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Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masse

Validation of the New HAG-B19 Scale for Measuring Lean and Fat Body Masses by Comparison With Routinely Used Bioelectrical Impedance Analysis and Dual X-Ray Absorptiometry in Western Healthy Adults: The Geneva HAG-BIA Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04504799
Acronym
HAG-BIA
Enrollment
160
Registered
2020-08-07
Start date
2020-09-03
Completion date
2021-02-25
Last updated
2021-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Body Composition

Keywords

Body composition, Bioimpendance analysis, Physical activity, Nutrition

Brief summary

Body composition measurement is an important tool for assessing the physical condition of sick or healthy people, as well as for monitoring changes in body composition and physical performance during diet and/or training. Many people self-monitor their body composition using portable and inexpensive assessment tools, but most of them have not been tested for accuracy and precision. This study aims to assess the accuracy and precision of a new portable impedancemeter scale to measure body composition in comparison with proven techniques, such as 4-electrode electrical bioimpedance analysis and dual X-ray absorptiometry.

Detailed description

This is an observational, prospective, cross-sectional study to evaluate the accuracy and precision of the new HAG-B19 in healthy Western adults. A stratified sampling method is used to recruit a heterogeneous sample of 160 subjects, covering a wide range of ages and body compositions according to gender specific BMI distributions in the population. Volunteers who signed the informed consent form are included in the study. A financial compensation of 50.- CHF is given to each participant (100.- to the 16 participants subjected to the DEXA measurements). The body composition of each subject (FM, LBM and FM%) is assessed with sequential measurements using 3 HAG-B19 and 3 Nutriguard-M® devices (Data Input, Germany). FM% values measured by HAG-B19 are compared to values by Nutriguard-M® to assess the accuracy and precision of HAG-B19 (main objective). Intra- and inter-device variability are obtained by comparing the 3 repeated measurements and the 3 HAG-B19 devices (secondary objective). In a subgroup of 16 individuals, the FM% values measured by HAG-B19 are compared to DEXA measurements (secondary objective). Pearson correlations and Bland-Altman graphs are performed to assess the agreement of the measurements between the devices and paired t-tests are used to determine if there is a bias between the devices. The significance of the statistical analysis is fixed at p \<0.05.

Interventions

DEVICEBody composition measurement with HAG-BIA scale

Bio-impendance analysis

Sponsors

Prof. Claude Pichard
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Healthy Caucasians/Hispanics adults who signed the informed consent form (healthy defined as no chronic disease, no hospitalisation for the last 6 months, no physical disability)

Exclusion criteria

* BMI \<18.5 or ≥ 30 kg/m2 * No informed consent form signed * Inability to understand the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant. * Medication impacting fluid and electrolyte balance (diuretics or calcium channel blocker) * Moderate to intense level physical activity 2-3 h before measurement * Pregnancy

Design outcomes

Primary

MeasureTime frameDescription
Accuracy of percent fat mass measurement6 monthsComparison between HAG-B19 and Nutriguard-M measurement

Secondary

MeasureTime frameDescription
Intra- and inter-device variability of percent fat mass measurement6 monthsComparison of measurements within and between three HAG-B19 devices.
Accuracy of percent fat mass measurement compared to gold standard6 monthsComparison between HAG-B19 and DEXA in 10 percents of participants

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026