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Background The aim of the present study evaluated the effect and process of the ToyBox-intervention on proxy-reported sedentary behaviours in 4- to 6-year-old preschoolers from six European countries. Methods In total, 2434 preschoolers’ parents/primary caregivers (mean age: 4.7±0.4 years, 52.2% boys) filled out a questionnaire, assessing preschoolers’ sedentary behaviours (TV/DVD/video viewing, computer/video games use and quiet play) on weekdays and weekend days. Multilevel repeated measures analyses were conducted to measure the intervention effects. Additionally, process evaluation data were included to better understand the intervention effects. Results Positive intervention effects were found for computer/video games use. In the total sample, the intervention group showed a smaller increase in computer/video games use on weekdays (s = -3.40, p = 0.06; intervention: +5.48 min/day, control: +8.89 min/day) and on weekend days (s = -5.97, p = 0.05; intervention: +9.46 min/day, control: +15.43 min/day) from baseline to follow-up, compared to the control group. Country-specific analyses showed similar effects in Belgium and Bulgaria, while no significant intervention effects were found in the other countries. Process evaluation data showed relatively low teachers’ and low parents’ process evaluation scores for the sedentary behaviour component of the intervention (mean: 15.6/24, range: 2.5–23.5 and mean: 8.7/17, range: 0–17, respectively). Higher parents’ process evaluation scores were related to a larger intervention effect, but higher teachers’ process evaluation scores were not. Conclusions The ToyBox-intervention had a small, positive effect on European preschoolers’ computer/video games use on both weekdays and weekend days, but not on TV/DVD/video viewing or quiet play. The lack of larger effects can possibly be due to the fact that parents were only passively involved in the intervention and to the fact that the intervention was too demanding for the teachers. Future interventions targeting preschoolers' behaviours should involve parents more actively in both the development and the implementation of the intervention and, when involving schools, less demanding activities for teachers should be developed. Trial registration clinicaltrials.gov NCT02116296

Since school-based interventions are mainly delivered by the school staff, they need to be well-trained and familiarized with the programme's aims, procedures and tools. Therefore, the institute, research group, governmental or non-governmental body in charge of the coordination and implementation of the programme needs to devote time and resources to train the school staff before programme's implementation. This is particularly crucial in multi-centre studies where more than one research teams are involved. Both research teams and school staff need to be trained, using standard protocols and procedures, to ensure that the intervention will be delivered in a standardized manner throughout the intervention centres. The ToyBox-intervention, a multi-component, kindergarten-based, family-involved intervention, focusing on water consumption, snacking, physical activity and sedentary behaviours in preschool children, was implemented over the academic year 2012-2013 in six European countries. As part of this intervention, three teachers' training sessions were delivered to motivate and train teachers in implementing the intervention. The local researchers were trained centrally before delivering the training sessions for the teachers and followed a common protocol using standardized presentations and procedures. The aim of the current paper is to describe the protocol and methodological issues related to the teachers' training sessions conducted within the ToyBox-intervention.

The development of the ToyBox-intervention was based on the outcomes of the preliminary phase of the ToyBox-study, aiming to identify young children's key behaviours and their determinants related to early childhood obesity. The ToyBox-intervention is a multi-component, kindergarten-based, family-involved intervention with a cluster-randomized design, focusing on the promotion of water consumption, healthy snacking, physical activity and the reduction/ breaking up of sedentary time in preschool children and their families. The intervention was implemented during the academic year 2012-2013 in six European countries: Belgium, Bulgaria, Germany, Greece, Poland and Spain. Standardized protocols, methods, tools and material were used in all countries for the implementation of the intervention, as well as for the process, impact, outcome evaluation and the assessment of its cost-effectiveness. A total sample of 7,056 preschool children and their parents/caregivers, stratified by socioeconomic level, provided data during baseline measurements and participated in the intervention. The results of the ToyBox-study are expected to provide a better insight on behaviours associated with early childhood obesity and their determinants and identify effective strategies for its prevention. The aim of the current paper is to describe the design of the ToyBox-intervention and present the characteristics of the study sample as assessed at baseline, prior to the implementation of the intervention.

Summary: Process evaluation (PE) is used for the in-depth evaluation of the implementation process of health promotion programmes. The aim of the current paper was to present the PE design and tools used in the ToyBox-intervention. The PE design was based on a three-step approach, including the identification of ToyBox-specific PE elements (step 1), the development of PE tools and harmonization of procedures (step 2), and the implementation of PE using standardized protocol and tools across the intervention countries (step 3). Specifically, to evaluate the implementation of the intervention, teachers' monthly logbooks were recorded (dose delivered, fidelity, dose received); post-intervention questionnaires were completed by parents/caregivers and teachers (dose received); participation and attrition rates were recorded (recruitment, reach); and audit questionnaires and retrospective information on weather conditions were collected (physical and social environment within which the intervention was implemented). Regarding the teachers' training sessions, the researchers who performed the trainings completed evaluation forms and documented teachers' attendance after each training (dose delivered, fidelity, dose received) and teachers completed evaluation forms after each training (dose received). The PE performed in the ToyBox-intervention may contribute in the evaluation of its effectiveness, guide the revision of the intervention material and provide insights for future health promotion programmes and public health policy.

The ToyBox-intervention is a kindergarten-based, family-involved intervention targeting multiple lifestyle behaviours in preschool children, their teachers and their families. This intervention was conducted in six European countries, namely Belgium, Bulgaria, Germany, Greece, Poland and Spain. The aim of this paper is to provide a descriptive overview of the harmonization and standardization procedures of the baseline and follow-up evaluation of the study (and substudies). Steps related to the study's operational, standardization and harmonization procedures as well as the impact and outcome evaluation assessment tools used are presented. Experiences from the project highlight the importance of safeguarding the measurement process to minimize data heterogeneity derived from potential measurement error and country-by-country differences. In addition, it was made clear that continuing quality control and support is an important component of such studies. For this reason, well-supported communication channels, such as regular email updates and teleconferences, and regular internal and external meetings to ensure smooth and accurate implementation were in place during the study. The ToyBox-intervention and its harmonized and standardized procedures can serve as a successful case study for future studies evaluating the efficacy of similar interventions.

The ToyBox-study aims to develop and test an innovative and evidence-based obesity prevention programme for preschoolers in six European countries: Belgium, Bulgaria, Germany, Greece, Poland and Spain. In multicentre studies, anthropometric measurements using standardized procedures that minimize errors in the data collection are essential to maximize reliability of measurements. The aim of this paper is to describe the standardization process and reliability (intra- and inter-observer) of height, weight and waist circumference (WC) measurements in preschoolers. All technical procedures and devices were standardized and centralized training was given to the fieldworkers. At least seven children per country participated in the intra- and inter-observer reliability testing. Intra-observer technical error ranged from 0.00 to 0.03kg for weight and from 0.07 to 0.20cm for height, with the overall reliability being above 99%. A second training was organized for WC due to low reliability observed in the first training. Intra-observer technical error for WC ranged from 0.12 to 0.71cm during the first training and from 0.05 to 1.11cm during the second training, and reliability above 92% was achieved. Epidemiological surveys need standardized procedures and training of researchers to reduce measurement error. In the ToyBox-study, very good intra- and-inter-observer agreement was achieved for all anthropometric measurements performed.

Overweight and obesity in children are recognized as a major health problem. The ToyBox-intervention was developed with the aim of preventing obesity in pre-schoolers. Because it is increasingly important to inform policy makers not only on the effects of prevention interventions, but also on their costs and cost-effectiveness, our purpose was to establish a method to estimate the cost-effectiveness of the ToyBox-intervention. In order to estimate the long-term impact of the ToyBox-intervention on health and societal costs, extrapolations of the intervention effect will be conducted to predict children's weight status (based on the body mass index) at adult age. Effects of the adult weight status on the prevalence of obesity-related complications will be modelled through a Markov model, with a total time horizon of 70 years and a cycle length of 1 year. The model will be conducted in six European countries participating in the ToyBox-intervention, based on country-specific economic and epidemiological data. This study describes the methodological rationale and implementation of an analytic model to examine the cost-effectiveness of the ToyBox-intervention for six European countries, in order to inform decision-makers on the value for money of this intervention in the prevention of obesity in pre-schoolers.

Reliable assessments of health-related behaviours are necessary for accurate evaluation on the efficiency of public health interventions. The aim of the current study was to examine the reliability of a self-administered primary caregivers questionnaire (PCQ) used in the ToyBox-intervention. The questionnaire consisted of six sections addressing sociodemographic and perinatal factors, water and beverages consumption, physical activity, snacking and sedentary behaviours. Parents/caregivers from six countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain) were asked to complete the questionnaire twice within a 2-week interval. A total of 93 questionnaires were collected. Test-retest reliability was assessed using intra-class correlation coefficient (ICC). Reliability of the six questionnaire sections was assessed. A stronger agreement was observed in the questions addressing sociodemographic and perinatal factors as opposed to questions addressing behaviours. Findings showed that 92% of the ToyBox PCQ had a moderate-to-excellent test-retest reliability (defined as ICC values from 0.41 to 1) and less than 8% poor test-retest reliability (ICC

The key person for the implementation of kindergarten-based behavioural interventions is the kindergarten teacher. When conducting intervention studies in kindergartens, training sessions are needed to train and motivate kindergarten teachers for programme implementation. This paper presents the systematic development of the teachers' trainings executed in the ToyBox-intervention - a kindergarten-based and family-involved obesity prevention programme for children aged 4-6. Based on concepts for the education of kindergarten teachers, on general strategies for successful programme implementation and on the ToyBox programme-specific requirements, the aims of the teachers' trainings were defined and an overall concept was deduced. Regarding the concept for the ToyBox teachers' training sessions, it is concluded that the training modules should focus on presenting information on the practical implementation of the intervention. Furthermore, these modules should also include self-efficacy enhancing components and should give kindergarten teachers opportunities to share experiences. Regarding the didactic methods applied in the ToyBox teachers' training sessions, constructivist learning approaches that facilitate active participation, reflective thinking and personal involvement were implemented. Emphasis was put not only on the content but especially on the didactic methods of teachers' trainings in order to enhance devotion to, and quality and sustainability of the ToyBox-intervention.