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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01676883
• Other study ID #: 2012/1018
• Status: Completed
• Phase: N/A
• First received: August 29, 2012
• Last updated: June 14, 2016
• Start date: October 2012
• Est. completion date: April 2013

Study information

• Verified date: June 2016
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Adults (18-50 years old)

• class 2 and 3 obesity (BMI > 35 kg/m2)

• moderate to severe callosities

Exclusion Criteria:

• Intractable plantar keratosis (IPK), which are painful plantar calluses located under the metatarsal heads.

• pregnancy

• menopause

• diseases that cause water retention (edema, renal insufficiency, hypertension, etc.)

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Device:
• Bioelectric impedance
removal of calluses and corns by pedicure
• Air displacement plethysmography

Locations

Country	Name	City	State
Norway	Obesity policlinic of St. Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Roekenes J, Strømmen M, Kulseng B, Martins C. The Impact of Feet Callosities, Arm Posture, and Usage of Electrolyte Wipes on Body Composition by Bioelectrical Impedance Analysis in Morbidly Obese Adults. Obes Facts. 2015;8(6):364-72. doi: 10.1159/00044203 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body composition	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)	1 day	No