The IDEFICS intervention trial to prevent childhood obesity: design ...

obesity reviews

doi: 10.1111/obr.12345

Supplement Article

The IDEFICS intervention trial to prevent childhood obesity: design and study methods I. Pigeot1,2, T. Baranowski3, S. De Henauw4 and the IDEFICS Intervention Study Group*, on behalf of the IDEFICS consortium

1

Leibniz Institute for Prevention Research and

Summary

Epidemiology – BIPS, Bremen, Germany;

Introduction: One of the major research dimensions of the Identification and

2

prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. Objective: This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some ‘best practice’ examples are described. Results: The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. Conclusion: This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results. Keywords: Childhood obesity, Europe, evaluation, primary prevention.

Institute of Statistics, Faculty of Mathematics

and Computer Science, University Bremen, Bremen, Germany; 3 USDA/ARS Children’s Nutrition Research Center, Department of Pediatrics, Baylor College of Medicine, Houston, TX, USA, and 4 Department of Public Health, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium

*The members of the IDEFICS Intervention Study Group are listed in Appendix 1.

Received 23 August 2015; accepted 25 September 2015

Address for correspondence: Prof. Dr. Stefaan De Henauw, Department of Public Health, Faculty of Medicine and Health Sciences, Ghent University, Ghent, Belgium. E-mail: [email protected]

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Introduction The increasing prevalence of obesity has led to many attempts to combat this epidemic by various types of intervention programmes. The most promising approaches target young children because prevention programmes in early life are both more likely to be successful (1) and childhood 4 16 (Suppl. 2), 4–15, December 2015

obesity tracks into adulthood (2). Although systematic reviews revealed inconsistent results with respect to the success of intervention programmes to tackle childhood obesity (3,4), the Federal Centre for Health Education in Germany (5,6) recommended a holistic approach simultaneously addressing the major risk factors physical activity, diet and stress-related behaviours in a comprehensive programme. It © 2015 World Obesity

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has been generally accepted that the planning and implementation of intervention programmes should be carried out within a theory-based framework for intervention methods – mainly based on the intervention mapping method developed by Bartholomew et al. (7) and with underlying theories for behaviour change, e.g. the theory of planned behaviour (8), the precede-proceed model (9), the transtheoretical model (10) or the social-ecological model (11). The Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study (12) was conducted from September 2006 through February 2012 and pursued two major aims as follows: (i) to enhance knowledge of health effects due to a changing diet and other lifestyles and due to an altered social environment among pre-school and schoolchildren in Europe and (ii) to develop, implement and evaluate a primary prevention study to reduce the prevalence of diet-related and lifestyle-related diseases and disorders with a focus on childhood obesity. The IDEFICS study was designed as a longitudinal population-based cohort study with an embedded non-randomized intervention trial running from 2008 to 2010 that involved an intervention and a control region in each of the participating countries. Eight European countries ranging from north to south and from west to east (Sweden, Germany, Hungary, Italy, Cyprus, Spain, Belgium and Estonia) participated in the IDEFICS study and recruited 16,228 children between 2 and 9.9 years via schools and kindergartens at baseline. All children passed an extensive examination protocol (12,13). These children were again examined at a follow-up survey 2 years later. In between these two surveys, a community-oriented setting-based primary prevention programme was implemented (14). The study population was recruited in two regions in each country with comparable socio-demographic profile. One region served as intervention and the second as a control. The objectives of the IDEFICS study included to (i) identify risk factors for overweight and obesity in children; (ii) describe actual status of dietary and lifestyle habits of children in Europe, taking into consideration regional, cultural, social, biological and sex-specific aspects; (iii) implement a programme for health promotion and prevention of overweight and obesity in kindergarten and primary school, which will be referred to in the following as the IDEFICS intervention; (iv) evaluate the effectiveness of this community-oriented setting-based intervention programme; and (v) propose guidelines for researchers and policymakers that demonstrate future ways for effective and efficient prevention of overweight in children. After a short introduction of the overall IDEFICS intervention design, the 10 primary prevention programme modules are described in detail, and a comprehensive overview of all intervention effects against the background of © 2015 World Obesity

Overview of IDEFICS intervention

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the process evaluation results is provided. All intervention results and the process evaluation are presented in detail in other papers in this supplement volume. The theoretical approach of the IDEFICS intervention, especially simultaneously targeting physical activity, nutritional behaviour and stress, will be scrutinized.

Design, participants and methods Design and statistical power The IDEFICS study was designed both to capture information on risk factors and habits (objectives (i) and (ii)) and to design, implement and evaluate an obesity prevention intervention (objectives (iii) and (iv)). Data on the same participants were used for both purposes. Intervention and control regions were selected by convenience in eight European countries. The study was powered to detect a statistically significant decrease in the combined prevalence of overweight and obesity from 15% to 12% in subgroups defined by sex and/or school level (primary school/ kindergarten) with α = 0.05 and 1-β = 0.8 (12).

Selection of study regions Countries participating in the IDEFICS study (intervention and cohort) were selected to achieve diversity across Europe, taking financial constraints into account, and were not randomly selected. Research teams experienced in conducting surveys and interventions were identified in each country. The intervention and control regions in each country were selected such that it was within a logistically reasonable distance for the research teams involved but sufficiently separated to avoid contamination between the regions. A random selection of all potentially eligible regions within each country was not feasible due both to budgetary constraints because travel costs would have had to be added for the field staff and to minimize inconvenience for the participants who had to visit the local research centres for specific examinations. Furthermore, logistic constraints such as the availability of facilities for examinations and for the conduct of regular site visits to monitor the quality of the examinations restricted the choice of potential regions. The intervention and the control regions in each country were selected to be comparable primarily with regard to socioeconomic characteristics and population size. Preexisting health-enhancing initiatives at the community level and infrastructural and sociodemographic characteristics as assessed through publicly available data were used as matching criteria. Although non-randomization may be considered a limitation, the Cochrane review by Waters et al. (4) comparing randomized versus non-randomized trials found no serious bias due to non-randomization. 16 (Suppl. 2), 4–15, December 2015

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The IDEFICS study was not designed as nationally representative surveys. In most countries, the selected regions were distinct cities or communities, most of them located in the same geographical area. In Italy, however, clusters of villages instead of urban areas were selected both for the intervention and control regions. To avoid contamination of intervention activities into the control region, none of the local media covered both the intervention and control regions. In almost all countries, all public primary schools and kindergartens in the intervention and control regions were recruited to participate in the IDEFICS study.

Study participants At baseline (T0), 16,857 children aged 2 to 9.9 years were examined in a population-based survey from September 2007 to May 2008, of whom 629 children were 10 years or older or did not provide data on sex, weight and height. Hence, 16,228 children were eligible for baseline analysis. Examinations at T0 included anthropometric data, lifestyle, biological markers, behavioural and socio-demographic characteristics and were based on a highly standardized protocol. The baseline survey has been thoroughly described (12). Two years later (T1, September 2009 to June 2010), all children included in the baseline database were invited for a follow-up survey and 68% (N = 11,498) of this cohort was willing to be re-examined (Figure 1). To both assess the development of the children and evaluate the effect of the intervention activities, exactly the same survey modules were deployed at baseline (T0) and at first followup (T1). The end of the trial was time-defined without a stopping rule. In autumn 2010, a second follow-up (T2)

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was conducted to assess sustainability of behavioural change using a questionnaire mailed to all intervention participants. All children in the defined age group who resided in the study regions and who attended the public primary schools (grades 1 and 2), pre-schools or kindergartens were eligible for participation. Children were approached via schools and kindergartens to facilitate representative enrolment of all social groups. In addition to the signed informed consent provided by parents, each child was asked to give verbal assent. As a result of the overall intervention concept and approach, all children in the intervention region were exposed to the intervention modules (see the following), irrespective of whether they were included in the baseline database or not.

Basic concept of the IDEFICS intervention During the application for funding of the IDEFICS study in the 6th EU-Framework Programme (October 2004– January 2005), the cornerstones of the IDEFICS intervention were fixed (i.e. children as target group; recruitment via kindergartens and schools; sample size; and the targets of nutrition, physical activity and stress). In 2007 (during the first year of the project), the design of the IDEFICS intervention was developed and refined as a community-oriented setting-based primary prevention programme building on the available knowledge and evidence at that time. Within the IDEFICS study, a childhood obesity prevention perspective was constructed using the socio-ecological paradigm, putting an individual’s risk for becoming overweight within a nexus of individual behavioural, social, cultural and economic determinants. From this point of view, pre-school

Figure 1 Overview of the study population and drop-outs in the IDEFICS intervention and control areas in different phases of the study – recruitment, baseline survey and follow-up survey (see also (20)).

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and primary schoolchildren were selected as main intervention targets, while their families, the schools and the communities were integrated within the overall approach. According to the five-step intervention mapping approach (7; for a detailed description, see (15)), focus groups were conducted to learn about the target groups’ needs and barriers to a healthy lifestyle (16,17). Physical inactivity, dietary imbalance and excessive stress experience were identified as modifiable risk drivers for childhood obesity; a comprehensive primary prevention programme was targeted at these dimensions. Six major intervention messages (see Figure 2 and in the following sections for further details) and appropriate corresponding communication strategies were developed in cooperation with a German public relations company. The overall intervention design and implementation were coordinated and followed up by a team of researchers from the University of Ghent and the University of Gothenburg. An intervention management panel was installed with representatives from each participating research centre (the so-called local intervention programme manager). These local managers took responsibility for the integration and implementation of the intervention in their country and stayed in close contact to the Ghent research group through regular face-to-face meetings, telephone conferences and email interactions. These local intervention programme managers were thereby supported by a local team (local intervention programme committee) for assistance and hands-on implementation of the different intervention modules. In addition to the local intervention programme committees, so-called community platforms were created (bringing together local


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public authorities, local public health actors and different stakeholders with potential impact on health behaviour) in each intervention community. These platforms supported the local research teams in implementing the intervention modules at the community level. Furthermore, round-table discussions under the lead of the intervention programme managers were conducted in each intervention region to involve teachers, educators and parents in the delivery of the intervention modules at the school or kindergarten level (these round tables were also called ‘school platform’). It was expected that the teachers would deliver the various modules after initial support of the research teams. Further modules addressing the families were provided to parents by the research teams, e.g. offering cooking courses or courses on how to restrict TV consumption of children. Details on the various intervention modules are given in the following. The standardized community intervention programme started from the schools and pre-schools and lasted about 2 years, where not each and every component was offered during the whole intervention period. For instance, the so-called Healthy Weeks (Table 1) were provided by the research teams during a period of 9 months only, but they could have been replicated by the teachers at any point thereafter. The core settings, dissemination channels, core intervention tools and modules were described in detail in a standardized intervention manual provided to all actors in the schools and pre-schools. Ten intervention modules were developed to implement key message-specific activities on community, setting and family levels (see the following). Local adaptations (of single activities within

Figure 2 The six key messages of the IDEFICS intervention; illustrations were used in corresponding leaflets for parents and children and to create window posters.


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Table 1

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Schedule of Healthy Weeks components of the IDEFICS intervention Intervention adoption period

Month

Theme of the HW

Key message highlighted

Oct 2008 Nov 2008 Dec 2008 Jan 2009 Feb 2009 Mar 2009 Apr 2009 May 2009 Jun 2009 Jul 2009 Aug 2009

Physical activity Diet Physical activity Diet Physical activity Diet Physical activity Diet Stress-coping and relaxation (optional)

Stimulating daily physical activity Stimulating daily consumption of fruit and vegetables Reducing television viewing Stimulating daily consumption of water Stimulating daily physical activity Stimulating daily consumption of fruit and vegetables Reducing television viewing Stimulating daily consumption of water Encouraging adequate sleep duration (optional)

Vacation period – no Healthy Weeks

one module) to the standardized interventions were allowed in all countries to account for cultural heterogeneity across Europe. Finally, a community-oriented setting-based primary prevention programme was implemented in each intervention region of the eight countries where about 500 pre-schoolers and 500 primary schoolchildren were involved in the intervention programme with the same number of children (per age group) recruited in each control region. This resulted in a desired sample of 2,000 per country. The data collection for the intervention was split in two complementary modules. Data for the impact evaluation were collected through the baseline and follow-up surveys. Details on these surveys have been published elsewhere (12,14). Data on process evaluation were collected through a series of questionnaires that were targeting school personnel, public health workers, nongovernmental organizations, stakeholders etc. and these were administered through the schools or through the community platform.

Evaluation concept of the IDEFICS intervention The evaluation of the IDEFICS intervention addressed (i) the development of the programme including costs, expenditure of time, practical problems faced during implementation and their solutions; (ii) implementation process including participation, feasibility, penetration and acceptance and sustainability; and (iii) intervention effects on the individual level with respect to changes in anthropometry, biomarkers and behaviour. The process evaluation is described by de Bourdeaudhuij et al. (18), including insights from an in-depth analysis conducted solely in Belgium as an exemplar country of the IDEFICS intervention (19).

Statistical analysis of intervention outcomes Effectiveness of the intervention on anthropometric variables and behavioural outcomes were assessed using multilevel models. Such models make optimal use of the available data as they allow considering children with varying numbers of measurements under a missing at 16 (Suppl. 2), 4–15, December 2015

random assumption (intention to treat analysis). In principle, a three-level model (country-individual-time) was used; if reasonable a four level model (country-school-individualtime) was conducted to account for the clustered study design as well as for the repeated measurements clustering within individuals. Significance of time × condition effects was investigated by F-tests, which were interpreted as intervention effects. For biomarkers, the number of missing values was quite high due to budgetary constraints. Thus, a complete case analysis was conducted using the individual change in biomarker levels between baseline and follow-up as outcome. Although the major analyses of each of the outcomes partly accounted for the multiplicity of our research questions, the analyses have not been adjusted for multiple testing across all papers. Thus, all results should be interpreted as exploratory to be confirmed or rejected by further studies. The IDEFICS investigators did not publish a protocol paper nor register the trial. The results of the evaluation of the IDEFICS intervention are described in detail in papers in this supplement (for anthropometry, see (20); for biomarkers, see (21); for physical activity and sedentary behaviour, see (22); for sleep, see (23); and for general behavioural effects, see (24)).

Quality management From the very start of the intervention programme design and implementation and throughout the project, strict quality assurance was adopted. The 10 intervention modules were translated into local languages according to a translation and back translation protocol. Cultural adaptations, i.e. deviations from the centrally standardized protocol, were thoroughly discussed with the whole team and were allowed only insofar as they could improve the standardization of the envisaged effect and impact on the target behaviours. The intervention programme team held telephone conferences every month and ad hoc to discuss progress in the different centres, follow up on the deliverables and troubleshoot whenever needed. All centres had to provide © 2015 World Obesity

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regular updates on the process of their implementation through standardized and centrally processed documentation completed by the research team and key local actors like school boards, parents and physical education teachers. On a regular basis, photographic material and/or videos were collected from local activities and were screened for their adherence to the central protocol. The databases from the intervention development and process evaluation were subjected to quality assurance protocols similar to other IDEFICS data, including data on the intervention programme outcome measures (i.e. anthropometry, lifestyle and biomarkers).

The intervention manual The overall programme was built on six key messages (Figure 2; (15)) addressing six key behavioural factors: (i) increase the consumption of water, (ii) increase the consumption of fruit and vegetables, (iii) decrease daily television (TV) viewing time, (iv) increase daily physical activity, (v) strengthen parent–child relationships by spending more time together and (vi) establish adequate sleep duration. Figure 2 provides examples for implementing these messages on different levels (Figure 3), e.g. on the individual and the school level: provision of water fountains in schools should lead to increased daily water consumption, which in turn should lead to decreased soft drink consumption; on the community level: encouraging children to be physically active should be supported by safe bicycle lanes and facilities for outdoor play; on the family level: recommending spending more time together should lead to more active family play or having meals together. Recommendations regarding these health-related behaviours with respect to childhood obesity prevention were based on accepted national or international guidelines (25). At baseline, only 1% of children ‘spontaneously’ adhered to five or six, 6% to four, 20% to three, 35% to

Figure 3 Levels and major intervention areas of the IDEFICS intervention (the authors acknowledge first and reference publication in the International Journal of Obesity (14)).



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two and 38% to only one or none of the key messages formulated (25). The prevention programme was formed into 10 modules (15) addressing the three intervention target behaviour dimensions and targeting the four levels of intervention (Figure 3) through non-selective primary prevention and health-promoting activities. At the community level (modules 1–3), we addressed the physical, social and political environments; at the pre-school and primary school levels (modules 4–9), we focussed on education, school food environment (catering/vending machines) and the school neighbourhood; at the family level (module 10), we provided education and motivation materials; and at the individual level (modules 5 and 7), we addressed lifestyle factors to achieve behaviour change. A full description of the IDEFICS intervention modules is available as an openaccess document (26).

Intervention modules on the community level Module 1 described how the community partners (e.g. local politicians, paediatricians, teachers, representatives of sports clubs and youth centres) should be involved in the overall process, with a focus on establishment of a community platform to which representatives of each important community stakeholder group were invited to join. This community platform was to assume responsibility to further develop and implement all community level intervention activities such as the public relations strategy of the IDEFICS campaign and the communication strategy. A cooking competition was performed in all intervention communities during the intervention period. The best recipes were collected and supplemented with traditional family games selected from each participating country in an educational book. This book was published by a German publisher of educational material for children, Westermann Verlag, in all languages of the participating countries. This book was given as a present and ‘Thank you’ to all participating families – regardless of whether they lived in the intervention or the control regions in each country – after the intervention period to not contaminate the comparison between regions. To increase visibility of the IDEFICS intervention, a 2-year media campaign was developed with a public relations agency. In Module 2, strategies and templates, such as window posters, were provided to visualize the key messages at important focal points in the community, e.g. shop windows near (school) bus stops. These points were selected with members of the community platform to reach a high proportion of children and families in the community on a daily basis. Module 3 described activities to lobby for community environmental and policy interventions. For instance, community interventions were to be launched to promote physical activity, e.g. advocating for ‘play streets’ and community playgrounds, and promoting water 16 (Suppl. 2), 4–15, December 2015

10 Overview of IDEFICS intervention I. Pigeot et al.

consumption after municipality funded quality checks of tap water in schools and kindergartens. This module included both a short-term perspective, which had the community platform implement actions within the intervention adoption period lasting from April 2008 to August 2009, and a longer-term perspective after the implementation phase, 2009 until 2010, aimed at triggering new initiatives during the IDEFICS intervention dissemination period from 2010 onwards. The community platform was supposed to advocate for environmental and policy interventions aimed at facilitating healthy lifestyle. While not paid for their services, members of the community platform were selected based on their strong dedication to combating child obesity.

Intervention modules at the school/kindergarten level Module 4 described actions to build partnerships on the school or kindergarten level. First, school and kindergarten staff as well as representatives of parents were made aware of the IDEFICS intervention by core intervention staff organizing monthly meetings. Second, a setting working group was created, composed of important school and kindergarten representatives, and those responsible for development and implementation of intervention modules at the school/kindergarten level, e.g. the organization of cooking competitions in the schools and kindergartens. Creating a school/kindergarten platform was suggested where all school/kindergarten working groups gathered to exchange their knowledge and experiences, share their opinions and elaborate new initiatives. Members of these working groups were requested to complete process evaluation sheets during each monthly meeting for precise documentation of activities. Module 5 addressed child education targeting behaviour change at the individual level, but implemented at the setting level. It described how to conduct eight so-called ‘Healthy Weeks’ activities during the school year (2008–2009) (Table 1), where four Healthy Weeks addressed physical activity and the remaining four addressed diet-related activities. The possibility of providing one additional Healthy Week about ‘adequate sleep duration’ was addressed. The key message ‘spend more time together’ was not addressed as a separate issue in a Healthy Week activity, but was systematically integrated within the other key messages. Exposure to the Healthy Weeks topics differed for schools and kindergartens. In primary schools, the teachers spent 8 class hours over 8 Healthy Weeks activities, whereas in kindergartens, every day of the Healthy Week was designed to be in the theme of the key message. An educational game poster and an IDEFICS card game were provided to all settings and integrated into the daily educational routine as well as into the Healthy Weeks activities. The poster offered different cards (in small pouches) with ideas on how to communicate the topics healthy diet, 16 (Suppl. 2), 4–15, December 2015

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physical activity and relaxation/stress to children. The poster was delivered with a training manual supplying educational staff with recommendations and suggestions for putting the cards to good use. The manual also contained templates for games and letters to parents, which could have been coloured by the children. The IDEFICS card game consisted of different game cards from three categories: food quiz, physical activity and family task. The card game may have been played at any time during the school or kindergarten day, and children were encouraged to supplement the game with self-designed cards. The most valuable player became ‘Fruit/Vegetable Queen/King’ of the day. Module 6 described possibilities for environmental changes to increase physical activity. For instance, guidance was provided on how to create an active playground by changing the playground’s physical design, providing attractive play equipment and implementing structural changes related to recess periods. It strongly recommended promoting an active school playground and coaching teachers to supervise the playground in an active way. Module 7 presented a physical education curriculum with guidelines and instructions for teachers, educators and/or nurses to (i) enhance time for physical activity among children e.g. during physical education classes or during the time spent in the kindergarten; (ii) develop child knowledge, social attitudes and movement skills necessary to lead an active lifestyle; and (iii) build children’s confidence (self-efficacy) in their physical abilities. Modules 8 and 9 addressed environmental school policy changes related to water (module 8) and fruit and vegetables consumption (module 9). Possibilities to increase daily water consumption included permanent provision of free water during breaks, play time and/or lessons as an environmental change. For example, providing safe drinking water in the settings and allowing water drinking during lessons were specified. School policy might require changes in the beverages supplied in schools, e.g. not allowing the sale of sugarsweetened beverages. Promoting the availability of water and clearly communicating the rules were strongly recommended, e.g. describing the water initiatives and regulations in the school journal and providing recyclable cups or tins for water. To increase the consumption of fruit and vegetables in schools and kindergartens as an environmental change, it was suggested to make fruit and vegetables available and accessible in schools and kindergarten, e.g. contracting with a local fruit and vegetable merchant and asking children to only bring fruit or vegetables instead of unhealthy snacks. Environment or school policy change might require a reorientation with respect to the food supply, e.g. increasing the price of high energy snacks, lowering the price of fruit and vegetables or not selling unhealthy snacks at all, replacing them with fruit and/or vegetables. © 2015 World Obesity

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Intervention modules on the family level The last IDEFICS intervention module addressed the education of parents. Educational folders (Figure 4) and videos were provided to inform parents about existing recommended units for the key messages and to teach parenting strategies that could remove barriers and facilitate their ability to create health-promoting family environments. The six key messages were addressed in general folders provided as a template, which had to be translated into the local language. Further folders had to be developed by every local survey centre, following general guidance given in the manual. Educational videos were produced by one professional partner of the IDEFICS consortium (see for instance (27,28)).

Best practice examples A core element of the IDEFICS intervention was advocacy for community environmental and policy change to promote physical activity. This comprised both short-term and longer-term measures to prevent childhood obesity. Within the Italian intervention regions, this was accomplished through the development and implementation of Healthy Walks (Figure 5). Each Healthy Walk consisted of a special route within each village, with signs reporting the number of steps done, the corresponding number of calories consumed and the equivalent in food portions for the defined energy expenditure. The ideal Healthy Walk in a town was roughly 4000–5000 steps long; each route was structured to walk in total or in part, according to personal

Figure 4

Overview of IDEFICS intervention I. Pigeot et al.

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preferences and fitness level. The attractiveness of the Healthy Walks was their concrete, visible example of how to make lifestyles healthier, ease of implementation, costeffectiveness and sustainability. Because they were applied at the population level, they were available to the whole community, children, families and older persons. To increase time spent in moderate to vigorous physical activities during breaks at school, politicians, representatives from the municipality, a property manager, teachers, pedagogues, children and the IDEFICS team in Sweden collaborated with an architecture pedagogue to create an inspiring school yard in West Sweden. The architecture pedagogue had regular meetings with schoolchildren of all age groups where they talked about how the school yard was being used, could be used and new ideas about how to change the school yard environment. After 3 months of work, a list of proposals was generated and the feasible proposals implemented. Key to the success was the active engagement with different stakeholder groups, particularly the children, as end users of the facility. This not only ensured their appropriateness for children but also promoted use of the facilities. The ideas to create more inspiring school yards were taken up across the municipality, and beyond the IDEFICS intervention regions, to expand the original impact In Cyprus, the primary school day ended at 13:05 h. The Open School Child Health programme kept school yards open for children and parents on Wednesday and Saturday afternoons. Parents and family members were encouraged

Flyer promoting improvement of physical activity.


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platform that actively engaged the gypsy community. The ‘Secretariado gitano de Huesca’ (Huesca gypsy secretariat) helped to spread the intervention messages to the gypsy families in addition to the activities through the schools. These are only a few good practice examples that resulted from the IDEFICS intervention that may have changed the obesogenic environment of children in a sustainable way and by this may have contributed to the prevention of childhood obesity on the community level.

Critical appraisal of the overall results

Figure 5 Sign indicating Healthy Walks in an Italian intervention region.

to attend, and activities were inclusive of children and families. Cooking classes for children and parents, healthy eating crossword puzzles and performances, parent relaxation techniques and advice on how to make vegetables more attractive were provided. Including both children and parents hopefully sustained the key messages beyond the classroom into the future. The municipality took the event under their auspices, including financial responsibility for the four physical education teachers. To discourage the consumption of sugar-sweetened beverages, the study encouraged increased plain water consumption within the school environment. Increased access to water was negotiated in German schools. More drinking water occasions were created in participating kindergartens and schools. This was implemented during breaks and throughout the day – even during classes. Part of this activity’s success may be attributed to the close staff contact with schools/kindergartens. Most classrooms had sinks installed to provide tap water. The activity was considered relatively easy to implement by teachers because of the lack of cost to them. After safety of tap water had been assured through municipal control analyses, payment for bottled water was stopped and invested for fruit and vegetable baskets once a week. These kindergartens progressed to implementing a healthy breakfast. To engage traditionally hard to reach lower socioeconomic communities in Spanish intervention regions in particular, the gypsy community was approached. Between March and August 2009, 13 cooking courses were conducted with its members. In contrast to the deficit model of health promotion and education (where people are assumed to lack knowledge which needs to be provided by experts), these classes took a collaborative approach. Traditional recipes were reviewed and modified to improve their nutritional value whilst maintaining their cultural identity. The impact on participants’ dietary habits was likely higher, as new dishes were not introduced. A key to this success was creation of an inclusive community 16 (Suppl. 2), 4–15, December 2015

The IDEFICS trial was a large multinational nonrandomized intervention to promote health and prevent obesity among young children by deploying synergistic community, family and school-based intervention procedures in eight countries in Europe (14). Six messages, two related to each behaviour: diet, physical activity and stress, were delivered through 10 modules targeted across all the levels. The multi-behavioural (6) outcomes targeted by the intervention programme was rooted in the general assumption that the pathophysiological basis of childhood overweight and obesity – a long-term disruption of energy balance – was not solely related to one single behaviour, but in most cases due to a combination of several behaviours converging in their pressure on the body’s energy homeostasis and subsequent unfavourable changes in body composition (29,30). Analysis of baseline data revealed that only 6.7% of the total sample adhered to at least four of the messages, suggesting no ceiling effect, i.e. there was adequate room for population change (31). The intervention was ambitious, attempting to introduce a common, but culturally adapted, intervention into the eight countries simultaneously. In spite of high expectations, the IDEFICS trial did not accomplish its primary objectives of mitigating or reversing the substantial increases in child obesity in Europe after 2 years of intervention (20). The IDEFICS intervention similarly did not impact the 2-year energy balance-related behaviours of dietary intake (24), physical activity, physical inactivity (22,24) or sleep (23), although an analysis 5 years after the intervention suggested that the intervention might have had an impact on water and sugar consumption (32). Without such behavioural or adiposity effects, it was not surprising that the IDEFICS trial had no impact on insulin resistance or markers of the metabolic syndrome (21). Despite these absent health or behaviour changes, the parents reported many positive effects and four negative effects (33), which might have led to positive effects 5 years later (32). These findings are consistent with the outcomes of other large community-based trials (4,34). Unexpectedly, process evaluation indicated that the intervention was not delivered with high fidelity. Both the interviews with the parents (18) and the interviews regarding the © 2015 World Obesity

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intervention components in Belgium (19) indicated that only half or less of the programme was delivered in the way it was meant to be. The IDEFICS trial was designed as an effectiveness trial, without a prior efficacy trial, in the expectation that such a grand-scale intervention would be effective and that the transition to common practice in those communities would be easier from an effectiveness design. Under the current circumstances, the lack of effectiveness might have been due to a misguided intervention design that had no chance of impacting the targeted variables, or the modest level of programme delivery that possibly impaired a likely to be effective intervention (if fully implemented). Future large investments in interventions should start with an efficacy trial. If the smaller (less costly) efficacy trial does not change targeted variables, there would be no reason to progress to a larger (more costly) effectiveness trial. Some rays of hope shined through the analyses. Exploratory analyses indicated that the intervention did have an impact on the initially overweight and obese children (35), similar to other large-scale trials (34). This suggests that the children who benefitted from the intervention were predisposed, either by being the participants who had the additional weight that was possible to lose or perhaps who adhered more to the messages. In addition, the identification of the changes in the community structures, i.e. the best practices, also indicated that such intervention components showed promise and should be more rigorously tested for their generalizability and effect on the obesogenic environment and behaviours, and thereby may be incorporated into future obesity prevention interventions. How best to understand this disappointing set of outcomes remains a challenge. Assuming the problem was not only lack of programme delivery, the lack of effectiveness could have been due to a misguided overly confident sense of what was possible (36), to the inadequate knowledge base available at the time of the design of the IDEFICS intervention (37), to the country-specific adaptations of unknown efficacy, or to some other factors. Much was expected of the local community platforms and members of the working groups. The extent to which they implemented their many tasks is not sufficiently well known, and may in part account for the weak outcomes. The absence of measurable effects may also reflect to some extent the relatively impoverished current state of measurement of the relevant variables (38). Finally, one could argue on a more intuitive basis that interventions targeting a multitude of behavioural variables may suffer from what could be coined ‘information stress’, leading to some sort of discouragement for people who otherwise would be willing and able to commit to just one or a few behavioural changes, but feel overwhelmed – and immobilized – by the multiple behavioural character of the lifestyle adjustments that seem desirable to meet with the programme’s © 2015 World Obesity


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objectives. Alternatively, participants may single out only one or two behaviours for change, which are relatively easy and they are already performing, and thereby excuse themselves from further change. These and other alternative hypotheses are worthy of further exploration. Anyway, each scientist reading these results will likely come to their own conclusions, which hopefully will lead to innovative insights into both the aetiology and prevention of obesity among children, and at some point lead to a sustainable public health answer to the child obesity crisis.

Concluding remarks Although the evaluation did not reveal strong and consistent intervention effects, a number of positive initiatives were observed at the level of communities and settings, which may have a sustainable impact and serve as good practice examples. A first step to ensure sustainability of the IDEFICS intervention that has been taken at the end of the study period was the ratification of the ‘IDEFICS charter’. This was developed in consultation with local policymakers who were involved in the IDEFICS intervention. The charter was formally launched at the second IDEFICS policy dissemination meeting in Partille, Sweden in May 2011 to which politicians and policymakers from the IDEFICS intervention regions were invited. The IDEFICS charter has been signed by mayors and their representatives from the intervention regions. The charter is an important symbol of local policymakers’ commitment to carry on with many different initiatives that parents, schools and civil servants have taken in the framework of the IDEFICS study.

Acknowledgements This work was done as part of the IDEFICS study (www. idefics.eu). We gratefully acknowledge the financial support of the European Community within the Sixth RTD Framework Programme Contract No. 016181 (FOOD). We are grateful for the support by school boards, headmasters and communities. The authors wish to thank the IDEFICS children and their parents for participating in this extensive examination. The authors are also grateful to the Federal Centre for Health Education, Germany, that financially supported the production of this supplement. We would also like to acknowledge all the members involved in the field work and the implementation of the intervention programme for their efforts and great enthusiasm. As representatives of the teams, we thank: Belgium: Mieke De Maeyer, Mia Bellemans, Melissa De Neve (dietitians), Ghent University, Ghent; Cyprus: Stalo Papoutsou (clinical dietician), Yiannis Kourides (paediatrician), Antonia Solea (health psychologist), Research and Education Institute of Child Health, Strovolos; Estonia: Helle-Mai Loit (local field 16 (Suppl. 2), 4–15, December 2015

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support), Leila Oja (physical activity and fitness leader), Marge Saamel (nutritionist), National Institute for Health Development, Tallinn; Germany: Wiebke von Atens-Kahlenberg and Heidegret Bosche (nutritionists), Ramona Dembski (study nurse), Ina Alvarez and Edda Hein (local field support), Leibniz Institute for Prevention Research and Epidemiology – BIPS, Bremen; Johann Böhmann (paediatrician), Paediatric Clinic Delmenhorst; Hungary: Dénes Molnár (principal investigator), Edina Mendl (dietician), Regina Felso (physiotherapist), University of Pécs; Italy: Gianni Barba (epidemiologist), Marika dello Russo (nutritionist), Emilia Donatiello (nutritionist), Annarita Formisano (food technologist), Pasquale Marena (biologist), Annunziata Nappo (biologist), Sonia Sparano (pharmacist), National Research Council, Avellino; Spain: Natalia Lascorz (BS), Alba Santaliestra-Pasías (PhD), Iris Iglesia-Altaba (RD), Esther González-Gil (RD), Pilar De Miguel-Etayo (RD), Silvia Bel-Serrat (PhD), Luis Gracia-Marco (PhD), University of Zaragoza; Sweden: Marie Lundell (study nurse), Lisen Grafström (study dietician), University of Gothenburg; Gert Johansson (public health planner), Malin Karlsson (public health project leader), Sigbritt Andreasson (public health project leader), Public Health Council, Partille Municipality; Mie Svennberg (architecture advisor for children and youth), Culture Affairs Administration, City of Gothenburg.

Statement of ethics We certify that all applicable institutional and governmental regulations concerning the ethical use of human volunteers were followed during this research. Approval by the appropriate Ethics Committees was obtained by each of the 8 centres doing the field work. Study children did not undergo any procedure before both they and their parents had given consent for examinations, collection of samples, subsequent analysis and storage of personal data and collected samples. Study subjects and their parents could consent to single components of the study while abstaining from others.

Conflict of interest statement There are no conflicts of interest to declare.

Appendix 1 The following investigators and institutions constitute the IDEFICS Intervention Study Group: Belgium: Ilse De Bourdeaudhuij, Vera Verbestel, Department of Movement and Sport Sciences, Lea Maes, Department of Public Health, Ghent University, Ghent; Cyprus: Michael Tornaritis, Charalambos Hadjigeorgiou, Research and Education Institute of Child Health, Strovolos; Estonia: Toomas Veidebaum, Kenn Konstabel, National Institute for 16 (Suppl. 2), 4–15, December 2015

Health Development, Tallinn; Germany: Wolfgang Ahrens, Antje Hebestreit, Leibniz Institute for Prevention Research and Epidemiology – BIPS, Bremen; Holger Hassel, Coburg University of Applied Sciences and Arts; Hungary: Eva Kovács, Eva Erhardt, Department of Paediatrics, Medical Faculty, University of Pécs; Italy: Alfonso Siani, Paola Russo, Fabio Lauria, Institute of Food Sciences, Unit of Epidemiology & Population Genetics, National Research Council, Avellino; Spain: Luis A. Moreno, Juan Fernandez-Alvira, GENUD (Growth, Exercise, Nutrition and Development) Research Group, University of Zaragoza, Zaragoza; Sweden: Staffan Mårild, Department of Pediatrics, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg; Lauren Lissner, Gabriele Eiben, Section for Epidemiology and Social Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg.

References 1. Procter KL. The aetiology of childhood obesity: a review. Nutr Res Rev 2007; 20: 29–45. 2. Singh AS, Mulder C, Twisk JW, van Mechelen W, Chinapaw MJ. Tracking of childhood overweight into adulthood: a systematic review of the literature. Obes Rev 2008; 9: 474–488. 3. Bleich SN, Segal J, Wu Y, Wilson R, Wang Y. Systematic review of community-based childhood obesity prevention studies. Pediatrics 2013; 132: E201–E210. 4. Waters E, de Silva-Sanigorski A, Hall BJ et al. Interventions for preventing obesity in children. Cochrane Database Syst Rev 2011; 12: CD001871. 5. Bundeszentrale für gesundheitliche Aufklärung. Qualitätskrierien für Maßnahmen der Gesundheitsförderung und Primärprävention von Übergewicht bei Kindern und Jugendlichen [in German]. Gesundheitsförderung konkret Band 13, Bundeszentrale für gesundheitliche Aufklärung (BZgA): Köln, 2010. 6. Bundeszentrale für gesundheitliche Aufklärung. Leitfaden Qualitätskriterien für Planung, Umsetzung und Bewertung von gesundheitsfördernden Maßnahmen mit dem Fokus auf Bewegung, Ernährung und Umgang mit Stress [in German]. Bundeszentrale für gesundheitliche Aufklärung (BZgA): Köln, 2012. 7. Bartholomew LK, Parcel GS, Kok G, Gottlieb NH, Fernandez ME. Planning Health Promotion Programs: An Intervention Mapping Approach, 3rd edn. Jossey-Bass: San Francisco, California, 2011. 8. Ajzen I. The theory of planned behavior. Organ Behav Hum Decis Process 1991; 50: 179–211. 9. Green L, Kreuter M. Health Program Planning: An Educational And Ecological Approach, 4th edn. McGraw Hill: New York, 2005. 10. Prochaska JO, Norcross JC. Stages of change. In: Norcross JC (ed.). Psychotherapy Relationships that Work. New York: Oxford University Press, 2002, pp. 303–313. 11. Gregsona J, Foersterb SB, Orrc R et al. System, environmental, and policy changes: using the social-ecological model as a framework for evaluating nutrition education and social marketing programs with low-income audiences. J Nutr Educ 2001; 33(Suppl. 1): S4–S15. 12. Ahrens W, Bammann K, Siani A et al., on behalf of the IDEFICS consortium. The IDEFICS cohort: design, characteristics and participation in the baseline survey. Int J Obes 2011; 35(Suppl. 1): S3–S15. 13. Bammann K, Peplies J, Sjöström M et al., on behalf of the IDEFICS consortium. Assessment of diet, physical activity and


obesity reviews

biological, social and environmental factors in a multi-centre European project on diet- and lifestyle-related disorders in children (IDEFICS). J Public Health 2006; 14: 279–289. 14. De Henauw S, Verbestel V, Mårild S et al., on behalf of the IDEFICS consortium. The IDEFICS community oriented intervention program. A new model for childhood obesity prevention in Europe. Int J Obes 2011; 35(Suppl. 1): S16–S23. 15. Verbestel V, De Henauw S, Maes L et al. Using the intervention mapping protocol to develop a community-based intervention for the prevention of childhood obesity in a multi-centre European project: the IDEFICS intervention. Int J Behav Nutr Phys Act 2011; 8: 82. 16. Haerens L, De Bourdeaudhuij I, Barba G et al., on behalf of the IDEFICS consortium. Developing the IDEFICS community-based intervention program to enhance eating behaviors in 2- to 8-year-old children: findings from focus groups with children and parents. Health Educ Res 2009; 24: 381–393. 17. Haerens L, De Bourdeaudhuij I, Eiben G et al. Formative research to develop the IDEFICS physical activity intervention component: findings from focus groups with children and parents. J Phys Act Health 2010; 7: 246–256. 18. De Bourdeaudhuij I, Verbestel V, De Henauw S et al., on behalf of the IDEFICS consortium. Implementation of the IDEFICS intervention across European countries: perceptions of parents and relationship with BMI. Obes Rev Suppl 2015; 16(Suppl. 2): 78–88. 19. Verloigne M, Ahrens W, De Henauw S et al., on behalf of the IDEFICS consortium. Process evaluation of the IDEFICS obesity prevention programme: putting the evaluation of the effect on children’s objectively measured physical activity and sedentary time in context. Obes Rev Suppl 2015; 16(Suppl. 2): 89–102. 20. De Henauw S, De Bourdeaudhuij I, Huybrechts I et al., on behalf of the IDEFICS consortium. Effects of a community-oriented obesity prevention programme on indicators of body fatness in preschool and primary school children. Main results from the IDEFICS study. Obes Rev Suppl 2015; 16(Suppl. 2): 16–29. 21. Mårild S, Russo P, Veidebaum T et al., on behalf of the IDEFICS consortium. Impact of a community based healthpromotion programme in 2-9 year old children in Europe on markers of the metabolic syndrome, the IDEFICS study. Obes Rev Suppl 2015; 16(Suppl. 2): 41–56. 22. Verbestel V, De Henauw S, Barba G et al., on behalf of the IDEFICS consortium. Effectiveness of the IDEFICS intervention on objectively measured physical activity and sedentary time in European children. Obes Rev Suppl 2015; 16(Suppl. 2): 57–67. 23. Michels N, De Henauw S, Eiben G et al., on behalf of the IDEFICS consortium. Effect of the IDEFICS multi-level obesity prevention on children’s sleep duration. Obes Rev Suppl 2015; 16(Suppl. 2): 68–77. 24. De Bourdeaudhuij I, Verbestel V, De Henauw S et al., on behalf of the IDEFICS consortium. Behavioural effects of a communityoriented setting-based intervention for prevention of childhood obesity in eight European countries. Main results from the IDEFICS study. Obes Rev Suppl 2015; 16(Suppl. 2): 30–40.



15

25. Kovács É, Siani A, Veidebaum T et al., on behalf of the IDEFICS consortium. Adherence to the obesity-related lifestyle intervention targets in the IDEFICS study. Int J Obes 2014; 38(Suppl. 2): S144–S151. 26. Verbestel V, De Henauw S, Mårild S et al. The IDEFICS Intervention Toolbox – a guide to successful obesity prevention at community level. In: Maddock J (ed.). Public Health – Social and Behavioral Health. InTech: Rijeka, 2012 and [WWW document] URL http://www.intechopen.com/books/public-health-social-andbehavioral-health/the-idefics-intervention-toolbox-a-guide-to-successful-obesity-prevention-at-community-level 27. IDEFICS study. IDEFICS Podcasts, 2006. [WWW document]. URL http://www.ideficsstudy.eu/Idefics/webcontent?cmd=innerDoc& path=3493&start=true 28. IDEFICS estudio. Fruits & vegetables taste delicious (Video), 2006. [WWW document]. URL http://www.ideficsstudy.eu/Idefics/ language?lan=Sp 29. Bleich SN, Ku R, Wang YC. Relative contribution of energy intake and energy expenditure to childhood obesity: a review of the literature and directions for future research. Int J Obes 2011; 35: 1–15. 30. Gubbels JS, van Assema P, Kremers SPJ. Physical activity, sedentary behavior, and dietary patterns among children. Curr Nutr Rep 2013; 2: 105–112. 31. Kovacs E, Hunsberger M, Reisch L et al., on behalf of the IDEFICS consortium. Adherence to combined lifestyle factors and their contribution to obesity in the IDEFICS study. Obes Rev Suppl 2015; 16(Suppl. 2): 138–150. 32. Arvidsson L, Bogl L-H, Eiben G et al., on behalf of the IDEFICS and I. Family consortia. fat, sugar and water intakes among families from the IDEFICS intervention and control groups: first observations from I.Family. Obes Rev Suppl 2015; 16(Suppl. 2): 127–137. 33. Nicholls SG, Pohlabeln H, De Bourdeaudhuij I et al., on behalf of the IDEFICS consortium. Parents’ evaluation of the IDEFICS intervention: an analysis focussing on socio-economic factors, child’s weight status, and intervention exposure. Obes Rev Suppl 2015; 16(Suppl. 2): 103–118. 34. HEALTHY Study Group, Foster GD, Linder B et al. A schoolbased intervention for diabetes risk reduction. N Engl J Med 2010; 363: 443–453. 35. Lissner L, De Bourdeaudhuij I, Konstabel K et al., on behalf of the IDEFICS consortium. Differential outcome of the IDEFICS intervention in overweight versus non-overweight children: did we achieve “primary” or “secondary” prevention? Obes Rev Suppl 2015; 16(Suppl. 2): 119–126. 36. Williams G. The IDEFICS intervention: what can we learn for public policy? Obes Rev Suppl 2015; 16(Suppl. 2): 151–161. 37. Baranowski T, Lytle L. Should the IDEFICS outcomes have been expected? Obes Rev Suppl 2015; 16(Suppl. 2): 162–172. 38. Archer E, Pavela G, Lavie CJ. The inadmissibility of what we eat in America and NHANES dietary data in nutrition and obesity research and the scientific formulation of national dietary guidelines. Mayo Clin Proc 2015; 90: 911–926.

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