Energy Expenditure and Physical Activity in Preschoolers

NCT ID: NCT02075359

Last Updated: 2020-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

119 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2015-04-30

Brief Summary

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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

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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.

Conditions

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Healthy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Preschoolers

Preschoolers, ages 3 to 5

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Drexel University

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Baylor College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Nancy Butte

Principal investigator and Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nancy Butte, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

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Children's Nutrition Research Center

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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R01DK085163

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H12067

Identifier Type: -

Identifier Source: org_study_id

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