Polypill Strategy in Secondary Cardiovascular Prevention.

BACKGROUND: A polypill that includes key medications associated with improved outcomes (aspirin, angiotensin-converting-enzyme [ACE] inhibitor, and statin) has been proposed as a simple approach to the secondary prevention of cardiovascular death and complications after myocardial infarction. METHODS: In this phase 3, randomized, controlled clinical trial, we assigned patients with myocardial infarction within the previous 6 months to a polypill-based strategy or usual care. The polypill treatment consisted of aspirin (100 mg), ramipril (2.5, 5, or 10 mg), and atorvastatin (20 or 40 mg). The primary composite outcome was cardiovascular death, nonfatal type 1 myocardial infarction, nonfatal ischemic stroke, or urgent revascularization. The key secondary end point was a composite of cardiovascular death, nonfatal type 1 myocardial infarction, or nonfatal ischemic stroke. RESULTS: A total of 2499 patients underwent randomization and were followed for a median of 36 months. A primary-outcome event occurred in 118 of 1237 patients (9.5%) in the polypill group and in 156 of 1229 (12.7%) in the usual-care group (hazard ratio, 0.76; 95% confidence interval [CI], 0.60 to 0.96; P = 0.02). A key secondary-outcome event occurred in 101 patients (8.2%) in the polypill group and in 144 (11.7%) in the usual-care group (hazard ratio, 0.70; 95% CI, 0.54 to 0.90; P = 0.005). The results were consistent across prespecified subgroups. Medication adherence as reported by the patients was higher in the polypill group than in the usual-care group. Adverse events were similar between groups. CONCLUSIONS: Treatment with a polypill containing aspirin, ramipril, and atorvastatin within 6 months after myocardial infarction resulted in a significantly lower risk of major adverse cardiovascular events than usual care. (Funded by the European Union Horizon 2020; SECURE ClinicalTrials.gov number, NCT02596126; EudraCT number, 2015-002868-17.).

Clustering of lifestyle behaviors and adiposity in early adolescents in Spain: findings from the SI! Program for Secondary Schools.

BACKGROUND: Several unhealthy lifestyle behaviors in adolescence are often linked to overweight/obesity. Some of them may be present simultaneously, leading to combined effects on health. Therefore, the clustering of several unhealthy behaviors in adolescents might be associated with adiposity excess. PURPOSE: To identify lifestyle patterns and analyze their association with adiposity in early adolescents. METHODS: A cross-sectional cluster analysis was performed in 1183 adolescents (50.5% girls) with a mean age of 12.5 (0.4) years included in the SI! Program for Secondary Schools in Spain to identify lifestyle patterns based on healthy diet, step counts, sleep time, and leisure screen time. Generalized mixed models were applied to estimate the association between lifestyle patterns and adiposity indices. RESULTS: Four lifestyle patterns were derived: Cluster 1-higher screen time and poorer diet (n = 213), Cluster 2-lower activity and longer sleepers (n = 388), Cluster 3-active and shorter sleepers (n = 280), and Cluster 4-healthiest (n = 302). Except for the number of steps (12,008 (2357) day), the lifestyle behaviors in our sample presented levels far below the recommendations, especially for sleep duration. Cluster 4 included the largest proportion of adolescents from high socioeconomic status families (47.7%) and the lowest prevalence of overweight/obesity (23.1%). Compared to Cluster 4-healthiest, adolescents in the remaining clusters presented a higher prevalence of overweight/obesity and central obesity, showing Cluster 3 the highest prevalences (PR:1.31 [95%CI: 1.31, 1.31] and PR:1.40 [95%CI: 1.33, 1.47]). CONCLUSIONS: Clustering of lifestyle patterns in early adolescence allows the identification of individuals with excess adiposity, in whom health promotion strategies should be stressed, especially in socioeconomically disadvantaged groups. TRIAL REGISTRATION: Clinical Trial Registry, NCT03504059. Registered 20/04/2018-Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT03504059 .

Prospective associations between social vulnerabilities and children's weight status. Results from the IDEFICS study.

BACKGROUND/OBJECTIVES: In high-income countries, childhood obesity follows a clear socioeconomic gradient with greater prevalence in children with lower socioeconomic status (SES). The extent to which the trend of other social vulnerabilities over time and the accumulation of these vulnerabilities can affect children's weight is still unknown. SUBJECTS/METHODS: In the IDEFICS study, 8624 children aged 2.0-9.9 years from eight European countries were examined at baseline and after 2 years. Sociodemographic variables, maternal body mass index (BMI), and lifestyle were reported by parents. Children were measured and classified as thin, normal weight, and overweight/obese using the extended IOTF criteria. Four vulnerable groups were defined: children whose parents were migrants, children whose parents lack a social network, children from non-traditional families (children not living with both biological parents), and children with unemployed parents. Logistic mixed-effects models were used to study the association between vulnerabilities and children's weight at baseline and follow-up, temporal trends in vulnerabilities and children's weight and accumulation of vulnerabilities and children's weight. Models were adjusted for lifestyle, maternal BMI, parental education, and income. RESULTS: Children whose parents lost their social support at follow-up were more likely to be thin than non-vulnerable children (OR = 1.69, 99% CI = 1.03-2.78). Children whose parents had a migrant background (OR = 1.30, 99% CI 1.04-1.62), children from non-traditional families at both time points (OR = 1.40, 99% CI 1.03-1.90) and whose parents were unemployed at baseline and follow-up (OR = 2.03, 99% CI 1.03-3.99) were more likely to be overweight/obese compared to non-vulnerable children. Cross-sectionally, we did not find an association between parental lack of network, non-traditional family structure, or employment and children's weight status. CONCLUSIONS: Policy actions are required to tackle inadequate weight loss and gain among vulnerable children (especially those exposed over the long term) since they are at a higher risk of thinness and overweight.

Social vulnerabilities as determinants of overweight in 2-, 4- and 6-year-old Spanish children.

Background: Differences in obesity prevalence among vulnerable groups exist in childhood but it remains unclear whether these differences may be partly determined by socioeconomic status (SES), parental body mass index (BMI) and early life risk factors. We aimed to explore (i) longitudinal associations between belonging to a minority group and being overweight/obese at age 2, 4 and 6 and (ii) associations between accumulation of social vulnerabilities and being overweight/obese at age 6. Methods: In total, 1031 children (53.8% boys) were evaluated at birth and re-examined during a 6-year follow-up in a representative cohort of Aragon (Spain). Children from minority (vulnerable) groups included Spanish Roma/gypsies, Eastern Europeans, Latin Americans and Africans. Two more vulnerable groups were defined at baseline as children whose parents reported low occupation and education. Ethnicity, SES and parental BMI were collected via interviews. We used logistic mixed-effects models and adjusted for parental BMI, SES, mother's tobacco use, maternal weight gain, birth weight, infant weight gain and breastfeeding practices. Results: Regardless of confounders, Roma/gypsy children (OR = 4.63;[1.69-12.70]95%CI) and with Latin American background (OR = 3.04;[1.59-5.82]95%CI) were more likely to be overweight/obese at age 6 compared with non-gypsy Spanish group. Children with three vulnerabilities (OR = 2.18;[1.31-3.64]95%CI) were more likely to be overweight/obese at age 6 compared with children with no vulnerabilities. No associations were found between belonging to a minority group and overweight/obesity in children under 6. Conclusion: Interventions should target Roma/gypsy children, Latin American children and those who accumulate more vulnerabilities as they are at higher risk of being overweight/obese at age 6.

A 30-month worksite-based lifestyle program to promote cardiovascular health in middle-aged bank employees: Design of the TANSNIP-PESA randomized controlled trial.

BACKGROUND: Cardiovascular disease (CVD) is the leading cause of death worldwide. With atherosclerosis as the underlying cause for many CVD events, prevention or reduction of subclinical atherosclerotic plaque burden (SAPB) through a healthier lifestyle may have substantial public health benefits. OBJECTIVE: The objective was to describe the protocol of a randomized controlled trial investigating the effectiveness of a 30-month worksite-based lifestyle program aimed to promote cardiovascular health in participants having a high or a low degree of SAPB compared with standard care. METHODS: We will conduct a randomized controlled trial including middle-aged bank employees from the Progression of Early Subclinical Atherosclerosis cohort, stratified by SAPB (high SAPB n=260, low SAPB n=590). Within each stratum, participants will be randomized 1:1 to receive a lifestyle program or standard care. The program consists of 3 elements: (a) 12 personalized lifestyle counseling sessions using Motivational Interviewing over a 30-month period, (b) a wrist-worn physical activity tracker, and (c) a sit-stand workstation. Primary outcome measure is a composite score of blood pressure, physical activity, sedentary time, body weight, diet, and smoking (ie, adapted Fuster-BEWAT score) measured at baseline and at 1-, 2-, and 3-year follow-up. CONCLUSIONS: The study will provide insights into the effectiveness of a 30-month worksite-based lifestyle program to promote cardiovascular health compared with standard care in participants with a high or low degree of SAPB.

Associations between social vulnerabilities and psychosocial problems in European children. Results from the IDEFICS study.

The effect of socioeconomic inequalities on children's mental health remains unclear. This study aims to explore the cross-sectional and longitudinal associations between social vulnerabilities and psychosocial problems, and the association between accumulation of vulnerabilities and psychosocial problems. 5987 children aged 2-9 years from eight European countries were assessed at baseline and 2-year follow-up. Two different instruments were employed to assess children's psychosocial problems: the KINDL (Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents) was used to evaluate children's well-being and the Strengths and Difficulties Questionnaire (SDQ) was used to evaluate children's internalising problems. Vulnerable groups were defined as follows: children whose parents had minimal social networks, children from non-traditional families, children of migrant origin or children with unemployed parents. Logistic mixed-effects models were used to assess the associations between social vulnerabilities and psychosocial problems. After adjusting for classical socioeconomic and lifestyle indicators, children whose parents had minimal social networks were at greater risk of presenting internalising problems at baseline and follow-up (OR 1.53, 99% CI 1.11-2.11). The highest risk for psychosocial problems was found in children whose status changed from traditional families at T0 to non-traditional families at T1 (OR 1.60, 99% CI 1.07-2.39) and whose parents had minimal social networks at both time points (OR 1.97, 99% CI 1.26-3.08). Children with one or more vulnerabilities accumulated were at a higher risk of developing psychosocial problems at baseline and follow-up. Therefore, policy makers should implement measures to strengthen the social support for parents with a minimal social network.

Associations between social vulnerabilities and dietary patterns in European children: the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study.

Socio-economic inequalities in childhood can determine dietary patterns, and therefore future health. This study aimed to explore associations between social vulnerabilities and dietary patterns assessed at two time points, and to investigate the association between accumulation of vulnerabilities and dietary patterns. A total of 9301 children aged 2-9 years participated at baseline and 2-year follow-up examinations of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS study. In all, three dietary patterns were identified at baseline and follow-up by applying the K-means clustering algorithm based on a higher frequency of consumption of snacks and fast food (processed), sweet foods and drinks (sweet), and fruits and vegetables (healthy). Vulnerable groups were defined at baseline as follows: children whose parents lacked a social network, children from single-parent families, children of migrant origin and children with unemployed parents. Multinomial mixed models were used to assess the associations between social vulnerabilities and children's dietary patterns at baseline and follow-up. Children whose parents lacked a social network (OR 1·31; 99 % CI 1·01, 1·70) and migrants (OR 1·45; 99 % CI 1·15, 1·83) were more likely to be in the processed cluster at baseline and follow-up. Children whose parents were homemakers (OR 0·74; 99 % CI 0·60, 0·92) were less likely to be in the processed cluster at baseline. A higher number of vulnerabilities was associated with a higher probability of children being in the processed cluster (OR 1·78; 99 % CI 1·21, 2·62). Therefore, special attention should be paid to children of vulnerable groups as they present unhealthier dietary patterns.

Pester power and its consequences: do European children's food purchasing requests relate to diet and weight outcomes?

OBJECTIVE: Children may influence household spending through 'pester power'. The present study examined pestering through parent-child food shopping behaviours in relation to children's diet and weight status. DESIGN: Cross-sectional and prospective analyses drawn from the IDEFICS study, a cohort study of parents and their children. Children's height and weight were measured and their recent diets were reported by parental proxy based on the Children's Eating Habits Questionnaire-FFQ at baseline and 2-year follow-up. Parents also completed questionnaires at both time points about pestering, including whether the child goes grocery shopping with them, asks for items seen on television and is bought requested food items. SETTING: Participants were recruited from eight European countries for the IDEFICS study (non-nationally representative sample). SUBJECTS: Study participants were children aged 2-9 years at enrolment and their parents. A total of 13 217 parent-child dyads were included at baseline. Two years later, 7820 of the children were re-examined. RESULTS: Most parents (63 %) at baseline reported 'sometimes' acquiescing to their children's requests to purchase specific foods. Pestering was modestly associated with weight and diet. At baseline, children whose parents 'often' complied consumed more high-sugar and high-fat foods. Children who 'often' asked for items seen on television were likely to become overweight after 2 years (OR=1·31), whereas 'never' asking protected against overweight (OR=0·72). CONCLUSIONS: Pestering was modestly related to diet and weight in cross-sectional, but not longitudinal analyses. Asking for items seen on television had the most robust relationships across child outcomes and over time.

Parental modeling, education and children's sports and TV time: the ENERGY-project.

OBJECTIVE: We assessed whether differences in children's sports participation and television time according to parental education were mediated by parental modeling. Moreover, we explored the differences between parental and child reports on parental sports participation and television time as potential mediators. METHODS: 5729 children and 5183 parents participating in the EuropeaN Energy balance Research to prevent excessive weight Gain among Youth (ENERGY-project) during 2010 in seven European countries provided information on sports participation and television time using validated self-report questionnaires. Multilevel country-specific mediation models analyzed the potential mediation effect of parental self-reports and child-reports on parental sports participation and television time. RESULTS: Significant mediation effect was found for parental self-reported television time in four countries (Greece, Hungary, The Netherlands and Slovenia), with the highest proportion for Slovenia (40%) and the lowest for Greece (21%). Child-reported parental television time showed mediation effect in Greece only. Parental self-reported sports participation showed significant mediation effect only in Greece. With child-reported parental sports participation, significant mediation was observed in Greece and Norway. CONCLUSIONS: Parental behaviors appear to be important in explaining parental educational differences in children's sports participation and television time. However, child reports on parental behavior appear to be more relevant than parents' self-reports as correlates of children's own sports participation and television time.

Differences in beliefs and home environments regarding energy balance behaviors according to parental education and ethnicity among schoolchildren in Europe: the ENERGY cross sectional study.

BACKGROUND: To explore differences in personal and home environmental factors that are regarded as determinants of energy balance-related behaviors (EBRBs) according to parental education and ethnic background among 10-12 year old schoolchildren across Europe. METHODS: A school-based survey among 10-12 year olds was conducted in eight countries across Europe. A range of personal and home environment variables relevant for soft drink consumption, daily breakfast, sport participation and TV time was assessed by means of child report. Personal factors included attitude, health beliefs, and preference/liking. Home environment factors included parental subjective norm, modeling, support, practices and home availability. Children were classified based on parental education (i.e., low vs. high) and ethnic background (i.e., native vs. non-native). Data from 6018 children originating from 83 schools were included in the analyses. RESULTS: Multilevel logistic regression analyses showed that the majority of the factors tested -and especially home environment variables- were more favorable among children from higher educated parents and from native ethnicity. None of the personal and home environment factors was found to be more favorable among children from lower educated parents or non-native ethnicity. CONCLUSIONS: The present study indicates that schoolchildren from lower educated and non-native parents across Europe have EBRB-related beliefs and are exposed to home environments that are less favorable for engagement in healthy EBRBs.