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International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01722500
Recruitment Status : Completed
First Posted : November 7, 2012
Last Update Posted : February 5, 2016
Sponsor:
Collaborator:
The Coca-Cola Company
Information provided by (Responsible Party):
Peter T. Katzmarzyk, Pennington Biomedical Research Center

Tracking Information
First Submitted Date October 29, 2012
First Posted Date November 7, 2012
Last Update Posted Date February 5, 2016
Study Start Date December 2010
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 15, 2015)
  • Testing of Children [ Time Frame: Baseline ]
    BMI (kg/m2)
  • Testing of Children [ Time Frame: Baseline ]
    Waist Circumference (cm)
  • Testing of Children [ Time Frame: Baseline ]
    Percent Body Fat (%)
Original Primary Outcome Measures
 (submitted: November 3, 2012)
Testing of Children [ Time Frame: Baseline ]
BMI, waist circumference and obesity
Change History
Current Secondary Outcome Measures
 (submitted: September 15, 2015)
  • Testing of Children [ Time Frame: Baseline ]
    Physical activity (minutes/day)
  • Testing of Children [ Time Frame: Baseline ]
    Dietary intake (principal components analysis score)
Original Secondary Outcome Measures
 (submitted: November 3, 2012)
  • Testing of Children [ Time Frame: Baseline ]
    Physical activity
  • Testing of Children [ Time Frame: Baseline ]
    Dietary intake
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title International Study of Childhood Obesity, Lifestyle and the Environment
Official Title International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE)
Brief Summary The primary aim of the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) is to determine the relationship between lifestyle characteristics and obesity in a large multi-national study of 10 year-old children, and to investigate the influence of behavioral settings and physical, social and policy environments on the observed relationships within each country.
Detailed Description Data will be collected in 12 countries (500 children per site) from five major regions of the world (Eurasia & Africa, Europe, Latin America, North America, and the Pacific). Cross-sectional evaluations will be undertaken in each country. The physical characteristics of the children will be directly measured in order to classify their body weight and adiposity status, and physical activity and dietary patterns will be measured with the most objective techniques currently available. A concise set of environmental measures that are feasible, valid and meaningful across the international settings included in this research will also be employed. The results of this study will provide a robust examination of the correlates of obesity and weight gain in children, focusing on both sides of the energy balance equation. The results will also provide important new information that will inform the development of lifestyle interventions to address childhood obesity that can be culturally adapted for implementation around the world.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population boys and girls who are approximately 10 years
Condition Childhood Obesity
Intervention Not Provided
Study Groups/Cohorts 10 year old children
500 children with mean age 10.5 years from each of 12 countries
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 27, 2015)
7806
Original Estimated Enrollment
 (submitted: November 3, 2012)
6000
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • students 10 years of age

Exclusion Criteria:

  • has pacemaker or other internal medical devices
Sex/Gender
Sexes Eligible for Study: All
Ages 9 Years to 11 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Australia,   Brazil,   Canada,   China,   Colombia,   Finland,   India,   Kenya,   Portugal,   South Africa,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01722500
Other Study ID Numbers PBRC 10042CC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Peter T. Katzmarzyk, Pennington Biomedical Research Center
Study Sponsor Pennington Biomedical Research Center
Collaborators The Coca-Cola Company
Investigators
Principal Investigator: Peter T. Katzmarzyk, PhD, FACSM Pennington Biomedical Research Center
Principal Investigator: Timothy S. Church, MD, MPH, PhD Pennington Biomedical Research Center
PRS Account Pennington Biomedical Research Center
Verification Date February 2016