Development and Validation of Equations to Evaluate Body Composition in Colombian Population - F20 Project
2 other identifiers
observational
130
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2024
Shorter than P25 for all trials
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
July 5, 2022
CompletedFirst Posted
Study publicly available on registry
July 8, 2022
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedSeptember 11, 2023
September 1, 2023
Same day
July 5, 2022
September 7, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Two-component model of body composition (fat mass and free mass)
Through DXA measurement and the estimation using anthropometry-based equations.
One year (March 2024 to June 2024)
Secondary Outcomes (1)
Anthropometry-based morphological
One year (March 2024 to June 2024)
Study Arms (3)
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.
Eligibility Criteria
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.
You may qualify if:
- +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 anthropometric and DXA measurements.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dynamical Business and Science Society - DBSS International SASlead
- CES Universitycollaborator
- Universidad de Córdobacollaborator
Study Sites (1)
Ces Nutral
Medellín, Antioquia, 050001, Colombia
Related Publications (1)
Bonilla DA, Duque-Zuluaga LT, Munoz-Urrego LP, Moreno Y, Velez-Gutierrez JM, Franco-Hoyos K, Agudelo-Martinez A, Humeres G, Kreider RB, Petro JL. Development and Validation of Waist Girth-Based Equations to Evaluate Body Composition in Colombian Adults: Rationale and STROBE-Nut-Based Protocol of the F20 Project. Int J Environ Res Public Health. 2022 Aug 27;19(17):10690. doi: 10.3390/ijerph191710690.
PMID: 36078407DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 5, 2022
First Posted
July 8, 2022
Study Start
March 1, 2024
Primary Completion
March 1, 2024
Study Completion
June 1, 2024
Last Updated
September 11, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share