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

NCT ID: NCT05450588

Last Updated: 2023-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

130 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-31

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Body Composition Obesity

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Sedentary

It will be obtained by open call for both students and administrative staff at the CES University.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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CES University

OTHER

Sponsor Role collaborator

Universidad de Córdoba

OTHER

Sponsor Role collaborator

Dynamical Business and Science Society - DBSS International SAS

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Diego A Bonilla, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Division, DBSS International SAS.

Jorge L Petro, PhD

Role: STUDY_CHAIR

Research Division, DBSS International SAS.

Laura P Muñoz, MSc

Role: STUDY_DIRECTOR

Grupo de Investigación Nutral, Facultad Ciencias de la Nutrición y los Alimentos, Universidad CES.

Leidy T Duque, MSc

Role: STUDY_DIRECTOR

Grupo de Investigación Nutral, Facultad Ciencias de la Nutrición y los Alimentos, Universidad CES.

Locations

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Ces Nutral

Medellín, Antioquia, Colombia

Site Status

Countries

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Colombia

Central Contacts

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Diego A Bonilla, PhD

Role: CONTACT

(57)3203352050

References

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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.

Reference Type DERIVED
PMID: 36078407 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/31911664/

Defining cutoffs to diagnose obesity using the relative fat mass (RFM): Association with mortality in NHANES 1999-2014

http://pubmed.ncbi.nlm.nih.gov/31649287/

Body shape indices are predictors for estimating fat-free mass in male athletes

Other Identifiers

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DBSS_F20_CES

Identifier Type: OTHER

Identifier Source: secondary_id

Acta0031Proy115TG

Identifier Type: -

Identifier Source: org_study_id

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