Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2012
CompletedFirst Posted
Study publicly available on registry
August 31, 2012
CompletedStudy Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJune 16, 2016
June 1, 2016
5 months
August 29, 2012
June 14, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
body composition assessment
EXPERIMENTALBioelectric impedance measurement pre- and post removal of calluses and corns (pedicure), then air-displacement plethysmography (gold standard)
Interventions
removal of calluses and corns by pedicure
Eligibility Criteria
You may qualify if:
- Adults (18-50 years old)
- class 2 and 3 obesity (BMI \> 35 kg/m2)
- moderate to severe callosities
You may not qualify if:
- 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.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Science and Technologylead
- St. Olavs Hospitalcollaborator
Study Sites (1)
Obesity policlinic of St. Olavs Hospital
Trondheim, Norway
Related Publications (1)
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.
PMID: 26584161RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bård Kulseng, MD PhD
St. Olavs Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2012
First Posted
August 31, 2012
Study Start
October 1, 2012
Primary Completion
March 1, 2013
Study Completion
April 1, 2013
Last Updated
June 16, 2016
Record last verified: 2016-06