Development and Validation of Equations to Evaluate Body Composition in Colombian Population - F20 Project

Sponsor

Dynamical Business and Science Society - DBSS International SAS (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05450588

Collaborator

CES University (Other), Universidad de Córdoba (Other)

130

Enrollment

Location

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Body Composition Obesity

Detailed Description

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. Kinanthropometry 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 Universidad CES, Universidad de Córdoba, Universidad 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

130 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Development and Validation of Waist Girth Based-equations to Evaluate Body Composition in Colombian Population With Different Physical Activity Levels - F20 Project

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Sedentary It will be obtained by open call for both students and administrative staff at the CES University.
Physically active 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.
Athletes 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.

Outcome Measures

Primary Outcome Measures

Two-component model of body composition (fat mass and free mass) [One year (January 2023 to December 2023)]
Through DXA measurement and the estimation using anthropometry-based equations.

Secondary Outcome Measures

Anthropometry-based morphological [One year (January 2023 to December 2023)]
Analysis to compare Colombian population with different physical activity levels.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 59 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

+18 years old (under 60 years)
Sedentary, Physically active and Athletes of competitive level.
Residing in the city of Medellín or nearby municipalities of the metropolitan area.
Signed informed consent.
Assist to kinanthropometric and DXA measurements.

Exclusion Criteria:

People with a disease and/or special condition that limits exposure to radiation emitted by DXA.
Adults over 60 years of age
Pregnant women
Athletes with injuries
People with implants or prostheses.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ces Nutral	Medellín	Antioquia	Colombia	050001

Sponsors and Collaborators

Dynamical Business and Science Society - DBSS International SAS
CES University
Universidad de Córdoba

Investigators

Principal Investigator: Diego A Bonilla, PhD, Research Division, DBSS International SAS.
Study Chair: Jorge L Petro, PhD, Research Division, DBSS International SAS.
Study Director: Laura P Muñoz, MSc, Grupo de Investigación Nutral, Facultad Ciencias de la Nutrición y los Alimentos, Universidad CES.
Study Director: Leidy T Duque, MSc, Grupo de Investigación Nutral, Facultad Ciencias de la Nutrición y los Alimentos, Universidad CES.