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Completed

NCT Number: NCT04504799

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

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.

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Key information

Conditions

Body Composition Behavior Motor Activity

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Geneva University Hospital

Geneva, Geneva 14, 1211, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Body composition measurement with HAG-BIA scale

Device

Bio-impendance analysis

Primary outcomes

  1. Accuracy of percent fat mass measurement

    Time frame: 6 months

    Comparison between HAG-B19 and Nutriguard-M measurement

Secondary outcomes

  1. Intra- and inter-device variability of percent fat mass measurement

    Time frame: 6 months

    Comparison of measurements within and between three HAG-B19 devices.

  2. Accuracy of percent fat mass measurement compared to gold standard

    Time frame: 6 months

    Comparison between HAG-B19 and DEXA in 10 percents of participants

Sponsors and collaborators

Lead sponsor

Prof. Claude Pichard

Other

Registry information

Official study title

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

Acronym: HAG-BIA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 7, 2020
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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