Multi-component, Kindergarten-based, Family-involved Inte... | NCT02116296

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

NCT02116296

Sponsor

Harokopio University

Status

Completed

Last Update Posted

Apr 16, 2014Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Prevention of Childhood Obesity

Interventions

ToyBox-intervention

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Jun 2013Actual

Completion Date

Not provided

First Submitted Date

Apr 2, 2014

First Submission Date that Met QC Criteria

Apr 15, 2014

First Posted Date

Apr 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2014

Last Update Posted Date

Apr 16, 2014Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Label	Type	Description	Intervention Names
LIfestyle counseling	Other		Behavioral: ToyBox-intervention

Name	Type	Description	Arm Group Labels	Other Names
ToyBox-intervention	Behavioral		LIfestyle counseling

Measure	Description	Time Frame
BMI z-score		1 year

Eligibility Module

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

42 Months

Maximum Age

66 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Harokopio University of Athens		Kallithea	Attica	17671	Greece

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41711919	Derived	Kotowska A, Kulaga Z, Socha P, Iotova V, Galcheva S, Cardon G, De Craemer M, Androutsos O, Gimenez-Legarre N, Koletzko B, Manios Y; ToyBox-study group. Associations among family sociodemographic factors, breakfast habits, and weight status in preschool children and the mediating role of breakfast habits: the ToyBox-study. Eur J Nutr. 2026 Feb 19;65(2):65. doi: 10.1007/s00394-026-03897-w.
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