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Abstract Background There is a lack of studies evaluating longitudinal changes in adiposity indicators and the association with 24-hour movement behavior guidelines in preschoolers. Therefore, this study aimed to investigate associations between changes in Body Mass Index (BMI) z-scores, waist circumference and waist-to-height ratio, and compliance with the 24-hour movement behavior guidelines in three- to six-year-old children from a European sample. Methods In total, data from a European sample of 719 preschoolers (50.9% boys, 4.76 ± 0.45 years) were analyzed at baseline and one year later. Physical activity (steps/day) was objectively measured using Omron pedometers. Screen time and sleep duration were subjectively measured using a parental questionnaire. Height, weight and waist circumference were measured by well-trained researchers, using standardized procedures and equipment, and were used to calculate BMI z-score and waist-to-height ratio. Linear mixed-effects models were used to investigate associations between changes in adiposity indicators (BMI z-score, waist circumference and waist-to-height ratio) and compliance with 24-hour movement behavior guidelines. Results BMI z-scores changed differently from baseline to follow-up according to compliance with the integrated guidelines, both for weekdays (effect estimate = -0.15, p = 0.001) and weekend days (effect estimate = -0.12, p = 0.046). Preschoolers who did not comply with the integrated guidelines showed a small, significant increase in BMI z-scores compared to compliers having no significant change in BMI z-score. No significant difference between both groups over time was found for waist circumference and waist-to-height ratio neither for weekdays nor weekend days. Conclusions The change in BMI z-scores after one year is less optimal for preschoolers who do not comply with the 24-hour movement behavior guidelines compared to preschoolers who comply with the integrated guidelines, although not clinically relevant. Future studies should incorporate longer follow-up periods to observe the effects of compliance to the integrated guidelines on adiposity indicators in preschool children.

Abstract Background Common mental disorders often emerge during childhood and adolescence, and their prevalence is disproportionately elevated among those affected by obesity. Early life growth patterns may provide a useful target for primordial prevention; however, research is lacking. Therefore, this study aimed to identify distinct body mass index (BMI) trajectories during the first year of life and to assess their associations with psychosocial outcomes in preadolescence (9–13 years). Methods Data were obtained from n = 1778 Greek children (9–13 years). Infant anthropometric data were obtained from paediatric health records and BMI trajectories during the first year of life were estimated using group-based trajectory modelling. Preadolescent emotional functioning, self-esteem, body image dissatisfaction and dieting behaviours were self-reported via validated questionnaires. Associations were estimated using binary and ordinal logistic regression, adjusted for key confounders. Results Four BMI trajectories were identified: low (26.7%), average (41.8%), high (25.2%), and very high (6.4%). Children belonging to the very high trajectory had greater odds of body image dissatisfaction (OR: 1.62, 95%CI: 1.11, 2.38), dieting behaviour (OR: 1.49, 95%CI: 1.01, 2.20) and restrained eating (OR: 1.69 95%CI: 1.14, 2.52) than children belonging to the average trajectory. Body image dissatisfaction was also greater in children belonging to the high trajectory (OR: 1.40, 95%CI: 1.11, 1.76). However, infant BMI trajectories did not significantly predict childhood emotional functioning or self-esteem status. Conclusion Infants with BMI growth in the high reference ranges had poorer psychosocial outcomes in preadolescence. Whilst further research is needed to replicate these findings, monitoring early infant growth trajectories may allow for early stratification of infants at risk of poor psychosocial outcomes.

In total, 3274 adults (65.2% females) from six European countries were included in this cross-sectional analysis using data from the baseline assessment of the Feel4Diabetes study. Anthropometric, sociodemographic, dietary and behavioral data were assessed, and the existence of metabolic syndrome (MetS) was recorded. Beverage consumption patterns (BCPs) were derived via principal component analysis. Three BCPs were derived explaining 39.5% of the total variation. BCP1 was labeled as “Alcoholic beverage pattern”, which loaded heavily on high consumption of beer/cider, wine and other spirits; BCP2 was labeled as “High in sugars beverage pattern” that was mainly characterized by high consumption of soft drinks with sugar, juice containing sugar and low consumption of water; and BCP3 was labeled as “Healthy beverage pattern” that was mainly characterized by high consumption of water, tea, fruit juice freshly squeezed or prepacked without sugar and low consumption of soft drinks without sugar. After adjusting for various confounders, BCP2 was positively associated with elevated triglycerides (p = 0.001), elevated blood pressure (p = 0.001) elevated fasting glucose (p = 0.008) and the existence of MetS (p = 0.006), while BCP1 was inversely associated with reduced HDL-C (p = 0.005) and BCP3 was inversely associated with elevated blood pressure (p = 0.047). The establishment of policy actions as well as public health nutritional education can contribute to the promotion of a healthy beverage consumption.

Abstract Background Obesity in adolescence has increased in the last decades. Adolescents fail to meet the recommended guidelines for physical activity (PA) and healthy diet. Adolescents with a low socioeconomic status (SES) particularly seem to have fewer healthy lifestyle behaviours. The European Science Engagement to Empower aDolescentS (SEEDS) project used an extreme citizen science approach to develop and implement healthy lifestyle behaviour interventions in high schools. As part of this project, key stakeholders were invited to reflect on the intentions of adolescents to engage in healthy lifestyle behaviours. The aim of this study was to gain stakeholder insights into the barriers and facilitators to healthy lifestyle behaviours of adolescents from low SES areas and on the possible role of these stakeholders in facilitating healthy lifestyle behaviours. Methods Six semi-structured focus groups were conducted in four European countries with 28 stakeholders from different settings (schools, community, and government), like teachers, policy advisors and youth workers. The theoretical framework of focus groups was based on the Theory of Planned Behaviour. The main questions of the focus groups were centred on PA and healthy diet. The focus groups were qualitatively analysed in NVivo using thematic analysis to identify topics and themes. Results According to stakeholders, adolescents have sufficient understanding of the importance of PA and a healthy diet, but nevertheless engage in unhealthy behaviour. Parents were mentioned as important facilitators for engaging adolescents in healthy lifestyle behaviours. Stakeholders listed lack of knowledge, time, and financial resources as barriers for adolescents from low SES families to engage in healthy lifestyle behaviours. The school environment was listed as an important facilitator of adolescents’ healthy lifestyle changes, but stakeholders acknowledged that current school days, curriculum and buildings are not designed to promote healthy lifestyle behaviours. External support and collaboration with community and governmental stakeholders was seen as potentially beneficial to improve healthy lifestyle behaviours. Conclusions This study shows the variety of barriers adolescents from low SES areas face, and the need for a broader collaboration between key stakeholders to facilitate healthy lifestyle behaviours. Schools are regarded specifically as important facilitators. Currently, the school environment entails various barriers. However, when addressing those, schools can increase opportunities for healthy lifestyle behaviours of adolescents from low SES areas. Trial registration This study is registered in ClinicalTrials.gov on 12/08/2021: NCT05002049.

ObjectiveThis study aimed to investigate growth and gut comfort of healthy infants fed with a partially hydrolysed cow's milk protein-based infant formula (pHF) compared to a standard intact cow's milk protein-based formula (IPF).MethodsA double-blind, multi-center, randomized, controlled trial was performed. Healthy full-term, exclusively formula-fed infants (n = 345), aged ≤28 days were allocated to consume either a pHF (n = 173) or an IPF (n = 172) until the age of 17 weeks. The primary outcome was equivalence of weight gain (g/d) until the age of 17 weeks. The secondary outcomes were equivalence of other growth parameters, i.e., infants’ weight, length, head circumference, body mass index (BMI) and anthropometric Z-scores, while tertiary outcomes were gut comfort, formula intake, and adverse events (AEs).ResultsOverall, 288 infants completed the study (pHF group: 138, IPF group: 150). No differences were observed between the two groups in weight gain (g/d) during the three-months intervention [p = 0.915 for the Per Protocol (PP) population]. The 90% CI was [−1.252 to 1.100] being within the pre-defined equivalence margin of ±3.0 g/d. Similar findings were observed in the Full Analysis Set (FAS) and the sensitivity analysis. Regarding the secondary outcomes, no differences over the intervention period were shown between the two groups in both the PP and FAS analysis sets. Average Z-scores were in the normal range based on World Health Organization (WHO) growth standards for both groups at all time points in both analysis sets. Stool consistency, amount, and colour were different in the two groups. No differences were observed in gut comfort, stool frequency, and formula intake, between the two groups. In total 14 AEs and 22 serious adverse events (SAEs) were reported of which 15 (12%) and 1 (5%) were considered as (possibly) related to the study product, respectively.ConclusionsThe study demonstrates that the consumption of pHF results in adequate infant growth, equivalent to that of infants consuming IPF. Furthermore, the overall gut comfort was comparable between the two groups. Therefore, it can be concluded that the pHF is safe for and well tolerated by healthy infants.Clinical Trial Registrationhttps://clinicaltrials.gov/study/NCT05757323?id=NCT05757323&rank=1, identifier (NCT05757323).

Abstract Digital health interventions have been shown to be clinically-effective for type 2 diabetes mellitus (T2DM) and hypertension prevention and treatment. This study synthesizes and compares the cost-effectiveness of text-messaging, smartphone application, and websites by searching CINAHL, Cochrane Central, Embase, Medline and PsycInfo for full economic or cost-minimisation studies of digital health interventions in adults with or at risk of T2DM and/or hypertension. Costs and health effects are synthesised narratively. Study quality appraisal using the Consensus on Health Economic Criteria (CHEC) list results in recommendations for future health economic evaluations of digital health interventions. Of 3056 records identified, 14 studies are included (7 studies applied text-messaging, 4 employed smartphone applications, and 5 used websites). Ten studies are cost-utility analyses: incremental cost-utility ratios (ICUR) vary from dominant to €75,233/quality-adjusted life year (QALY), with a median of €3840/QALY (interquartile range €16,179). One study finds no QALY difference. None of the three digital health intervention modes is associated with substantially better cost-effectiveness. Interventions are consistently cost-effective in populations with (pre)T2DM but not in populations with hypertension. Mean quality score is 63.0% (standard deviation 13.7%). Substandard application of time horizon, sensitivity analysis, and subgroup analysis next to transparency concerns (regarding competing alternatives, perspective, and costing) downgrades quality of evidence. In conclusion, smartphone application, text-messaging, and website-based interventions are cost-effective without substantial differences between the different delivery modes. Future health economic studies should increase transparency, conduct sufficient sensitivity analyses, and appraise the ICUR more critically in light of a reasoned willingness-to-pay threshold. Registration: PROSPERO (CRD42021247845).

This randomized, double-blinded, experimental study investigated the effects of a four-week daily pre-workout supplementation (200 mg caffeine, 3.3 g creatine monohydrate, 3.2 g β-alanine, 6 g citrulline malate, and 5 g BCAA) vs. placebo (isocaloric maltodextrin) on anaerobic (jumping, sprinting, agility, and the running-based anaerobic sprint test: RAST) and aerobic (Yo-Yo intermittent recovery test level 1) performance, as well as on body composition and selective muscle damage/health-related blood markers in well-trained basketball players during the in-season period. Eighteen basketball players (age: 24.4 ± 6.3 years, height: 185.7 ± 8.0 cm, weight: 85.7 ± 12.8 kg, body fat: 16.5 ± 4.2%) were randomly assigned into two groups: pre-workout supplement (PWS, n = 10) or placebo (PL, n = 8). PWS consumption increased aerobic performance (PWS: 8 ± 6%; PL: −2 ± 6%; p = 0.004) compared to PL. A significant decrease was observed in peak (F = 7.0; p = 0.017), average (F = 10.7; p = 0.005), and minimum power (F = 5.1; p = 0.039) following 4 weeks of supplementation in both groups. No other significant changes were observed between groups (p > 0.05). In conclusion, the consumption of the current PWS over a four-week period appears to positively influence the aerobic performance of well-trained basketball players during the in-season period. However, it does not appear to mitigate the observed decline in anaerobic power, nor does it affect performance in jumping, sprinting, and agility, or alter body composition or selective muscle damage/health-related blood markers.

Screen time among children in most European countries is notably high and is influenced by various sociodemographic and other factors. Our study aimed to explore the associations between parents’ sociodemographic characteristics, socioeconomic status, body mass index (BMI), physical activity, risk status for type 2 diabetes, and their children’s BMI, physical activity, and screen time. The data were sourced from the 2016 Feel4Diabetes study, involving 12,280 parents and 12,211 children aged 6–9 years (average age 8.21 years) in a cross-sectional study design. We used a logistic regression model to identify potential factors associated with children’s screen time. The results showed that mothers with tertiary education (OR = 0.64; 95%CI = 0.49–0.82; p < 0.001), the middle age group (45–54 years) (OR = 0.81 95%CI = 0.66–0.98; p = 0.033), and families with higher incomes (middle–OR = 0.85; 95%CI = 0.75–0.97; p = 0.014; high–OR = 0.8; 95%CI = 0.69–0.93; p = 0.003) were associated with a decreased chance of children spending more than 2 h/day in front of the screen. In contrast, maternal overweight/obesity (OR = 1.15; 95%CI = 1.03–1.29; p = 0.013) and lower physical activity in children were linked to an increased likelihood of more than 2 h of screen time per day. Our findings suggest that targeted interventions should be developed to mitigate excessive screen time, particularly focusing on low-income families and mothers with low educational levels.

Abstract Background A healthy lifestyle decreases the risk of developing type 2 diabetes mellitus. The current cross-sectional study aimed to describe self-reported lifestyle behaviours and compare them to current health guidelines in European Feel4Diabetes-families at risk for developing type 2 diabetes across six countries (Belgium, Finland, Spain, Greece, Hungary and Bulgaria). Methods Parents and their children were recruited through primary schools located in low socio-economic status areas. Parents filled out the FINDRISC-questionnaire (eight items questioning age, Body Mass Index, waist circumference, PA, daily consumption of fruit, berries or vegetables, history of antihypertensive drug treatment, history of high blood glucose and family history of diabetes), which was used for the risk assessment of the family. Sociodemographic factors and several lifestyle behaviours (physical activity, sedentary behaviour, water consumption, fruit and vegetable consumption, soft drink consumption, sweets consumption, snack consumption, breakfast consumption) of both adults and children were assessed by parental questionnaires. Multilevel regression analyses were conducted to investigate families’ lifestyle behaviours, to compare these levels to health guidelines and to assess potential differences between the countries. Analyses were controlled for age, sex and socio-economic status. Results Most Feel4Diabetes-families at risk (parents and their children) did not comply with the guidelines regarding healthy behaviours, set by the WHO, European or national authorities. Less than half of parents and children complied with the physical activity guidelines, less than 15% of them complied with the fruit and vegetable guideline, and only 40% of the children met the recommendations of five glasses of water per day. Clear differences in lifestyle behaviours in Feel4Diabetes-families at risk exist between the countries. Conclusions Countries are highly recommended to invest in policy initiatives to counter unhealthy lifestyle behaviours in families at risk for type 2 diabetes development, taking into account country-specific needs. For future research it is of great importance to focus on families at risk in order to counter the development of type 2 diabetes and reduce health inequity.

Abstract Background Natural enrichment of sn-2 palmitate content of infant formulae by using bovine milk fat is known to reduce formation of faecal fatty acid soaps and to improve stool consistency, but effects on gut microbiota composition are unknown. The purpose of this study was to test the influence of milk fat-based formula high in sn-2 palmitate on the infants’ gut microbiota composition and to confirm the beneficial effects of the formula on formation of faecal fatty acid soaps and stool consistency. Methods Twenty-two healthy term, formula-fed infants were enrolled in a single-blinded randomized, crossover, placebo-controlled trial. After a 2-week run-in period, infants received either a 50% milk fat-based formula containing 39% sn-2 palmitate (MF) or a vegetable fat-based formula (VF) containing 10% sn-2 palmitate in a 2 × 2-week crossover design. Faecal microbiota composition was the primary outcome of the study. Other outcomes included faecal fatty acid soap excretion, calcium excretion, gut comfort parameters and faecal metabolites. Results Microbiota analysis showed that bifidobacteria dominated the gut microbiota of most infants. Neither alpha- nor beta-diversity was significantly influenced by the intervention. Also, abundance of metabolic pathways was independent of the intervention. The MF formula resulted in significantly lower faecal levels of palmitic acid soap (p = 0.0002) and total fatty acid soaps (p = 0.0001) than the VF formula. Additionally, calcium excretion and palmitic acid concentration were significantly (p = 0.0335) lower in stool samples after MF intervention. Furthermore, a significant physiological effect on softer stools was observed in the MF intervention compared to the VF intervention (p = 0.02). Of the 870 measured faecal metabolites, 190 were significantly different after MF and VF intervention (FDR corrected p

BackgroundThe World Health Organization’s strategy toward healthy aging fosters person-centered integrated care sustained by eHealth systems. However, there is a need for standardized frameworks or platforms accommodating and interconnecting multiple of these systems while ensuring secure, relevant, fair, trust-based data sharing and use. The H2020 project GATEKEEPER aims to implement and test an open-source, European, standard-based, interoperable, and secure framework serving broad populations of aging citizens with heterogeneous health needs. ObjectiveWe aim to describe the rationale for the selection of an optimal group of settings for the multinational large-scale piloting of the GATEKEEPER platform. MethodsThe selection of implementation sites and reference use cases (RUCs) was based on the adoption of a double stratification pyramid reflecting the overall health of target populations and the intensity of proposed interventions; the identification of a principles guiding implementation site selection; and the elaboration of guidelines for RUC selection, ensuring clinical relevance and scientific excellence while covering the whole spectrum of citizen complexities and intervention intensities. ResultsSeven European countries were selected, covering Europe’s geographical and socioeconomic heterogeneity: Cyprus, Germany, Greece, Italy, Poland, Spain, and the United Kingdom. These were complemented by the following 3 Asian pilots: Hong Kong, Singapore, and Taiwan. Implementation sites consisted of local ecosystems, including health care organizations and partners from industry, civil society, academia, and government, prioritizing the highly rated European Innovation Partnership on Active and Healthy Aging reference sites. RUCs covered the whole spectrum of chronic diseases, citizen complexities, and intervention intensities while privileging clinical relevance and scientific rigor. These included lifestyle-related early detection and interventions, using artificial intelligence–based digital coaches to promote healthy lifestyle and delay the onset or worsening of chronic diseases in healthy citizens; chronic obstructive pulmonary disease and heart failure decompensations management, proposing integrated care management based on advanced wearable monitoring and machine learning (ML) to predict decompensations; management of glycemic status in diabetes mellitus, based on beat to beat monitoring and short-term ML-based prediction of glycemic dynamics; treatment decision support systems for Parkinson disease, continuously monitoring motor and nonmotor complications to trigger enhanced treatment strategies; primary and secondary stroke prevention, using a coaching app and educational simulations with virtual and augmented reality; management of multimorbid older patients or patients with cancer, exploring novel chronic care models based on digital coaching, and advanced monitoring and ML; high blood pressure management, with ML-based predictions based on different intensities of monitoring through self-managed apps; and COVID-19 management, with integrated management tools limiting physical contact among actors. ConclusionsThis paper provides a methodology for selecting adequate settings for the large-scale piloting of eHealth frameworks and exemplifies with the decisions taken in GATEKEEPER the current views of the WHO and European Commission while moving forward toward a European Data Space.

Introduction Improving healthy lifestyles of adolescents is challenging. Citizen Science is a way to engage them in the design and delivery of interventions, and may also increase their interest in science, technology, engineering and mathematics (STEM). The Science Engagement to Empower aDolescentS (SEEDS) project aims to use an equity-lens, and engage and empower boys and girls from deprived areas by designing and cocreating interventions to promote healthy lifestyles, and to seed interest in STEM.Methods and analysis SEEDS is a cluster randomised controlled trial in four countries (Greece, the Netherlands, Spain and the UK). Each country will recruit six to eight high schools from lower socioeconomic neighbourhoods. Adolescents aged 13–15 years are the target population. High schools will be randomised into intervention or control group. Each country will select 15 adolescents from intervention schools called ambassadors, who will be involved throughout the project.In each country, focus groups with ambassadors and stakeholders will focus on physical activity, snacking behaviour and STEM. The input from focus groups will be used to shape Makeathon events, cocreation events where adolescents and stakeholders will develop the interventions. The resultant intervention will be implemented in the intervention schools during 6 months. In total, we aim to recruit 720 adolescents who will complete questionnaires related to healthy lifestyles and STEM outcomes at baseline (November 2021) and after the 6 months (June 2022).Ethics and dissemination The four countries obtained approval from their corresponding Ethics Committees (Greece: Bioethics Committee of Harokopio University; the Netherlands: The Medical Research Ethics Committee of the Erasmus Medical Center; Spain: The Drug Research Ethics Committee of the Pere Virgili Health Research Institute; UK: Sport and Health Sciences Ethics Committee of the University of Exeter). Informed consent will be collected from adolescents and their parents in line with General Data Protection Regulation legislation. The findings will be disseminated by conference presentations, publications in scientific peer-reviewed journals and during (local) stakeholders and public events. Lessons learnt and the main results will also be used to provide policy recommendations.Trial registration number NCT05002049.

Summary: Background and aims: The aim of this cross-sectional study was to examine whether underreporting of dietary intake is associated with individual physical and lifestyle parameters, and body image perception. Methods: Dietary intake was assessed using 24h recalls in 490 individuals. Underreporters were compared to normal reporters regarding age, body fat, years of education, number of cigarettes, physical activity level (PAL) and body image self-belief, body image wish and body image wish minus belief according to Stunkard Figure Rating Scale (FRS). Odds ratio of underreporting in relation to negative perception of body image was performed. Results: Underreporting was positively associated with older age in total sample (p=0.004), higher body fat percentage in both genders (p

Introduction The aim of this randomised controlled trial (RCT) is to investigate whether prolonged consumption of sweeteners and sweetness enhancers (S&SEs) within a healthy diet will improve weight loss maintenance and obesity-related risk factors and affect safety markers compared with sugar.Methods and analysis SWEET (S&SEs: prolonged effects on health, obesity and safety) is a 1-year multicentre RCT including at least 330 adults with overweight (18–65 years, body mass index (BMI) >25 kg/m2) and 40 children (6–12 years, BMI-for-age >85th percentile). In an initial 2-month period, adults will consume a low-energy diet with the aim to achieve ≥5% weight loss. Children are advised to consume a generally healthy diet to maintain body weight, thus reducing their BMI-for-age z-score. In the following 10 months, participants will be randomised to follow a healthy ad libitum diet with or without S&SE products. Clinical investigations are scheduled at baseline, after 2, 6 and 12 months. The primary outcomes are body weight for efficacy and gut microbiota composition (in relation to metabolic health) for safety, both in adults. Secondary outcomes include anthropometry, risk markers for type-2 diabetes and cardiovascular diseases, questionnaires including, for example, food preferences, craving and appetite and tests for allergenicity.Ethics and dissemination The trial protocol has been approved by the following national ethical committees; The research ethics committees of the capital region (Denmark), approval code: H-19040679, The medical ethics committee of the University Hospital Maastricht and Maastricht University (the Netherlands), approval code: NL70977.068.19/METC19-056s, Research Ethics Committee of the University of Navarra (Spain), approval code: 2019.146 mod1, Research Ethics Committee of Harokopio University (Greece), approval code: 1810/18-06-2019. The trial will be conducted in accordance with the Declaration of Helsinki. Results will be published in international peer-reviewed scientific journals regardless of whether the findings are positive, negative or inconclusive.Trial registration number NCT04226911 (Clinicaltrials.gov)

During puberty, rapid, complex hormonal, physical and cognitive changes occur that affect body image and eating behavior. The aim of this cross-sectional study, a secondary analysis of data from the Greek Healthy Growth Study, was to explore associations of disordered eating behaviors and body image in 1206 10–12-year-old girls during pubertal maturation, with serum leptin and adiponectin levels, according to body mass index (BMI). Eating behavior and disordered eating were assessed with the Dutch Eating Behavior Questionnaire (DEBQ) and the Children Eating Attitudes Test Questionnaire (ChEAT), respectively. Associations of components of DEBQ and ChEAT with maturation according to Tanner Stage (TS) and levels of leptin and adiponectin were explored by univariate and multivariate regression analysis. Adiponectin levels in girls at TS 1 were positively associated with the “social pressure to eat” score of ChEAT. Leptin levels in girls at TS 4 were positively correlated with the “restraint eating” score of DEBQ, and the “dieting”, “body image” and “food awareness” scores of ChEAT. After adjustment for TS and BMI, only “body image” and leptin remained significant. Further research may shed light on how these hormonal changes affect eating behaviors at various pubertal stages, contributing to “TS-specific” preventive strategies for eating disorders in girls.

Abstract Background This study investigated the effect of the Feel4Diabetes-intervention, a 2-year multilevel intervention, on energy balance-related behaviors among European families at risk for developing type 2 diabetes. Intervention effects on self-reported physical activity, sedentary behavior and eating behaviors were investigated across and within the participating countries: Belgium, Finland, Greece, Spain, Hungary and Bulgaria. Methods Families were recruited through schools, located in low socio-economic status areas. In total, 4484 families at risk for developing type 2 diabetes were selected using the FINDRISC-questionnaire. Parents’ and children’s energy balance-related behaviors data were collected by questionnaires at three time points (baseline, mid- and post intervention). Families assigned to the intervention group were invited to participate in a 2-year school-, community-, and family-based intervention to promote a healthier lifestyle, including counseling sessions (first intervention year) and text messages (second intervention year). Families assigned to the control group received standard care, including medical check-up results and recommendations and tips regarding a healthy lifestyle. To assess the intervention-effects, Mixed Models were conducted using the R-Package “lmer “with R v3.2. Results Significant intervention effects were found on a certain number of families’ lifestyle behaviors. Significant favorable intervention effects were detected on parents’ water consumption and consumption of fruit and vegetables, and on children’s consumption of sweets and moderate-to-vigorous physical activity. Analyses by country revealed significant favorable intervention effects on water consumption and on moderate-to-vigorous physical activity in Belgian parents and on fruit and vegetable consumption among Belgian children, on sweets consumption among Spanish parents and children, and on moderate-to-vigorous physical activity among Finnish children. Unfavorable intervention effects were found on the consumption of soft drinks and sugar-containing juices among Hungarian children and parents, while when examining the intervention effects for the overall population and per country, 10 from the 112 investigated outcome variables were improved in the intervention group compared to the control group (9%). Conclusions The Feel4Diabetes-intervention managed to improve a certain number of targeted lifestyle behaviors while the intervention was not effective on a large number of targeted lifestyle behaviors. The findings of the current study are encouraging, but further research is needed on how we can further improve effectiveness of lifestyle interventions to prevent type 2 diabetes in families at risk. Trial registration The Feel4Diabetes-study is registered with the clinical trials registry http://clinicaltrials.gov , ID: 643708.

Abstract Background The effect of personalised nutrition advice on discretionary foods intake is unknown. To date, two national classifications for discretionary foods have been derived. This study examined changes in intake of discretionary foods and beverages following a personalised nutrition intervention using these two classifications. Methods Participants were recruited into a 6-month RCT across seven European countries (Food4Me) and were randomised to receive generalised dietary advice (control) or one of three levels of personalised nutrition advice (based on diet [L1], phenotype [L2] and genotype [L3]). Dietary intake was derived from an FFQ. An analysis of covariance was used to determine intervention effects at month 6 between personalised nutrition (overall and by levels) and control on i) percentage energy from discretionary items and ii) percentage contribution of total fat, SFA, total sugars and salt to discretionary intake, defined by Food Standards Scotland (FSS) and Australian Dietary Guidelines (ADG) classifications. Results Of the 1607 adults at baseline, n = 1270 (57% female) completed the intervention. Percentage sugars from FSS discretionary items was lower in personalised nutrition vs control (19.0 ± 0.37 vs 21.1 ± 0.65; P = 0.005). Percentage energy (31.2 ± 0.59 vs 32.7 ± 0.59; P = 0.031), percentage total fat (31.5 ± 0.37 vs 33.3 ± 0.65; P = 0.021), SFA (36.0 ± 0.43 vs 37.8 ± 0.75; P = 0.034) and sugars (31.7 ± 0.44 vs 34.7 ± 0.78; P

Introduction: Carbohydrate intake and physical activity are related to glucose homeostasis, both being influenced by individual genetic makeup. However, the interactions between these 2 factors, as affected by genetics, on glycaemia have been scarcely reported. Objective: We focused on analysing the interplay between carbohydrate intake and physical activity levels on blood glucose, taking into account a genetic risk score (GRS), based on SNPs related to glucose/energy metabolism. Methods: A total of 1,271 individuals from the Food4Me cohort, who completed the nutritional intervention, were evaluated at baseline. We collected dietary information by using an online-validated food frequency questionnaire, a questionnaire on physical activity, blood biochemistry by analysis of dried blood spots, and by analysis of selected SNPs. Fifteen out of 31 SNPs, with recognized participation in carbohydrate/energy metabolism, were included in the component analyses. The GRS included risk alleles involved in the control of glycaemia or energy-yielding processes. Results: Data concerning anthropometric, clinical, metabolic, dietary intake, physical activity, and genetics related to blood glucose levels showed expected trends in European individuals of comparable sex and age, being categorized by lifestyle, BMI, and energy/carbohydrate intakes, in this Food4Me population. Blood glucose was inversely associated with physical activity level (β = −0.041, p = 0.013) and positively correlated with the GRS values (β = 0.015, p = 0.047). Interestingly, an interaction affecting glycaemia, concerning physical activity level with carbohydrate intake, was found (β = −0.060, p = 0.033), which also significantly depended on the genetic background (GRS). Conclusions: The relationships of carbohydrate intake and physical activity are important in understanding glucose homeostasis, where a role for the genetic background should be ascribed.

Background: The databases of children’s anthropometric parameters are often outdated, rarely representative and are not always available at an international level. Objectives: To present children’s anthropometric parameters in six European countries that contributed to the Feel4Diabetes project and find country-specific differences. Design/Setting: The Feel4Diabetes study was performed between 2016 and 2018, targeting children in Belgium, Bulgaria, Finland, Greece, Hungary and Spain. The current study presents data from the baseline and the yearly follow-up anthropometric measurements. Subjects: In total, 20,832 measurements of children (48.7% boys) between 6 and 10 years of age were conducted. Main outcome measure: weight, height, BMI. Results: Belgian boys had the lowest body weight and height, while Greek boys had the highest body weight, and Finnish had the highest body height. The highest proportion of overweight (percentile above 85%) and obese boys (percentile above 95%) was in Greece, followed by Hungarian, Spanish, Bulgarian and Finnish boys. In contrast, Belgian boys had the lowest ratio in both categories. Among girls, Greece had the highest; Belgium had the lowest body weight; Finland was the highest in all age categories. The ratio in the overweight range was the highest in Greece, followed by Spanish, Bulgarian and Hungarian girls, who were second in the obese category. Finnish girls had lower and Belgian girls had the lowest ratio in both BMI categories. All the detailed data are presented in tables, and the trends are figures. Conclusions: Our study presents fresh and comparable anthropometric data of children between 6 and 10 years of age in six European countries, supporting the need for appropriate obesity prevention.

Abstract Obesity is the result of interactions between genes and environmental factors. Since monogenic etiology is only known in some obesity-related genes, a genetic risk score (GRS) could be useful to determine the genetic predisposition to obesity. Therefore, the aim of our study was to build a GRS able to predict genetic predisposition to overweight and obesity in European adolescents. A total of 1069 adolescents (51.3% female), aged 11–19 years participating in the Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA) cross-sectional study were genotyped. The sample was divided in non-overweight (non-OW) and overweight/obesity (OW/OB). From 611 single nucleotide polymorphisms (SNP) available, a first screening of 104 SNPs univariately associated with obesity (p

Background: Metabolic syndrome (MetS) occurs in a proportion of overweight and obese children and increases their future risk of serious health complications, even in adolescence and young adulthood. We aimed to explore the role of certain adipokines and inflammatory markers in identifying children with MetS. Methods: This study is a secondary analysis of data coming from the Healthy Growth Study, a cross-sectional study conducted with schoolchildren in Greece. The present study included data from a representative sample of 1376 schoolchildren (mean age: 11.19 ± 0.66 years), recruited from 77 primary schools in four large regions in Greece. Anthropometric, clinical and biochemical data were recorded. Children’s body weight status and the presence of MetS were determined and their correlation with the serum levels of leptin, adiponectin and C-reactive protein (CRP) was explored. Results: The prevalence of the MetS was 21.7 % and 3.7 % in obese and overweight children, respectively. The balance of adipokines was disturbed in obesity, as the serum level of adiponectin decreased as body weight increased, while the serum level of leptin increased. The serum level of the inflammatory marker CRP increased significantly as body weight increased. Discriminant analysis showed that these factors could distinguish the children with MetS as compared to children with no MetS. Conclusions: In the under study Mediterranean childhood population, monitoring of the levels of adipokines and CRP could identify the overweight and obese children with MetS. Appropriate individualized dietary and lifestyle interventions can be applied in these children to prevent health complications associated with MetS.

BackgroundThe role of partially hydrolyzed formulas (pHF) as part of nutritional interventions to prevent the development of allergic manifestations (AM) is questioned, and efficacy of each specific pHF should be substantiated.ObjectiveTo investigate the risk-reduction effect of a whey-based pHF on the development of cow's milk protein allergy (CMPA) and atopic dermatitis (AD) in infants at high-risk for allergy within the first 6 months of life.Materials and MethodsIn a multicenter double-blinded randomized controlled setting, healthy non-exclusively breastfed full-term infants, received either a specific whey-based pHF or a standard cow's milk-based formula (SF) and were clinically assessed for AM at 2, 4, and 6 months of age, supported by the objective scoring tools SCORAD and CoMiSS. CMPA was confirmed by open food challenge. Intention-to-Treat (ITT) and Per-Protocol (PP) analyses were performed.ResultsOf 331 randomized subjects (ITT analysis set), 160 received the pHF and 171 the SF. Six (3.8%) infants in the pHF and 12 (7%) in the SF group developed CMPA (p = 0.186). AD incidence was significantly lower in those receiving pHF as compared to SF (10.6% vs. 18.7%, p = 0.024) with a relative risk (RR, 95% CI) of 0.54 (0.32, 0.92), in particular when adjusting for family history of AD [6.5% vs. 27.3%, RR 0.24 (0.07, 0.78), p = 0.018] representing a risk reduction of 76%. The PP analysis showed similar results.ConclusionThis specific whey-based pHF reduced the risk of AD development, particularly in those with a family history of AD, and tended to reduce the development of CMPA in non-exclusively breastfed infants at high-risk for allergy. The A.R.T. study suggests that this particular pHF may contribute to measures aimed at prevention of allergic manifestations. However, further studies are needed to confirm this risk-reduction effect.

Abstract Background Palmitic acid (PA) is predominantly esterified at the SN-2 position of triacylglycerols in human milk. PA at the SN-2 position is more efficiently absorbed and results in reduced formation of PA soaps, as well as reduced fatty acid (FA) and calcium malabsorption. Bovine milk fat (MF), a natural source of SN-2-palmitate, was used in the fat blend of infant formulae (IF) in the current study to investigate its effect on stool fatty acid soaps, calcium excretion and stool characteristics. Methods Two double-blind, randomised cross-over trials (CS1, CS2) were conducted in parallel with healthy term, formula-fed infants aged 9–14 weeks. After a two-week run-in period, infants in CS1 (n = 17) were randomly allocated to receive either a 50% MF-based formula (50MF) or a 100% vegetable fat (VF) formula; in CS2 (n = 18), infants received either a 20% MF-based formula (20MF) or the VF formula, in a 2 × 2-week cross-over design. At the end of each two-week intervention period, stool samples were collected for FA, FA soaps and calcium excretion analysis and stool consistency was assessed according to the Amsterdam Infant Stool Scale (AISS). Results MF-based groups showed no significant difference in PA in stools compared to VF group, although reduced stool PA soaps (CS1: 111.28 ± 18.33 vs. 220.25 ± 29.35 mg/g dry weight, p

Abstract Background The study aimed to investigate the effectiveness of the European Feel4Diabetes intervention, promoting a healthy lifestyle, on physical activity and its correlates among families at risk for type 2 diabetes mellitus (based on the Finnish Diabetes Risk Score) in Belgium. Methods The Feel4Diabetes intervention involved three components: family, school and community component, with the family component consisting of 6 counseling sessions for families at risk. Main outcomes were objectively measured physical activity levels and its subjectively measured correlates. The final sample consisted of 454 parents (mean age 39.4 years; 72.0% women) and 444 children (mean age 8.0 years; 50.1% girls). Multilevel repeated measures analyses were performed to assess intervention effectiveness after 1 year. Results In parents, there was no significant intervention effect. In children, there were only significant negative effects for moderate to vigorous physical activity (p = 0.05; ηp 2 = 0.008) and steps (p = 0.03; ηp 2 = 0.006%) on weekdays, with physical activity decreasing (more) in the intervention group. Conclusions The F4D-intervention lacks effectiveness on high-risk families’ physical activity and its correlates in Belgium. This could partially be explained by low attendance rates and a large drop-out. To reach vulnerable populations, future interventions should invest in more appropriate recruitment (e.g. more face-to-face contact) and more bottom-up development of the intervention (i.e. co-creation of the intervention with the target group). Trial registration The Feel4Diabetes-study was prospectively registered at clinicaltrials.gov as NCT02393872 on 20 March 2015.

Abstract Background The aim of this paper is to present the development of the Feel4Diabetes Healthy Diet Score and to evaluate its clinical validity. Methods Study population consisted of 3268 adults (63% women) from high diabetes risk families living in 6 European countries. Participants filled in questionnaires at baseline and after 1 year, reflecting the dietary goals of the Feel4Diabetes intervention. Based on these questions the Healthy Diet Score was constructed, consisting of the following components: breakfast, vegetables, fruit and berries, sugary drinks, whole-grain cereals, nuts and seeds, low-fat dairy products, oils and fats, red meat, sweet snacks, salty snacks, and family meals. Maximum score for each component was set based on its estimated relative importance regarding T2DM risk, higher score indicating better quality of diet. Clinical measurements included height, weight, waist circumference, heart rate, blood pressure, and fasting blood sampling, with analyses of glucose, total cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides. Analysis of (co) variance was used to compare the Healthy Diet Score and its components between countries and sexes using baseline data, and to test differences in clinical characteristics between score categories, adjusted for age, sex and country. Pearson’s correlations were used to study the association between changes from baseline to year 1 in the Healthy Diet Score and clinical markers. To estimate reproducibility, Pearson’s correlations were studied between baseline and 1 year score, within the control group only. Results The mean total score was 52.8 ± 12.8 among women and 46.6 ± 12.8 among men (p

Abstract Background Although there are many interventions targeting childhood obesity prevention, only few have demonstrated positive results. The current review aimed to gather and evaluate available school-based intervention studies with family involvement targeting dietary, physical activity and sedentary behaviors among primary schoolchildren and their families, in order to identify the most effective strategies. Methods Studies published between 2000 and January 2015 were retrieved from scientific electronic databases and grey literature. The databases used included MEDLINE/PubMed, Web-of-Science, CINAHL and Scopus. Included studies had to be experimental controlled studies and had duration over 1 school year, had family involvement, combined PA and dietary behaviors and were implemented in school setting. A complementary search was executed to update the review to cover the period from February 2015 to January 2019. Results From the studies examined (n = 425), 27 intervention programs (33 publications) fulfilled the inclusion criteria. Among these, 15 presented significant effect on weight status and/ or overweight/ obesity or clinical indices, 3 presented significant effect on most energy balance-related behaviors (EBRBs) while 9 presented significant effect on some/few EBRBs or determinants. Strategies implemented in effective interventions were: teachers acting as role-models and being actively involved in the delivery of the intervention, school policies supporting the availability of healthy food and beverage choices and limiting unhealthy snacks, changes in the schoolyard, in the recess rules and in the physical education classes to increase physical activity, and involving parents in the intervention via assignments, meetings, informative material and encouraging them to improve the home environment. Use of incentives for children, social marketing techniques, collaboration with local stakeholders were found to increase effectiveness. Programs that focused only on educational sessions and material for parents, without promoting relevant environmental and policy changes, were found to be less effective. Cultural adaptations have been suggested to increase the intervention’s acceptance in specific or vulnerable population groups. Conclusions Several effective strategies were identified in the reviewed programs. Outcomes of the current review were taken into account in developing the Feel4Diabetes-intervention and summed up as recommendations in the current work in order to facilitate other researchers designing similar childhood obesity prevention initiatives.

Abstract Background Feel4Diabetes was a school and community based intervention aiming to promote healthy lifestyle and tackle obesity for the prevention of type 2 diabetes among families in 6 European countries. We conducted this literature review in order to guide the development of evidence-based implementation of the Feel4Diabetes intervention. We focused on type 2 diabetes prevention strategies, including all the phases from risk identification to implementation and maintenance. Special focus was given to prevention among vulnerable groups and people under 45 years. Methods Scientific and grey literature published between January 2000 and January 2015 was searched for relevant studies using electronic databases. To present the literature review findings in a systematic way, we used the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. A complementary literature search from February 2015 to December 2018 was also conducted. Results The initial review included 27 studies with a follow-up ≥12 months and 9 studies with a follow-up ≥6 months and with a participant mean age

Abstract Background Feel4Diabetes was a large-scale, multicenter lifestyle intervention aiming to prevent type 2 diabetes among families from vulnerable population groups in six European countries (Belgium, Bulgaria, Finland, Greece, Hungary and Spain). The current study aimed to describe the process that was followed to harmonize and standardize the measurement of anthropometric (weight, height and waist circumference) and blood pressure (systolic and diastolic) indices, as well as to assess the intra- and inter- observer reliability of these measurements. Methods A central training workshop was conducted prior to the baseline measurements of the Feel4Diabetes-intervention. One researcher from each intervention country, as well as 12 adults and 12 children (for the anthropometric measurements) and 21 adults (for the blood pressure measurements) participated in this workshop. Technical Error of Measurement (TEM) and reliability (%R) were calculated to assess the reliability of the indices which were assessed to evaluate the outcome of the Feel4Diabetes-intervention. The Feel4Diabetes-intervention is registered at https://clinicaltrials.gov/ (NCT02393872). Results Intra-observer reliability was found to be higher than 99.5% for all anthropometric measurements in both children and adults. Inter-observer reliability was found to be higher than 98% regarding the anthropometric measurements, while for blood pressure measurements %R was 76.62 and 91.38% for systolic and diastolic blood pressure measurements, respectively. Conclusion The central training of the Fee4Diabetes-intervention ensured that the data collected for the outcome evaluation of the Feel4Diabetes-intervention in the six European countries at three different time points (baseline, follow-up 1 and follow-up 2) were valid and comparable.

Abstract Background Levels of physical activity and variation in physical activity and sedentary time by place and person in European children and adolescents are largely unknown. The objective of the study was to assess the variations in objectively measured physical activity and sedentary time in children and adolescents across Europe. Methods Six databases were systematically searched to identify pan-European and national data sets on physical activity and sedentary time assessed by the same accelerometer in children (2 to 9.9 years) and adolescents (≥10 to 18 years). We harmonized individual-level data by reprocessing hip-worn raw accelerometer data files from 30 different studies conducted between 1997 and 2014, representing 47,497 individuals (2–18 years) from 18 different European countries. Results Overall, a maximum of 29% (95% CI: 25, 33) of children and 29% (95% CI: 25, 32) of adolescents were categorized as sufficiently physically active. We observed substantial country- and region-specific differences in physical activity and sedentary time, with lower physical activity levels and prevalence estimates in Southern European countries. Boys were more active and less sedentary in all age-categories. The onset of age-related lowering or leveling-off of physical activity and increase in sedentary time seems to become apparent at around 6 to 7 years of age. Conclusions Two third of European children and adolescents are not sufficiently active. Our findings suggest substantial gender-, country- and region-specific differences in physical activity. These results should encourage policymakers, governments, and local and national stakeholders to take action to facilitate an increase in the physical activity levels of young people across Europe.

Abstract Background The clinical and economic burden of type 2 diabetes mellitus on society is rising. Effective and efficient preventive measures may stop the increasing prevalence, given that type 2 diabetes mellitus is mainly a lifestyle-driven disease. The Feel4Diabetes-study aimed to tackle unhealthy lifestyle (unhealthy diet, lack of physical activity, sedentary behaviour, and excess weight) of families with a child in the first grades of elementary school. These schools were located in regions with a relatively low socio-economic status in Belgium, Bulgaria, Finland, Greece, Hungary and Spain. Special attention was paid to families with a high risk of developing type 2 diabetes mellitus. Methods The aim of this paper is to describe the detailed methodology of the intervention’s cost-effectiveness analysis. Based on the health economic evaluation of the Toybox-study, both a decision analytic part and a Markov model have been designed to assess the long-term (time horizon of 70 year with one-year cycles) intervention’s value for money. Data sources used for the calculation of health state incidences, transition probabilities between health states, health state costs, and health state utilities are listed. Intervention-related costs were collected by questionnaires and diaries, and attributed to either all families or high risk families only. Conclusions The optimal use of limited resources is pivotal. The future results of the health economic evaluation of the Feel4Diabetes-study will contribute to the efficient use of those resources.

Abstract Background Type 2 diabetes mellitus (T2DM) comprises the vast majority of all diabetes cases in adults, with alarmingly increasing prevalence over the past few decades worldwide. A particularly heavy healthcare burden of diabetes is noted in Europe, where 8.8% of the population aged 20–79 years is estimated to have diabetes according to the International Diabetes Federation. Multiple risk factors are implicated in the pathogenesis of T2DM with complex underlying interplay and intricate gene-environment interactions. Thus, intense research has been focused on studying the role of T2DM risk factors and on identifying vulnerable groups for T2DM in the general population which can then be targeted for prevention interventions. Methods For this narrative review, we conducted a comprehensive search of the existing literature on T2DM risk factors, focusing on studies in adult cohorts from European countries which were published in English after January 2000. Results Multiple lifestyle-related and sociodemographic factors were identified as related to high T2DM risk, including age, ethnicity, family history, low socioeconomic status, obesity, metabolic syndrome and each of its components, as well as certain unhealthy lifestyle behaviors. As Europe has an increasingly aging population, multiple migrant and ethnic minority groups and significant socioeconomic diversity both within and across different countries, this review focuses not only on modifiable T2DM risk factors, but also on the impact of pertinent demographic and socioeconomic factors. Conclusion In addition to other T2DM risk factors, low socioeconomic status can significantly increase the risk for prediabetes and T2DM, but is often overlooked. In multinational and multicultural regions such as Europe, a holistic approach, which will take into account both traditional and socioeconomic/socioecological factors, is becoming increasingly crucial in order to implement multidimensional public health programs and integrated community-based interventions for effective T2DM prevention.

Abstract Background Assessment of diet and physical activity and their determinants still remains a demanding task, especially when the objective is to evaluate the efficacy of lifestyle interventions. In the context of the Feel4Diabetes study (a European community based intervention study in families with school aged children and at high risk of developing diabetes), we aimed to develop questionnaires for the assessment of food-frequency and eating behaviors, and physical activity and sedentary behaviors in both parents and school-aged children and a questionnaire for overall family’s energy balance-related behaviors. Methods Questionnaires were developed to be used in 6 countries under standardized harmonization procedures and included questions regarding not only food intake and physical activity, but also questions of their determinants. A reliability study was conducted in 191 pairs of parents and their children (N = 191). Parents completed the questionnaires on two occasions, within a 1–2 week interval. Reliability was tested by the intra-class correlation coefficients (ICC) of test-retest. Results Most of the questions in all questionnaires had excellent reliability, assessed as an ICC of > 0.810. Mean ICCs for food-frequency and eating behaviors questionnaires were 0.838 and 0.787, and for physical activity and sedentary behaviors questionnaires were 0.734 and 0.793, in adults and children respectively. Mean ICC for overall family’s energy balance-related behaviors and their determinants was 0.659. Conclusion The developed questionnaires showed acceptable reliability and may be valuable tools in the assessment of children’s and parents’ behaviors related to diet, physical activity, sedentary behavior and overall energy balance in school- and community-based interventions.

Abstract Background The implementation of population screening and early prevention strategies targeting individuals at high-risk for type 2 diabetes (T2D) seems to be a public health priority. The current work aimed to describe the screening procedure applied in the Feel4Diabetes-study and examine its effectiveness in identifying individuals and families at high risk, primarily for T2D and secondarily for hypertension, among vulnerable populations in low to middle-income countries (LMICs) and high-income countries (HICs) across Europe. Methods A two-stage screening procedure, using primary schools as the entry-point to the community, was applied in low socioeconomic status (SES) regions in LMICs (Bulgaria-Hungary), HICs (Belgium-Finland) and HICs under austerity measures (Greece-Spain). During the first-stage screening via the school-setting, a total of 20,501 parents (mothers and/or fathers) of schoolchildren from 11,396 families completed the Finnish Diabetes Risk Score (FINDRISC) questionnaire, while their children underwent anthropometric measurements in the school setting. Parents from the identified “high-risk families” (n = 4484) were invited to participate in the second-stage screening, including the measurement of fasting plasma glucose (FPG) and blood pressure (BP). In total, 3153 parents participated in the second-stage screening (mean age 41.1 ± 5.6 years, 65.8% females). Results Among parents who attended the second-stage screening, the prevalence of prediabetes (as defined by impaired fasting glucose; FPG 100-125 mg/dl) and T2D (FPG > 126 mg/dl) was 23.2 and 3.0% respectively, and it was found to be higher in the higher FINDRISC categories. The percentage of undiagnosed T2D among the participants identified with T2D was 53.5%. The prevalence of high normal BP (systolic BP 130-139 mmHg and/ or diastolic BP 85-89 mmHg) and hypertension (systolic BP ≥ 140 mmHg and/ or diastolic BP ≥ 90 mmHg) was 14 and 18.6% respectively, which was also higher in the higher FINDRISC categories. The percentage of cases not receiving antihypertensive treatment among the participants identified with hypertension was 80.3%. Conclusion The findings of the current study indicate that the two-stage school and community-based screening procedure followed, effectively identified high-risk individuals and families in vulnerable populations across Europe. This approach could be potentially scalable and sustainable and support initiatives for the early prevention of T2D and hypertension. Trial registration The Feel4Diabetes-intervention is registered at https://clinicaltrials.gov/ (NCT02393872; date of trial registration: March 20, 2015).

Food cue exposure can trigger eating. Food cue reactivity (FCR) is a conditioned response to food cues and includes physiological responses and activation of reward-related brain areas. FCR can be affected by hunger and weight status. The appetite-regulating hormones ghrelin and leptin play a pivotal role in homeostatic as well as hedonic eating. We examined the association between ghrelin and leptin levels and neural FCR in the fasted and sated state and the association between meal-induced changes in ghrelin and neural FCR, and in how far these associations are related to BMI and HOMA-IR. Data from 109 participants from three European centers (age 50±18 y, BMI 27±5 kg/m2) who performed a food viewing task during fMRI after an overnight fast and after a standardized meal were analyzed. Blood samples were drawn prior to the viewing task in which high-caloric, low-caloric and non-food images were shown. Fasting ghrelin was positively associated with neural FCR in the inferior and superior occipital gyrus in the fasted state. This was partly attributable to BMI and HOMA-IR. These brain regions are involved in visual attention, suggesting that individuals with higher fasting ghrelin have heightened attention to food cues. Leptin was positively associated with high calorie FCR in the medial prefrontal cortex (PFC) in the fasted state and to neural FCR in the left supramarginal gyrus in the fasted versus sated state, when correcting for BMI and HOMA-IR, respectively. This PFC region is involved in assessing anticipated reward value, suggesting that for individuals with higher leptin levels high-caloric foods are more salient than low-caloric foods, but foods in general are not more salient than non-foods. There were no associations between ghrelin and leptin and neural FCR in the sated state, nor between meal-induced changes in ghrelin and neural FCR. In conclusion, we show modest associations between ghrelin and leptin and neural FCR in a relatively large sample of European adults with a broad age and BMI range. Our findings indicate that people with higher leptin levels for their weight status and people with higher ghrelin levels may be more attracted to high caloric foods when hungry. The results of the present study form a foundation for future studies to test whether food intake and (changes in) weight status can be predicted by the association between (mainly fasting) ghrelin and leptin levels and neural FCR.

Background: The aim of this study is to use different regression models to capture the association between cardiorespiratory fitness VO2max (measured in mL/kg/min) and somatometric characteristics and sports activities and making better predictions. Methods: multiple linear regression (MLR), quantile regression (QR), ridge regression (RR), support vector regression (SVR) with three different kernels, artificial neural networks (ANNs), and boosted regression trees (RTs) were compared to explain and predict VO2max and to choose the best performance model. The sample consisted of 4908 children (2314 males and 2594 females) aged between 6 and 17. Cardiorespiratory fitness was assessed by the 20 m maximal multistage shuttle run test and maximal oxygen uptake (VO2max) was calculated. Welch t-tests, Mann–Whitney-U tests, X2 tests, and ANOVA tests were performed. The performance measures were root mean square error (RMSE), mean absolute error (MAE), and coefficient of determination (R2). All analyses were stratified by gender. Results: A comparison of the statistical indices for both the predicted and actual data indicated that in boys, the MLR model outperformed all other models in all indices, followed by the linear SVR model. In girls, the MLR model performed better than the other models in R2 but was outperformed by SVR-RBF in terms of RMSE and MAE. The overweight and obesity categories in both sexes (p < 0.001) and maternal prepregnancy obesity in girls had a significant negative effect on VO2max. Age, weekly football training, track and field, basketball, and swimming had different positive effects based on gender. Conclusion: The MLR model showed remarkable performance against all other models and was competitive with the SVR models. In addition, this study’s data showed that changes in cardiorespiratory fitness were dependent, to a different extent based on gender, on BMI category, weight, height, age, and participation in some organized sports activities. Predictors that are not considered modifiable, such as gender, can be used to guide targeted interventions and policies.

Abstract Background Most research on parenting and childhood obesity and obesity-related behaviours has focused on mothers while fathers have been underrepresented. Yet, recent literature has suggested that fathers uniquely influence their children’s lifestyle behaviours, and hence could also affect their weight status, but this has not yet been scientifically proven. Therefore, the present study aimed to determine whether the association between fathers’ weight status and their children’s weight status is mediated by fathers’ and children’s movement behaviours (i.e. physical activity (PA) and screen time (ST)). Methods Cross-sectional data of 899 European fathers and their children were analyzed. Fathers/male caregivers (mean age = 43.79 ± 5.92 years, mean BMI = 27.08 ± 3.95) completed a questionnaire assessing their own and their children’s (mean age = 8.19 ± 0.99 years, 50.90% boys, mean BMI zscore = 0.44 ± 1.07) movement behaviours. Body Mass Index (BMI, in kg/m2) was calculated based on self-reported (fathers) and objectively measured (children) height and weight. For children, BMI z-scores (SD scores) were calculated to obtain an optimal measure for their weight status. Serial mediation analyses were performed using IBM SPSS 25.0 Statistics for Windows to test whether the association between fathers’ BMI and children’s BMI is mediated by fathers’ PA and children’s PA (model 1) and fathers’ ST and children’s ST (model 2), respectively. Results The present study showed a (partial) mediation effect of fathers’ PA and children’s PA (but not father’s ST and children’s ST) on the association between fathers’ BMI and children’s BMI (model for PA; coefficient: 0.001, 95% CI: [0.0001, 0.002]; model for ST; coefficient: 0.001, 95% CI: [0.000, 0.002]). Furthermore, fathers’ movement behaviours (PA and ST) were positively associated with their children’s movement behaviours (PA and ST) (model for PA, coefficient: 0.281, SE: 0.023, p

Abstract Background High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Methods Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. Results The preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Conclusions Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention. Trial registration ISRCTN12831555

Abstract Adolescence is a critical stage of development and has an important influence on energy balance-related behaviours (EBRBs). When adolescents are associated with obesity it can lead to increased cardiometabolic risk. Here we assess if EBRBs adopted by adolescents included in a subsample are associated with markers of total and abdominal adiposity in a multicentre European study, Healthy Lifestyle in Europe by Nutrition in Adolescence (HELENA-CSS) and a Brazilian study, Brazilian Cardiovascular Adolescent Health (BRACAH study), and whether sleep duration influence the association between skipping breakfast, physical activity and sedentary behaviours, with total and abdominal obesity (AO). Multilevel linear regression models using fixed and random intercepts were used to analyse the association between markers of obesity and EBRBs. Skipping breakfast was the prevalent behaviour in association with obesity among European and Brazilian boys besides European girls, even after stratification by sleep time. Moreover, European boys who slept properly and skipped breakfast had an increased waist circumference (WC), while body mass index (BMI) increased in Brazilian boys. Among Brazilian boys less sleep was protective for total obesity (β = −0.93 kg/m2; 95% CI: −1.80; −0.07). European girls when they were more sedentary, showed an increase in WC, especially for those who reported they slept adequately. Skipping breakfast was associated with total and AO in adolescents independent of sleep duration.

Purpose: This study aims to compare adolescents’ cardiometabolic risk score through an integrative classification of physical activity (PA), which involves the combination of moderate-to-vigorous physical activity (MVPA) and sedentary behavior (SB). Methods: A cross-sectional study derived from the Healthy Lifestyle in Europe by Nutrition in Adolescence Cross-Sectional Study database (2006–2008) was conducted in adolescents (n = 548; boys, 47.3%; 14.7 ± 1.2 years) from 10 European cities. MVPA and SB were objectively measured using accelerometry. Adolescents were divided into 4 categories according to MVPA (meeting or not meeting the international recommendations) and the median of SB time (above or below sex- and age-specific median) as follows: High-SB & Inactive, Low-SB & Inactive, High-SB & Active, and Low-SB & Active. A clustered cardiometabolic risk score was computed using the homeostatic model assessment, systolic blood pressure, triglycerides, total cholesterol/high-density lipoprotein cholesterol, sum 4 skinfolds, and cardiorespiratory fitness (CRF). Analyses of covariance were performed to discern differences on cardiometabolic risk scores among PA categories and each health component. Results: The cardiometabolic risk score was lower in adolescents meeting the MVPA recommendation and with less time spent in SB in comparison to the high-SB & Inactive group (p < 0.05). However, no difference in cardiometabolic risk score was established between High-SB or Low-SB groups in inactive adolescents. It is important to note that CRF was the only variable that showed a significant modification (higher) when children were compared from the category of physically inactive with “active” but not from high- to low-SB. Conclusion: Being physically active is the most significant and protective outcome in adolescents to reduce cardiometabolic risk. Lower SB does not exhibit a significant and extra beneficial difference. Keywords: Accelerometry, Cardiovascular disease, Exercise, Metabolic disease, Sedentary lifestyles

BackgroundFetal smoke exposure is a common and key avoidable risk factor for birth complications and seems to influence later risk of overweight. It is unclear whether this increased risk is also present if mothers smoke during the first trimester only or reduce the number of cigarettes during pregnancy, or when only fathers smoke. We aimed to assess the associations of parental smoking during pregnancy, specifically of quitting or reducing smoking and maternal and paternal smoking combined, with preterm birth, small size for gestational age, and childhood overweight.Methods and findingsWe performed an individual participant data meta-analysis among 229,158 families from 28 pregnancy/birth cohorts from Europe and North America. All 28 cohorts had information on maternal smoking, and 16 also had information on paternal smoking. In total, 22 cohorts were population-based, with birth years ranging from 1991 to 2015. The mothers' median age was 30.0 years, and most mothers were medium or highly educated. We used multilevel binary logistic regression models adjusted for maternal and paternal sociodemographic and lifestyle-related characteristics. Compared with nonsmoking mothers, maternal first trimester smoking only was not associated with adverse birth outcomes but was associated with a higher risk of childhood overweight (odds ratio [OR] 1.17 [95% CI 1.02-1.35], P value = 0.030). Children from mothers who continued smoking during pregnancy had higher risks of preterm birth (OR 1.08 [95% CI 1.02-1.15], P value = 0.012), small size for gestational age (OR 2.15 [95% CI 2.07-2.23], P value < 0.001), and childhood overweight (OR 1.42 [95% CI 1.35-1.48], P value < 0.001). Mothers who reduced the number of cigarettes between the first and third trimester, without quitting, still had a higher risk of small size for gestational age. However, the corresponding risk estimates were smaller than for women who continued the same amount of cigarettes throughout pregnancy (OR 1.89 [95% CI 1.52-2.34] instead of OR 2.20 [95% CI 2.02-2.42] when reducing from 5-9 to ≤4 cigarettes/day; OR 2.79 [95% CI 2.39-3.25] and OR 1.93 [95% CI 1.46-2.57] instead of OR 2.95 [95% CI 2.75-3.15] when reducing from ≥10 to 5-9 and ≤4 cigarettes/day, respectively [P values < 0.001]). Reducing the number of cigarettes during pregnancy did not affect the risks of preterm birth and childhood overweight. Among nonsmoking mothers, paternal smoking was associated with childhood overweight (OR 1.21 [95% CI 1.16-1.27], P value < 0.001) but not with adverse birth outcomes. Limitations of this study include the self-report of parental smoking information and the possibility of residual confounding. As this study only included participants from Europe and North America, results need to be carefully interpreted regarding other populations.ConclusionsWe observed that as compared to nonsmoking during pregnancy, quitting smoking in the first trimester is associated with the same risk of preterm birth and small size for gestational age, but with a higher risk of childhood overweight. Reducing the number of cigarettes, without quitting, has limited beneficial effects. Paternal smoking seems to be associated, independently of maternal smoking, with the risk of childhood overweight. Population strategies should focus on parental smoking prevention before or at the start, rather than during, pregnancy.

Abstract Background Gestational weight gain differs according to pre-pregnancy body mass index and is related to the risks of adverse maternal and child health outcomes. Gestational weight gain charts for women in different pre-pregnancy body mass index groups enable identification of women and offspring at risk for adverse health outcomes. We aimed to construct gestational weight gain reference charts for underweight, normal weight, overweight, and grades 1, 2 and 3 obese women and to compare these charts with those obtained in women with uncomplicated term pregnancies. Methods We used individual participant data from 218,216 pregnant women participating in 33 cohorts from Europe, North America, and Oceania. Of these women, 9065 (4.2%), 148,697 (68.1%), 42,678 (19.6%), 13,084 (6.0%), 3597 (1.6%), and 1095 (0.5%) were underweight, normal weight, overweight, and grades 1, 2, and 3 obese women, respectively. A total of 138, 517 women from 26 cohorts had pregnancies with no hypertensive or diabetic disorders and with term deliveries of appropriate for gestational age at birth infants. Gestational weight gain charts for underweight, normal weight, overweight, and grade 1, 2, and 3 obese women were derived by the Box-Cox t method using the generalized additive model for location, scale, and shape. Results We observed that gestational weight gain strongly differed per maternal pre-pregnancy body mass index group. The median (interquartile range) gestational weight gain at 40 weeks was 14.2 kg (11.4–17.4) for underweight women, 14.5 kg (11.5–17.7) for normal weight women, 13.9 kg (10.1–17.9) for overweight women, and 11.2 kg (7.0–15.7), 8.7 kg (4.3–13.4) and 6.3 kg (1.9–11.1) for grades 1, 2, and 3 obese women, respectively. The rate of weight gain was lower in the first half than in the second half of pregnancy. No differences in the patterns of weight gain were observed between cohorts or countries. Similar weight gain patterns were observed in mothers without pregnancy complications. Conclusions Gestational weight gain patterns are strongly related to pre-pregnancy body mass index. The derived charts can be used to assess gestational weight gain in etiological research and as a monitoring tool for weight gain during pregnancy in clinical practice.

Obesity in children and adolescents is a public health problem and diet can play a major role in this condition. We aimed to identify sex-specific dietary patterns (DP) and to evaluate the association with overweight/obesity in European adolescents. We conducted a cross-sectional analysis with 2327 adolescents aged between 12.5 to 17.5 years from a multicenter study across Europe. The body mass index was categorized in “normal weight” and “overweight/obesity”. Two non-consecutive 24-h dietary recalls were collected with a computerized self-reported software. Principal component factor analysis was used to identify DP. Mixed-effect logistic regression models were used to evaluate the association between the sex-specific DP and overweight/obesity outcome. As a result, we found three DP in boys (snacking and bread, Mediterranean diet, and breakfast) and four DP in girls (convenience, plant-based and eggs, Western, and breakfast). The association between DP and overweight/obesity highlights that those adolescents with higher adherence to the breakfast DP had lower odds for overweight/obesity, even after the inclusion of covariables in the adjustments. In European adolescents, the breakfast DP positively characterized by breakfast cereals, fruit, milk, and dairy and negatively characterized by sugar-sweetened beverages in boys and negatively characterized by cereals (pasta, rice, and others) in girls, was inversely associated with overweight/obesity.

Abstract Background National guidelines emphasize healthy eating to promote wellbeing and prevention of non-communicable diseases. The perceived healthiness of food is determined by many factors affecting food intake. A positive perception of healthy eating has been shown to be associated with greater diet quality. Internet-based methodologies allow contact with large populations. Our present study aims to design and evaluate a short nutritional perception questionnaire, to be used as a screening tool for assessing nutritional status, and to predict an optimal level of personalisation in nutritional advice delivered via the Internet. Methods Data from all participants who were screened and then enrolled into the Food4Me proof-of-principle study (n = 2369) were used to determine the optimal items for inclusion in a novel screening tool, the Nutritional Perception Screening Questionnaire-9 (NPSQ9). Exploratory and confirmatory factor analyses were performed on anthropometric and biochemical data and on dietary indices acquired from participants who had completed the Food4Me dietary intervention (n = 1153). Baseline and intervention data were analysed using linear regression and linear mixed regression, respectively. Results A final model with 9 NPSQ items was validated against the dietary intervention data. NPSQ9 scores were inversely associated with BMI (β = −0.181, p

Abstract Background The ToyBox-intervention is a theory- and evidence-based intervention delivered in kindergartens to improve four- to six-year-old children’s energy balance-related behaviours and prevent obesity. The current study aimed to (1) examine the effect of the ToyBox-intervention on increasing European four- to six-year-old children’ steps per day, and (2) examine if a higher process evaluation score from teachers and parents was related to a more favourable effect on steps per day. Methods A sample of 2438 four- to six-year-old children (51.9% boys, mean age 4.75 ± 0.43 years) from 6 European countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain) wore a motion sensor (pedometer or accelerometer) for a minimum of two weekdays and one weekend day both at baseline and follow-up to objectively measure their steps per day. Kindergarten teachers implemented the physical activity component of the ToyBox-intervention for 6 weeks in total, with a focus on (1) environmental changes in the classroom, (2) the child performing the actual behaviour and (3) classroom activities. Children’s parents received newsletters, tip cards and posters. To assess intervention effects, multilevel repeated measures analyses were conducted for the total sample and the six intervention countries separately. In addition, process evaluation questionnaires were used to calculate a total process evaluation score (with implementation and satisfaction as a part of the overall score) for teachers and parents which was then linked with the physical activity outcomes. Results No significant intervention effects on four- to six-year-old children’ steps per weekday, steps per weekend day and steps per average day were found, both in the total sample and in the country-specific samples (all p > 0.05). In general, the intervention effects on steps per day were least favourable in four- to six-year-old children with a low teachers process evaluation score and most favourable in four- to six-year-old children with a high teachers process evaluation score. No differences in intervention effects were found for a low, medium or high parents’ process evaluation score. Conclusion The physical activity component of the ToyBox-intervention had no overall effect on four- to six-year-old children’ steps per day. However, the process evaluation scores showed that kindergarten teachers that implemented the physical activity component of the ToyBox-intervention as planned and were satisfied with the physical activity component led to favourable effects on children’s steps per day. Strategies to motivate, actively involve and engage the kindergarten teachers and parents/caregivers are needed to induce larger effects.

BackgroundMaternal obesity and excessive gestational weight gain may have persistent effects on offspring fat development. However, it remains unclear whether these effects differ by severity of obesity, and whether these effects are restricted to the extremes of maternal body mass index (BMI) and gestational weight gain. We aimed to assess the separate and combined associations of maternal BMI and gestational weight gain with the risk of overweight/obesity throughout childhood, and their population impact.Methods and findingsWe conducted an individual participant data meta-analysis of data from 162,129 mothers and their children from 37 pregnancy and birth cohort studies from Europe, North America, and Australia. We assessed the individual and combined associations of maternal pre-pregnancy BMI and gestational weight gain, both in clinical categories and across their full ranges, with the risks of overweight/obesity in early (2.0-5.0 years), mid (5.0-10.0 years) and late childhood (10.0-18.0 years), using multilevel binary logistic regression models with a random intercept at cohort level adjusted for maternal sociodemographic and lifestyle-related characteristics. We observed that higher maternal pre-pregnancy BMI and gestational weight gain both in clinical categories and across their full ranges were associated with higher risks of childhood overweight/obesity, with the strongest effects in late childhood (odds ratios [ORs] for overweight/obesity in early, mid, and late childhood, respectively: OR 1.66 [95% CI: 1.56, 1.78], OR 1.91 [95% CI: 1.85, 1.98], and OR 2.28 [95% CI: 2.08, 2.50] for maternal overweight; OR 2.43 [95% CI: 2.24, 2.64], OR 3.12 [95% CI: 2.98, 3.27], and OR 4.47 [95% CI: 3.99, 5.23] for maternal obesity; and OR 1.39 [95% CI: 1.30, 1.49], OR 1.55 [95% CI: 1.49, 1.60], and OR 1.72 [95% CI: 1.56, 1.91] for excessive gestational weight gain). The proportions of childhood overweight/obesity prevalence attributable to maternal overweight, maternal obesity, and excessive gestational weight gain ranged from 10.2% to 21.6%. Relative to the effect of maternal BMI, excessive gestational weight gain only slightly increased the risk of childhood overweight/obesity within each clinical BMI category (p-values for interactions of maternal BMI with gestational weight gain: p = 0.038, p < 0.001, and p = 0.637 in early, mid, and late childhood, respectively). Limitations of this study include the self-report of maternal BMI and gestational weight gain for some of the cohorts, and the potential of residual confounding. Also, as this study only included participants from Europe, North America, and Australia, results need to be interpreted with caution with respect to other populations.ConclusionsIn this study, higher maternal pre-pregnancy BMI and gestational weight gain were associated with an increased risk of childhood overweight/obesity, with the strongest effects at later ages. The additional effect of gestational weight gain in women who are overweight or obese before pregnancy is small. Given the large population impact, future intervention trials aiming to reduce the prevalence of childhood overweight and obesity should focus on maternal weight status before pregnancy, in addition to weight gain during pregnancy.

BACKGROUND:This study aimed to investigate the effect of integrating a video intervention "Movie Models" within the Feel4Diabetes-study on specific parenting practices and related parental self-efficacy regarding children's physical activity, screen-time and eating behaviour in vulnerable families (i.e. families living in low socioeconomic municipalities and at risk for developing type 2 diabetes). Additionally, there was examination of how the intervention was perceived by the parents. METHODS:Within randomly selected low socioeconomic municipalities in Belgium, families were recruited through primary schools. Families at risk for developing type 2 diabetes were identified using the FINDRISC questionnaire (n = 457). Afterwards, the municipalities were randomly assigned to the intervention or control condition. At risk families assigned to the intervention group were invited to participate in six Feel4Diabetes counselling sessions in which families were encouraged to adopt a healthier lifestyle. The "Movie Models" videos were integrated within two sessions by using a face-to-face group discussion approach. Parenting-related factors were assessed before and after the integration of the videos, using a questionnaire. After integrating the videos, some extra evaluation questions were assessed. In total, 126 families were included in a per protocol evaluation and Repeated Measures ANOVAs were conducted to evaluate the potential intervention effects. RESULTS:Some favourable intervention effects were found on parenting practices and related parental self-efficacy regarding children's eating behaviours, however almost no effects were found on parenting-related factors regarding children's physical activity and screen-time. In total, 60.0% of the participants indicated that they applied tips regarding parenting practices and 52.0% indicated that discussions with other participants regarding the videos were useful for them. CONCLUSION:The integration of "Movie Models" within the Feel4Diabetes-study was effective in improving some parenting-related factors regarding children's health behaviours, however most parenting-related factors could not be improved. The implementation of "Movie Models" as a face-to-face group discussion approach was relatively well received and may be a promising way to improve parenting-related factors in vulnerable families. TRIAL REGISTRATION:ClinicalTrials.gov NCT02278809.

IntroductionUnderstanding context and how this can be systematically assessed and incorporated is crucial to successful implementation. We describe how context has been assessed (including exploration or evaluation) in Global Alliance for Chronic Diseases (GACD) implementation research projects focused on improving health in people with or at risk of chronic disease and how contextual lessons were incorporated into the intervention or the implementation process.MethodsUsing a web-based semi-structured questionnaire, we conducted a cross-sectional survey to collect quantitative and qualitative data across GACD projects (n = 20) focusing on hypertension, diabetes and lung diseases. The use of context-specific data from project planning to evaluation was analyzed using mixed methods and a multi-layered context framework across five levels; 1) individual and family, 2) community, 3) healthcare setting, 4) local or district level, and 5) state or national level.ResultsProject teams used both qualitative and mixed methods to assess multiple levels of context (avg. = 4). Methodological approaches to assess context were identified as formal and informal assessments, engagement of stakeholders, use of locally adapted resources and materials, and use of diverse data sources. Contextual lessons were incorporated directly into the intervention by informing or adapting the intervention, improving intervention participation or improving communication with participants/stakeholders. Provision of services, equipment or information, continuous engagement with stakeholders, feedback for personnel to address gaps, and promoting institutionalization were themes identified to describe how contextual lessons are incorporated into the implementation process.ConclusionsContext is regarded as critical and influenced the design and implementation of the GACD funded chronic disease interventions. There are different approaches to assess and incorporate context as demonstrated by this study and further research is required to systematically evaluate contextual approaches in terms of how they contribute to effectiveness or implementation outcomes.