (UPC: 791555289926)
- Wyze Scale (SKU: WHSCL1)
- INEVIFIT Smart Body Fat Scale (UPC: 711841680565; EAN: 0711841680565)
- WeightWatchers Scale by Conair (model: WW721XF)
- Tanita UM-081 (model: UM-081; EAN: 0742496801012 and 0885157966993)
- VitaGoods FormFit Digital Scale and Body Analyzer (model: VG42252-0000)
- Omron HBF 516 Body Composition Monitor (model: HBF-516B)
- Seca sensa 804
- Withings/Nokia BodyCardio Body Composition Digital Scale (model: WBS04b-Black-All-Inter)
- Tanita BC554 IronMan Body Composition Monitor (model: BC-554)
- Tanita BC568 InnerScan Segmental Body Composition Monitor (model: BC-568)
- InBody H2ON Smart Full Body Composition Analyzer
Additionally, several laboratory-grade bioimpedance technologies will be performed, including ImpediMed SFB7 bioimpedance spectroscopy and Seca mBCA 515/514 multi-frequency bioelectrical impedance analysis. Urine specific gravity will also be assessed using digital refractometry, and height will be assessed via stadiometer. As part of the ADP test, body mass estimates from a calibrated, research-grade scale will be obtained (Modified BWB-627-A, Tanita Corporation).
The test-retest reliability of the commercially available bioelectrical impedance analysis devices will be examined through duplicate assessments. The validity of the commercially available bioelectrical impedance analysis devices will be examined as compared to the criterion laboratory methods, namely the 4-compartment model for total body composition and DXA and/or laboratory-grade segmental bioimpedance technologies for segmental body composition.
- Conditions
- Body Composition
- Keywords
- body composition, fat mass, fat-free mass, body fat percentage
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 1 day
Secondary outcomes (3)
Segmental body fat percentage
Body fat percentage provided for specific body segments (i.e., trunk/torso, arms, and legs). These values are provided by some, but not all, of the body composition assessment devices being tested (see list of devices in Study Description).
Measured: 1 day
Segmental fat-free mass
Fat-free mass (i.e., body mass minus fat mass) provided for specific body segments (i.e., trunk/torso, arms, and legs). These values are provided by some, but not all, of the body composition assessment devices being tested (see list of devices in Study Description).
Measured: 1 day
Segmental fat mass
Fat mass provided for specific body segments (i.e., trunk/torso, arms, and legs). These values are provided by some, but not all, of the body composition assessment devices being tested (see list of devices in Study Description).
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start9 Jun 2021
- Primary completion10 Dec 2021
- Study completion10 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Grant Tinsley, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026697
- Sponsor's protocol ID
- IRB2021-107
- Acronym
- CBIA
- Status last verified
- Aug 2022
- First submitted
- 3 Jun 2021
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Reliability of Commercially Available Bioelectrical Impedance Analysis Devices
- ClinicalTrials.gov ID
- NCT05026697
- Acronym / sponsor ID
- CBIA / IRB2021-107
- Conditions
- Body Composition
- Keywords
- body composition, fat mass, fat-free mass, body fat percentage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This study will involve 1-2 total visits: one initial visit followed by an optional follow-up visit 12-16 weeks later. These visits will consist of body composition assessments after an overnight fast. Before the overnight fast, the individual will be asked to drink 1 liter (the equivalent of two 16.9-ounce water bottles) between the final meal of the day and the beginning of the 8-hour fasting period. At the first visit, participants will undergo dual x-ray absorptiometry (DXA; GE Lunar Prodigy), air displacement plethysmography (ADP; Cosmed Bod Pod), a 3D body scan (SizeStream SS20), and several multi- and single-frequency bioelectrical impedance analysis (BIA) assessments. The BIA assessment methods will be conducted twice. This will allow for test-retest reliability assessment of each of the BIA devices being assessed in our study. At the optional second visit, all assessment methods utilized in our laboratory will be conducted once. By comparing these values to the values from the first visit, we will be able to establish the cumulative error due to technical error and biological error (i.e. random biological differences in the participants between the two assessments). We will collect data in a similar fashion during this second visit in order to compare the changes over time between the measurements provided by the commercially available BIA devices against the changes detected by a validated 4-compartment model of body composition, which uses research-grade devices. Cumulatively, this information will provide essential data to consumers regarding both the immediate and long-term test-retest reliability as well as the validity of commercially available BIA devices such as home body fat scales.
The commercially available BIA devices being examined in the present study includes:
- Omron HBF-306
- RENPHO Smart Bathroom Scale (item number: ES-26BB-B)
- Hawanna Body Fat Scale (UPC: 791555289926)
- Wyze Scale (SKU: WHSCL1)
- INEVIFIT Smart Body Fat Scale (UPC: 711841680565; EAN: 0711841680565)
- WeightWatchers Scale by Conair (model: WW721XF)
- Tanita UM-081 (model: UM-081; EAN: 0742496801012 and 0885157966993)
- VitaGoods FormFit Digital Scale and Body Analyzer (model: VG42252-0000)
- Omron HBF 516 Body Composition Monitor (model: HBF-516B)
- Seca sensa 804
- Withings/Nokia BodyCardio Body Composition Digital Scale (model: WBS04b-Black-All-Inter)
- Tanita BC554 IronMan Body Composition Monitor (model: BC-554)
- Tanita BC568 InnerScan Segmental Body Composition Monitor (model: BC-568)
- InBody H2ON Smart Full Body Composition Analyzer
Additionally, several laboratory-grade bioimpedance technologies will be performed, including ImpediMed SFB7 bioimpedance spectroscopy and Seca mBCA 515/514 multi-frequency bioelectrical impedance analysis. Urine specific gravity will also be assessed using digital refractometry, and height will be assessed via stadiometer. As part of the ADP test, body mass estimates from a calibrated, research-grade scale will be obtained (Modified BWB-627-A, Tanita Corporation).
The test-retest reliability of the commercially available bioelectrical impedance analysis devices will be examined through duplicate assessments. The validity of the commercially available bioelectrical impedance analysis devices will be examined as compared to the criterion laboratory methods, namely the 4-compartment model for total body composition and DXA and/or laboratory-grade segmental bioimpedance technologies for segmental body composition.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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).
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- Failing to meet any of the aforementioned inclusion criteria or self-reporting a body composition abnormality (due to medical condition, lifestyle practices, etc.)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Body fat percentage
Time frame: 1 day
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).
Fat-free mass
Time frame: 1 day
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).
Fat mass
Time frame: 1 day
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).
3 secondary outcomes
Segmental body fat percentage
Time frame: 1 day
Segmental fat-free mass
Time frame: 1 day
Segmental fat mass
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Tinsley, PhD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body fat percentage (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.