AzTrials
AzTrials

Childhood ObesityISCOLENCT01722500

International Study of Childhood Obesity, Lifestyle and the Environment

An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 12 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 9 to 11 yearsHealthy volunteers can take part
Conditions the study is for
Childhood Obesity
How many people
7,806 participants
Where
12 sitesin 12 countries
Study dates
Dec 2010to Dec 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 11 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: boys and girls who are approximately 10 years

Who may be able to join

  • students 10 years of age

Who cannot join

  • has pacemaker or other internal medical devices

Trial locations and contacts

12 sites in 12 countries.

12 sites in 12 countries

United States1 site

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808

Other trials in United States

Australia1 site

  • School of Health Sciences at University of South Australia

    Adelaide, 5001

Other trials in Australia

Brazil1 site

  • Centro de Estudos do Laboratório de Aptidão Física de São Caetano do Sul (CELAFISCS)

    São Paulo, 09501-000

Other trials in Brazil

Canada1 site

  • Department of Pediatrics, University of Ottawa

    Ottawa, Ontario, K1N 6N5

Other trials in Canada

China1 site

  • Tianjin Women's & Children's Health Center

    Tianjin, 300070

Other trials in China

Colombia1 site

  • Department of Public Health School of Medicine at Universidad de los Andes

    Carrera, Bogata

Other trials in Colombia

Finland1 site

  • Department of Food & Environmental Sciences, University of Helsinki

    Helsinki, 00014

Other trials in Finland

India1 site

  • St John's National Academy of Health Sciences

    Bangalore, Karnataka, 560034

Other trials in India

Kenya1 site

  • Department of Exercise, Recreation and Sports Science at Kenyatta University

    Nairobi

Other trials in Kenya

Portugal1 site

  • Faculty of Sport Sciences and Physical Education - University of Porto

    Porto, 4200-450

Other trials in Portugal

South Africa1 site

  • University of Cape Town

    Rondebosch, Cape Town, 7701

Other trials in South Africa

United Kingdom1 site

  • Department of Health at University of Bath

    Bath, BA2 7AY

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Keywords
International, Childhood, Obesity, ISCOLE, Pennington Biomedical Research Center, PBRC, longitudinal, multinational
Medical subject headings
Pediatric Obesity, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01722500
Study groupRoleWhat they receive
10 year old children500 children with mean age 10.5 years from each of 12 countries

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Testing of Children

    BMI (kg/m2)

    Measured: Baseline

  2. Testing of Children

    Waist Circumference (cm)

    Measured: Baseline

  3. Testing of Children

    Percent Body Fat (%)

    Measured: Baseline

Secondary outcomes (2)

  1. Testing of Children

    Physical activity (minutes/day)

    Measured: Baseline

  2. Testing of Children

    Dietary intake (principal components analysis score)

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Nov 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
7,806 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01722500
Sponsor's protocol ID
PBRC 10042CC
Acronym
ISCOLE
Status last verified
Feb 2016
First submitted
29 Oct 2012
Last updated
5 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Katzmarzyk PT, Barreira TV, Broyles ST, Champagne CM, Chaput JP, Fogelholm M, Hu G, Johnson WD, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Onywera V, Sarmiento OL, Standage M, Tremblay MS, Tudor-Locke C, Zhao P, Church TS. The International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE): design and methods. BMC Public Health. 2013 Sep 30;13:900. doi: 10.1186/1471-2458-13-900.

    PubMed 24079373

  • Tudor-Locke C, Barreira TV, Schuna JM Jr, Mire EF, Katzmarzyk PT. Fully automated waist-worn accelerometer algorithm for detecting children's sleep-period time separate from 24-h physical activity or sedentary behaviors. Appl Physiol Nutr Metab. 2014 Jan;39(1):53-7. doi: 10.1139/apnm-2013-0173. Epub 2013 Jun 26.

    PubMed 24383507

  • Barreira TV, Schuna JM Jr, Mire EF, Katzmarzyk PT, Chaput JP, Leduc G, Tudor-Locke C. Identifying children's nocturnal sleep using 24-h waist accelerometry. Med Sci Sports Exerc. 2015 May;47(5):937-43. doi: 10.1249/MSS.0000000000000486.

    PubMed 25202840

  • Katzmarzyk PT, Barreira TV, Broyles ST, Champagne CM, Chaput JP, Fogelholm M, Hu G, Johnson WD, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Onywera V, Sarmiento OL, Standage M, Tremblay MS, Tudor-Locke C, Zhao P, Church TS. Physical Activity, Sedentary Time, and Obesity in an International Sample of Children. Med Sci Sports Exerc. 2015 Oct;47(10):2062-9. doi: 10.1249/MSS.0000000000000649.

    PubMed 25751770

  • Tudor-Locke C, Barreira TV, Schuna JM Jr, Mire EF, Chaput JP, Fogelholm M, Hu G, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Onywera V, Sarmiento OL, Standage M, Tremblay MS, Zhao P, Church TS, Katzmarzyk PT; ISCOLE Research Group. Improving wear time compliance with a 24-hour waist-worn accelerometer protocol in the International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE). Int J Behav Nutr Phys Act. 2015 Feb 11;12:11. doi: 10.1186/s12966-015-0172-x.

    PubMed 25881074

  • Pereira S, Gomes TN, Borges A, Santos D, Souza M, dos Santos FK, Chaves RN, Katzmarzyk PT, Maia JA. Variability and Stability in Daily Moderate-to-Vigorous Physical Activity among 10 Year Old Children. Int J Environ Res Public Health. 2015 Aug 7;12(8):9248-63. doi: 10.3390/ijerph120809248.

    PubMed 26262632

  • Gomes TN, Hedeker D, dos Santos FK, Pereira S, Katzmarzyk PT, Maia JA. Why Are Children Different in Their Daily Sedentariness? An Approach Based on the Mixed-Effects Location Scale Model. PLoS One. 2015 Jul 31;10(7):e0132192. doi: 10.1371/journal.pone.0132192. eCollection 2015.

    PubMed 26230652

  • Gomes TN, Katzmarzyk PT, dos Santos FK, de Chaves RN, Santos D, Pereira S, Champagne CM, Hedeker D, Maia J. Are BMI and Sedentariness Correlated? A Multilevel Study in Children. Nutrients. 2015 Jul 16;7(7):5889-904. doi: 10.3390/nu7075258.

    PubMed 26193311

  • Katzmarzyk PT, Barreira TV, Broyles ST, Champagne CM, Chaput JP, Fogelholm M, Hu G, Johnson WD, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Onywera V, Sarmiento OL, Standage M, Tremblay MS, Tudor-Locke C, Zhao P, Church TS; ISCOLE Research Group. Relationship between lifestyle behaviors and obesity in children ages 9-11: Results from a 12-country study. Obesity (Silver Spring). 2015 Aug;23(8):1696-702. doi: 10.1002/oby.21152. Epub 2015 Jul 14.

    PubMed 26173093

  • LeBlanc AG, Katzmarzyk PT, Barreira TV, Broyles ST, Chaput JP, Church TS, Fogelholm M, Harrington DM, Hu G, Kuriyan R, Kurpad A, Lambert EV, Maher C, Maia J, Matsudo V, Olds T, Onywera V, Sarmiento OL, Standage M, Tudor-Locke C, Zhao P, Tremblay MS; ISCOLE Research Group. Correlates of Total Sedentary Time and Screen Time in 9-11 Year-Old Children around the World: The International Study of Childhood Obesity, Lifestyle and the Environment. PLoS One. 2015 Jun 11;10(6):e0129622. doi: 10.1371/journal.pone.0129622. eCollection 2015.

    PubMed 26068231

  • Pereira S, Katzmarzyk PT, Gomes TN, Borges A, Santos D, Souza M, dos Santos FK, Chaves RN, Champagne CM, Barreira TV, Maia JA. Profiling physical activity, diet, screen and sleep habits in Portuguese children. Nutrients. 2015 Jun 2;7(6):4345-62. doi: 10.3390/nu7064345.

    PubMed 26043034

  • Borghese MM, Tremblay MS, Katzmarzyk PT, Tudor-Locke C, Schuna JM Jr, Leduc G, Boyer C, LeBlanc AG, Chaput JP. Mediating role of television time, diet patterns, physical activity and sleep duration in the association between television in the bedroom and adiposity in 10 year-old children. Int J Behav Nutr Phys Act. 2015 May 13;12:60. doi: 10.1186/s12966-015-0221-5.

    PubMed 25967920

  • Tudor-Locke C, Mire EF, Dentro KN, Barreira TV, Schuna JM Jr, Zhao P, Tremblay MS, Standage M, Sarmiento OL, Onywera V, Olds T, Matsudo V, Maia J, Maher C, Lambert EV, Kurpad A, Kuriyan R, Hu G, Fogelholm M, Chaput JP, Church TS, Katzmarzyk PT; ISCOLE Research Group. A model for presenting accelerometer paradata in large studies: ISCOLE. Int J Behav Nutr Phys Act. 2015 Apr 20;12:52. doi: 10.1186/s12966-015-0213-5.

    PubMed 25927615

  • Ferrari GL, Oliveira LC, Araujo TL, Matsudo V, Barreira TV, Tudor-Locke C, Katzmarzyk P. Moderate-to-Vigorous Physical Activity and Sedentary Behavior: Independent Associations With Body Composition Variables in Brazilian Children. Pediatr Exerc Sci. 2015 Aug;27(3):380-9. doi: 10.1123/pes.2014-0150. Epub 2015 Apr 22.

    PubMed 25902556

  • Ferrari GL, Araujo TL, Oliveira L, Matsudo V, Mire E, Barreira TV, Tudor-Locke C, Katzmarzyk PT. Association Between Television Viewing and Physical Activity in 10-Year-Old Brazilian Children. J Phys Act Health. 2015 Oct;12(10):1401-8. doi: 10.1123/jpah.2014-0406. Epub 2015 Mar 31.

    PubMed 25831554

Questions about this trial

What is this clinical trial studying?

An observational study of Childhood Obesity, run by Pennington Biomedical Research Center at 12 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Australia, Brazil, Canada, China and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Testing of Children (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01722500, which also lists 36 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in