OverweightGRECONCT02102763
Greek Childhood Obesity (GRECO) Study
An observational study of Overweight and Obesity, run by Agricultural University of Athens at 1 site in Greece.
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… Read more about this study
- Who is it for?
- Ages 10 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Overweight, Obesity, Dietary Habits
- How many people
- 5,000 participants
- Where
- 1 siteGreece
- Study dates
- Oct 2008to May 2009
- 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 10 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: A nationwide cross-sectional sample of 10-12 years old Greek schoolchildren
Who may be able to join
- Within the age range
- 5th and 6th grade public schools children
- Consent form provided by the parents
Who cannot join
- Not providing signed parental consent forms
- Outside the required age range
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Food Science and Human Nutrition, Agricultural University of Athens
Athens, Attica, 11855
About this study
Official title: Greek Childhood Obesity Study
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.
- Conditions
- Overweight, Obesity, Dietary Habits, Physical Activity, Blood Pressure
- Keywords
- Overweight, Obesity, Dietary intake, Physical activity levels, Blood pressure levels, Family perceptions
- Medical subject headings
- Overweight, Obesity, Feeding Behavior, Motor Activity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 8 months
Secondary outcomes (3)
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.
Measured: 8 months
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.
Measured: 8 months
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.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2014 (estimated)
- Study startOct 2008
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agricultural University of Athens
- Sponsor type
- University, hospital or other
- Collaborators
- General Secretariat of Consumers-Greek Ministry of Development, Hellenic Association of Food and Beverage Companies, Coca Cola Hellas, Coca Cola Hellenic Bottling Company, Cereal Partners Hellas, FAGE S.A., Unilever Hellas, Nestle Hellas, Kraft Foods Hellas, European Union and Greek national funds - Research Funding Program: Heraclitus II.
- Responsible party
- Principal investigator, Paul Farajian, Agricultural University of Athens
- Investigators
- Paul Farajian, PhD, Principal investigator, Agricultural University of Athens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02102763
- Sponsor's protocol ID
- AgriculturalUA
- Acronym
- GRECO
- Status last verified
- Apr 2014
- First submitted
- 31 Mar 2014
- Last updated
- 8 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21561621Magriplis 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.
PubMed 21451420Farajian 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.
PubMed 22625663Risvas 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.
PubMed 23856452
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Greek Childhood Obesity Study
- ClinicalTrials.gov ID
- NCT02102763
- Acronym / sponsor ID
- GRECO / AgriculturalUA
- Conditions
- Overweight, Obesity, Dietary Habits, Physical Activity, Blood Pressure
- Keywords
- Overweight, Obesity, Dietary intake, Physical activity levels, Blood pressure levels, Family perceptions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Agricultural University of AthensUniversity, hospital or other
- Collaborators
- General Secretariat of Consumers-Greek Ministry of Development, Hellenic Association of Food and Beverage Companies, Coca Cola Hellas, Coca Cola Hellenic Bottling Company, Cereal Partners Hellas, FAGE S.A., Unilever Hellas, Nestle Hellas, Kraft Foods Hellas, European Union and Greek national funds - Research Funding Program: Heraclitus II.
- Study start
- Oct 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 3 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- A nationwide cross-sectional sample of 10-12 years old Greek schoolchildren
Key inclusion criteria (3 listed)
- Within the age range
- 5th and 6th grade public schools children
- Consent form provided by the parents
Key exclusion criteria (2 listed)
- Not providing signed parental consent forms
- Outside the required age range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overweight and obesity prevalence in a representative sample of primary schoolchildren aged 10-12 years old
Time frame: 8 months
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
3 secondary outcomes
Dietary intake assessment
Time frame: 8 months
Assessment of eating behaviors
Time frame: 8 months
Assessment of physical activity and inactivity levels
Time frame: 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2014.
- Background: PubMed 21561621Farajian 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.
- Background: PubMed 21451420Magriplis 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.
- Background: PubMed 22625663Farajian 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.
- Background: PubMed 23856452Risvas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Farajian, PhD principal investigator
Agricultural University of Athens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight and Obesity, run by Agricultural University of Athens at 1 site in Greece.
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 3 inclusion and 2 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 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. 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?
Overweight and obesity prevalence in a representative sample of primary schoolchildren aged 10-12 years old (time frame: 8 months). 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 NCT02102763, which also lists 4 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 8 Apr 2014.