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

Primary Purpose

Prevention of Childhood Obesity

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
ToyBox-intervention
Sponsored by
Harokopio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prevention of Childhood Obesity

Eligibility Criteria

42 Months - 66 Years (Child, Adult, Older Adult)All Sexes

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

Sites / Locations

  • Harokopio University of Athens

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

LIfestyle counseling

Arm Description

Outcomes

Primary Outcome Measures

BMI z-score

Secondary Outcome Measures

Full Information

First Posted
April 2, 2014
Last Updated
April 15, 2014
Sponsor
Harokopio University
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1. Study Identification

Unique Protocol Identification Number
NCT02116296
Brief Title
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

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harokopio University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prevention of Childhood Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable

8. Arms, Groups, and Interventions

Arm Title
LIfestyle counseling
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
ToyBox-intervention
Primary Outcome Measure Information:
Title
BMI z-score
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
42 Months
Maximum Age & Unit of Time
66 Years
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
Facility Information:
Facility Name
Harokopio University of Athens
City
Kallithea
State/Province
Attica
ZIP/Postal Code
17671
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
28380053
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.
Results Reference
derived
PubMed Identifier
26733186
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.
Results Reference
derived
Links:
URL
http://www.toybox-study.eu/
Description
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Multi-component, Kindergarten-based, Family-involved Intervention for the Prevention of Childhood Obesity:The ToyBox-study

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