6 research outputs found

    "Mi voglio bene": a pediatrician-based randomized controlled trial for the prevention of obesity in Italian preschool children

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    <p>Abstract</p> <p>Background</p> <p>The first years of life are crucial to start preventive interventions that can have an impact on lifestyle and later overweight and obesity. Under the Italian National Health System (INHS), children are cared for by family pediatricians who perform health balances at regular intervals. The Italian Society of Preventive and Social Pediatrics (SIPPS) has designed a randomized controlled trial (RCT) to evaluate the effectiveness of family pediatricians for the prevention of childhood obesity in preschool children. We report the rationale and protocol of such trial, named the "Mi voglio bene" ("I love myself") study.</p> <p>Methods</p> <p>"Mi voglio bene" is a parallel-arm RCT. Family pediatricians willing to participate to the trial will be randomly assigned to a control group and to an experimental group. The control group will provide the usual standard of care while the experimental group will implement 10 preventive actions (promotion of breastfeeding, avoidance of solid foods, control of protein intake, avoidance of sugar-sweetened beverages, avoidance of bottle, active means of transportation, identification of early adiposity rebound, limitation of television viewing, promotion of movement, and teaching portion size) at 10 time points during a 6-yr follow-up. The main outcome measures is the prevalence of overweight and obesity at 6 years of age. The experimental intervention is expected to reduce the prevalence of overweight and obesity from 25% to 20% and the study requires a total of 3610 children. Each pediatrician will enroll 30 consecutive newborns into the study so that a total of 120 pediatricians will participate to the study.</p> <p>Discussion</p> <p>"Mi voglio bene" is expected to provide important information for the INHS and possibly other institutional child care settings about the effectiveness of a pediatrician-based approach to the prevention of childhood obesity. We published this study protocol with the aim of opening a discussion with all people interested in fighting childhood obesity and to receive useful criticisms.</p

    Perceived Difficulty with Physical Tasks, Lifestyle, and Physical Performance in Obese Children

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    We estimated perceived difficulty with physical tasks, lifestyle, and physical performance in 382 children and adolescents (163 obese, 54 overweight, and 165 normal-weight subjects) and the relationship between perceived physical difficulties and sports participation, sedentary behaviors, or physical performance. Perceived difficulty with physical tasks and lifestyle habits was assessed by interview using a structured questionnaire, while physical performance was assessed through the six-minute walking test (6 MWT). Obese children had higher perceived difficulty with several activities of daily living, were less engaged in sports, and had lower physical performance than normal-weight or overweight children; on the contrary, they did not differ with regard to time spent in sedentary behaviors. Perceived difficulty in running and hopping negatively predicted sports participation (P < 0.05 and <0.01, resp.), while perceived difficulty in almost all physical activities negatively predicted the 6 MWT, independently of BMI (P < 0.01). Our results indicate that perception of task's difficulty level may reflect an actual difficulty in obese children. These findings may have practical implications for approaching physical activity in obese children. Exploring both the perception of a task's difficulty level and physical performance may be useful to design exercise programs that allow safe and successful participation

    Biomarkers of Angiogenesis and Clinical Outcomes to Cabozantinib and Everolimus in Patients with Metastatic Renal Cell Carcinoma from the Phase III METEOR Trial

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    Purpose: Anti-angiogenic VEGF-receptor (VEGFR) inhibitors are approved for metastatic clear cell renal cell carcinoma (mccRCC) and their efficacy is higher in high angiogenic tumors. As cabozantinib inhibits multiple tyrosine kinase receptors, including VEGFRs, we tested whether markers of angiogenesis, including microvascular density (MVD) and mast cell density (MCD), could predict benefit from cabozantinib versus everolimus, using RCC samples from the METEOR (NCT01865747) trial. Experimental design: MVD and MCD were studied in 430 patients (cabozantinib = 216, everolimus = 214) by double immunohistochemistry for CD31 (vascular marker) and tryptase (mast cell marker) coupled with automated image analysis. Results from evaluable cases (MVD = 360, MCD =325) were correlated with progression-free survival (PFS), overall survival (OS), and objective response rate (ORR). Results: MVD was positively correlated with MCD. In the whole cohort, high MVD and high MCD were associated with longer PFS; improved PFS was most evident in patients with high levels of both MCD and MVD. Cabozantinib was associated with improved PFS, OS, and ORR compared to everolimus, irrespective of MVD levels. Cabozantinib was also associated with improved ORR compared to everolimus, irrespective of MCD levels. For PFS and OS, the treatment effect for cabozantinib versus everolimus tended to be greater in tumors with low MCD. Conclusions: High MVD and high MCD are associated with improved outcome in mccRCC but don't predict efficacy to cabozantinib versus everolimus. The high efficacy of cabozantinib in low angiogenic tumors allows us to speculate that its anti-tumor activity is not exclusively mediated by VEGFR inhibition

    The rehabilitation of children and adolescents with severe or medically complicated obesity: an ISPED expert opinion document

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    Severe/medically complicated obesity in childhood, and particularly in adolescence, is a real disability that requires an intensive and continuous approach which should follow the procedures and schedule of rehabilitation medicine. Given the lack of a specific document focusing on children and adolescents, the Childhood Obesity Study Group set out to explore the available evidence for the treatment of severe or medically complicated obesity and to set standards tailored to the specific context of the Italian Health Service. Through a series of meetings and electronic communications, the writing committee (selected from members of the Study Group) selected the key issues, explored the literature and produced a draft document which was submitted to the other experts until the final synthesis was approved by the group. In brief, the following issues were involved: (1) definition and epidemiology; (2) identification of common goals designed to regain functional competence and limit the progression of metabolic and psychological complications; (3) a multi-professional team approach; (4) the care setting. This paper is an expert opinion document on the rehabilitation of severe and medically complicated obesity in children and adolescents produced by experts belonging to the Childhood Obesity Study Group of the Italian Society for Pediatric Endocrinology and Diabetology (ISPED)
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