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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Scientific title
International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE)
Secondary ID [1] 0 0
PBRC 10042CC
Universal Trial Number (UTN)
Trial acronym
ISCOLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
10 year old children - 500 children with mean age 10.5 years from each of 12 countries
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Testing of Children
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Testing of Children
Timepoint [2] 0 0
Baseline
Primary outcome [3] 0 0
Testing of Children
Timepoint [3] 0 0
Baseline
Secondary outcome [1] 0 0
Testing of Children
Timepoint [1] 0 0
Baseline
Secondary outcome [2] 0 0
Testing of Children
Timepoint [2] 0 0
Baseline

Eligibility
Key inclusion criteria
* students 10 years of age
Minimum age
9 Years
Maximum age
11 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* has pacemaker or other internal medical devices

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2014
Sample size
Target
Accrual to date
Final
7806
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
School of Health Sciences at University of South Australia - Adelaide
Recruitment postcode(s) [1] 0 0
5001 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Louisiana
Country [2] 0 0
Brazil
State/province [2] 0 0
Sao Paulo
Country [3] 0 0
Canada
State/province [3] 0 0
Ontario
Country [4] 0 0
China
State/province [4] 0 0
Tianjin
Country [5] 0 0
Colombia
State/province [5] 0 0
Bogata
Country [6] 0 0
Finland
State/province [6] 0 0
Helsinki
Country [7] 0 0
India
State/province [7] 0 0
Karnataka
Country [8] 0 0
Kenya
State/province [8] 0 0
Nairobi
Country [9] 0 0
Portugal
State/province [9] 0 0
Porto
Country [10] 0 0
South Africa
State/province [10] 0 0
Cape Town
Country [11] 0 0
United Kingdom
State/province [11] 0 0
Bath

Funding & Sponsors
Primary sponsor type
Other
Name
Pennington Biomedical Research Center
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
The Coca-Cola Company
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT01722500
Trial related presentations / 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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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: 10.3390/ijerph120302557.
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.
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.
Muthuri SK, Wachira LJ, Onywera VO, Tremblay MS. Associations Between Parental Perceptions of the Neighborhood Environment and Childhood Physical Activity: Results from ISCOLE-Kenya. J Phys Act Health. 2016 Mar;13(3):333-43. doi: 10.1123/jpah.2014-0595. Epub 2015 Aug 13.
Borghese MM, Tremblay MS, Leduc G, Boyer C, Belanger 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. J Nutr Sci. 2015 Feb 27;4:e8. doi: 10.1017/jns.2014.72. eCollection 2015.
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/s12966-015-0197-1.
Mcneil J, Tremblay MS, Leduc G, Boyer C, Belanger 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/jsr.12241. Epub 2014 Sep 30.
Chaput JP, Leduc G, Boyer C, Belanger 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(4):e273-9. doi: 10.17269/cjph.105.4511.
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: 10.3109/03014460.2014.932847. Epub 2014 Jul 15.
Borghese MM, Tremblay MS, Leduc G, Boyer C, Belanger 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 Physiol Nutr Metab. 2014 Aug;39(8):937-43. doi: 10.1139/apnm-2013-0551. Epub 2014 Mar 14.
Larouche R, Chaput JP, Leduc G, Boyer C, Belanger 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;14:497. doi: 10.1186/1471-2458-14-497.
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.
Santos MD, Ferrari G, Drenowatz C, Estivaleti JM, de Victo ER, de Oliveira LC, Matsudo V. Association between breastfeeding, parents' body mass index and birth weight with obesity indicators in children. BMC Pediatr. 2022 Oct 18;22(1):604. doi: 10.1186/s12887-022-03641-3.
Barreira TV, Broyles ST, Tudor-Locke C, Chaput JP, Fogelholm M, Hu G, Kuriyan R, Lambert EV, Maher CA, Maia JA, Olds T, Onywera V, Sarmiento OL, Standage M, Tremblay MS, Katzmarzyk PT; ISCOLE Research Group. Epidemiological Transition in Physical Activity and Sedentary Time in Children. J Phys Act Health. 2019 Jun 27;16(7):518-524. doi: 10.1123/jpah.2018-0546.
Zakrzewski-Fruer JK, Gillison FB, Katzmarzyk PT, Mire EF, Broyles ST, Champagne CM, Chaput JP, Denstel KD, Fogelholm M, Hu G, Lambert EV, Maher C, Maia J, Olds T, Onywera V, Sarmiento OL, Tremblay MS, Tudor-Locke C, Standage M; ISCOLE Research Group. Association between breakfast frequency and physical activity and sedentary time: a cross-sectional study in children from 12 countries. BMC Public Health. 2019 Feb 21;19(1):222. doi: 10.1186/s12889-019-6542-6.
Wilkie HJ, Standage M, Gillison FB, Cumming SP, Katzmarzyk PT. Correlates of intensity-specific physical activity in children aged 9-11 years: a multilevel analysis of UK data from the International Study of Childhood Obesity, Lifestyle and the Environment. BMJ Open. 2018 Feb 3;8(2):e018373. doi: 10.1136/bmjopen-2017-018373.
Sullivan SM, Broyles ST, Barreira TV, 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, Tudor-Locke C, Zhao P, Katzmarzyk PT; ISCOLE Research Group. Associations of neighborhood social environment attributes and physical activity among 9-11 year old children from 12 countries. Health Place. 2017 Jul;46:183-191. doi: 10.1016/j.healthplace.2017.05.013. Epub 2017 May 22.
Dumuid D, Olds T, Lewis LK, Martin-Fernandez JA, Katzmarzyk PT, Barreira T, Broyles ST, Chaput JP, Fogelholm M, Hu G, Kuriyan R, Kurpad A, Lambert EV, Maia J, Matsudo V, Onywera VO, Sarmiento OL, Standage M, Tremblay MS, Tudor-Locke C, Zhao P, Gillison F, Maher C; International Study of Childhood Obesity, Lifestyle and the Environment (ISCOLE) research group. Health-Related Quality of Life and Lifestyle Behavior Clusters in School-Aged Children from 12 Countries. J Pediatr. 2017 Apr;183:178-183.e2. doi: 10.1016/j.jpeds.2016.12.048. Epub 2017 Jan 10.
Roman-Vinas B, Chaput JP, Katzmarzyk PT, Fogelholm M, Lambert EV, Maher C, Maia J, Olds T, Onywera V, Sarmiento OL, Standage M, Tudor-Locke C, Tremblay MS; ISCOLE Research Group. Proportion of children meeting recommendations for 24-hour movement guidelines and associations with adiposity in a 12-country study. Int J Behav Nutr Phys Act. 2016 Nov 25;13(1):123. doi: 10.1186/s12966-016-0449-8.
Harrington DM, Gillison F, Broyles ST, Chaput JP, Fogelholm M, Hu G, Kuriyan R, Kurpad A, LeBlanc AG, Maher C, Maia J, Matsudo V, Olds T, Onywera V, Sarmiento OL, Standage M, Tremblay MS, Tudor-Locke C, Zhao P, Katzmarzyk PT; ISCOLE Research Group. Household-level correlates of children's physical activity levels in and across 12 countries. Obesity (Silver Spring). 2016 Oct;24(10):2150-7. doi: 10.1002/oby.21618. Epub 2016 Aug 25.
Wilkie HJ, Standage M, Gillison FB, Cumming SP, Katzmarzyk PT. Multiple lifestyle behaviours and overweight and obesity among children aged 9-11 years: results from the UK site of the International Study of Childhood Obesity, Lifestyle and the Environment. BMJ Open. 2016 Feb 24;6(2):e010677. doi: 10.1136/bmjopen-2015-010677.
Public notes

Contacts
Principal investigator
Name 0 0
Peter T. Katzmarzyk, PhD, FACSM
Address 0 0
Pennington Biomedical Research Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01722500