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NCT Number: NCT01722500

International Study of Childhood Obesity, Lifestyle and the Environment

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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Key information

Conditions

Childhood Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pediatric Obesity Signs and Symptoms

Age range

9 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

School of Health Sciences at University of South Australia, Adelaide, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • students 10 years of age

Exclusion criteria

  • has pacemaker or other internal medical devices

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Testing of Children

    Time frame: Baseline

    Physical activity (minutes/day)

  2. Testing of Children

    Time frame: Baseline

    Dietary intake (principal components analysis score)

Sponsors and collaborators

Lead sponsor

Pennington Biomedical Research Center

Other

Collaborators

  • The Coca-Cola Company

Registry information

Official study title

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

Acronym: ISCOLE

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Nov 7, 2012
Registry last updated
Feb 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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