Longitudinal associations between diet quality, sedentary behaviours and physical activity and risk of overweight and obesity in preschool children: The ToyBox-study.

BACKGROUND: Lifestyle behaviours related to diet and physical activity are associated with increased risk of obesity and evidence suggests that associations might be stronger when a synergetic effect is examined. OBJECTIVE: To examine the cross-sectional and longitudinal associations between diet, screen time (ST) and step recommendations and risk of overweight and obesity in European preschoolers participating in the ToyBox-study. METHODS: In this cluster-randomized clinical trial, 718 children (51.4% boys) from six European countries participated. Parents filled out questionnaires with information on socio-demographic status, step recommendations and ST. RESULTS: Longitudinal results indicate that participants having a low Diet Quality Index (DQI), not meeting ST and step recommendations at T0 and T1 had higher odds of having overweight/obesity at T1 (odds ratio [OR] = 1.116; 95% confidence interval [CI] = 1.104-2.562) than those children having a high DQI and meeting ST and step recommendations at T0 and T1. Similarly, participants having a high DQI, but not meeting ST and step recommendations at T0 and T1 had increased odds of having overweight/obesity (OR = 2.515; 95% CI = 1.171-3.021). CONCLUSIONS: The proportion of participants having a low DQI, not adhering to both step and ST recommendations was very high, and it was associated with a higher probability of having overweight and obesity.

A lifestyle pattern characterised by high consumption of sweet and salty snacks, sugar sweetened beverages and sedentary time is associated with blood pressure in families at risk for type 2 diabetes mellitus in Europe. The Feel4Diabetes Study.

BACKGROUND: Individuals from families at high-risk for type 2 diabetes mellitus (T2DM) are also at high risk for hypertension (HTN) and cardiovascular disease. Studies identifying lifestyle patterns (LPs) combining dietary, physical activity or sedentary variables and examining their possible role with respect to developing blood pressure (BP) are limited. The present study aimed to examine the association of different LPs with BP levels in families at high risk for T2DM in Europe. METHODS: In total, 1844 adults (31.6% males) at high-risk for T2DM across six European countries were included in this cross-sectional study using data from the baseline assessment of the Feel4Diabetes Study. BP measurements and dietary and physical activity assessments were conducted, and screen times were surveyed. LPs were revealed with principal component analysis of various data regarding diet, physical activity, screen time and smoking. RESULTS: Three LPs were identified. LP3 (high consumption of sweet and salty snacks, sugar sweetened soft drinks and juices, and high amount of screen time) was positively associated with diastolic BP (B, 0.52; 95% confidence interval = 0.05-0.99) and the existence of HTN (odds ratio = 1.12; 95% confidence interval = 1.00-1.25). Participants in the highest tertile of LP3 spent mean 3 h of screen time, consumed 1.5 portions of sweet and/or salty snacks and 1 L of soft drinks on a daily basis, were associated with 12% higher risk of HTN. CONCLUSIONS: Focusing on the combination of eating and lifestyle behaviours may more accurately identify, and therefore guide preventive measures tailored to the specific needs of high-risk populations.

Association of diet quality with glycemia, insulinemia, and insulin resistance in families at high risk for type 2 diabetes mellitus in Europe: Feel4 Diabetes Study.

OBJECTIVE: The aim of the present study was to investigate the association of diet quality with fasting glycemia, insulinemia, and insulin resistance in a cross-sectional sample of adults from families at high risk for type 2 diabetes mellitus (T2DM) from six European countries, taking into account their socioeconomic status (SES). METHODS: Baseline data from non-diabetic adults from the Feel4 Diabetes study were used and diet was assessed by the Healthy Diet Score (HDS). Insulin resistance (IR) was determined by homeostasis model assessment of IR (HOMA-IR). Sociodemographic and lifestyle characteristics were assessed through standardized questionnaires. Multiple linear regressions were adjusted for many confounders, in the total sample and by SES category. RESULTS: In 1980 adults, the third tertile of diet quality was inversely associated with insulin levels (-1.48; 95% confidence interval [CI], -2.34 to 0.62), and HOMA-IR (-0.33; 95% CI, -0.57 to 0.09), yet with no statistically significant results for glucose levels. In the SES subgroup analysis, in the high SES group, both second and third diet score tertiles were inversely associated with insulin levels (-1.81; 95% CI, -2.66 to 0.95) and HOMA-IR values (-0.45; 95% CI -0.69 to 0.21), independent of age, sex, smoking and body mass index. No such associations were observed for glucose levels in the high SES group and for all indices in the low SES group. CONCLUSION: In adults from families at high risk for T2DM, higher diet quality was negatively associated with fasting insulin levels and IR, only in the high SES group and not in the low SES group. Future larger studies may be able to explore further this association, as well as the potential factors that mitigate its strength in the low SES groups.

Diabetes-related antibody-testing is a valuable screening tool for identifying monogenic diabetes - A survey from the worldwide SWEET registry.

AIMS: To evaluate access to screening tools for monogenic diabetes in paediatric diabetes centres across the world and its impact on diagnosis and clinical outcomes of children and youth with genetic forms of diabetes. METHODS: 79 centres from the SWEET diabetes registry including 53,207 children with diabetes participated in a survey on accessibility and use of diabetes related antibodies, c-peptide and genetic testing. RESULTS: 73, 63 and 62 participating centres had access to c-peptide, antibody and genetic testing, respectively. Access to antibody testing was associated with higher proportion of patients with rare forms of diabetes identified with monogenic diabetes (54 % versus 17 %, p = 0.01), lower average whole clinic HbA1c (7.7[Q1,Q2: 7.3-8.0]%/61[56-64]mmol/mol versus 9.2[8.6-10.0]%/77[70-86]mmol/mol, p < 0.001) and younger age at onset (8.3 [7.3-8.8] versus 9.7 [8.6-12.7] years p < 0.001). Additional access to c-peptide or genetic testing was not related to differences in age at onset or HbA1c outcome. CONCLUSIONS: Clinical suspicion and antibody testing are related to identification of different types of diabetes. Implementing access to comprehensive antibody screening may provide important information for selecting individuals for further genetic evaluation. In addition, worse overall clinical outcomes in centers with limited diagnostic capabilities indicate they may also need support for individualized diabetes management. TRIAL REGISTRATION: NCT04427189.

The challenge to prove a rare cause of secondary arterial hypertension. A case report of a pediatric renal solitary fibrous tumor.

BACKGROUND: Childhood hypertension is getting more attention in recent years. We present a case report of a rare cause of secondary arterial hypertension in a teenage girl - a solitary fibrous tumor of the kidney. The case demonstrates that standard imaging techniques, computed tomography and magnetic resonance imaging, are not fully reliable in the diagnosis of renovascular hypertension. CASE: A 15-year old girl was admitted to the Pediatric Department because of episodes of stiffness in the limbs, accompanied by pale skin and lips, dated 4 months back. During these episodes, high blood pressure up to 160/100 mmHg was measured. A 24-hour blood pressure monitoring demonstrated arterial hypertension stage II. Renovascular hypertension was suspected, but the computed tomography examination of the abdomen showed normal-sized renal arteries. In the left kidney hilum, an intraparenchymal formation was discovered. The data presented a non-specific lesion with a wide differential diagnosis. Given the fact that the patient had been treated with an ACE-inhibitor, serum renin level could not be correctly interpreted. The lesion was removed through a laparoscopic intervention. Intraoperatively, the tumor was compressing a small intra-renal vessel - a finding that hadn`t been discovered by the previous imaging studies. The final pathologist diagnosis was: solitary fibrous tumor. During the next six months of follow-up, the maximal blood pressure values of the patient were up to 120/80 mmHg. CONCLUSIONS: Solitary fibrous tumors of the kidneys are infrequent in children. The presented case displays a rare form of initial clinical manifestation of this tumor. It is also a demonstration that standard imaging techniques are not able to get a precise visualization of the small intra-renal vessels. At the same time, the decision of whether or not to perform a more invasive procedure should be based on the clinical conditions and risks of the individual patient.

Analysis of therapy monitoring in the International Congenital Adrenal Hyperplasia Registry.

OBJECTIVE: Congenital adrenal hyperplasia (CAH) requires exogenous steroid replacement. Treatment is commonly monitored by measuring 17-OH progesterone (17OHP) and androstenedione (D4). DESIGN: Retrospective cohort study using real-world data to evaluate 17OHP and D4 in relation to hydrocortisone (HC) dose in CAH patients treated in 14 countries. PATIENTS: Pseudonymized data from children with 21-hydroxylase deficiency (21OHD) recorded in the International CAH Registry. MEASUREMENTS: Assessments between January 2000 and October 2020 in patients prescribed HC were reviewed to summarise biomarkers 17OHP and D4 and HC dose. Longitudinal assessment of measures was carried out using linear mixed-effects models (LMEM). RESULTS: Cohort of 345 patients, 52.2% female, median age 4.3 years (interquartile range: 3.1-9.2) were taking a median 11.3 mg/m2 /day (8.6-14.4) of HC. Median 17OHP was 35.7 nmol/l (3.0-104.0). Median D4 under 12 years was 0 nmol/L (0-2.0) and above 12 years was 10.5 nmol/L (3.9-21.0). There were significant differences in biomarker values between centres (p < 0.05). Correlation between D4 and 17OHP was good in multiple regression with age (p < 0.001, R2 = 0.29). In longitudinal assessment, 17OHP levels did not change with age, whereas D4 levels increased with age (p < 0.001, R2 = 0.08). Neither biomarker varied directly with dose or weight (p > 0.05). Multivariate LMEM showed HC dose decreasing by 1.0 mg/m2 /day for every 1 point increase in weight standard deviation score. DISCUSSION: Registry data show large variability in 17OHP and D4 between centres. 17OHP correlates with D4 well when accounting for age. Prescribed HC dose per body surface area decreased with weight gain.

Sociodemographic, anthropometric, and lifestyle correlates of prediabetes and type 2 diabetes in europe: The Feel4Diabetes study.

BACKGROUND AND AIMS: The current work aimed to identify the predominant correlates of prediabetes and T2DM among a variety of socio-demographic, anthropometric and lifestyle indices, in a large sample of adults from families at high risk for T2DM. METHODS AND RESULTS: In this cross-sectional study, 2816 adults were recruited from low-socioeconomic areas in high-income countries (HICs) (Belgium-Finland), HICs under austerity measures (Greece-Spain), and low/middle-income countries (LMICs) (Bulgaria-Hungary). A positive association between the male sex (OR, 95% C.I.2.77 (1.69-4.54)) and prediabetes was revealed compared to females, while there was a negative association between younger age (<45 years) (OR, 95% C.I. 0.58 (0.37-0.92)), and low/medium levels of waist circumference (OR, 95% C.I. 0.44 (0.22-0.89)) with prediabetes compared to older age and high levels of waist circumference, respectively. Concerning T2DM, 0-0.5 cups/day of fruits and berries (OR, 95% C.I.2. 13 (1.16-3.91)) and 150-300 g fish/week (OR, 95% C.I. 2.55 (1.01-6.41)) have a positive association compared to higher consumptions, respectively. Conversely, <1 cup/week legumes (OR, 95% C.I. 0.55 (0.31-0.99) as well as 0-0.5 servings (OR, 95% C.I. 0.34 (0.12-0.95) and 0.5-1 servings (OR, 95% C.I. 0.37 (0.19-0.71) of full-fat dairy/day have a negative association compared to higher consumptions, respectively. CONCLUSION: These findings indicate the need for diabetes prevention measures targeting young adults and especially men, above 45 years of age, with central obesity and poor dietary habits and prioritize vulnerable groups and populations living in LMICs. NATIONAL CLINICAL TRIAL NUMBER: NCT02393872.

Can food parenting practices explain the association between parental education and children's food intake? The Feel4Diabetes-study.

OBJECTIVE: This study aimed to investigate the mediating role of food parenting practices (FPP), including home availability of different types of foods and drinks, parental modelling of fruit intake, permissiveness and the use of food as a reward in the relationship between parental education and dietary intake in European children. DESIGN: Single mediation analyses were conducted to explore whether FPP explain associations between parents' educational level and children's dietary intake measured by a parent-reported FFQ. SETTING: Six European countries. PARTICIPANTS: Parent-child dyads (n 6705, 50·7 % girls, 88·8 % mothers) from the Feel4Diabetes-study. RESULTS: Children aged 8·15 ± 0·96 years were included. Parental education was associated with children's higher intake of water, fruits and vegetables and lower intake of sugar-rich foods and savoury snacks. All FPP explained the associations between parental education and dietary intake to a greater or lesser extent. Specifically, home availability of soft drinks explained 59·3 % of the association between parental education and sugar-rich food intake. Home availability of fruits and vegetables was the strongest mediators in the association between parental education and fruit and vegetable consumption (77·3 % and 51·5 %, respectively). Regarding savoury snacks, home availability of salty snacks and soft drinks was the strongest mediators (27·6 % and 20·8 %, respectively). CONCLUSIONS: FPP mediate the associations between parental education and children's dietary intake. This study highlights the importance of addressing FPP in future interventions targeting low-educated populations.

Diet quality in association to lipidaemic profile in adults of families at high-risk for type 2 diabetes in Europe: The Feel4Diabetes study.

BACKGROUND AND AIMS: The role of diet in blood lipids is scarcely investigated in adults at risk of Type 2 Diabetes Mellitus (T2DM) and even less studied regarding their socioeconomic status (SES). This study aimed to investigate the associations of diet quality with blood lipids in adults from families at high-risk for developing T2DM from six European countries, considering their SES. METHODS AND RESULTS: In total 2049 adults (67% women) from relatively low-SES regions and high T2DM risk families were enrolled. Dietary habits, sedentary behaviour and sociodemographic characteristics were assessed using standardised questionnaires. The associations of tertiles of healthy diet score (HDS) with blood lipids were tested by univariate analysis of variance (UNIANOVA). HDL-Cholesterol (HDL-C) was positively (B 1.54 95%CI 0.08 to 2.99) and LDL-Cholesterol (LDL-C) (B -4.15 95%CI -7.82 to -0.48), ratio of total cholesterol to HDL-C (B -0.24 95%CI -0.37 to -0.10), ratio of LDL-C to HDL-C (B -0.18 95%CI -0.28 to -0.08) and Atherogenic Index of Plasma (B -0.03 95%CI -0.06 to 0.00) inversely associated with the highest tertile of diet score compared to the lowest tertile independently of age, sex, Body Mass Index, total screen time and smoking. In sub-analysis of education (<14 and ≥ 14 years of education), these findings were only significant in the high-SES group. CONCLUSION: While diet quality was poorer in the low-SES group, an association between diet quality and lipidemic profile was not found, as increased central obesity and smoking prevalence might have confounded this association. These findings indicate the need for tailor-made interventions, guided by the specific risk factors identified per population sub groups.

Surgical Practice in Girls with Congenital Adrenal Hyperplasia: An International Registry Study.

In this article international trends in surgical practice in girls with congenital adrenal hyperplasia (CAH) are evaluated. All cases that had been classified in the I-CAH/I-DSD registry as 46,XX CAH and who were born prior to 2017 were identified. Centers were approached to obtain information on surgical decision making. Of the 330 included participants, 208 (63.0%) presented within the first month of life, and 326 (98.8%) cases were assigned female. Genital surgery had been performed in 250 (75.8%). A total of 64.3, 89.2, and 96.8% of cases residing in Europe, South America and Asia, respectively, had at least one surgery. In a logistic regression model for the probability of surgery before the second birthday (early surgery) over time an increase of probability for early vaginal surgery could be identified, but not for clitoral surgery or both surgeries combined. Genitoplasty in girls with CAH remains controversial. This large international study provides a snapshot of current practice and reveals geographical and temporal differences. Fewer surgeries were reported for Europe, and there seems to be a significant trend towards aiming for vaginal surgery within the first 2 years of life.

Breastfeeding and Overweight in European Preschoolers: The ToyBox Study.

The benefits of breastfeeding (BF) include risk reduction of later overweight and obesity. We aimed to analyse the association between breastfeeding practices and overweight/obesity among preschool children participating in the ToyBox study. Data from children in the six countries, participating in the ToyBox-study (Belgium, Bulgaria, Germany, Greece, Poland, and Spain) 7554 children/families and their age is 3.5-5.5 years, 51.9% were boys collected cross-sectionally in 2012. The questionnaires included parents' self-reported data on their weight, height, socio-demographic status, and infant feeding practices. Measurements of preschool children's weight and height were done by trained researchers using standard protocols and equipment. The ever breastfeeding rate in the total sample was 85.0% (n = 5777). Only 6.3% (n = 428) of the children from the general sample were exclusively breastfed (EBF) for the duration of the first six months. EBF for four to six months was significantly (p < 0.001) less likely among mothers with formal education < 12 years (adjusted Odds Ratio (OR) = 0.61; 95% Confidence interval (CI) 0.44-0.85), smoking throughout pregnancy (adjusted OR = 0.39; 95% CI 0.24-0.62), overweight before pregnancy (adjusted OR = 0.67; 95%CI 0.47-0.95) and ≤25 years old. The median duration of any breastfeeding was five months. The prevalence of exclusive formula feeding during the first five months in the general sample was about 12% (n = 830). The prevalence of overweight and obesity at preschool age was 8.0% (n = 542) and 2.8% (n = 190), respectively. The study did not identify any significant association between breastfeeding practices and obesity in childhood when adjusted for relevant confounding factors (p > 0.05). It is likely that sociodemographic and lifestyle factors associated with breastfeeding practices may have an impact on childhood obesity. The identified lower than desirable rates and duration of breastfeeding practices should prompt enhanced efforts for effective promotion, protection, and support of breastfeeding across Europe, and in particular in regions with low BF rates.

The effect of a cluster-randomized controlled trial on lifestyle behaviors among families at risk for developing type 2 diabetes across Europe: the Feel4Diabetes-study.

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.

European Childhood Obesity Risk Evaluation (CORE) index based on perinatal factors and maternal sociodemographic characteristics: the Feel4Diabetes-study.

The aim of this study was to develop and examine the predictive accuracy of an index that estimates obesity risk in childhood based on perinatal factors and maternal sociodemographic characteristics. Analysis was conducted by using cross-sectional and retrospective data collected from a European cohort of 2775 schoolchildren and their families participating in the Feel4Diabetes-study. The cohort was randomly divided by using two-thirds of the sample for the development of the index and the remaining one third for assessing its predictive accuracy. Logistic regression analyses determined a prediction model for childhood obesity. The area under the receiver operating characteristic curve (AUC-ROC), sensitivity, specificity, and positive and negative predictive values (PPV, NPV) were calculated. Cut-off analysis was applied to identify the optimal value of the index score that predicts obesity with the highest possible sensitivity and specificity. Eight factors were found to be significantly associated with obesity and were included as components in the European "Childhood Obesity Risk Evaluation" (CORE) index: region of residence, maternal education, maternal pre-pregnancy weight status, gestational weight gain, maternal smoking during pregnancy, birth weight for gestational age, infant growth velocity, and exclusive breastfeeding during the first 6 months. Risk score ranged from 0 to 22 corresponding to a risk from 0.9 to 54.6%. The AUC-ROC was 0.725 with optimal cut-off ≥9 (sensitivity = 74.1%, specificity = 61.0%, PPV = 11.3%, NPV = 97.2%).Conclusion: The European CORE index can be used as a screening tool for the identification of infants at high-risk for becoming obese at 6-9 years. This tool could assist healthcare professionals in initiating preventive measures from the early life.Trial registration: The Feel4Diabetes-intervention is registered at https://clinicaltrials.gov/ ; number, CT02393872; date, March 20, 2015. What is Known: • As prevention of obesity should start early in life, there is a compelling rationale for the early identification of high-risk children to facilitate targeted intervention. What is New: • This study developed and assessed the predictive accuracy of an index for the Childhood Obesity Risk Evaluation (CORE), combining certain perinatal factors and maternal sociodemographic characteristics in a large European cohort. • The European CORE index can be used as a screening tool for identifying infants at high-risk for becoming obese at 6-9 years and assist health professionals in initiating early prevention strategies.

Complementary Feeding and Overweight in European Preschoolers: The ToyBox-Study.

Complementary feeding (CF) should start between 4-6 months of age to ensure infants' growth but is also linked to childhood obesity. This study aimed to investigate the association of the timing of CF, breastfeeding and overweight in preschool children. Infant-feeding practices were self-reported in 2012 via a validated questionnaire by >7500 parents from six European countries participating in the ToyBox-study. The proportion of children who received breast milk and CF at 4-6 months was 51.2%. There was a positive association between timing of solid food (SF) introduction and duration of breastfeeding, as well as socioeconomic status and a negative association with smoking throughout pregnancy (p < 0.005). No significant risk to become overweight was observed among preschoolers who were introduced to SF at 1-3 months of age compared to those introduced at 4-6 months regardless of the type of milk feeding. Similarly, no significant association was observed between the early introduction of SF and risk for overweight in preschoolers who were breastfed for ≥4 months or were formula-fed. The study did not identify any significant association between the timing of introducing SF and obesity in childhood. It is likely that other factors than timing of SF introduction may have impact on childhood obesity.

Gonadectomy in conditions affecting sex development: a registry-based cohort study.

OBJECTIVES: To determine trends in clinical practice for individuals with DSD requiring gonadectomy. DESIGN: Retrospective cohort study. METHODS: Information regarding age at gonadectomy according to diagnosis; reported sex; time of presentation to specialist centre; and location of centre from cases reported to the International DSD Registry and who were over 16 years old in January 2019. RESULTS: Data regarding gonadectomy were available in 668 (88%) individuals from 44 centres. Of these, 248 (37%) (median age (range) 24 (17, 75) years) were male and 420 (63%) (median age (range) 26 (16, 86) years) were female. Gonadectomy was reported from 36 centres in 351/668 cases (53%). Females were more likely to undergo gonadectomy (n = 311, P < 0.0001). The indication for gonadectomy was reported in 268 (76%). The most common indication was mitigation of tumour risk in 172 (64%). Variations in the practice of gonadectomy were observed; of the 351 cases from 36 centres, 17 (5%) at 9 centres had undergone gonadectomy before their first presentation to the specialist centre. Median age at gonadectomy of cases from high-income countries and low-/middle-income countries (LMIC) was 13.0 years (0.1, 68) years and 16.5 years (1, 28), respectively (P < 0.0001) with the likelihood of long-term retention of gonads being higher in LMIC countries. CONCLUSIONS: The likelihood of gonadectomy depends on the underlying diagnosis, sex of rearing and the geographical setting. Clinical benchmarks, which can be studied across all forms of DSD will allow a better understanding of the variation in the practice of gonadectomy.

Lipidemic Profile Changes over a Two-Year Intervention Period: Who Benefited Most from the Feel4Diabetes Program?

Identification of participants' characteristics who benefited most from large community-based intervention studies may guide future prevention initiatives in order to maximize their effectiveness. The current study aimed to examine the socio-demographic, anthropometric, and behavioral characteristics, as well as the health and eating perceptions of those who improved their lipidemic profile, in the Feel4Diabetes early screening and prevention program. In the present analyses, 1773 adults from families at high risk for developing type 2 diabetes mellitus (T2DM) were enrolled, receiving either the standard care or the more intensive intervention, and 33.3-55.2% of them improved one or more of their lipidemic indices by >5%. Women, people living in Southeastern Europe, coming from two-parent families, having higher financial security, educational level and better diet quality were associated with a 27-64% higher likelihood for benefiting from the program regarding one or more of their lipidemic profile indices. Participants who were overweight or obese (especially with central obesity), employed, with prolonged sedentary behavior, prone to emotional eating and perceiving their weight status as lower than their actual weight were 24-43% less likely to have benefited. These findings should guide future interventions, prioritizing regions in greater need, and being tailor-made to specific population characteristics in order to further improve their effectiveness.

Combining Effect and Process Evaluation on European Preschool Children's Snacking Behavior in a Kindergarten-Based, Family-Involved Cluster Randomized Controlled Trial: The ToyBox Study.

This study aimed at (1) studying the effect of the standardized ToyBox intervention on European preschoolers' snacking behavior, and (2) studying whether a higher process evaluation score from teachers and parents/caregivers was associated with a more positive result for preschoolers' snack intake. A sample of 4970 preschoolers (51.4% boys, 4.74 ± 0.44 years) from six European countries provided information on snack intake with the use of a Food Frequency Questionnaire. To investigate the effect of the intervention, multilevel repeated measures analyses were executed for the total sample and the six country-specific samples. Furthermore, questionnaires to measure process evaluation were used to compute a total process evaluation score for teachers and parents/caregivers. No significant intervention effects on preschoolers' snack intake were found (all p > 0.003). In general, no different effects of the intervention on snack intake were found according to kindergarten teachers' and parents'/caregivers' process evaluation scores. The lack of effects could be due to limited intervention duration and dose. To induce larger effects on preschoolers' snack intake, a less standardized intervention which is more tailored to the local needs might be needed.

Lifestyle Changes Observed among Adults Participating in a Family- and Community-Based Intervention for Diabetes Prevention in Europe: The 1st Year Results of the Feel4Diabetes-Study.

The Feel4Diabetes intervention was a school and community-based intervention aiming to promote healthy lifestyle and tackle obesity and obesity-related metabolic risk factors for the prevention of type 2 diabetes (T2D) among families at risk of developing this disease. The current study aims to present the results on lifestyle behaviors obtained from parents during the first year of the Feel4Diabetes intervention. This multicomponent intervention had a cluster randomized design and was implemented in Belgium, Bulgaria, Finland, Greece, Hungary and Spain over two years (2016-2018). Standardized protocols and procedures were used by the participating centers in all countries to collect data on parents' lifestyle behaviors (diet, physical activity, sedentary behavior). The Feel4Diabetes intervention was registered at clinicaltrials.gov (registration number: NCT02393872). In total, 2110 high-risk parents participated in the baseline and 12-month follow-up examination measurements. Participants allocated to the intervention group reduced their daily consumption of sugary drinks (p = 0.037) and sweets (p = 0.031) and their daily screen time (p = 0.032), compared with the control group. In addition, participants in the intervention group in Greece and Spain increased their consumption of breakfast (p = 0.034) and fruits (p = 0.029), while in Belgium and Finland they increased their water intake (p = 0.024). These findings indicate that the first year of the Feel4Diabetes intervention resulted in the improvement of certain lifestyle behaviors in parents from high-risk families.

Two-stage, school and community-based population screening successfully identifies individuals and families at high-risk for type 2 diabetes: the Feel4Diabetes-study.

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).

Development and reliability of questionnaires for the assessment of diet and physical activity behaviors in a multi-country sample in Europe the Feel4Diabetes Study.

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.