Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons
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|ClinicalTrials.gov Identifier: NCT01676883|
Recruitment Status : Completed
First Posted : August 31, 2012
Last Update Posted : June 16, 2016
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).
|Condition or disease||Intervention/treatment||Phase|
|Obesity, Morbid||Device: Bioelectric impedance Device: Air displacement plethysmography||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2013|
|Actual Study Completion Date :||April 2013|
Experimental: body composition assessment
Bioelectric impedance measurement pre- and post removal of calluses and corns (pedicure), then air-displacement plethysmography (gold standard)
Device: Bioelectric impedance
removal of calluses and corns by pedicure
Other Name: BIA
Device: Air displacement plethysmography
Other Name: ADP
- Body composition [ Time Frame: 1 day ]Bioelectric impedance (using InBody 720) at three standardized arm postures angled at 15, 45 and 90 degrees, in randomized order; Air displacement plethysmography (ADP,using BodPod)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01676883
|Obesity policlinic of St. Olavs Hospital|
|Study Director:||Bård Kulseng, MD PhD||St. Olavs Hospital|