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

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

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.

Study Overview

• Status: Completed
• Conditions: Body Composition
• Intervention / Treatment: Device: Body composition measurement with HAG-BIA scale

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.

• Study Type: Observational
• Enrollment (Actual): 160

Contacts and Locations

Study Locations

• Switzerland
  • Geneva 14
    • Geneva, Geneva 14, Switzerland, 1211
      • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy Caucasians/Hispanics adults

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of percent fat mass measurement	Comparison between HAG-B19 and Nutriguard-M measurement	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intra- and inter-device variability of percent fat mass measurement	Comparison of measurements within and between three HAG-B19 devices.	6 months
Accuracy of percent fat mass measurement compared to gold standard	Comparison between HAG-B19 and DEXA in 10 percents of participants	6 months

Collaborators and Investigators

• Sponsor: Prof. Claude Pichard
• Investigators: Study Director: Claude Pichard, Prof, University Hospital, Geneva

Publications and helpful links

General Publications

• Hamilton-James K, Collet TH, Pichard C, Genton L, Dupertuis YM. Precision and accuracy of bioelectrical impedance analysis devices in supine versus standing position with or without retractable handle in Caucasian subjects. Clin Nutr ESPEN. 2021 Oct;45:267-274. doi: 10.1016/j.clnesp.2021.08.010. Epub 2021 Sep 6.

Study record dates

Study Major Dates

• Study Start (Actual): September 3, 2020
• Primary Completion (Actual): February 25, 2021
• Study Completion (Actual): February 25, 2021

Study Registration Dates

• First Submitted: August 5, 2020
• First Submitted That Met QC Criteria: August 5, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 12, 2021
• Last Update Submitted That Met QC Criteria: August 5, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: Nutrition; Physical activity; Body composition; Bioimpendance analysis
• Other Study ID Numbers: 2020-01613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No