Energy Expenditure and Physical Activity in Preschoolers

Completed

• Conditions: Healthy

• Registration Number: NCT02075359
• Lead Sponsor: Baylor College of Medicine

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2012-08
• Study First Submitted: 2014-02-21
• Study First Submitted QC: 2014-02-27
• Study First Posted: 2014-03-03
• Study Completion: 2015-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-24
• Last Update Posted: 2020-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 119

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.

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Energy expenditure	up to 1 year	Energy expenditure will be measured by calorimetry and the doubly labeled water method.

Secondary Outcome Measures

Name	Time	Method
physical activity	Up to 1 year	The physical activity level of children will be measured by accelerometry and heart rate monitoring.

Trial Locations

Locations (1)

Children's Nutrition Research Center; 🇺🇸 Houston, Texas, United States