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.
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.
Although sufficient physical activity is beneficial for preschoolers' health, activity levels in most preschoolers are low. As preschoolers spend a considerable amount of time at home and at kindergarten, interventions should target both environments to increase their activity levels. The aim of the current paper was to describe the six different steps of the Intervention Mapping protocol towards the systematic development and implementation of the physical activity component of the ToyBox-intervention. This intervention is a kindergarten-based, family-involved intervention implemented across six European countries. Based on the results of literature reviews and focus groups with parents/caregivers and kindergarten teachers, matrices of change objectives were created. Then, theory-based methods and practical strategies were selected to develop intervention materials at three different levels: (i) individual level (preschoolers); (ii) interpersonal level (parents/caregivers) and (iii) organizational level (teachers). This resulted in a standardized intervention with room for local and cultural adaptations in each participating country. Although the Intervention Mapping protocol is a time-consuming process, using this systematic approach may lead to an increase in intervention effectiveness. The presented matrices of change objectives are useful for future programme planners to develop and implement an intervention based on the Intervention Mapping protocol to increase physical activity levels in preschoolers.
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 0.03 kg for weight and from 0.07 to 0.20 cm 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 0.71 cm during the first training and from 0.05 to 1.11 cm 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.
Quality of life is a key outcome that is not rigorously measured in obesity treatment research due to the lack of standardization of patient-reported outcomes (PROs) and PRO measures (PROMs). The S.Q.O.T. initiative was founded to Standardize Quality of life measurement in Obesity Treatment. A first face-to-face, international, multidisciplinary consensus meeting was conducted to identify the key PROs and preferred PROMs for obesity treatment research. It comprised of 35 people living with obesity (PLWO) and healthcare providers (HCPs). Formal presentations, nominal group techniques, and modified Delphi exercises were used to develop consensus-based recommendations. The following eight PROs were considered important: self-esteem, physical health/functioning, mental/psychological health, social health, eating, stigma, body image, and excess skin. Self-esteem was considered the most important PRO, particularly for PLWO, while physical health was perceived to be the most important among HCPs. For each PRO, one or more PROMs were selected, except for stigma. This consensus meeting was a first step toward standardizing PROs (what to measure) and PROMs (how to measure) in obesity treatment research. It provides an overview of the key PROs and a first selection of the PROMs that can be used to evaluate these PROs.
The lack of standardization in patient-reported outcome measures (PROMs) has made measurement and comparison of quality of life (QoL) outcomes in research focused on obesity treatment challenging. This study reports on the results of the second and third global multidisciplinary Standardizing Quality of life measures in Obesity Treatment (S.Q.O.T.) consensus meetings, where a core set of PROMs to measure nine previously selected patient-reported outcomes (PROs) in obesity treatment research was established. The S.Q.O.T. II online and S.Q.O.T. III face-to-face hybrid consensus meetings were held in October 2021 and May 2022. The meetings were led by an independent moderator specializing in PRO measurement. Nominal group techniques, Delphi exercises, and anonymous voting were used to select the most suitable PROMs by consensus. The meetings were attended by 28 and 27 participants, respectively, including a geographically diverse selection of people living with obesity (PLWO) and experts from various disciplines. Out of 24 PROs and 16 PROMs identified in the first S.Q.O.T. consensus meeting, the following nine PROs and three PROMs were selected via consensus: BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), IWQOL-Lite (self-esteem), and QOLOS (excess skin). No PROM was selected to measure stigma as existing PROMs deemed to be inadequate. A core set of PROMs to measure QoL in research focused on obesity treatment has been selected incorporating patients' and experts' opinions. This core set should serve as a minimum to use in obesity research studies and can be combined with clinical parameters.
Early childhood is an important period for adopting positive health-related behaviours. More than 95% of European preschool children attend kindergartens, making these settings ideal for the implementation of health promotion interventions. The ToyBox-intervention addressed preschool children, their parents/caregivers and teachers. The aim of the intervention was to improve four energy balance-related behaviours (i.e. healthy snacking, water consumption, physical activity and sedentary behaviour) by implementing a kindergarten-based, family-involved intervention in six European countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain). The intervention material was developed following the intervention mapping protocol, taking into account local and cultural differences among the intervention countries. The present paper focuses on the development of the physical activity component of the intervention. Parental involvement was addressed by providing parents/caregivers with two newsletters, two tip cards and a poster. Teachers received a handbook with guidance on environmental changes in the classroom, 26 physical education sessions and suggestions for fun, interactive classroom activities aiming at total class participation to increase preschoolers' physical activity levels. The ToyBox-intervention material was distributed according to a standard time frame. Teachers received their material prior to the start of the intervention and parents/caregivers received their material during the intervention when each energy balance-related behaviour was implemented.
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 < 0.40). Out of the total ICC values, 67% showed good-to-excellent reliability (ICC from 0.61 to 1). We conclude that the PCQ is a reliable tool to assess sociodemographic characteristics, perinatal factors and lifestyle behaviours of pre-school children and their families participating in 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.
The increasing childhood obesity epidemic calls for appropriate measures and effective policies to be applied early in life. Large-scale socioecological frameworks providing a holistic multifactorial and cost-effective approach necessary to support obesity prevention initiatives in this age are however currently missing. To address this missing link, ToyBox-study aims to build and evaluate a cost-effective kindergarten-based, family-involved intervention scheme to prevent obesity in early childhood, which could potentially be expanded on a pan-European scale. A multidisciplinary team of researchers from 10 countries have joined forces and will work to realize this according to a systematic stepwise approach that combines the use of the PRECEDE-PROCEED model and intervention mapping protocol. ToyBox-study will conduct systematic and narrative reviews, secondary data analyses, focus group research and societal assessment to design, implement and evaluate outcome, impact, process and cost effectiveness of the intervention. This is the first time that such a holistic approach has been used on a pan-European scale to promote healthy weight and healthy energy balance-related behaviours for the prevention of early childhood obesity. The results of ToyBox-study will be disseminated among key stakeholders including researchers, policy makers, practitioners and the general population.
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.
Obesity prevention efforts for school-aged children and adolescents are increasing in number. However, little has been done to address the problem in the preschool age. To address this age group, an evidence-based preschool programme on physical activity (PA) and nutrition is developed within the ToyBox project. Environmental influencing factors such as policies and competitive health promotion activities could inhibit or induce a successful health promotion programme. This paper describes an overview of existing policies, legislation and/or regulations and health promotion activities in the preschool setting. Method: data were gathered on policies and activities aiming to improve healthy eating and PA of young children (age group 4-6 years) in Belgium-Flanders, Bulgaria, Germany, Greece, Poland and Spain. A limited number of influencing policies, regulations and/or legislation exists; agenda setting of health promotion and policy evaluations in all relevant policy areas was lacking. Also, health promotion activities in preschool the setting did not exist in all six European countries and high-quality preschool-based health interventions existed in three of the six ToyBox countries.
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.
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.
In 2007, the Scandinavian Obesity Surgery Registry (SOReg) was started by the profession to monitor the results of bariatric surgery and to provide a high-quality database for research. In the end of August 2023, SOReg contains 88,379 patients (body mass index [BMI] 41.7 kg/m2 , 41.2 years, 77.1% females, gastric bypass 76.8%). In this narrative review, we demonstrate that preoperative weight loss is of value and that the laparoscopic double omega-loop technique is highly suitable for gastric bypass. Closing the mesenteric openings is, however, important. Swedish bariatric surgery has low mortality, and our results are comparative to those of other countries. Significant long-term improvements are found in common obesity-related diseases such as diabetes, hypertension, and sleep apnea. Furthermore, the risk for cardiac failure and major adverse cardiovascular events is significantly reduced. Pregnancy-related outcomes are also improved. Gastric bypass results in significant improvements in quality of life and seems to be cost saving. We have revealed that low socioeconomic status is associated with reduced chance of undergoing bariatric surgery and inferior outcomes. Of note, we have performed several randomized clinical trials within the registry database. In conclusion, high-quality national registry databases, such as SOReg, are important for maintaining high-quality care and present a platform for extensive research.
Childhood obesity is a serious global health problem. Waist circumference (WC) and waist-to-height ratio (WHtR) reflect body fat distribution in children. The objectives of this study were to assess WC and WHtR in 7-year-old children and to determine body mass index (BMI), WC, and WHtR differences in children from 10 selected countries across Europe (Bulgaria, Czechia, Greece, Ireland, Latvia, Lithuania, North Macedonia, Norway, Spain, and Sweden) participating in the World Health Organization (WHO) Europe Childhood Obesity Surveillance Initiative (COSI). The 50th and 90th percentile of WC (according to COSI and "Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS" (IDEFICS) cutoff values) and WHtR above 0.5 were used as measures of abdominal obesity in a unique sample of 38,975 children aged 7.00-7.99 years. Southern European countries, including Greece and Spain, showed significantly higher BMI, WC, and WHtRin both genders (p < 0.0001) than Eastern and Northern Europe. The highest values for WC were observed in Greece (60.8 ± 7.36 cm boys; 60.3 ± 7.48 cm girls), North Macedonia (60.4 ± 7.91 cm boys; 59.0 ± 8.01 cm girls), and Spain (59.7 ± 6.96 cm boys; 58.9 ± 6.77 cm girls). WC and WHtRin may add an information about the occurrence of central obesity in children.
Caregivers' feeding practices are critical in shaping preschool children's eating habits and preventing childhood obesity. We conducted a systematic review and meta-analysis to evaluate the effectiveness of existing interventions targeting caregivers of preschool children, which aimed to promote child healthy eating and/or manage child weight and/or prevent child nutrition-related problems and included feeding practices as one of the outcomes. Eighteen studies with 18 intervention programs and 3887 respondents that completed baseline evaluations were eligible for data synthesis. Behavior change techniques (BCTs) frequently used included the following: instruction on how to perform the behavior and demonstration of the behavior. The pooled effects of randomized controlled trials (RCTs) on pressure to eat (pooled standardized mean difference [SMD] = 0.61; 95%CI: -1.16, -0.06), use of food as a reward (pooled SMD = -0.31; 95%CI: -0.61, -0.01), and emotional feeding (pooled SMD = -0.36; 95%CI: -0.66, -0.06) were found statistically significant compared with control groups at post-intervention. However, there were no pooled effects on restrictive feeding and pressure to eat at other follow-ups or on other feeding practices at post-intervention. Interventions may have short-term effects on decreasing the adoption of coercive control. Future interventions should directly and adequately optimize feeding practices, include components of individual support, and contribute to the maintenance of the effects over the long term.