Workpackage 07

Implementation and evaluation of a cluster randomized intervention

Yannis Manios

Leader Institution:
Harokopio University

A cluster randomized intervention will be implemented in six different European countries, namely Greece, Spain, Belgium, Germany, Poland, Bulgaria. Comprehensibility, readability, relevance, credibility, attractiveness of the intervention will be tested, so that the intervention components can be adapted if necessary. Furthermore, it will be tested whether the intervention induces changes in important energy balance behaviours and their determinants.
The target of this intervention will be children (4-6 year olds), their parents and the teachers. The intervention will be implemented in the pre-primary education setting by teachers and will be tested in a pre-test post-test design including an intervention and a control group. The pre- and post intervention period is estimated to last two months and in order to avoid seasonality effect, the pre- and post-examination will take place at the same time of the year leaving 9-10 months in between for implementation. Only 4-5 years old (with a parental signed consent form) will be examined at baseline and only these children will be re-examined at the follow up, about a year later.
From each country 20 pre-primary education schools with 2 classes each (20 children per class on average) will participate in the evaluation study, resulting in about 4800 participating children on a European level. Power calculations based on previous studies of school-based interventions indicates that this sample size is sufficient to detect changes in energy balance behaviours and their determinants.
The schools will be assigned randomly as intervention or controls in a 2:1 ratio. The control group will not receive any intervention materials but will continue to follow the standard curriculum. Schools will be the level of randomisation in order to prevent contamination of intervention activities. This WP will also be responsible for the coordination of data entry of pre- and post-intervention evaluation.


7.1 Development and implementation of an intervention procedure.

7.2 Evaluation of the process of the intervention to ensure that the intervention is implemented as intended.

7.3 Evaluation of the effectiveness of the intervention in terms of impact and outcome changes.