Clinical trial NCT02116296: Multi-component, Kindergarten-based, Family-involved Intervention for the Prevention of Childhood Obesity:The ToyBox-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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prevention of Childhood Obesity
Lead sponsor: Harokopio University
Sponsor class: OTHER
First posted: 2014-04-16
Sex: ALL
Minimum age (years): 42
Maximum age (years): 66
Standard ages: CHILD
ADULT
OLDER_ADULT
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Primary outcomes:
measure: BMI z-score
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kallithea
country: Greece
facility: Harokopio University of Athens
state: Attica
Study officials:
References:
citation: 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.
citation: 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.