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

April 15, 2014 updated by: Yannis Manios, Harokopio University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
    • Attica
      • Kallithea, Attica, Greece, 17671
        • Harokopio University of Athens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 66 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: LIfestyle counseling
Behavioral: ToyBox-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
BMI z-score
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harokopio University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 15, 2014

First Posted (Estimate)

April 16, 2014

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

April 15, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ToyBox-study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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