Clinical Trials Directory

Trials / Completed

CompletedNCT01676883

Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (actual)
Sponsor
Norwegian University of Science and Technology · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

Studies have confirmed the association between plantar callosities and severely obese individuals. Bioelectrical impedance analysis (BIA) is an increasingly popular tool for estimating body composition because it is easy to use, noninvasive, relatively inexpensive, and can be performed across a wide range of subjects. Our hypotheses for this study are: (1)plantar callosities influence the body composition measurements obtained by bioelectrical impedance analysis BIA, and (2) BIA underestimates the percentage of body fat compared with air-displacement plethysmography (BodPod).

Detailed description

As the prevalence of obesity continues to increase, many parts of the world are progressively facing a rise in the number of people who fall under WHO obesity class 2 and 3. Since severe obesity is characterized by large alterations in body compartments when compared to overweight or non-obese individuals, there is a need for the evaluation of the body composition of severely obese persons. There is very few published research available on what methods of body composition measurements can be used on this population. Other studies have also shown the tendency of bioelectrical impedance analysis (BIA) instruments to underestimate percentage of fat mass and overestimate the percentage of fat free nass, compared with gold-standard techniques. We think that plantar callosities might have contributed to the lack of accurate measurements. Thus, the primary aim of this study is to determine whether plantar callosities influence the validity of body composition measurements obtained by BIA, using the InBody 720. The secondary aim is to assess the validity of the body composition measurements obtained by BIA (InBody 720) in severely obese individuals, using air-displacement plethysmography (BodPod) as the gold standard. Additionally, we will explore various sources of error using test-retest reliabilities by measuring body composition with different arm postures. We will examine this further to rule out the possibility of "positions of measurement" as a potential confounder of this study.

Conditions

Interventions

TypeNameDescription
DEVICEBioelectric impedanceremoval of calluses and corns by pedicure
DEVICEAir displacement plethysmography

Timeline

Start date
2012-10-01
Primary completion
2013-03-01
Completion
2013-04-01
First posted
2012-08-31
Last updated
2016-06-16

Locations

1 site across 1 country: Norway

Source: ClinicalTrials.gov record NCT01676883. Inclusion in this directory is not an endorsement.