Low incidence of inflammatory bowel disease adverse events in adalimumab clinical trials across nine different diseases

OBJECTIVE: Adalimumab is approved for treatment of Crohn's disease and ulcerative colitis. Thus, we postulated that exacerbation or new-onset of inflammatory bowel disease (IBD) would be rare events in patients treated with adalimumab for non-IBD indications. This analysis evaluated the incidence of IBD adverse events (AEs) across adalimumab trials. METHODS: IBD AE rates in 75 adalimumab clinical trials in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, pediatric enthesitis-related arthritis, uveitis, hidradenitis suppurativa, adult and pediatric psoriasis, psoriatic arthritis, non-psoriatic arthritis peripheral spondyloarthritis (pSpA), axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis, were analyzed. Search terms for IBD AEs (new onset or worsening/flare) included IBD, ulcerative colitis, Crohn's disease, and ulcerative proctitis. RESULTS: This analysis included 24,114 patients, representing 36,508 patient-years (PY) of adalimumab exposure. The overall rate (95% CI) of IBD AEs in adalimumab-treated patients was 0.1 (0.1-0.2)/100 PY (41 events), ranging from no events (psoriatic arthritis, uveitis, and pediatric trials) to 0.8 (0.2-2.2)/100 PY in pSpA; the rate of IBD in axSpA was 0.6 (0.4-1.0)/100 PY. During placebo-controlled trials, the overall IBD rate was 0.1 (0.0-0.3)/100 PY for adalimumab (3 events in 6781 patients; 2752 PY of exposure) and 0.1 (0.0-0.4)/100 PY for placebo (1 event in 3493 patients; 1246 PY of exposure) groups; IBD rates in axSpA were 0.5 (0.1-1.4)/100 PY and 0.6 (0.0-3.1)/100 PY, respectively. CONCLUSION: The rates of IBD AEs in adalimumab clinical trials were generally low across the evaluated diseases, including axSpA; all events occurred in adult patients

Physical activity and beverage consumption in preschoolers: Focus groups with parents and teachers

Background: Qualitative research is a method in which new ideas and strategies can be discovered. This qualitative study aimed to investigate parents’ and teachers’ opinions on physical activity and beverage consumption of preschool children. Through separate, independent focus groups, they expressed their perceptions on children’s current physical activity and beverage consumption levels, factors that influence and enhance these behaviours, and anticipated barriers to making changes. Methods: Multi-cultural and multi-geographical focus groups were carried out in six European countries (Belgium, Bulgaria, Germany, Greece, Poland and Spain). In total, twenty-four focus groups with 122 parents and eighteen focus groups with 87 teachers were conducted between October 2010 and January 2011. Based on a semi-structured interview guide, questions on preschoolers’ physical activity (opinions on preschoolers’ physical factivity, how to increase physical activity, facilitators and barriers of physical activity) and beverage consumption (rules and policies, factors influencing promotion of healthy drinking, recommendations for future intervention development) were asked. The information was analyzed using qualitative data analysis software (NVivo8). Results: The focus group results indicated misperceptions of caregivers on preschoolers’ physical activity and beverage consumption levels. Caregivers perceived preschoolers as sufficiently active; they argue that children need to learn to sit still in preparation for primary school. At most preschools, children can drink only water. In some preschools sugar-sweetened beverages like chocolate milk or fruit juices, are also allowed. It was mentioned that sugar-sweetened beverages can be healthy due to mineral and vitamin content, although according to parents their daily intake is limited. These opinions resulted in low perceived needs to change behaviours. Conclusions: Although previous research shows need of change in obesity-related behaviours, the participants in the current study didn’t perceive such. The awareness of parents and teachers needs to be raised concerning their shared responsibility about healthy behaviours in preschoolers. Providing preschool teachers with ready-to-use classroom material will encourage them to change physical activity and beverage consumption, and to implement related activities in the classroom. Involvement in activities that their children perform at preschool will motivate parents to extend these behaviours to the home environment.

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. © 2021, The Author(s)

Parental education and perception of outdoor playing time for preschoolers

Abstract Aim: The objective of this study was to analyze whether or not socioeconomic positions influence outdoor playtime during the week (WK) and on the weekends (WEND). Methods: The sample consisted of 485 (girls; n=223) healthy preschoolers, aged from 3 to 6 years, enrolled in kindergartens from the metropolitan area of Porto, Portugal. Physical Activity (PA) was assessed for 7 consecutive days with an accelerometer. The time playing outdoors during the WK or the WEND was reported by parents. Anthropometric data (weight and height) was collected following standardized protocols. Socioeconomic position was assessed by Parental Education (PE), according to the Portuguese education system. Results: We found differences in time spent playing outdoors either for the WK or WEND, but not for Total PA (TPA), in both sexes. However, regression analysis showed that after age adjustment, BMI and TPA for both sexes, we only found significant associations between low PE (LPE) and high PE (HPE) groups on WK or WEND. However, we found no statistically significant association for boys on the WK (p=0.06). Conclusion: Our findings suggest that socioeconomic position can influence the children’s time spent in outdoor activities, especially on the weekends. This may have implications for future interventions with this age group