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LILCAL: Energy Expenditure and Physical Activity in Preschoolers

Sponsor
Baylor College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT02075359
Collaborator
Drexel University (Other), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
119
Enrollment
1
Location
59
Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    119 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Novel Models to Predict Energy Expenditure and Physical Activity in Preschoolers
    Study Start Date :
    May 1, 2010
    Actual Primary Completion Date :
    Aug 1, 2012
    Actual Study Completion Date :
    Apr 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    Preschoolers

    Preschoolers, ages 3 to 5

    Outcome Measures

    Primary Outcome Measures

    1. Energy expenditure [up to 1 year]

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

    Secondary Outcome Measures

    1. physical activity [Up to 1 year]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Nutrition Research Center Houston Texas United States 77030

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Nancy Butte, Ph.D, Baylor College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nancy Butte, Principal investigator and Professor, Baylor College of Medicine
    ClinicalTrials.gov Identifier:
    NCT02075359
    Other Study ID Numbers:
    • H12067
    • R01DK085163
    First Posted:
    Mar 3, 2014
    Last Update Posted:
    Feb 26, 2020
    Last Verified:
    Feb 1, 2020
    Keywords provided by Nancy Butte, Principal investigator and Professor, Baylor College of Medicine
    Total Energy Expenditure
    Physical Activity Levels
    Body Mass Index
    Children

    Study Results

    No Results Posted as of Feb 26, 2020