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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01722500
Registration number
NCT01722500
Ethics application status
Date submitted
29/10/2012
Date registered
7/11/2012
Date last updated
5/02/2016
Titles & IDs
Public title
International Study of Childhood Obesity, Lifestyle and the Environment
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Scientific title
International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE)
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Secondary ID [1]
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PBRC 10042CC
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Universal Trial Number (UTN)
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Trial acronym
ISCOLE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Childhood Obesity
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Condition category
Condition code
Diet and Nutrition
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Obesity
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Metabolic and Endocrine
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Other metabolic disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
10 year old children - 500 children with mean age 10.5 years from each of 12 countries
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Testing of Children
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Assessment method [1]
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BMI (kg/m2)
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Testing of Children
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Assessment method [2]
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Waist Circumference (cm)
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Timepoint [2]
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Baseline
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Primary outcome [3]
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Testing of Children
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Assessment method [3]
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Percent Body Fat (%)
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Timepoint [3]
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Baseline
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Secondary outcome [1]
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Testing of Children
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Assessment method [1]
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Physical activity (minutes/day)
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Timepoint [1]
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Baseline
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Secondary outcome [2]
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Testing of Children
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Assessment method [2]
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Dietary intake (principal components analysis score)
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Timepoint [2]
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Baseline
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Eligibility
Key inclusion criteria
- students 10 years of age
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Minimum age
9
Years
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Maximum age
11
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
- has pacemaker or other internal medical devices
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Study design
Purpose
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Duration
Cross-sectional
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2014
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Sample size
Target
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Accrual to date
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Final
7806
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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School of Health Sciences at University of South Australia - Adelaide
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Recruitment postcode(s) [1]
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5001 - Adelaide
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Louisiana
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Country [2]
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Brazil
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State/province [2]
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Sao Paulo
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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China
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State/province [4]
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Tianjin
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Country [5]
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Colombia
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State/province [5]
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Bogata
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Country [6]
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Finland
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State/province [6]
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Helsinki
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Country [7]
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India
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State/province [7]
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Karnataka
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Country [8]
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Kenya
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State/province [8]
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Nairobi
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Country [9]
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Portugal
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State/province [9]
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Porto
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Country [10]
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South Africa
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State/province [10]
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Cape Town
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Country [11]
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United Kingdom
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State/province [11]
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Bath
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Funding & Sponsors
Primary sponsor type
Other
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Name
Pennington Biomedical Research Center
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Address
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Country
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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The Coca-Cola Company
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01722500
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Peter T. Katzmarzyk, PhD, FACSM
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Address
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Pennington Biomedical Research Center
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01722500
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