S. De Henauw

Design and implementation of the Healthy Lifestyle in Europe by Nutrition in Adolescence Cross-Sectional Study.

Objective:To provide an overview of the Healthy Lifestyle in Europe by Nutrition in Adolescence Cross-Sectional Study (HELENA-CSS) design, with particular attention to its quality control procedures. Other important methodological aspects are described in detail throughout this supplement.Design:Description of the HELENA-CSS sampling and recruitment approaches, standardization and harmonization processes, data collection and analysis strategies and quality control activities.Results:The HELENA-CSS is a multi-centre collaborative study conducted in European adolescents located in urban settings. The data management systems, quality assurance monitoring activities, standardized manuals of operating procedures and training and study management are addressed in this paper. Various quality controls to ensure collection of valid and reliable data will be discussed in this supplement, as well as quantitative estimates of measurement error.Conclusion:The great advantage of the HELENA-CSS is the strict standardization of the fieldwork and the blood analyses, which precludes to a great extent the kind of immeasurable confounding bias that often interferes when comparing results from isolated studies.

The IDEFICS cohort: design, characteristics and participation in the baseline survey.

Background:The European IDEFICS (Identification and prevention of dietary- and lifestyle-induced health effects in children and infants) study was set up to determine the aetiology of overweight, obesity and related disorders in children, and to develop and evaluate a tailored primary prevention programme.Objective:This paper focuses on the aetiological element of the multicentre study, the measures and examinations, sociodemographic characteristics of the study sample and proportions of participation.Design:Prospective cohort study with an embedded intervention study that started with a baseline survey in eight countries in 2007–2008.Subjects and measurements:Baseline participants of the prospective cohort study were 16 224 children aged 2–9 years. Parents reported sociodemographic, behavioural, medical, nutritional and other lifestyle data for their children and families. Examinations of children included anthropometry, blood pressure, fitness, accelerometry, DNA from saliva and physiological markers in blood and urine. The built environment, sensory taste perception and other mechanisms of childrens food choices and consumer behaviour were studied in subgroups.Results:Between 1507 and 2567, children with a mean age of 6.0 years and an even sex distribution were recruited from each country. Of them, 82% lived in two-parent families. The distribution of standardised income levels differed by study sample, with low-income groups being strongly represented in Cyprus, Italy and Germany. At least one 24-h dietary recall was obtained for two-thirds of the children. Blood pressure and anthropometry were assessed in more than 90%. A 3-day accelerometry was performed in 46%, motor fitness was assessed in 41%, cardiorespiratory fitness in 35% and ∼11% participated in taste perception tests. The proportion of children donating venous blood, urine and saliva was 57, 86 and 88%, respectively.Conclusion:The IDEFICS cohort provides valuable data to investigate the interplay of social, environmental, genetic, physiological and behavioural factors in the development of major diet- and lifestyle-related disorders affecting children at present.

Development and evaluation of a self-administered computerized 24-h dietary recall method for adolescents in Europe

Objective:To describe the development of a European computerized 24-h dietary recall method for adolescents, and to investigate the feasibility of self-administration (self report) by comparison with administration by a dietician (interview).Methods:Two hundred and thirty-six adolescents (mean age 14.6 years (s.d.=1.7)) of eight European cities completed the 24-h recall (Young Adolescents Nutrition Assessment on Computer (YANA-C)) twice (once by self-report and once by interview).Results:A small but significant underestimate in energy (61 (s.e.=31) kcal) and fat (4.2 (s.e.=1.7) g) intake was found in the self-reports in comparison with the interviews; no significant differences were found for the intake of carbohydrates, proteins, fibre, calcium, iron and ascorbic acid. Spearmans correlations were highly significant for all nutrients and energy ranging between 0.86 and 0.91. Agreement in categorizing the respondents as consumers and non-consumers for the 29 food groups was high (kappa statistics ⩾0.73). Percentage omissions were on average 3.7%; percentage intrusions: 2.0%. Spearmans correlations between both modes were high for all food groups, for the total sample (⩾0.76) as well as for the consumers only (⩾0.72). Analysing the consumer only, on an average 54% of the consumed amounts were exactly the same; nevertheless, only for one group ‘rice and pasta’ a significant difference in consumption was found.Conclusion:Adaptation, translation and standardization of YANA-C make it possible to assess the dietary intake of adolescents in a broad international context. In general, good agreement between the administration modes was found, the latter offering significant potential for large-scale surveys where the amount of resources to gather data is limited.

Quality assurance of ethical issues and regulatory aspects relating to good clinical practices in the HELENA Cross-Sectional Study

Rationale:Research involving humans is regulated by regulatory authorities through their specific requirements and controls. The Healthy Life Style in Europe by Nutrition in Adolescence Cross-Sectional Study (HELENA-CSS) is a multicenter biomedical research study of adolescents in several representative European cities, which requires satisfying medico-regulatory requirements including Independent Ethics Committee (IEC) approval and agreement by the national or local regulatory authorities. To achieve a high level of quality assurance relating to ethical issues, we followed the good clinical practices (GCP) described at the International Conference on Harmonisation (ICH), which we adapted to the national and local situations of each of the 11 participating cities in 10 European countries.Objective:The main objective of the HELENA-CSS is to evaluate reliable and comparable data of nutritional habits and lifestyle in a representative sample of European adolescents. The aim of this paper is to present the methods relating to the ethical and regulatory issues of this study and to describe the current state of the medico-regulatory requirements involved in conducting this kind of study in each country.Materials and Methods:Following the GCP–ICH guidelines, a protocol describing the HELENA-CSS was written and approved by all partners. In the pilot study, a case report form adapted to the study objectives and its manual of operation was constructed and used by all partners. All information letters to adolescents and their parents and consent forms were first written in English, then translated into the local language, and adapted to each local situation. All documents were then checked centrally for any deviation and corrected if required. An operation manual relating to ethical issues and other medico-regulatory requirements was also developed. This paper presents the current status of the medico-regulatory requirements from each HELENA-CSS participant country.Results:Before the beginning of the study, most centers had satisfied the medico-regulatory requirements of IEC approval and agreement with other national or local regulatory authorities/organizations. For a few centers, some problems were detected and corrective actions were taken to improve missing information to reach a high level of quality assurance of ethical issues.Conclusion:The GCP–ICH guidelines about nontherapeutic biomedical research are interpreted and applied differently across Europe. This study shows that high-quality nontherapeutic biomedical research can address the ethical issues included in the GCP–ICH regulations and can be harmonized among the HELENA European partners.

Estimating the distribution of usual dietary intake by short-term measurements.

Objective: To estimate the habitual dietary intake distribution in a population on the basis of repeated short-term measurements, especially of multiple 24 h diet recalls.Methods: Six different statistical methods were evaluated and compared. The comparison referred to theoretical assumptions, admitted data transformations, statistical foundations, available software packages, and applications to real data of dietary intake.Results: The Nusser method and a simplified version of it proposed in the paper have proved to be universally applicable methods for estimating the usual intake distribution for food groups and nutrients. Also, the Buck method seemed to be a robust estimation procedure suitable for the description of food consumption data, whereas the other considered methods were only applicable for log–normally distributed intake data or required a comprehensive data simulation. Characteristics of the estimated usual intake distribution were a decreased standard deviation, increased lower percentiles, and decreased upper percentiles compared to the observed sample distribution of individual means. Empirical results concerning total fat and vegetable intake in three different European consumption surveys showed that the estimated percentiles of the usual intake distribution did not depend markedly on the number of sampling days.Conclusions: Repeated short-term measurements like 24 h diet recalls can be used to describe the habitual dietary intake distribution in food consumption surveys. Recommended is a sampling design of two non-consecutive sampling days. The sampling days of all participants should be selected in such a way that they cover all seasons and days of the week.Sponsorship: European Commission, DG SANCO F/3, Health Monitoring.

Analysis of phthalates in food products and packaging materials sold on the Belgian market

Phthalates are organic lipophilic compounds that are principally used as plasticiser to increase the flexibility of plastic polymers. Other applications are a.o. the use of phthalates in printing inks and lacquers. Human exposure to phthalates mainly occurs via food ingestion and can induce adverse health effects. In this study, the presence of eight phthalate compounds--dimethyl phthalate (DMP), diethyl phthalate (DEP), diisobutyl phthalate (DiBP), di-n-butyl phthalate (DnBP), benzylbutyl phthalate (BBP), di(2-ethylhexyl) phthalate (DEHP), dicyclohexyl phthalate (DCHP) and di-n-octyl phthalate (DnOP)--was investigated in 400 food products, divided over eleven groups, and packages sold on the Belgian market. For this purpose, suitable extraction techniques were developed and validated for four different matrices, namely high-fat foods, low-fat food products, aqueous-based beverages and packaging materials. The instrumental analysis was performed by means of gas chromatography-low resolution-mass spectrometry with electron impact ionisation (GC-EI-MS). A wide variety of phthalate concentrations was observed in the different groups. DEHP was found in the highest concentration in almost every group. Moreover, DEHP was the most abundant phthalate compound, followed by DiBP, DnBP and BBP. This survey is part of the PHTAL project, which is the first project that discusses phthalate contamination on the Belgian food market.

Stronger associations between daily mortality and fine particulate air pollution in summer than in winter: evidence from a heavily polluted region in western Europe.

Background: Numerous studies have shown a strong association between daily mortality and small particulate with a diameter of <10 µm (PM10) air pollution, but the effects of season have not always been well characterised. Aim: To study the shape of the association between short-term mortality and PM10 across seasons and quintiles of outdoor temperature. Design, setting and participants: Daily data on mortality (n = 354 357), outdoor temperature and PM10 in Flanders, Belgium, from January 1997 to December 2003, were analysed across warm versus cold periods of the year (April–September v October–March), with seasons and quintiles of outdoor temperature as possible effect modifiers. Results: There was a significant (p<0.001) interaction between PM10 and period of the year in relation to mortality. To allow for non-linearity, daily mean PM10 concentrations were categorised into quartiles. Season-specific PM10 quartiles showed a strong and steep linear association between mortality and PM10 in summer and a less linear association in spring and autumn, whereas in winter the association was less strong and mortality was only increased in the highest PM10 quartile. The effect sizes expressed as the percentage increase in mortality on days in the highest season-specific PM10 quartile versus the lowest season-specific PM10 quartile were 7.8% (95% CI 6.1 to 9.6) in summer, 6.3% (4.7 to 7.8) in spring, 2.2% (0.58 to 3.8) in autumn and 1.4% (0.06 to 2.9) in winter. An analysis by quintiles of temperature confirmed these effect sizes. Conclusion: The short-term effect of particulate air pollution on mortality strongly depends on outdoor temperature, even in a temperate climate.

A European food consumption survey method–conclusions and recommendations

Objective: To discuss the general outcome and conclusions of a European project (EFCOSUM); to develop a method for a European food consumption survey that delivers internationally comparable data on a set of policy relevant nutritional indicators.Design and methods: The EFCOSUM project was carried out within the framework of the European Health Monitoring Programme by 14 Member States as well as nine other European countries. Activities of the project included plenary sessions, desk research and working group activities, building on existing experience from such projects as DAFNE, EPIC, FLAIR Eurofoods-Enfant project, COST Action 99 and others. All participating states took part in one or more working group activities, which were discussed, adapted and finally approved in plenary sessions.Results and conclusions: For a limited number of countries available food consumption data can be made comparable at the food intake level, but not at the nutrient level. To achieve comparability at the food intake level, a considerable amount of work still has to be done. A minimum list of dietary indicators considered to be the most relevant to be collected for the Health information exchange and monitoring system was identified. As the most suitable method to get internationally comparable new data on population means and distributions of actual intake the 24 h recall was selected, to be conducted at least twice. This also allows for the estimation of usual intake by a modelling technique that separates intra- and inter-individual intake. For a number of micronutrients the use of biomarkers is recommended. Aspects of food classification and food composition were discussed thoroughly, as well as statistical and data collection aspects. For the implementation of a pan-European survey the establishment of a European co-ordinating centre is recommended. The standardization of field work work procedures and other aspects of operationalization have been discussed in detail. It is concluded that there is broad European consensus on the most suitable method for a pan-European dietary survey for the purposes of the EU Health Monitoring Programme. It is further concluded that such a pan-European survey is feasible, if the funds are made available.Sponsorship: European Commission, DG SANCO F/3, Health Monitoring Programme.

Prevalence of overweight and obesity in European children below the age of 10

Background:There is a lack of common surveillance systems providing comparable figures and temporal trends of the prevalence of overweight (OW), obesity and related risk factors among European preschool and school children. Comparability of available data is limited in terms of sampling design, methodological approaches and quality assurance. The IDEFICS (Identification and prevention of Dietary- and lifestyle-induced health Effects in Children and infantS) study provides one of the largest European data sets of young children based on state-of-the-art methodology.Objective:To assess the European distribution of weight status according to different classification systems based on body mass index (BMI) in children (2.0–9.9 years). To describe the prevalence of weight categories by region, sex, age and socioeconomic position.Design:Between 2007 and 2010, 18 745 children from eight European countries participated in an extensive, highly standardised protocol including, among other measures, anthropometric examinations and parental reports on socio-demographic characteristics.Results:The combined prevalence of OW/obesity ranges from more than 40% in southern Europe to less than 10% in northern Europe. Overall, the prevalence of OW was higher in girls (21.1%) as compared with boys (18.6%). The prevalence of OW shows a negative gradient with social position, with some variation of the strength and consistency of this association across Europe. Overall, population groups with low income and/or lower education levels show the highest prevalence of obesity. The use of different reference systems to classify OW results in substantial differences in prevalence estimates and can even reverse the reported difference between boys and girls.Conclusions:There is a higher prevalence of obesity in populations from southern Europe and in population groups with lower education and income levels. Our data confirm the need to develop and reinforce European public health policies to prevent early obesity and to reduce these health inequalities and regional disparities.

Chronic stress and obesity in adolescents: Scientific evidence and methodological issues for epidemiological research

AIMS This review describes the role of chronic stress in the development of obesity and available methodologies for the assessment of chronic stress in humans, in particular adolescents, with the aim of developing a feasible methodology to implement in an epidemiological study. DATA SYNTHESIS Chronic stress seems to be associated with the aetiology of obesity by interacting with both mechanisms of energy intake (increase of appetite and energy intake) and expenditure (decrease of physical activity) and by stimulating visceral fat accumulation in favour of abdominal obesity. However, more research is necessary to unravel the underlying mechanisms of the obesity-inducing effects of chronic stress, especially in adolescents. In addition to experimental research, epidemiological observational studies, in particular cohort studies, are appropriate given their non-intervening character, lower budgetary costs and natural setting. In practice, stress can be assessed by means of either a subjective approach using stressor checklists or interviews, or an objective approach measuring biomarkers of stress. In epidemiological research in adolescents, a combination of both strategies is recommended, with a preference for a general stressor checklist for adolescents and measurement of salivary cortisol, one of the most used and well-characterized biomarkers of stress. CONCLUSION This review provides basic evidence for the positive association between chronic stress and obesity, but also points out the need for more research in adolescents to further elucidate the role of chronic stress in the aetiology of obesity in this crucial life period. Good, well-standardized epidemiological surveys could be of great benefit in this research area.