The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05450588
Recruitment Status : Not yet recruiting
First Posted : July 8, 2022
Last Update Posted : September 11, 2023
Sponsor:
Collaborators:
CES University
Universidad de Córdoba
Information provided by (Responsible Party):
Dynamical Business and Science Society - DBSS International SAS

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
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. 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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated 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
Estimated Study Start Date : March 2024
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2024
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Two-component model of body composition (fat mass and free mass) [ Time Frame: One year (March 2024 to June 2024) ]
    Through DXA measurement and the estimation using anthropometry-based equations.


Secondary Outcome Measures :
  1. Anthropometry-based morphological [ Time Frame: One year (March 2024 to June 2024) ]
    Analysis to compare Colombian population with different physical activity levels.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. +18 years old (under 60 years)
  2. Sedentary, Physically active and Athletes of competitive level.
  3. Residing in the city of Medellín or nearby municipalities of the metropolitan area.
  4. Signed informed consent.
  5. Assist to anthropometric and DXA measurements.

Exclusion Criteria:

  1. People with a disease and/or special condition that limits exposure to radiation emitted by DXA.
  2. Adults over 60 years of age
  3. Pregnant women
  4. Athletes with injuries
  5. People with implants or prostheses.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05450588


Contacts
Layout table for location contacts
Contact: Diego A Bonilla, PhD (57)3203352050 dabonilla@dbss.pro

Locations
Layout table for location information
Colombia
Ces Nutral
Medellín, Antioquia, Colombia, 050001
Sponsors and Collaborators
Dynamical Business and Science Society - DBSS International SAS
CES University
Universidad de Córdoba
Investigators
Layout table for investigator information
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.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Dynamical Business and Science Society - DBSS International SAS
ClinicalTrials.gov Identifier: NCT05450588    
Other Study ID Numbers: Acta0031Proy115TG
DBSS_F20_CES ( Other Identifier: DBSS International SAS )
First Posted: July 8, 2022    Key Record Dates
Last Update Posted: September 11, 2023
Last Verified: September 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dynamical Business and Science Society - DBSS International SAS:
Body composition
Waist Girth
Regression Ecuations
Fat mass
Fat free mass