NCT02116296

Brief 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. 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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 2, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 16, 2014

Completed
Last Updated

April 16, 2014

Status Verified

April 1, 2014

Enrollment Period

3.3 years

First QC Date

April 2, 2014

Last Update Submit

April 15, 2014

Conditions

Prevention of Childhood Obesity

Outcome Measures

Primary Outcomes (1)

  • BMI z-score

    1 year

Study Arms (1)

LIfestyle counseling

OTHER
Behavioral: ToyBox-intervention

Interventions

ToyBox-interventionBEHAVIORAL
LIfestyle counseling

Eligibility Criteria

Age42 Months - 66 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harokopio University of Athens

Kallithea, Attica, 17671, Greece

Location

Related Publications (3)

  • Flores-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.

    PMID: 38788341DERIVED

  • Latomme 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.

    PMID: 28380053DERIVED

  • De 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.

    PMID: 26733186DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Purpose
PREVENTION
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 2, 2014

First Posted

April 16, 2014

Study Start

March 1, 2010

Primary Completion

June 1, 2013

Last Updated

April 16, 2014

Record last verified: 2014-04

Locations

GR(1)