Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01722500
Previous Study | Return to List | Next Study

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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
Childhood Obesity

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 7806 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE)
Study Start Date : December 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
10 year old children
500 children with mean age 10.5 years from each of 12 countries


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Testing of Children [ Time Frame: Baseline ]
    BMI (kg/m2)

  2. Testing of Children [ Time Frame: Baseline ]
    Waist Circumference (cm)

  3. Testing of Children [ Time Frame: Baseline ]
    Percent Body Fat (%)


Secondary Outcome Measures :
  1. Testing of Children [ Time Frame: Baseline ]
    Physical activity (minutes/day)

  2. Testing of Children [ Time Frame: Baseline ]
    Dietary intake (principal components analysis score)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   9 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
boys and girls who are approximately 10 years
Criteria

Inclusion Criteria:

  • students 10 years of age

Exclusion Criteria:

  • has pacemaker or other internal medical devices
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01722500


Locations
Layout table for location information
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Australia
School of Health Sciences at University of South Australia
Adelaide, Australia, 5001
Brazil
Centro de Estudos do Laboratório de Aptidão Física de São Caetano do Sul (CELAFISCS)
Sao Paulo, Brazil, 09501-000
Canada, Ontario
Department of Pediatrics, University of Ottawa
Ottawa, Ontario, Canada, K1N 6N5
China
Tianjin Women's & Children's Health Center
Tianjin, China, 300070
Colombia
Department of Public Health School of Medicine at Universidad de los Andes
Carrera, Bogata, Colombia
Finland
Department of Food & Environmental Sciences, University of Helsinki
Helsinki, Finland, 00014
India
St John's National Academy of Health Sciences
Bangalore, Karnataka, India, 560034
Kenya
Department of Exercise, Recreation and Sports Science at Kenyatta University
Nairobi, Kenya
Portugal
Faculty of Sport Sciences and Physical Education - University of Porto
Porto, Portugal, 4200-450
South Africa
University of Cape Town
Rondebosch, Cape Town, South Africa, 7701
United Kingdom
Department of Health at University of Bath
Bath, United Kingdom, BA2 7AY
Sponsors and Collaborators
Pennington Biomedical Research Center
The Coca-Cola Company
Investigators
Layout table for investigator information
Principal Investigator: Peter T. Katzmarzyk, PhD, FACSM Pennington Biomedical Research Center
Principal Investigator: Timothy S. Church, MD, MPH, PhD Pennington Biomedical Research Center
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Peter T. Katzmarzyk, Associate Executive Director of Population Science, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01722500    
Other Study ID Numbers: PBRC 10042CC
First Posted: November 7, 2012    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Peter T. Katzmarzyk, Pennington Biomedical Research Center:
International
Childhood
Obesity
ISCOLE
 Pennington Biomedical Research Center
PBRC
longitudinal
multinational
Additional relevant MeSH terms:
Layout table for MeSH terms
Obesity
Pediatric Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms