Overview

This trial is active, not recruiting.

Condition healthy
Sponsor Baylor College of Medicine
Collaborator Drexel University
Start date May 2010
End date April 2014
Trial size 150 participants
Trial identifier NCT02075359, H12067, R01DK085163

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Arm
Preschoolers, ages 3 to 5

Primary Outcomes

Measure
Energy expenditure
time frame: up to 1 year

Secondary Outcomes

Measure
physical activity
time frame: Up to 1 year

Eligibility Criteria

Male or female participants from 3 years up to 5 years old.

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.

Additional Information

Official title Novel Models to Predict Energy Expenditure and Physical Activity in Preschoolers
Principal investigator Nancy Butte, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.