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

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Bioelectric impedance
Air displacement plethysmography
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obesity, Morbid focused on measuring Body constitution, Anthropometry, Electric impedance

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Obesity policlinic of St. Olavs Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

body composition assessment

Arm Description

Bioelectric impedance measurement pre- and post removal of calluses and corns (pedicure), then air-displacement plethysmography (gold standard)

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
August 29, 2012
Last Updated
June 14, 2016
Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01676883
Brief Title
Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons
Official Title
Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Body constitution, Anthropometry, Electric impedance

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
body composition assessment
Arm Type
Experimental
Arm Description
Bioelectric impedance measurement pre- and post removal of calluses and corns (pedicure), then air-displacement plethysmography (gold standard)
Intervention Type
Device
Intervention Name(s)
Bioelectric impedance
Other Intervention Name(s)
BIA
Intervention Description
removal of calluses and corns by pedicure
Intervention Type
Device
Intervention Name(s)
Air displacement plethysmography
Other Intervention Name(s)
ADP
Primary Outcome Measure Information:
Title
Body composition
Description
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)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bård Kulseng, MD PhD
Organizational Affiliation
St. Olavs Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Obesity policlinic of St. Olavs Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
26584161
Citation
Roekenes J, Strommen 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: 10.1159/000442033. Epub 2015 Nov 20.
Results Reference
result

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

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