NCT02075359

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 21, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2014

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

February 26, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

February 21, 2014

Last Update Submit

February 24, 2020

Conditions

Healthy

Keywords

Total Energy ExpenditurePhysical Activity LevelsBody Mass IndexChildren

Outcome Measures

Primary Outcomes (1)

  • Energy expenditure

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

    up to 1 year

Secondary Outcomes (1)

  • physical activity

    Up to 1 year

Study Arms (1)

Preschoolers

Preschoolers, ages 3 to 5

Eligibility Criteria

Age3 Years - 5 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Child (3-5 years)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Location

Study Officials

  • Nancy Butte, Ph.D

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator and Professor

Study Record Dates

First Submitted

February 21, 2014

First Posted

March 3, 2014

Study Start

May 1, 2010

Primary Completion

August 1, 2012

Study Completion

April 1, 2015

Last Updated

February 26, 2020

Record last verified: 2020-02

Locations

US(1)