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Health Education Research, Vol. 18, No. 5, 611-626, October 2003
© 2003 Oxford University Press

The European Smoking prevention Framework Approach (EFSA): an example of integral prevention

Hein de Vries, Aart Mudde, Ingrid Leijs, Anne Charlton1, Errki Vartiainen2, Goof Buijs3, Manuel Pais Clemente3, Hans Storm5, Andrez González Navarro6, Manel Nebot7, Trudy Prins8 and Stef Kremers

Department of Health Education, Maastricht University, 6200 MD Maastricht, The Netherlands, 1 Department of Epidemiology and Health Sciences, University of Manchester, Manchester M13 9PT, UK, 2 National Public Health Institute, 00300 Helsinki, Finland, 3 National Institute for Health Promotion and Prevention (NIGZ), 3440 AM Woerden, The Netherlands, 4 Portuguese Council for Smoking Prevention, 1700-165 Lisbon, Portugal, 5 Danish Cancer Society, Department of Cancer Prevention and Documentation, 2100 Copenhagen, Denmark, 6 Regional Office for Cancer Coordination, 28003 Madrid, Spain, 7 Municipal Institute of Health, Health Promotion Unit, 08023 Barcelona, Spain, and 8 Stivoro, 2500BB The Hague, The Netherlands

E-mail: hein.devries{at}gvo.unimaas.nl


    Abstract
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
A smoking prevention project in six European countries (European Smoking prevention Framework Approach) was developed, featuring activities for adolescents, schools and parents, including out-of-school activities. Con sensus meetings resulted in agreement between the countries on goals, objectives and theoretical methods. Countries’ specific objectives were also included. National diversities re quired country-specific methods to realize the goals and objectives. The community intervention trial was used as the research design. Since interventions took place at the community level, communities or regions were allocated at random to the experimental or control conditions. Complete randomization was achieved in four countries. At baseline, smoking prevalence among 23 125 adolescents at the start of the project was 5.6% for regular smoking and 4.0% for daily smoking. Smoking prevalence rates were higher among girls than boys in all countries as far as weekly smoking was concerned. Process evaluations revealed that the project’s ambitions were high, but were limited by various constraints including time and delays in receiving funds. Future smoking prevention projects should aim to identify the effective components within the social influence approach as well as within broader approaches and on reaching sustained effects.


    Introduction
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Smoking is a major preventable cause of premature death and disability throughout the world (US Department of Health and Human Services, 1994Go). The estimated annual mortality is 540 000 in the European Union, 461 000 in the USA and 457 000 in the former USSR (Peto et al., 1994Go). While overall smoking prevalence among adults has declined, prevalence in adolescents remains unchanged. Prevention of adolescent smoking continues to be an important health goal.

Since the 1970s, smoking prevention programmes have been heavily influenced by the social influence approach initiated by Evans et al. (Evans, 1976Go). A meta-analysis of 207 school-based prevention programmes concluded that social influence approaches can be effective but have limited effects (Tobler et al., 2000Go). A meta-analysis by Rooney and Murray (Rooney and Murray, 1996Go) found modest effect sizes for school-based programmes of 0.10 SDs. The authors conclude that, even under optimal conditions, reductions in smoking may reach 20–30%. European applications also yielded similar mixed results (De Vries et al., 2003aGo). Comprehensive approaches can be effective (Wakefield and Chaloupka, 2000Go), but require substantial resources to be able to bring about effects (Centers for Disease Control and Prevention, 1999Go). Since the effects of the smoking prevention programmes often deteriorate over time, doubts may arise about the feasibility of attaining long-term change with these approaches (Reid et al., 1995Go). The results of more comprehensive community approaches may provide directions for future projects (Perry et al., 1992Go; Vartiainen et al., 1998Go; Biglan et al., 2000Go; Lantz et al., 2000Go). Similar findings for tobacco and substance abuse are also reported (Johnson et al., 1990Go). Community interventions mainly targeting adults, however, do not necessarily lead to changes in adolescents smoking (Bowen, 2002Go). Consequently, smoking prevention activities should be embedded in a comprehensive approach that specifically addresses youngsters, but should also aim at changing the smoking and parenting behavior of parents and teachers, and at creating non-smoking policies in schools and other places where youngsters congregate (Charlton et al., 1990Go). This implies more collaboration between national and regional organizations, and determination to reach important target groups at micro, meso and macro levels (Tones and Tilford, 1994Go). This results in what we propose to refer to as ‘integral prevention’—preferably with outcomes assessed at various levels. The European Smoking prevention Framework Approach (ESFA) project (1997–2002) intended to incorporate principles of this approach by aiming at changes at the micro and the meso levels. The overall ESFA goal was to reduce smoking onset in the experimental group by 10% in comparison with the control group after 4 years.

The Attitude–Social influence–self-Efficacy (ASE) model (see Fig. 1) served as the theoretical framework for the analysis of the determinants, and for programme development and evaluation (De Vries and Mudde, 1998Go; De Vries et al., 2000Go). Originally, the ASE model originated from the Theory of Reasoned Action (Fishbein and Ajzen, 1975Go), but has incorporated insights of various other theories, such as Social Cognitive Theory (Bandura, 1986Go), the Transtheoretical Model (Prochaska and DiClemente, 1983Go) and the Precaution Adoption Model (Weinstein, 1988Go), and resulted in an integrative model explaining motivational and behavioral change. It states that behavior is the result of a person’s intentions and abilities. A person’s intentions can range from no intention to change (precontemplation) to an intention to change the behavior (preparation). A person’s abilities and environmental barriers determine whether their intentions will be realized. Important abilities are plans to implement intentions by specific actions to reach the goal behavior and actual skills [see, e.g. (Bandura, 1986Go; Locke and Lathan, 1990Go; Gollwitzer and Schaal, 1998Go)]. Motivational factors, such as various attitudes, social influences and self-efficacy, determine a person’s intention. Motivational factors are determined by various predisposing factors, information factors (the quality of messages, channels and sources used) and awareness factors (knowledge, risk perceptions and cues to action)



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Fig. 1. An integrated Model for Change

 
The ESFA project had several goals: (1) to realize European collaboration and joint programme development, (2) to implement and test the efficacy of an integral approach using common core objectives, and (3) to conduct theoretical research regarding differences and commonalities in the determinants of smoking onset in the various European countries.

This paper provides a summary of programme preparation and development, programme management, research development, baseline smoking in boys and girls, and summarizes some of the theoretical findings. The results of the effects of the project on smoking behavior in adolescents will be published elsewhere (De Vries et al., 2003aGo); publications on other research questions can also be found elsewhere (Kremers et al., 2001a,b, 2003Go; Nebot et al., 2002Go; De Vries et al., 2003bGo; De Vries, H., Wetzels, J., Kremers, S., Ariza, C., Duarte Vittória, P., Holm, K., Jansen, K., Lehtuvuori, R., Fielder, A., Fresnillo, L. and Mudde, A. (2003) Why are more girls than boys starting to smoke? Submitted; Holm et al., 2003Go).


    Methods
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Participants
Six states of the European Community (Denmark, Finland, The Netherlands, Spain, Portugal and the UK) took part in the project. In Spain, both Madrid and Barcelona took part as separate sites. Each site was represented by a co-contractor and hosted a National Programme Manager (NPM). A staff of five people at Maastricht University coordinated the programme’s development, implementation and evaluation. The European Commission funded 71% of the total budget and the participating organizations contributed 29% (European Smoking prevention Framework Approach, 2002).

Project management
In annual consensus meetings, all co-contractors, NPMs and members of the central staff agreed about the core elements of the ESFA approach, such as common programme goals and objectives, research design and instruments, publications and financial matters, and strategies. Two consensus meetings were held in the first year, followed by annual meetings during the next 4 years. The NPMs needed additional meetings to prepare programme plans. Consequently, two meetings were held annually with NPMs. Two members of the staff (the overall project manager and the methods manager) held regularly telephone and E–mail meetings. The overall project manager and the research manager visited the participating sites every year to discuss progress and problems.

Project development
The ESFA project made use of a combination of health promotion models. The Precede model (Green and Kreuter, 1991Go) and the ABC planning model (De Vries, 1998Go), were used to guide the planning process. In addition to the ASE model, programme development was inspired by persuasive communication theories (McGuire, 1985Go; De Vries, 1998Go), Micro-Macro Level Theory (Tones and Tillford, 2001Go) and Intervention Mapping (Bartholomew et al., 1998Go). In the first year, interventions were prepared for the micro, meso and macro levels (Tones and Tillford, 2001Go). These levels were translated into four target group levels: the individual, school, parental and out-of-school level. In the first year, plans were discussed with national advisory boards, during meetings with the NPMs and meetings with contractors. Questionnaire development took place and regions were selected for participation. In the second year, the first interventions were prepared and implemented. During the first intervention year, an in-class prevention programme was implemented covering principles of the social influence approach and the introduction of a non-smoking policy manual in schools. In the third, fourth and fifth intervention years, intervention boosters were implemented for the in-class programme, the implementation of the school policy manual activities was intensified, several activities for parents as well as for out-of-school situations were realized and data analyses were conducted (European Smoking prevention Framework Approach, 2002; De Vries et al., 2003aGo).

Research design
The research design used principles from the Community Intervention Trial (CIT), the community-based equivalent of the randomized control trail (Kremers et al., 1999Go). Since interventions were planned to take place at the community level, communities (or regions) were chosen as the unit of allocation. Experimental regions would provide the ESFA programme, while control regions would provide usual care. The NPMs were asked to invite four regions to participate. The random allocation of regions to the experimental and the control conditions was prepared in the spring of 1998. Schools in these regions were asked to participate in the project, indicating that they would have a 50% chance of becoming an experimental school. For each country, power calculations were run with the software programme Power (Lawrence Erlbaum Associates) in order to estimate the number of pupils to be included in each national sample. Power analysis calculations were based on the smoking incidence rates of adolescents at the age of 15 years, the age of most pupils at the time of the third post-test. Based on earlier experiences, a dropout rate of 30% was hypothesized for all countries except for Finland, where a 20% dropout rate was expected. The participating countries could be divided into two groups: countries with a relatively low last 4-weeks smoking incidence at the age of 15 years (29% or less: Denmark, Finland and Portugal) and countries with a higher incidence (between 34.5 and 41%: The Netherlands, Spain and the UK). Applying conservative parameters (significance level of 0.001 and power of 0.95) and hypothesizing differences between the probabilities of success (P) in both conditions of 10% (e.g. P = 0.29 in the control condition and P = 0.19 in the experimental condition), the power calculations resulted in recommended sample sizes of at least 2 x 1200 pupils for the countries with a relatively low smoking incidence and at least 2 x 1500 pupils for countries with a higher incidence (including expected dropout).

Evaluation strategy
The ESFA evaluation model (see Fig. 1) was based on the ASE model for motivational and behavioral change (De Vries and Mudde, 1998Go) and used principles of the proximal–distal chain of interventions model (Green and Tones, 1999Go), and earlier work by others (Steckler et al., 1992Go; Edmundson et al., 1994Go; Elder et al., 1994Go; Lytle et al., 1994Go).

Smoking behavior was classified into never smokers (never having smoked a cigarette, not even a single puff), non-smoking deciders (having tried or experimented with smoking, but had quit experimenting), triers (in the initial stage of trying smoking), experimenters (further experimentation with cigarettes, but not smoking weekly), regular smokers (smoking at least once a week) and quitters (quit smoking after having smoked at least once a week) (Kremers et al., 1999Go).

Attitudes, social influences, self-efficacy and various demographic variables were assessed as cognitive determinants of smoking behavior; further details of the questionnaire can be found elsewhere (Kremers et al., 2001aGo,b; De Vries et al., 2003aGo). Consequently, both changes in smoking behavior and smoking-related beliefs served as outcome parameters for the effect analyses.

Process evaluations, using questionnaires and logs, were based on principles identified by earlier studies (Steckler et al., 1992Go; Goodman et al., 1992Go; De Vries et al., 1994Go; Dijkstra et al., 1999Go). Adolescents completed a base-line questionnaire and three subsequent follow-up questionnaires at 1-year intervals. These questionnaires assessed smoking beliefs, behavior and demographic variables, as well as process measures. Adolescents were asked for their perceptions of interventions at each level and their satisfaction with the interventions. Contact people in the schools and implementing teachers were questioned by means of questionnaires or interviews regarding awareness, concern, perceived benefits, level of use, level of success and institutionalization of intervention elements. Teachers and school contact people were asked to keep a log to assess the completeness and fidelity of the implementation of intervention elements; each country used their own format. NPMs and ESFA staff also collected information and kept the minutes of meetings.


    Results
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Comparability of the ESFA countries: baseline data
In total, 23 531 adolescents participated in the first ESFA measurement. The percentage of refusals to participate was below 0.5%. Of the remaining 23 125 adolescents (98%), complete data was obtained in the first measurement. Overall and country-specific information about participation, smoking prevalence, alcohol consumption and demographic variables is provided in Table I. The mean age of the respondents was 13.3 years; 49.8% of the sample were boys. Sample sizes varied between centers, in all cases exceeding the advised sample sizes. The highest weekly and daily smoking rates were found in Finland, followed by Denmark, the UK and The Netherlands. Smoking rates were considerably lower in the Southern European samples and the lowest was in the sample from Barcelona. The percentage of never smokers was 63.0% of the total sample. The highest percentages of never smokers were found in the Portuguese and Madrid samples, while the lowest percentages of never smokers were identified in the Danish and Dutch samples. The percentage of quitters for the total sample was 2.0% with no great differences between countries.

Prevalence of smoking in boys and girls
Table I also shows comparative smoking rates of boys and girls. The differences between both groups were analyzed using binary logistic regression analyses, controlling for age, religion, ethnic background, alcohol consumption, working status of parents and disrupted family. Overall, significantly more weekly smokers were found among girls than among boys. This pattern was identified for all European countries, with significant differences in the samples for Finland, The Netherlands, Portugal, Madrid and the UK. When analyzing differences between the daily smoking patterns of girls and boys, a similar difference was found. Significantly more girls than boys smoked daily in Finland, Portugal and the UK. Reversed, but non-significant patterns, were observed in other countries, with the greatest differences found in Denmark. More detailed information on the determinants of these differences between boys and girls can be found elsewhere (De Vries et al., 2003c).


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Table I. Overall and centre specific participation, smoking prevalence rates, alcohol consumption and demographic variables
 
Programme development
The meetings of project managers resulted in the preparation of plans that were discussed during the annual consensus meetings. These plans constituted the framework of intervention goals and objectives, and the theoretical methods to be used to accomplish the goals and objectives. An adapted version of the persuasion communication matrix of McGuire (McGuire, 1985Go) was used (De Vries and Kok, 1986Go; De Vries, 1998Go). The programme matrix distinguishes several chains of events in the process of behavioral change, starting at increasing attention and comprehension, changing attitudes, perceptions of social influences, self-efficacy beliefs, and reinforcing healthy behavior. Consequently, goals were developed for each chain and these goals were translated into more specific objectives. As can be noted from Table II, many objectives were identified, but not all could be selected as core objectives because of differences regarding focus and priorities between the countries. Consensus was derived on core objectives that would be addressed by all countries (bold type in Table II). Several countries felt the need to include more objectives. Hence, countries had the freedom to add additional objectives from the sample of total objectives identified (standard type in Table II).


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Table II. Example of overview of goals and objectives for the second intervention year for the individual level (source: European Smoking Prevention Framework Approach, 2002)
 
Cultural differences and differences in the availability of methods in each participating country resulted in the adoption of different methods for achieving the objectives. As a result, every country had its own specific methods, with communalities on core objectives, and differences regarding additional country specific objectives and most methods used. Table III shows how the translation of objectives resulted in different methods in each country. Countries conducted an access point analysis in order to identify where adolescents could be reached for future out-of-school activities. The NPMs provided feedback to the ESFA methods manager on how core objectives were realized in their programmes.


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Table III. Elaboration of the goals into methods for intervention year 1
 
Meetings with contractors and NPMs revealed that the project’s goals were very ambitious for a single NPM who had to fulfill the roles of programme manager, programme developer and researcher simultaneously. National capacities for the development of skills training programmes were more limited than anticipated, which resulted in more time being required to develop this element. While the development of a smoke-free school policy manual did not result in problems, its actual implementation was only partly achieved and differed for each country. Measurement of policy changes was not feasible. Developing out-of-school activities took much more time than anticipated. In sum, the NPMs were confronted with many demands regarding programme development, which also had to be combined with the demands of the research team of the coordinating university in Maastricht. Finally, the delay in receiving European funds resulted in a serious threat for the continuity of the project, consequently temporarily reducing motivation among contractors and project managers to carry out the programme, and resulting in the temporary postponement of collaboration by one partner (European Smoking prevention Framework Approach, 2002).

Random allocation
Random allocation was not achieved in Spain or The Netherlands (see Table IV). In Denmark, Portugal and the UK, random allocation of regions was achieved. In some countries, participating and co-financing organizations had demands that were inconsistent with the original design. In Finland, the participating organization demanded that participating schools should be located exclusively in Helsinki, which then became the research community. The selection of schools still occurred randomly. In The Netherlands, many schools already made use of a national schools’ drug-use prevention programme that also covered smoking prevention. Consequently, schools were assigned in accordance with their allocation preferences: the national programme alone or the national programme with ESFA components. In Madrid, sudden changes in the educational system in one of the control regions just before the start of the base-line test resulted in dropout. Another control region needed to be included. Logistical problems in Madrid ultimately resulted in a delay in programme implementation, making it impossible to include their data in the overall efficacy study. In Barcelona, the participating municipal organization had to integrate the ESFA project into an existing project. Consequently, the control condition for the ESFA project was to be selected from the control condition of the existing project by means of matching.


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Table IV. Randomization outcomes for the seven ESFA sites
 
Theoretical findings
The concept of motivational stages has also been applied to describe the process of smoking commencement (Pallonen et al., 1998Go). We applied these concepts and the analyses revealed three groups within the precontemplation stage of adolescent smoking commencement that appear to have different cognitive profiles: (1) adolescents strongly committed to non-smoking, (2) adolescents not planning to start smoking within 5 years, and (3) adolescents planning to start within 5 years, but not within the next 6 months (Kremers et al., 2001aGo,b).

Furthermore, our studies confirmed the existence of two different subscales within smoking-related attitudes referring to the advantages and disadvantages of smoking behavior. We also found three different subfactors with the self-efficacy construct: social self-efficacy (the confidence not to smoke when with others), stress self-efficacy (the confidence not to smoke when confronted with emotional and stressful situations) and routine self-efficacy (the confidence not to smoke when carrying out routine activities) (Kremers et al., 2001aGo,b; De Vries et al., 2003aGo).

Finally, a couple of studies analyzed the assumption that smoking onset was mainly predicted by smoking peers. The results showed a high association between adolescent and peer smoking when cross-sectional data were used, but revealed that this impact was not very strong using longitudinal research designs and suggested alternative mechanisms of smoking onset such as self-selection processes (De Vries et al., 2003bGo,c) and unmotivated experimentation processes (Kremers et al., 2003bGo).


    Discussion
 Top
 Abstract
 Introduction
 Methods
 Results
 Discussion
 References
 
Baseline data revealed smoking prevalence of 5.6% for regular smoking and 4.0% for daily smoking. Prevalence rates were highest in Finland, followed by Denmark, the UK, The Netherlands, Portugal, Spain (Madrid) and Spain (Barcelona). Smoking prevalence was higher among girls than boys in all countries where weekly smoking was concerned. Further in-depth analyses are needed to identify factors discriminating boys’ uptake from girls’ uptake of smoking and whether smoking prevention programmes need to be fine-tuned to specific gender sensitive issues (De Vries et al., 2003c).

The ESFA aimed at integral preventive efforts by addressing target groups at the micro and meso levels (European Smoking prevention Framework Approach, 2002). The project had several potential strengths. (1) Long-term European collaboration regarding smoking prevention programme development and testing is still rare and this project was the first common research–based prevention project. Consequently, capacity building within Europe as well as international exchange was stimulated. Organizations were encouraged to collaborate for a longer period of time, which was an innovation for most organizations. (2) The systematic combination of research and theory-based programme development was fostered. (3) A smoking prevention approach aimed at intervening at several levels simultaneously was initiated. (4) The utilization of one common instrument for studying the determinants of smoking onset and cessation provided a good opportunity for international comparisons.

The ESFA approach also had several limitations. (1) While consensus on overall goals and specific objectives was reached, national needs resulted in the addition of country-specific objectives, and each country wanted to use country-specific materials. Consequently, our approach resulted in both similarities and differences in approaches. This also resulted in a desire in the participating countries to conduct country-specific process evaluations. However, this strategy limited in-depth international comparisons. Furthermore, teacher’s compliance in filling in their logs appeared to be low (European Smoking prevention Framework Approach, 2002). (2) The intention to achieve randomization at the regional level could not be fulfilled in all countries. Specific national, community and school policies obstructed complete randomization for four out of seven sites. The principle of approaching at least four communities (in order to reduce the potential impact of dropout during the project) was not feasible in many countries, because of the size of the communities. (3) The project’s ambitions were high—perhaps too high—taking into account the amount of funding, materials and time available. (4) The delay in receiving European funds resulted in serious threats for the continuity of the project, the motivation of contractors and project managers in the execution of the programme, and the temporary postponement of collaboration by one partner (European Smoking prevention Framework Approach, 2002). (5) Only outcomes at the individual level could be assessed.

In addition to testing the efficacy of the various approaches in each country (De Vries et al., 2003aGo), some analyses tested applications of theoretical constructs and resulted in the recognition of various phases with respect to smoking onset (Kremers et al., 2001aGo,b) as well as the recognition that the process of smoking onset is not only determined by peer pressure mechanisms; a finding also suggested by others (Bauman and Ennett, 1996Go; Engels et al., 1999Go; De Vries et al., 2003aGo). In-depth analyses of the acquisition process also showed that adolescents may start experimenting with smoking without little cognitive basis for their decision making. This observation suggests that current motivational approaches, aiming at reinforcing non-smoking cognitions, may be less applicable for smoking prevention than initially assumed and thus questions the accuracy of current psychological models for the development of effective smoking prevention interventions (Kremers et al., 2003bGo). Further studies are needed regarding the process of smoking onset in order to identify how experimentation with cigarettes can be stopped most effectively, as well as how to involve parents in future smoking prevention programmes.

To sum up, an integral preventive perspective implies sufficient amounts of time and capacity, good planning, and a good infrastructure to be able to integrate and attune activities of various national and international organizations. Capacity building at the European level needs to be given top priority in future national and international policies for European tobacco control. When setting up mutual European programmes aimed at smoking prevention, sufficient financial and personal resources need to be available. European collaboration should be intensified to be able to develop and test specific smoking prevention programme elements that can be used by several countries when shown to be effective. Current smoking prevention projects continue to show great variety in the outcomes of smoking prevention projects (Peterson et al., 1998; Sussman et al, 1999Go; Thomas, 2003Go; De Vries et al., 2003aGo). More comprehensive school-based approaches also showed significant reductions in smoking (Perry et al., 1992Go; Botvin et al., 1995Go; Vartiainen et al., 1998Go). The disappointing outcomes of some studies may lead to the erroneous conclusion that smoking prevention can only have limited effects. A more constructive inference is to conclude that we still do not know the main components of social influence approaches as well as more comprehensive approaches, and how to sustain short-term effects (McCaul and Glasgow, 1985Go; Dijkstra et al., 1999Go; Botvin et al., 2001). The ESFA approach was, in this respect, a first step towards more intensified European collaboration and did not yet allow vigorous fundamental variations in research designs. Future European collaborative projects, however, should incorporate fundamental research to identify which elements within smoking prevention approaches are effective for particular age groups.


    Acknowledgements
 
The ESFA project is financed by a grant from the European Commission (The Tobacco Research and Information Fund; 96/IT/13-B96 Soc96201157). We thank Martijntje Bakker, Kerstin van der Groot (former European Project Managers), Carles Ariza, Paulo Duarte Vitória, Klavs Holm, Karin Jansen, Riku Lehtuvuori, Anne Fielder, Lourdes Fresnillo (former National Project Managers), António Romeiro (co-contractor for Portugal), and all the teachers, health intermediaries and others who were involved in the ESFA project for their input in the project.


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 Introduction
 Methods
 Results
 Discussion
 References
 
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Received on July 31, 2002; accepted on January 31, 2003


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