Prevention of Childhood Obesity Clinical Trial
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
| NCT number | NCT02116296 |
| Other study ID # | ToyBox-study |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | April 2, 2014 |
| Last updated | April 15, 2014 |
| Start date | March 2010 |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | June 2013 |
| Accepts healthy volunteers | |
| Gender | Both |
| Age group | 42 Months to 66 Years |
| Eligibility |
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 Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Greece | Harokopio University of Athens | Kallithea | Attica |
| Lead Sponsor | Collaborator |
|---|---|
| Harokopio University |
Greece,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | BMI z-score | 1 year |