Skip to main content
OpenTrials
Completed

NCT Number: NCT02116296

Multi-component, Kindergarten-based, Family-involved Intervention for the Prevention of Childhood Obesity:The ToyBox-study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

42 month–66 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harokopio University of Athens

Kallithea, Attica, 17671, Greece

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ToyBox-intervention

Behavioral

Primary outcomes

  1. BMI z-score

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Harokopio University

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2013
First posted
Apr 16, 2014
Registry last updated
Apr 16, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.