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Completed

NCT Number: NCT02075359

Energy Expenditure and Physical Activity in Preschoolers

The purpose of this study is to calibrate the Actigraph, Respironics and CamNtech monitors, in a wide range of children using energy expenditure measured by respiration calorimetry. Energy expenditure will be predicted from the combination of heart rate and activity measured by accelerometry. Prediction equations for energy expenditure will be tested and validated against a stable isotope method called doubly labeled water for the measurement of free-living total energy expenditure.

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Key information

Conditions

Healthy

Age range

3 year–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Nutrition Research Center

Houston, Texas, 77030, United States

About this study

In this study, the investigators will apply advanced technology (fast-response room calorimetry, doubly labeled water (DLW), accelerometers and miniaturized HR monitors) and sophisticated mathematical modeling techniques (cross-sectional time series, CSTS and multivariate adaptive regression splines, MARS) to develop and validate prediction models that capture the dynamic nature of physical activity (PA) and energy expenditure (EE) in preschool-aged children. CSTS and MARS models for the assessment of PA based on activity energy expenditure (AEE) and for the prediction of minute-by-minute EE will be developed in 100 preschool-aged children using 12-h room respiration calorimetry as the criterion method and validated in an independent sample (n=50) against 12-h room respiration calorimetry and the 7-d DLW method. In addition, the investigators will develop algorithms for the classification of PA levels and sleep/awake periods using statistical and machine learning methods and incorporate the results into our prediction models.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Boys and girls between the ages of 3-5 years will be recruited from the local community. A total of 150 children will be studied. In Phase I, 100 children will be studied and in Phase II 50 children will be studied.

Exclusion criteria

  • any medical illness or medication affecting growth or limiting participation in physical activities or sports.

Treatment and study plan

Primary outcomes

  1. Energy expenditure

    Time frame: up to 1 year

    Energy expenditure will be measured by calorimetry and the doubly labeled water method.

Secondary outcomes

  1. physical activity

    Time frame: Up to 1 year

    The physical activity level of children will be measured by accelerometry and heart rate monitoring.

Sponsors and collaborators

Lead sponsor

Baylor College of Medicine

Other

Collaborators

  • Drexel University
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Novel Models to Predict Energy Expenditure and Physical Activity in Preschoolers

Acronym: LILCAL

Important dates

Study start
2010
Primary completion
2012
Study completion
2015
First posted
Mar 3, 2014
Registry last updated
Feb 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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