An observational study in Body Composition and Obesity, sponsored by Dynamical Business and Science Society - DBSS International SAS. Status unknown at 1 site in Colombia. Open to participants aged 18 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-11.
Sponsored by Dynamical Business and Science Society - DBSS International SAS · Observational
The assessment of body composition is one of the main components within the evaluation of nutritional status under the ABCDE model. Generally, the use of equations to estimate components is a frequent strategy since it represents a doubly indirect method that has good correlation with methods of higher sensitivity (i.e., NMR, DXA, etc.). In this sense, the waist girth or circumference (WC) represents a quick, simple and inexpensive tool to evaluate the excess of fat mass in the human being; however, this measurement does not provide information on body composition in isolation and has been used as an important independent variable in some recent equations (e.g., relative fat mass [RFM]). Considering the lack of formulas or external validation of RFM in the Colombian population, the aim of this STROBE-Nut-based cross-sectional study is to develop and validate simple equations that use WC as an independent variable to estimate fat mass and fat-free mass in a population with different physical activity levels.
This research aims to validate and develop WC-based equations due to the estimation potential to assess body composition in the athletic, physically active and sedentary Colombian population. We will follow the standardized reporting guidelines of the Strengthening the Reporting of Observational Studies in Epidemiology-Nutritional Epidemiology (STROBE-nut). Stratified probability sampling techniques will be used. Participants of >18 years old, residing in Medellín or its metropolitan area, with different physical activity levels, and that give consent to be evaluated by health professionals will be invited to participate. Anthropometry and DXA assessment will be carried out in the participants. Subsequently, validation of the RFM will be performed by comparing the estimation results with gold standard methods using correlation and agreement (Bland-Altman) analyses. Finally, several models will be developed to estimate fat mass and fat-free mass in the population subgroups (athletes, physically active individuals and sedentary people). The results of this research will improve professional practice in health, exercise and sports science.
The F20 project is developed by the Research Division of the Dynamical Business \& Science Society-DBSS International SAS with the support of University CES, University de Córdoba, University Distrital Francisco José de Caldas, Exercise \& Sport Nutrition Laboratory at Texas A\&M University, the R\&D department of ARTHROS IPS, Smart Fit, and IPS Diagnosticarte.
6,583 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 130 is close to the median of 132 across 1,339 observational studies indexed under Obesity.
Browse Obesity studies →Dynamical Business and Science Society - DBSS International SAS is the lead sponsor of 7 studies on the registry; 3 are open to participants now.
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According to previous recommendations (Knofczynski and Mundfrom,2007), 130 participants will be needed to obtain a coefficient of determination (R2) of 0.5 with an excellent level of prediction and with three independent variables. The subjects will be divided into three groups for validation and development of the new equations, the total number of participants will be divided into 3 strata following optimal allocation methods. Assigned a fixed cost for each stratum (sedentary people, C1; physically active subjects, C2; and sportsmen, C3, given that C3>C2>C1).The values obtained for the sedentary group were n=54, the physically active population group n= 43, and the sportsmen group n=33. In the new equation, the development/validation ratio will be 70/30 over the number of subjects.
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Exclusion Criteria:
It will be obtained by open call for both students and administrative staff at the CES University.
Under the collaboration framework bet ween DBSS international SAS and Smart Fit Colombia, a sample of personal trainers who reside and work in Medellín, or its metropolitan area will be invited to participate.
Under the collaboration framework between DBSS international SAS and ARTHROS Physiotherapy and Exercise Center, a sample of professional athletes from different sports disciplines will be invited to participate.
Two-component model of body composition (fat mass and free mass)
Through DXA measurement and the estimation using anthropometry-based equations.
Time frame: One year (March 2024 to June 2024)
Anthropometry-based morphological
Analysis to compare Colombian population with different physical activity levels.
Time frame: One year (March 2024 to June 2024)
Plan to share: No
This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Dynamical Business and Science Society - DBSS International SAS