Calibrate Samsung's BIA to Meseaure Body Composition

NCT02115425 | Completed

• 1 other identifier: PBRC 2014-005
• Study Type: observational
• Target: 421
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to collect body composition data using bioimpedance analysis (Samsung) and DXA (GE Medical). Both of the methods are explained in more detail in section 5 of this consent. The data collected will help Samsung improve the products the company offers.

Conditions

Body Composition; Circumference Measurements; Tissue Thickness Measurements

Outcome Measures

Primary Outcomes (1)

• Calibrate the Samsung BIA System by collecting body composition using two different methods and 5 different equipment

  The study will be conducted in two overlapping phases. In Phase I, approximately 300 adult subjects (\>18 to 80 yrs, equal numbers of female and male) will be recruited to take part in this study as detailed below: (1) Underweight (BMI\<18.5 k/m2), 50 subjects. (2) Normal-Overweight (18.5-30), 150 subjects. (3) Obese (\>30), 100 subjects. Phase II, planned to start later this spring and summer, will involve evaluation of children and 100 subjects (10-\</=18 yrs, equal numbers of female and male) are planned in this phase as: (1) Normal-Overweight (18.5-30), 50 subjects. (2) Obese (\>30), 50 subjects. An addendum describing details of this study phase will be forthcoming. Informed consent for both adults and children will be obtained for this study. Written and verbal assents for children will be obtained for this study.

  First Visit (Only one visit)

Secondary Outcomes (1)

• Improve the BIA body composition predictions using circumference and tissue thickness measurements

  First Visit (Only one visit)

Study Arms (2)

Age 10-17

Participants age 5 - 17 will complete the following Body Measurements Body Composition and Circumference Measurements Whole Body DXA Scan Bioelectrical Impedance Analysis (BIA)

Other: Body Measurements; Other: Whole Body DXA Scan; Other: Bioelectrical Impedance Analysis (BIA); Other: add name here

Age 18-80

Age 18-80 years Participants age 18-80 will complete the following Body Measurements Body Composition and Circumference Measurements Whole Body DXA Scan Bioelectrical Impedance Analysis (BIA)

Other: Body Measurements; Other: Whole Body DXA Scan; Other: Bioelectrical Impedance Analysis (BIA); Other: add name here

Interventions

Body Measurements OTHER

A series of body measurements will be taken by trained staff. These measurements include height and weight. These measurements will be completed twice during this time. You will wear a hospital gown and bathing suit for these measurements.

Age 10-17; Age 18-80

Whole Body DXA Scan OTHER

This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. You will be required to wear a hospital gown, to remove all metal-containing objects from your body, and to lie down on the table.

Also known as: Dual-energy X-ray Absorptiometry Scan

Age 10-17; Age 18-80

Bioelectrical Impedance Analysis (BIA) OTHER

These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. Once changed and barefoot, you will be asked to stand on a scale (similar to a large gym scale) and to hold on to hand electrodes on each side of the scale. You will be asked to step off of the scale once the measurement is complete (less than one minute). You will also hold on to hand electrodes for three other BIA systems.

Also known as: InBody720, http://www.biospaceamerica.com/Product/ib720.html

Age 10-17; Age 18-80

add name here OTHER

Age 10-17; Age 18-80

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male or Female age 10-80 years of age.

You may qualify if:

• Being either male or female
• Being from 18 to 80 years of age
• Being considered underweight, normal weight, overweight, or obese based on specified BMI ranges
• Having a body weight of less than 440 pounds
• Being willing to comply with the study procedures
• Females must not be pregnant, breastfeeding, or planning to become pregnant within the next 6 months.

You may not qualify if:

• Being Asian. Note that Asian subjects have already been evaluated as part of the Korean phase of this investigation.
• Having a significant chronic disease as judged by the investigator
• Having metal-containing objects in your body
• Being pregnant or attempting to become pregnant
• Having medical implants such as a pacemaker or metal joint replacements
• Being a professional athlete or someone with severe edema or dehydration
• Having a body weight greater than 440 pounds
• Being a body builder as judged by the investigator
• Adults unable to consent
• Prisoners

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead
• Samsung: collaborator

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Interventions

Body Weights and Measures; Absorptiometry, Photon

Intervention Hierarchy (Ancestors)

Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Anthropometry; Investigative Techniques; Physiological Phenomena; Radiography; Diagnostic Imaging; Densitometry; Photometry; Chemistry Techniques, Analytical

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 16, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

US (1)