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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02102763
Other study ID # AgriculturalUA
Secondary ID
Status Completed
Phase N/A
First received March 31, 2014
Last updated April 7, 2014
Start date October 2008
Est. completion date May 2009

Study information

Verified date April 2014
Source Agricultural University of Athens
Contact n/a
Is FDA regulated No
Health authority Greece: Research Committtee
Study type Observational

Clinical Trial Summary

The purpose of the GRECO study were to: a) to provide national data on overweight and obesity prevalence in a representative sample of primary schoolchildren aged 10-12 years old, b) to identify those socio-economic, demographic factors, as well as dietary and physical activity habits and familial characteristics that are associated with childhood and preadolescent overweight and obesity, c) to identify lifestyle and dietary patterns that are associated with elevated blood pressure levels and dietary sodium intake.


Recruitment information / eligibility

Status Completed
Enrollment 5000
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 10 Years to 12 Years
Eligibility Inclusion Criteria:

- Within the age range

- 5th and 6th grade public schools children

- Consent form provided by the parents

Exclusion Criteria:

- Not providing signed parental consent forms

- Outside the required age range

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Locations

Country Name City State
Greece Department of Food Science and Human Nutrition, Agricultural University of Athens Athens Attica

Sponsors (11)

Lead Sponsor Collaborator
Agricultural University of Athens Cereal Partners Hellas, Coca Cola Hellas, Coca Cola Hellenic Bottling Company, European Union and Greek national funds - Research Funding Program: Heraclitus II., FAGE S.A., General Secretariat of Consumers-Greek Ministry of Development, Hellenic Association of Food and Beverage Companies, Kraft Foods Hellas, Nestle Hellas, Unilever Hellas

Country where clinical trial is conducted

Greece, 

References & Publications (4)

Farajian P, Panagiotakos DB, Risvas G, Karasouli K, Bountziouka V, Voutzourakis N, Zampelas A. Socio-economic and demographic determinants of childhood obesity prevalence in Greece: the GRECO (Greek Childhood Obesity) study. Public Health Nutr. 2013 Feb;16(2):240-7. doi: 10.1017/S1368980012002625. Epub 2012 May 25. — View Citation

Farajian P, Risvas G, Karasouli K, Pounis GD, Kastorini CM, Panagiotakos DB, Zampelas A. Very high childhood obesity prevalence and low adherence rates to the Mediterranean diet in Greek children: the GRECO study. Atherosclerosis. 2011 Aug;217(2):525-30. doi: 10.1016/j.atherosclerosis.2011.04.003. Epub 2011 Apr 13. — View Citation

Magriplis E, Farajian P, Pounis GD, Risvas G, Panagiotakos DB, Zampelas A. High sodium intake of children through 'hidden' food sources and its association with the Mediterranean diet: the GRECO study. J Hypertens. 2011 Jun;29(6):1069-76. doi: 10.1097/HJH.0b013e328345ef35. — View Citation

Risvas G, Papaioannou I, Panagiotakos DB, Farajian P, Bountziouka V, Zampelas A. Perinatal and family factors associated with preadolescence overweight/obesity in Greece: the GRECO study. J Epidemiol Glob Health. 2012 Sep;2(3):145-53. doi: 10.1016/j.jegh.2012.06.002. Epub 2012 Aug 18. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other Blood pressure measurements Blood pressure was measured in a single occasion within the schools' settings using validated oscillometric devices 8 months No
Primary Overweight and obesity prevalence in a representative sample of primary schoolchildren aged 10-12 years old Assessment of overweight and obesity by measuring body weight and standing height. Body mass index was calculated by dividing weight (kg) by standing height squared (m2). Obesity and overweight among children were calculated using the International Obesity Task Force (IOTF) age and gender specific body mass index cut-off criteria 8 months No
Secondary Dietary intake assessment Dietary assessment was based on a validated self-reported, semi-quantitative picture-aid food frequency questionnaire (FFQ), consisted of 48 food items commonly used in the local Greek cuisine. 8 months No
Secondary Assessment of eating behaviors Assessment of the frequency of breakfast consumption and number of eating occasions (number of meals and snacks during the day), as well as the frequency of having meals in front of a screen (watching television/DVD/videos and/or using of games consoles/computer), and the frequency of having meals together with the whole family or at least with one family member. 8 months No
Secondary Assessment of physical activity and inactivity levels Physical activity levels assessment was performed by the Physical Activity Questionnaire for older Children. Children were also asked whether they had television or computer in their room and were asked to report the average weekdays and weekend time (h/d) spent on sedentary activities and more specifically on watching television/DVD/movies and/or recreational usage of games consoles/computer. 8 months No
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