Body CompositionNCT05450588
Development and Validation of Equations to Evaluate Body Composition in Colombian Population - F20 Project
An observational study of Body Composition and Obesity, run by Dynamical Business and Science Society - DBSS International SAS at 1 site in Colombia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Composition, Obesity
- How many people
- 130 participants
- Where
- 1 siteColombia
- Study dates
- Mar 2024to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- +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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Validation of Waist Girth Based-equations to Evaluate Body Composition in Colombian Population With Different Physical Activity Levels - F20 Project
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.
Read the 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.
- Conditions
- Body Composition, Obesity
- Keywords
- Body composition, Waist Girth, Regression Ecuations, Fat mass, Fat free mass
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Two-component model of body composition (fat mass and free mass)
Through DXA measurement and the estimation using anthropometry-based equations.
Measured: One year (March 2024 to June 2024)
Secondary outcomes (1)
Anthropometry-based morphological
Analysis to compare Colombian population with different physical activity levels.
Measured: One year (March 2024 to June 2024)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2022
- Study startMar 2024 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Body CompositionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynamical Business and Science Society - DBSS International SAS
- Sponsor type
- Research network
- Collaborators
- CES University, Universidad de Córdoba
- Responsible party
- Sponsor
- Investigators
- Diego A Bonilla, PhD, Principal investigator, Research Division, DBSS International SAS.Jorge L Petro, PhD, Study chair, Research Division, DBSS International SAS.Laura P Muñoz, MSc, Study director, Grupo de Investigación Nutral, Facultad Ciencias de la Nutrición y los Alimentos, Universidad CES.Leidy T Duque, MSc, Study director, Grupo de Investigación Nutral, Facultad Ciencias de la Nutrición y los Alimentos, Universidad CES.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450588
- Sponsor's protocol ID
- Acta0031Proy115TG
- Other IDs
- DBSS_F20_CES
- Status last verified
- Sep 2023
- First submitted
- 5 Jul 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36078407
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Waist Girth Based-equations to Evaluate Body Composition in Colombian Population With Different Physical Activity Levels - F20 Project
- ClinicalTrials.gov ID
- NCT05450588
- Acronym / sponsor ID
- Acta0031Proy115TG
- Conditions
- Body Composition, Obesity
- Keywords
- Body composition, Waist Girth, Regression Ecuations, Fat mass, Fat free mass
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Dynamical Business and Science Society - DBSS International SASResearch network
- Collaborators
- CES University, Universidad de Córdoba
- Study start
- Mar 2024 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 8 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- +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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Anthropometry-based morphological
Time frame: One year (March 2024 to June 2024)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Derived from this study: PubMed 36078407Bonilla 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.
- Defining cutoffs to diagnose obesity using the relative fat mass (RFM): Association with mortality in NHANES 1999-2014Link provided by the sponsor.
- Body shape indices are predictors for estimating fat-free mass in male athletesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diego A Bonilla, PhD principal investigator
Research Division, DBSS International SAS.
Jorge L Petro, PhD study chair
Research Division, DBSS International SAS.
Laura P Muñoz, MSc study director
Grupo de Investigación Nutral, Facultad Ciencias de la Nutrición y los Alimentos, Universidad CES.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Body Composition and Obesity, run by Dynamical Business and Science Society - DBSS International SAS at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Diego A Bonilla, PhD ((57)3203352050, dabonilla@dbss.pro), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Two-component model of body composition (fat mass and free mass) (time frame: One year (March 2024 to June 2024)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05450588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2023.