An observational study in Sedentary, Physical Activity and Athletes, sponsored by Dynamical Business and Science Society - DBSS International SAS. Not yet recruiting at 2 sites in Colombia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Dynamical Business and Science Society - DBSS International SAS · Observational
Total daily energy expenditure (TDEE) is known as the energy used by an organism during a day. The TDEE is divided into resting energy expenditure (REE), the thermic effect of food (TFE), and the energy expenditure of physical activity. There are multiple methods of measuring REE (e.g., estimating equations, direct and indirect calorimetry) among which there are significant discrepancies in its calculation in specific populations. Considering the lack of validation in the Colombian population to estimate the REE, the objective of the present research study is to compare the methods for estimating resting energy expenditure in the Colombian population with different levels of physical activity. This cross-sectional-observational study will be carried out through the guidelines for strengthening the reporting of observational studies in nutritional epidemiology (STROBE-Nut). The study population will be 130 adults from the city of Medellín, Bogotá and metropolitan areas with different levels of physical activity according to the results of the International Physical Activity Questionnaire (IPA-Q) where a high (athletes), moderate (physically active people) and low (sedentary) categorization will be made, then the indirect calorimetry tests will be applied. The development of the equation to estimate the REE will be carried out with multiple regression models under traditional and Bayesian approaches with three independent variables. It is expected to obtain a simple and valid equation to estimate the REE and contribute to the good practices of Colombian practitioners in health sciences, exercise, and sports.
Determination of the total daily energy expenditure (TDEE) is of great importance as a starting point for professional support and the achievement of physical, aesthetic, and health goals. Considering that TDEE is mainly composed of resting energy expenditure (REE), nutrition and health professionals generally estimate REE and then add values for the thermic effect of food (TFE) and physical activity expenditure. As well as allostatic load and stress may increase the REE, depending on the intensity and duration of the stressor. Based on predictor variables, REE estimating equations are used. However, the values yielded by the estimating equations can be inaccurate due to variations in the characteristics of the population. Considering the lack of validation in the Colombian population to estimate the REE, the objective of the present research study is to compare the methods for estimating resting energy expenditure in the Colombian population with different levels of physical activity. This is a cross-sectional-observational study that will be carried out by means of the guidelines for strengthening the reporting of observational studies in nutritional epidemiology (STROBE-Nut). Likewise, the data collection will be carried out with a pilot test where ISAK-certified personnel in levels 2 and 3 will offer specialized training to the research assistants to allow standardization in the taking of anthropometric measurements, which minimizes the error in the data collection. This process prior to data collection allows adjustment of the methodology and procedures during the research. In addition, technical staff with a master's degree in sports science, a master's degree in exercise physiology, or a medical degree will be available for the measurement of the REE by indirect calorimetry. The measurement will be performed after device calibration and a pilot test will be performed to standardize the work methodology and calculate the coefficient of variation of the equipment.
The NRG project is developed by the Research Division of the Dynamical Business \& Science Society-DBSS International with the support of University CES, University of Cordoba, the R\&D department of ARTHROS IPS, Smart Fit, INDEPORTES Antioquia, and the University Santo Tomás in Bogotá. The development of the equation to estimate the REE will be carried out with multiple regression models under traditional and Bayesian approaches with three independent variables. It is expected to obtain a simple and valid equation to estimate the REE and contribute to the good practices of Colombian practitioners in health sciences, exercise, and sports.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's planned enrollment of 90 is below the median of 158 across 176 observational studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Dynamical Business and Science Society - DBSS International SAS is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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The study population will be people between 18-60 years of age with different levels of physical activity, male and female residents of the cities of Medellin and Bogota. It will include residents of nearby municipalities that make up the metropolitan area of these cities (Andean Region of Colombia).
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
It will be obtained by open call for both students and administrative staff at the CES University (Medellín) and Universidad Santo Tomás (Bogotá).
A sample of physical education majors and personal trainers who reside and work in Medellín and Bogotá will be invited to participate (Universidad Santo Tomás and Smart Fit).
A sample of elite and sub-elite athletes with \>2 years at the competitive level will be invited to participate (ARTHROS Physiotherapy and Exercise Center, INDEPORTES Antioquia, and Universidad Santo Tomás).
Estimation of resting energy expenditure.
The resting energy expenditure in subjects with different levels of physical activity will be obtained by means of indirect calorimetry.
Time frame: August 2023 to December2023
Anthropometry-Based Analysis of Body Composition.
Musculoskeletal mass indicators will be obtained as a variable to estimate energy expenditure at rest and compare them with indirect calorimetry data.
Time frame: August 2023 to December2023
Development of equations to estimate resting energy expenditure.
It will be carried out with multiple regression models multiple regression models under traditional and Bayesian approaches with three independent variables, to obtain equations that can improve the estimates of resting energy expenditure.
Time frame: August 2023 to December2023
Plan to share: No
Start is estimated for Sep 2023; primary completion for Dec 2023, 3 months later.
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This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Dynamical Business and Science Society - DBSS International SAS