Prevention of Childhood ObesityNCT02116296
Multi-component, Kindergarten-based, Family-involved Intervention for the Prevention of Childhood Obesity:The ToyBox-study
A study testing ToyBox-intervention in people with Prevention of Childhood Obesity, run by Harokopio University at 1 site in Greece.
Trial summary
The ToyBox proposal addresses Knowledge-Based Bio-Economy (KBBE)-2009-2-1-03 - Behavioural models for prevention of obesity, with a particular focus on children. It will primary aim to influence children's behaviours and prevent obesity in early childhood. Read more about this study
- Who is it for?
- Ages 42 months to 66 years
- Conditions the study is for
- Prevention of Childhood Obesity
- What is being tested?
- ToyBox-intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteGreece
- Study dates
- Mar 2010to Jun 2013
- Phase
- Interventional
- 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 42 months to 66 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- children aged between 3.5 and 5 years at the time of recruitment (i.e. born between January 2007 and December 2008)
- signed consent form provided by parents/caregivers
- not participating in any other clinical trial or other health-oriented project during the academic years 2012-2013 and 2013-2014
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multifactorial Evidence Based Approach Using Behavioural Models in Understanding and Promoting Fun, Healthy Food, Play and Policy for the Prevention of Obesity in Early Childhood
The ToyBox proposal addresses Knowledge-Based Bio-Economy (KBBE)-2009-2-1-03 - Behavioural models for prevention of obesity, with a particular focus on children. It will primary aim to influence children's behaviours and prevent obesity in early childhood. The proposal will identify key behaviours related to early childhood obesity and their determinants and evaluate behavioural models and educational strategies. Based on the obtained insights at a local level, a multidisciplinary team will develop and implement a school based family involved intervention programme that could be applied on a European scale. Process, impact, outcome and cost-effectiveness evaluation will be conducted to support decision making for European Public Health Policy. The combined use of Precede-Proceed Model and Intervention Mapping will provide the framework for the development, implementation and evaluation of the ToyBox intervention. To achieve this, the project will be subdivided into 10 Work Packages (WPs). This carefully planned stepwise approach will include systematic reviews, secondary analyses of existing data sets, focus group research and school policies overview. The ToyBox project consortium spans the necessary multidisciplinary variety of experts such as public health experts, epidemiologists, nutritionists, physical activity experts, pedagogists, psychologists, behavioural scientists, nutritionists, paediatricians, early childhood psychologists, health economists, totalling 15 partners, from 10 countries. The consortium, consists of 11 universities, 1 research institute, 2 advocacy groups and a small to medium enterprise (SME) representing all regions of Europe. The consortium has ample experience in conducting and coordinating multi-centre international research as well as undertaking dissemination activities to all relevant stakeholders.
- Conditions
- Prevention of Childhood Obesity
- Being tested
- ToyBox-intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ToyBox-interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| LIfestyle counseling | Other | Not described Receives: Behavioral: ToyBox-intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMI z-score
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMar 2010
- Primary completionJun 2013
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 Prevention of Childhood ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
Sponsor and investigators
- Lead sponsor
- Harokopio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannis Manios, Harokopio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116296
- Sponsor's protocol ID
- ToyBox-study
- Status last verified
- Apr 2014
- First submitted
- 2 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
Publications
Kotowska A, Kulaga Z, Socha P, Iotova V, Galcheva S, Cardon G, De Craemer M, Androutsos O, Gimenez-Legarre N, Koletzko B, Manios Y; ToyBox-study group. Associations among family sociodemographic factors, breakfast habits, and weight status in preschool children and the mediating role of breakfast habits: the ToyBox-study. Eur J Nutr. 2026 Feb 19;65(2):65. doi: 10.1007/s00394-026-03897-w.
PubMed 41711919Flores-Barrantes P, De Miguel-Etayo P, Iglesia I, ChinAPaw MJ, Cardon G, De Craemer M, Iotova V, Usheva N, Kulaga Z, Kotowska A, Koletzko B, Birnbaum J, Manios Y, Androutsos O, Moreno LA, Gibson EL; ToyBox-study Group. Longitudinal associations between food parenting practices and dietary intake in preschool children: The ToyBox Study. Nutrition. 2024 Aug;124:112454. doi: 10.1016/j.nut.2024.112454. Epub 2024 Apr 6.
PubMed 38788341Latomme J, Cardon G, De Bourdeaudhuij I, Iotova V, Koletzko B, Socha P, Moreno L, Androutsos O, Manios Y, De Craemer M; ToyBox-study group. Effect and process evaluation of a kindergarten-based, family-involved intervention with a randomized cluster design on sedentary behaviour in 4- to 6- year old European preschool children: The ToyBox-study. PLoS One. 2017 Apr 5;12(4):e0172730. doi: 10.1371/journal.pone.0172730. eCollection 2017.
PubMed 28380053De Craemer M, De Decker E, Verloigne M, De Bourdeaudhuij I, Manios Y, Cardon G; ToyBox-study group. The effect of a cluster randomised control trial on objectively measured sedentary time and parental reports of time spent in sedentary activities in Belgian preschoolers: the ToyBox-study. Int J Behav Nutr Phys Act. 2016 Jan 5;13:1. doi: 10.1186/s12966-015-0325-y.
PubMed 26733186
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Evidence Based Approach Using Behavioural Models in Understanding and Promoting Fun, Healthy Food, Play and Policy for the Prevention of Obesity in Early Childhood
- ClinicalTrials.gov ID
- NCT02116296
- Acronym / sponsor ID
- ToyBox-study
- Conditions
- Prevention of Childhood Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Harokopio UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2013 (actual)
- First posted
- 16 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 ToyBox proposal addresses Knowledge-Based Bio-Economy (KBBE)-2009-2-1-03 - Behavioural models for prevention of obesity, with a particular focus on children. It will primary aim to influence children's behaviours and prevent obesity in early childhood. The proposal will identify key behaviours related to early childhood obesity and their determinants and evaluate behavioural models and educational strategies. Based on the obtained insights at a local level, a multidisciplinary team will develop and implement a school based family involved intervention programme that could be applied on a European scale. Process, impact, outcome and cost-effectiveness evaluation will be conducted to support decision making for European Public Health Policy. The combined use of Precede-Proceed Model and Intervention Mapping will provide the framework for the development, implementation and evaluation of the ToyBox intervention. To achieve this, the project will be subdivided into 10 Work Packages (WPs). This carefully planned stepwise approach will include systematic reviews, secondary analyses of existing data sets, focus group research and school policies overview. The ToyBox project consortium spans the necessary multidisciplinary variety of experts such as public health experts, epidemiologists, nutritionists, physical activity experts, pedagogists, psychologists, behavioural scientists, nutritionists, paediatricians, early childhood psychologists, health economists, totalling 15 partners, from 10 countries. The consortium, consists of 11 universities, 1 research institute, 2 advocacy groups and a small to medium enterprise (SME) representing all regions of Europe. The consortium has ample experience in conducting and coordinating multi-centre international research as well as undertaking dissemination activities to all relevant stakeholders.
Study design
- Primary purpose
- Prevention
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LIfestyle counseling | Other | Behavioral: ToyBox-intervention |
Who may qualify
- Ages
- 42 months to 66 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- children aged between 3.5 and 5 years at the time of recruitment (i.e. born between January 2007 and December 2008)
- signed consent form provided by parents/caregivers
- not participating in any other clinical trial or other health-oriented project during the academic years 2012-2013 and 2013-2014
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ToyBox-intervention | Behavioural | LIfestyle counseling |
Primary outcome
BMI z-score
Time frame: 1 year
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 16 Apr 2014.
- Derived from this study: PubMed 41711919Kotowska A, Kulaga Z, Socha P, Iotova V, Galcheva S, Cardon G, De Craemer M, Androutsos O, Gimenez-Legarre N, Koletzko B, Manios Y; ToyBox-study group. Associations among family sociodemographic factors, breakfast habits, and weight status in preschool children and the mediating role of breakfast habits: the ToyBox-study. Eur J Nutr. 2026 Feb 19;65(2):65. doi: 10.1007/s00394-026-03897-w.
- Derived from this study: PubMed 38788341Flores-Barrantes P, De Miguel-Etayo P, Iglesia I, ChinAPaw MJ, Cardon G, De Craemer M, Iotova V, Usheva N, Kulaga Z, Kotowska A, Koletzko B, Birnbaum J, Manios Y, Androutsos O, Moreno LA, Gibson EL; ToyBox-study Group. Longitudinal associations between food parenting practices and dietary intake in preschool children: The ToyBox Study. Nutrition. 2024 Aug;124:112454. doi: 10.1016/j.nut.2024.112454. Epub 2024 Apr 6.
- Derived from this study: PubMed 28380053Latomme J, Cardon G, De Bourdeaudhuij I, Iotova V, Koletzko B, Socha P, Moreno L, Androutsos O, Manios Y, De Craemer M; ToyBox-study group. Effect and process evaluation of a kindergarten-based, family-involved intervention with a randomized cluster design on sedentary behaviour in 4- to 6- year old European preschool children: The ToyBox-study. PLoS One. 2017 Apr 5;12(4):e0172730. doi: 10.1371/journal.pone.0172730. eCollection 2017.
- Derived from this study: PubMed 26733186De Craemer M, De Decker E, Verloigne M, De Bourdeaudhuij I, Manios Y, Cardon G; ToyBox-study group. The effect of a cluster randomised control trial on objectively measured sedentary time and parental reports of time spent in sedentary activities in Belgian preschoolers: the ToyBox-study. Int J Behav Nutr Phys Act. 2016 Jan 5;13:1. doi: 10.1186/s12966-015-0325-y.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ToyBox-intervention in people with Prevention of Childhood Obesity, run by Harokopio University 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 0 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 16 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?
BMI z-score (time frame: 1 year). 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 NCT02116296, 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 16 Apr 2014.