International Study of Childhood Obesity, Lifestyle and the Environment

Childhood Obesity Clinical Trial

— ISCOLE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01722500
• Other study ID #: PBRC 10042CC
• Status: Completed
• Phase: N/A
• First received: October 29, 2012
• Last updated: February 4, 2016
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2016
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical 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 and policy environments on the observed relationships within each country.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7806
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 11 Years

Eligibility

Inclusion Criteria:

• students 10 years of age

Exclusion Criteria:

• has pacemaker or other internal medical devices

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Childhood Obesity
• Obesity
• Pediatric Obesity

Locations

Country	Name	City	State
Australia	School of Health Sciences at University of South Australia	Adelaide
Brazil	Centro de Estudos do Laboratório de Aptidão Física de São Caetano do Sul (CELAFISCS)	Sao Paulo
Canada	Department of Pediatrics, University of Ottawa	Ottawa	Ontario
China	Tianjin Women's & Children's Health Center	Tianjin
Colombia	Department of Public Health School of Medicine at Universidad de los Andes	Carrera	Bogata
Finland	Department of Food & Environmental Sciences, University of Helsinki	Helsinki
India	St John's National Academy of Health Sciences	Bangalore	Karnataka
Kenya	Department of Exercise, Recreation and Sports Science at Kenyatta University	Nairobi
Portugal	Faculty of Sport Sciences and Physical Education - University of Porto	Porto
South Africa	University of Cape Town	Rondebosch	Cape Town
United Kingdom	Department of Health at University of Bath	Bath
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center	The Coca-Cola Company

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  China,  Colombia,  Finland,  India,  Kenya,  Portugal,  South Africa,  United Kingdom, 

References & Publications (27)

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. — View Citation

Borges A, Gomes TN, Santos D, Pereira S, dos Santos FK, Chaves R, Katzmarzyk PT, Maia J. A count model to study the correlates of 60 min of daily physical activity in Portuguese children. Int J Environ Res Public Health. 2015 Feb 26;12(3):2557-73. doi: 10 — View Citation

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 — View Citation

Borghese MM, Tremblay MS, Leduc G, Boyer C, Bélanger P, LeBlanc AG, Francis C, Chaput JP. Independent and combined associations of total sedentary time and television viewing time with food intake patterns of 9- to 11-year-old Canadian children. Appl Phys — View Citation

Borghese MM, Tremblay MS, Leduc G, Boyer C, Bélanger P, LeBlanc AG, Francis C, Chaput JP. Television viewing and food intake during television viewing in normal-weight, overweight and obese 9- to 11-year-old Canadian children: a cross-sectional analysis. — View Citation

Chaput JP, Leduc G, Boyer C, Bélanger P, LeBlanc AG, Borghese MM, Tremblay MS. Electronic screens in children's bedrooms and adiposity, physical activity and sleep: do the number and type of electronic devices matter? Can J Public Health. 2014 Jul 11;105( — View Citation

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.2 — View Citation

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 — View Citation

Gomes TN, dos Santos FK, Santos D, Pereira S, Chaves R, Katzmarzyk PT, Maia J. Correlates of sedentary time in children: a multilevel modelling approach. BMC Public Health. 2014 Aug 30;14:890. doi: 10.1186/1471-2458-14-890. — View Citation

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.01 — View Citation

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. — View Citation

Gomes TN, Katzmarzyk PT, dos Santos FK, Souza M, Pereira S, Maia JA. Overweight and obesity in Portuguese children: prevalence and correlates. Int J Environ Res Public Health. 2014 Nov 3;11(11):11398-417. doi: 10.3390/ijerph111111398. — View Citation

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. Physic — View Citation

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 In — View Citation

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 — View Citation

Larouche R, Chaput JP, Leduc G, Boyer C, Bélanger P, LeBlanc AG, Borghese MM, Tremblay MS. A cross-sectional examination of socio-demographic and school-level correlates of children's school travel mode in Ottawa, Canada. BMC Public Health. 2014 May 23;14 — View Citation

LeBlanc AG, Broyles ST, Chaput JP, Leduc G, Boyer C, Borghese MM, Tremblay MS. Correlates of objectively measured sedentary time and self-reported screen time in Canadian children. Int J Behav Nutr Phys Act. 2015 Mar 18;12:38. doi: 10.1186/s12966-015-0197 — View Citation

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; ISCOL — View Citation

Mcneil J, Tremblay MS, Leduc G, Boyer C, Bélanger P, Leblanc AG, Borghese MM, Chaput JP. Objectively-measured sleep and its association with adiposity and physical activity in a sample of Canadian children. J Sleep Res. 2015 Apr;24(2):131-9. doi: 10.1111/ — View Citation

Muthuri SK, Wachira LJ, Onywera VO, Tremblay MS. Associations Between Parental Perceptions of the Neighbourhood Environment and Childhood Physical Activity: Results from ISCOLE-Kenya. J Phys Act Health. 2015 Aug 13. [Epub ahead of print] — View Citation

Muthuri SK, Wachira LJ, Onywera VO, Tremblay MS. Correlates of objectively measured overweight/obesity and physical activity in Kenyan school children: results from ISCOLE-Kenya. BMC Public Health. 2014 May 9;14:436. doi: 10.1186/1471-2458-14-436. — View Citation

Muthuri SK, Wachira LJ, Onywera VO, Tremblay MS. Direct and self-reported measures of physical activity and sedentary behaviours by weight status in school-aged children: results from ISCOLE-Kenya. Ann Hum Biol. 2015;42(3):237-45. doi: 10.3109/03014460.20 — View Citation

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):924 — View Citation

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: 10.3 — View Citation

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 — View Citation

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; — View Citation

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 Res — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testing of Children	BMI (kg/m2)	Baseline	No
Primary	Testing of Children	Waist Circumference (cm)	Baseline	No
Primary	Testing of Children	Percent Body Fat (%)	Baseline	No
Secondary	Testing of Children	Physical activity (minutes/day)	Baseline	No
Secondary	Testing of Children	Dietary intake (principal components analysis score)	Baseline	No