Growth and gut comfort of healthy term infants exclusively fed with a partially hydrolysed protein-based infant formula: a randomized controlled double-blind trial.

Objective: This 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). Methods: A 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). Results: Overall, 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. Conclusions: The 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 Registration: https://clinicaltrials.gov/study/NCT05757323?id=NCT05757323&rank=1, identifier (NCT05757323).

Factors affecting continuous participation in follow-up evaluations during a lifestyle intervention programme for type 2 diabetes prevention: The Feel4Diabetes-study.

AIMS: Community- and school-based lifestyle interventions are an efficient method of preventing type 2 diabetes in vulnerable populations. Many participants, however, fail to complete the necessary follow-ups. We investigated factors affecting the continuous participation in follow-up evaluations during the Feel4Diabetes-study, a multilevel intervention programme implemented across Europe. METHODS: Socioeconomic, sociodemographic and clinical factors were assessed for 2702 participants within six participating countries: Bulgaria and Hungary (low-to-middle-income countries, LMIC), Belgium and Finland (high-income countries, HIC) and Greece and Spain (high-income countries under austerity measures, HICAM). RESULTS: Statistically significant differences were detected with respect to sex, control group, education level, employment status, BMI and blood pressure measurements (systolic and diastolic blood pressure). Post hoc analysis revealed significant differences within socioeconomic regions. Higher levels of education were associated with significantly lower attrition in HIC (p < 0.05) and HICAM (p < 0.001), higher employment status was associated with lower attrition in HICAM (p < 0.001) and being female was associated with lower attrition in LMIC (p < 0.001). Surprisingly, the intervention group exhibited higher-than-expected attrition in HIC (p < 0.001) and HICAM (p = 0.003), and lower attrition in LMIC (p = 0.007). When tested together in the same multivariable predictive model, all sociodemographic and socioeconomic variables along with higher BMI retained their statistical significance, while systolic and diastolic blood pressure failed to remain significant. CONCLUSIONS: Key socioeconomic and sociodemographic factors along with BMI play a significant role in determining continuous participation in follow-up evaluations during school- and community-based intervention programmes.

Physical activity in relation to metabolic health and obesity: The Feel4Diabetes study.

AIM: To examine physical activity levels in association with metabolic health and estimate the stability of metabolically healthy obese (MHO) phenotypes over a 2-year period. METHODS: In total, 2848 men and women from families at risk of the development of diabetes were recruited. Participants were classified as obese or non-obese and metabolic health was defined using five existing definitions. Physical activity was estimated with the International Physical Activity Questionnaire and pedometers. RESULTS: Prevalence of the MHO phenotype varied among definitions (0% to 20.2%). Overall, the MHO were more active than the metabolically unhealthy obese (MUO). Daily sitting hours (odds ratio [OR] = 1.055, 95% confidence interval [CI]: 1.009-1.104) and daily steps (per 500; OR = 0.934, 95% CI: 0.896-0.973) were remarkable predictors of metabolic health in individuals with obesity; and likewise, in individuals without obesity. After 2 years, 44.1% of baseline MHO adults transitioned to MUO, while 84.0% of the MUO at baseline remained at the same phenotype. Although physical activity was not a major determinant in phenotype transitioning, daily steps were associated with the maintenance of metabolic health over time in the non-obese group. CONCLUSION: A universally accepted definition for MHO is needed. Being physically active can contribute to a metabolically healthy profile even in the presence of obesity; still, MHO is a transient condition and physical activity alone may not be an adequate factor for its maintenance.

Effects of Four Weeks of In-Season Pre-Workout Supplementation on Performance, Body Composition, Muscle Damage, and Health-Related Markers in Basketball Players: A Randomized Controlled Study.

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 ß-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.

Longitudinal associations between food parenting practices and dietary intake in preschool children: The ToyBox Study.

INTRODUCTION: Food Parenting Practices (FPPs) include the practices parents use in the act of feeding their children, which may further influence their health. OBJECTIVES: To assess associations between changes in FPPs (permissiveness, food availability, guided choices, water encouragement, rules and limits and the use of food as reward) over 1 year and dietary intake (water, energy-dense/nutrient-poor and nutrient-dense foods) at follow-up in 4- to 6-year-old preschool-aged children. METHODS: Longitudinal data from the control group of the ToyBox study, a cluster-randomized controlled intervention study, was used (NCT02116296). Multilevel ordinal logistic regression analyses including FPP as the independent variables and dietary intake as outcome. RESULTS: Nine hundred sixty-four parent-child dyads (50.5% boys and 95.0% mothers) were included. Limited changes on the use of FPPs were observed over time. Nevertheless, in boys, often having F&V at home was associated with higher F&V consumption (OR = 6.92 [1.58; 30.38]), and increasing home availability of F&V was directly associated with higher water consumption (OR = 7.62 [1.63; 35.62]). Also, not having sweets or salty snacks available at home was associated with lower consumption of desserts (OR = 4.34 [1.75; 10.75]). In girls, having F&V availability was associated with higher F&V consumption (OR = 6.72 [1.52; 29.70]) and lower salty snack consumption (OR = 3.26 [1.50; 7.10]) and never having soft drinks at home was associated with lower consumption of sweets (OR = 7.89 [6.32; 9.86]). Also, never being permissive about soft drink consumption was associated with lower soft drink consumption (OR = 4.09 [2.44; 6.85]). CONCLUSION: Using favorable FPPs and avoiding the negative ones is prospectively associated with healthier dietary intake, especially of F&V, and less intake of soft drinks, desserts, and salty snacks.

Association between Screen Time and Sociodemographic Factors, Physical Activity, and BMI among Children in Six European Countries (Feel4Diabetes): A Cross-Sectional Study.

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.

Addressing chronic diseases: a comparative study of policies towards type-2 diabetes and hypertension in selected European countries.

BACKGROUND: Type-2 diabetes (T2D) and hypertension (HTN) are two of the most prevalent non-communicable diseases (NCDs): they both cause a relevant number of premature deaths worldwide and heavily impact the national health systems. This study illustrates the impact of HTN and T2D in four European countries (Albania, Bulgaria, Greece and Spain) and compares their policies towards the monitoring and management of HTN and T2D and the prevention of NCDs as a whole. This analysis is conducted throughout the DigiCare4You Project (H2020)-which implements an innovative solution involving digital tools for the prevention and management of T2D and HTN. METHODS: The analysis is implemented through desk research, and it is enriched with additional information directly provided by the local coordinators in the four countries, by filling specific semi-structured forms. RESULTS: The countries exhibit significant differences in the prevalence of HTN and T2D and available policies and programs targeted to these two chronic conditions. Each country has implemented strategies for HTN and T2D, including prevention initiatives, therapeutic guidelines, educational programs and children's growth monitoring programs. However, patient education on proper disease management needs improvement in all countries, registries about patients affected by HTN and T2D are not always available, and not all countries promoted acts to contain the increasing rates of risk factors related to NCDs. CONCLUSIONS: While political awareness of the risks associated with HTN, T2D and NCDs in general is growing, there is a collective need for countries to strengthen their policies for preventing and managing these chronic diseases.

Interplay of the Mediterranean diet and genetic hypertension risk on blood pressure in European adolescents: Findings from the HELENA study.

Early-life onset of high blood pressure is associated with the development of cardiovascular diseases in adulthood. In adolescents, limited evidence exists regarding the association between adherence to the Mediterranean Diet (MedDiet) and normal blood pressure (BP) levels, as well as its potential to modulate genetic predisposition to HTN. This study investigated the interaction between a MedDiet score and a recently developed HTN-genetic risk score (HTN-GRS) on blood pressure levels in a European adolescent cohort. The MedDiet score was derived from two non-consecutive 24-h dietary recalls and ranged from 0 (indicating low adherence) to 9 (indicating high adherence). Multiple linear regression models, adjusted for covariates, were employed to examine the relationship between the MedDiet score and BP z-scores and to assess the interaction effects between the MedDiet score and HTN-GRS on BP z-scores. MedDiet score showed a negative association with z-systolic BP (SBP) (ß = -0.40, p < 0.001) and z-diastolic BP (DBP) (ß = -0.29, p = 0.001). Additionally, a significant interaction effect was identified between the MedDiet score and HTN-GRS on z-SBP (ß = 0.02, p < 0.001) and z-DBP (ß = 0.02, p < 0.001). The modulatory effect of the MedDiet was more pronounced in females than in males, and HTN-GRS exhibited a stronger influence on DBP than on SBP.   Conclusion: The study suggests that higher adherence to the MedDiet is associated with reduced BP levels in adolescents and provides evidence of a genetic-diet interaction influencing BP in adolescents. What is Known: • Adherence to the Mediterranean diet may reduce BP levels. What is New: • It is the first study to assess the connection between adherence to a Mediterranean diet, a hypertension genetic risk score, and how they interact in influencing blood pressure. • It is conducted within a multicenter cohort of European adolescents.

Associations between household food environment and daily intake of regular and diet soft drinks per BMI status of European children: Feel4Diabetes Study.

The objective of this study was to investigate how the availability of food in the household environment is associated with a daily intake of regular and diet soft drinks in European children, considering BMI status. This cross-sectional study utilised baseline data from 12 211 schoolchildren participating in the Feel4Diabetes European lifestyle modification intervention. Sociodemographics, soft drink intake and household food availability data were collected using parent-completed questionnaires. Anthropometry was recorded, and children were classified into BMI categories according to the International Obesity Task Force cut-offs. In the multivariate logistic regression analysis controlled for children's sex, mother's BMI, and educational level, frequent household availability of fruit juice (sugar added), regular soft drinks and salty snacks compared to less frequent were positively associated with daily regular soft drink intake in children, regardless of BMI group (ORs range 1.59-6.69). Conversely, frequent availability of fruit juice (no added sugar) was inversely related to regular soft drink intake in both BMI groups, as was the availability of fresh fruit in the overweight/obesity group, and the availability of diet soft drinks in the underweight/normal-weight (ORs range 0.31-0.54). In conclusion, habitual household availability of selected energy-dense foods/beverages was positively associated with a daily intake of regular soft drinks in European children, regardless of BMI status. Contrastingly, household availability of fresh fruit, fruit juice (no added sugar) and diet soft drinks were inversely associated with regular soft drink intake. Programmes focusing on reducing children's soft drink intake should consider reducing the availability of sugar-added beverages in the household food environment and encouraging water consumption, as a practical, healthier alternative suggestion.

Association between adherence to the EAT-Lancet sustainable reference diet and cardiovascular health among European adolescents: the HELENA study.

BACKGROUND: The EAT-Lancet Commission proposed a global reference diet to promote healthy diets within planetary boundaries. Studies evaluating the associations between the reference diet with health outcomes among adolescents are scarce. Thus, our aim was to assess the association between adherence to the EAT-Lancet diet and cardiovascular health among European adolescents. METHODS: Data from the HELENA study were used. Usual dietary intake was assessed using two 24-h dietary recalls and adherence to the EAT-Lancet diet was assessed using the Planetary Health Diet Index (PHDI), a 16-component index that ranges from 0 to 150 points. Cardiovascular health was assessed through the seven-component Ideal Cardiovascular Health (ICH) score: never smoked, eutrophic body mass index, moderate-to-vigorous physical activity, healthy dietary pattern, low blood pressure, low fasting plasma glucose, and low total cholesterol. Total ICH score was categorized into ideal (5-7) and non-ideal (0-4). RESULTS: A 10-point increment in the PHDI was associated with a lower probability of a non-ideal ICH status (OR 0.84, [95% CI: 0.75, 0.94]) among European adolescents, after adjusting for age, sex, socio-economic status, and total energy intake. Furthermore, a 10-point increment in the PHDI was associated with lower probability of high blood pressure (OR: 0.87 [0.79, 0.96]) and a lower probability of high blood cholesterol (OR: 0.88 [0.78, 0.99]). CONCLUSION: Our study suggests that a higher PHDI may be associated with a better cardiovascular health status among European adolescents.

Parental practices and children's lifestyle correlates of childhood overweight/obesity in Europe: The Feel4Diabetes study.

BACKGROUND: Parental influences on children's eating and physical activity (PA) and consequently on their weight are fundamental. The present study aimed to identify the predominant correlates of childhood overweight/obesity among a variety of parental practices and children's lifestyle indices in a large sample of children in Europe. METHODS: Families from low socio-economic status regions were recruited through schools, located in six European countries (Belgium, Finland, Greece, Spain, Bulgaria and Hungary). Seven thousand three hundred ninety-seven children 4-12 years old and their parents were selected using the FINDRISC-questionnaire. Parental practices assessed included parental role modelling, permissiveness and reward. Children's dietary intake and lifestyle behaviours were assessed through parent-reported questionnaires. RESULTS: Regarding parental practices, it was revealed that being sometimes (odds ratio [OR] = 1.26; 95% confidence interval [CI] = 1.10-1.43) or rarely (OR = 1.43; 95% CI = 1.21-1.69) physically active with the child was associated with greater overweight/obesity risk, whereas rare permission of computer/mobile/tablet (OR = 0.81; 95% CI = 0.67-0.98) and sometimes (OR = 0.77; 95% CI = 0.68-0.88) or rare (OR = 0.77; 95% CI = 0.66-0.91) reward with PA were associated with lower risk. Regarding children's lifestyle factors, consuming > 3 cups/week fresh fruit juices (OR = 1.28; 95% CI = 1.13-1.45), skipping breakfast (OR = 1.37; 95% CI = 1.17-1.61), absence of 1 h of daily PA (OR = 1.40; 95% CI = 1.24-1.58) and increased daily screen time (ST) (OR = 1.23; 95% CI = 1.09-1.39) were associated with greater overweight/obesity risk. All the variables were adjusted for maternal education, child's sex and age. CONCLUSIONS: These findings emphasize the necessity of family-centered approaches in health promotion and obesity prevention programs for children. Such programs should focus on parents as the primary role models in exerting positive influence and encouraging healthy eating habits, PA, and ST behaviors in their children, which in turn, may have a substantial impact on children's overall weight status.

The Association of Maternal Weight Status throughout the Life-Course with the Development of Childhood Obesity: A Secondary Analysis of the Healthy Growth Study Data.

Maternal weight-status at various time-points may influence child obesity development, however the most critical time-point remains unidentified. We used data from the Healthy Growth Study, a cross-sectional study of 2666 Greek schoolchildren aged 9-13 years, exploring associations between childhood obesity and maternal weight-status at pre-pregnancy, during pregnancy/gestational weight gain, and at the child's pre-adolescence. Logistic regression analyses examined associations between maternal weight-status being "below" or "above" the recommended cut-off points (WHO BMI thresholds or IOM cut-off points), at the three time-points, individually or combined into weight-status trajectory groups to determine the strongest associations with child obesity in pre-adolescence. Adjusted models found significant associations and the highest odds ratios [95% Confidence Intervals] for mothers affected by obesity before pregnancy (4.16 [2.47, 7.02]), those with excessive gestational weight gain during pregnancy (1.50 [1.08, 2.08]), and those affected by obesity at their child's pre-adolescence (3.3 [2.29, 4.87]). When combining these weight-status groups, mothers who were above-above-below (3.24 [1.10, 9.55]), and above-above-above (3.07 [1.95, 4.85]) the healthy weight recommendation-based thresholds in each time-point, had a three-fold higher likelihood of child obesity, compared to the below-below-below trajectory group. Maternal obesity across all examined time-points was significantly associated with childhood obesity. Effective childhood obesity preventive initiatives should commence at pre-conception, targeting maternal weight throughout the life-course and childhood developmental stages.

Associations of Maternal Educational Level, Proximity to Greenspace During Pregnancy, and Gestational Diabetes With Body Mass Index From Infancy to Early Adulthood: A Proof-of-Concept Federated Analysis in 18 Birth Cohorts.

International sharing of cohort data for research is important and challenging. We explored the feasibility of multi-cohort federated analyses by examining associations between three pregnancy exposures (maternal education, exposure to green vegetation and gestational diabetes) with offspring BMI from infancy to 17 years. We used data from 18 cohorts (n=206,180 mother-child pairs) from the EU Child Cohort Network and derived BMI at ages 0-1, 2-3, 4-7, 8-13 and 14-17 years. Associations were estimated using linear regression via one-stage IPD meta-analysis using DataSHIELD. Associations between lower maternal education and higher child BMI emerged from age 4 and increased with age (difference in BMI z-score comparing low with high education age 2-3 years = 0.03 [95% CI 0.00, 0.05], 4-7 years = 0.16 [95% CI 0.14, 0.17], 8-13 years = 0.24 [95% CI 0.22, 0.26]). Gestational diabetes was positively associated with BMI from 8 years (BMI z-score difference = 0.18 [CI 0.12, 0.25]) but not at younger ages; however associations attenuated towards the null when restricted to cohorts which measured GDM via universal screening. Exposure to green vegetation was weakly associated with higher BMI up to age one but not at older ages. Opportunities of cross-cohort federated analyses are discussed.

The body mass index increases the genetic risk scores' ability to predict risk of hepatic damage in European adolescents: The HELENA study.

BACKGROUND: Hepatic disorders are often complex and multifactorial, modulated by genetic and environmental determinants. During the last years, the hepatic disease has been progressively established from early stages in life. The use of genetic risk scores (GRS) to predict the genetic susceptibility to a particular phenotype among youth has gained interest in recent years. Moreover, the alanine aminotransferase (ALT) blood biomarker is often considered as hepatic screening tool, in combination with imaging techniques. The aim of the present study was to develop an ALT-specific GRS to help in the evaluation of hepatic damage risk in European adolescents. METHODS: A total of 972 adolescents (51.3% females), aged 12.5-17.5 years, from the Healthy Lifestyle in Europe by Nutrition in Adolescence study were included in the analyses. The sample incorporated adolescents in all body mass index (BMI) categories and was divided considering healthy/unhealthy ALT levels, using sex-specific cut-off points. From 1212 a priori ALT-related single nucleotide polymorphisms (SNPs) extracted from candidate gene selection, a first screening of 234 SNPs univariately associated was established, selecting seven significant SNPs (p < .05) in the multivariate model. An unweighted GRS (uGRS) was developed by summing the number of reference alleles, and a weighted GRS (wGRS), by multiplying each allele to its estimated coefficient. RESULTS: The uGRS and wGRS were significantly associated with ALT (p < .001). The area under curve was obtained integrating BMI as clinical factor, improving the predictive ability for uGRS (.7039) and wGRS (.7035), using 10-fold internal cross-validation. CONCLUSIONS: Considering BMI status, both GRSs could contribute as complementary tools to help in the early diagnosis of hepatic damage risk in European adolescents.

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.

Cost effectiveness review of text messaging, smartphone application, and website interventions targeting T2DM or hypertension.

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).

Role of parenting practices and digital media on beverage intake in European schoolchildren of different weight status. Feel4Diabetes-study.

OBJECTIVES: Halting the rise in childhood obesity is an ongoing challenge in Europe. Sugar-sweetened beverage (SSB) and artificially sweetened beverage (ASB) consumption has become common practice at home and during family meals. The objective of this study was to investigate associations of parenting practices and home digital media availability with beverage intake in European schoolchildren of different weight groups. METHODS: Cross-sectional data were derived from six countries taking part in the multicentered Feel4Diabetes-study. Anthropometric data were measured for 12 030 schoolchildren (n = 6097 girls; median age = 8.1 y). Details on sociodemographic characteristics, beverage intake, food parenting practices, and home availability of digital media were collated from questionnaires. The outcomes, daily SSB and ASB intakes, were included as dependent variables in multivariable regression models that provided odds ratios reflecting their association with parenting practices and digital media (exposures), after stratifying for children's weight status (underweight or normal versus overweight or obese). RESULTS: After controlling for children's sex, region, maternal body mass index, and education, the multivariate model found that in both body mass index groups, permissive parenting practices, such as rewarding and allowing consumption of unhealthy foods "very often or often," as compared with "rarely or never," were associated with a high daily intake of SSBs and ASBs in children, while parents "watching television together with their child," rewarding with screen time, and availability of television in children's rooms increased the likelihood of both beverages in the underweight or normal-weight group. CONCLUSIONS: Modification of permissive parenting practices and removal of television from children's rooms could effectively reduce SSB intake and curb the ongoing threat of child obesity in Europe.

Parental BMI and country classification by Gross National Income are stronger determinants of prospective BMI deterioration compared to perinatal risk factors at pre-adolescence: Feel4Diabetes Study.

OBJECTIVES: This study aimed to evaluate all known risk factors, from perinatal to adolescence and identify those predominantly related with prospective BMI deterioration. METHODS: Prospective data analysis from the European Feel4Diabetes-study involving 12,211 children from six countries. Details on perinatal and sociodemographic characteristics were collected by parental self-reported questionnaires. Children's anthropometric data were measured by research personnel. Associations between risk factors and children's BMI deterioration (i.e increase) from baseline (mean age 8.2 ± 0.98 years) to the 2-year follow-up (10.3 ± 1.0 years) were explored by applying logistic regression analyses. RESULTS: Univariate analysis revealed that all known risk factors for early overweight/obesity development, remained dominant in prospective BMI deterioration. When multivariate analysis was applied including additional variables such as parents' current BMI status, family socio-demographic characteristics and country economic classification based on Gross National Income, most perinatal risk factors were no longer significant. Multivariate analysis revealed that pre-pregnancy maternal overweight/obesity (OR, 95%CI: 2.71, 1.67-4.38), early introduction of solid foods (2.54, 1.21-5.31), parental current BMI status (3.53, 2.17-5.72) and country economic classification (low income: 4.67, 2.20-9.93; under austerity measures: 6.78, 3.18-14.48) were the only parameters associated with higher odds for children's BMI deterioration from the study baseline to 2-year follow-up after adjusting for children's gender. CONCLUSIONS: The most predominant risk factors influencing children's prospective BMI deterioration were parental BMI and country economic classification as compared to perinatal. These findings should guide public health initiatives aiming to tackle the childhood obesity epidemic and social inequalities on a European level.

The Association of Lifestyle Patterns with Prediabetes in Adults from Families at High Risk for Type 2 Diabetes in Europe: The Feel4Diabetes Study.

The increasing prevalence of prediabetes globally does not bode well for the growing epidemic of type 2 diabetes (T2D) and its complications. Yet there is a lack of studies regarding lifestyle patterns (LPs) and their association with prediabetes. The present study aimed to examine the association of different LPs with the existence of prediabetes in adults from families at high risk for T2D in Europe. In total, 2759 adults (66.3% 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 fasting blood glucose measurements were also obtained. LPs were derived via principal component analysis. Two LPs were derived, explaining 32% of the total variation. LP 1 was characterized by breakfast consumption, high consumption of fruits and berries, vegetables and nuts and seeds, and low consumption of salty snacks and soft drinks with sugar, while LP 2 was characterized by high consumption of salty and sweet snacks, soft drinks with sugar and juice with sugar and sedentary behavior. After adjusting for various confounders, LP 2 was positively associated with the existence of prediabetes (odds ratio = 1.02, 95% CI 1.01-1.04), while LP 1 was not significantly associated with prediabetes. Understanding LPs would provide necessary evidence for planning intervention and education strategies for prediabetes and T2D.

Sugar and low/no-calorie-sweetened beverage consumption and associations with body weight and waist circumference changes in five European cohort studies: the SWEET project.

PURPOSE: Results of prospective studies investigating associations between low/no-calorie sweeteners (LNCS) and body weight-related outcomes are inconclusive. We conducted dose-response and theoretical replacement individual patient data meta-analyses using harmonised prospective data to evaluate associations between sugar-sweetened beverage (SSB) consumption, low/no-calorie sweetened beverage (LNCB) consumption, and changes in body weight and waist circumference. METHODS: Individual participant data were obtained from five European studies, i.e., Lifelines Cohort Study, NQplus study, Alpha Omega Cohort, Predimed-Plus study, and Feel4diabetes study, including 82,719 adults aged 18-89 with follow-up between 1 and 9 years. Consumption of SSB and LNCB was assessed using food-frequency questionnaires. Multiple regression analyses adjusting for major confounders and including substitution models were conducted to quantify associations in individual cohorts; random-effects meta-analyses were performed to pool individual estimates. RESULTS: Overall, pooled results showed weak adverse associations between SSB consumption and changes in body weight (+ 0.02 kg/y, 95%CI 0.00; 0.04) and waist circumference (+ 0.03 cm/y, 95%CI 0.01; 0.05). LNCB consumption was associated with higher weight gain (+ 0.06 kg/y, 95%CI 0.04; 0.08) but not with waist circumference. No clear associations were observed for any theoretical replacements, i.e., LNCB or water for SSB or water for LNCB. CONCLUSION: In conclusion, this analysis of five European studies found a weak positive association between SSB consumption and weight and waist change, whilst LNCB consumption was associated with weight change only. Theoretical substitutions did not show any clear association. Thus, the benefit of LNCBs as an alternative to SSBs remains unclear.