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

This study has been completed.
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01676883
First received: August 29, 2012
Last updated: April 8, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Obesity, Morbid
 Device: Bioelectric impedance
Device: Air displacement plethysmography

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Plantar Callosities and the Validity of Body Composition Assessment by Bio-impedance in Severely Obese Persons

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Body composition [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    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)


Enrollment: 40
Study Start Date: October 2012
Study Completion Date: April 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01676883

Locations
Norway
Obesity policlinic of St. Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
Study Director: Bård Kulseng, MD PhD St Olavs Hospital Trondheim University Hospital
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01676883     History of Changes
Other Study ID Numbers: 2012/1018
Study First Received: August 29, 2012
Last Updated: April 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Norwegian University of Science and Technology:
Body constitution
Anthropometry
Electric impedance

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Callosities
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms
Keratosis
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013