Evaluation of a health promotion program in children: Study protocol and design of the cluster-randomized Baden-Württemberg primary school study [DRKS-ID: DRKS00000494]

<p>Abstract</p> <p>Background</p> <p>Increasing prevalences of overweight and obesity in children are known problems in industrialized countries. Early prevention is important as overweight and obesity persist over time and are related with health problems later in adulthood. "Komm mit in das gesunde Boot - Grundschule" is a school-based program to promote a healthier lifestyle. Main goals of the intervention are to increase physical activity, decrease the consumption of sugar-sweetened beverages, and to decrease time spent sedentary by promoting active choices for healthy lifestyle. The program to date is distributed by 34 project delivery consultants in the state of Baden-Württemberg and is currently implemented in 427 primary schools. The efficacy of this large scale intervention is examined via the Baden-Württemberg Study.</p> <p>Methods/Design</p> <p>The Baden-Württemberg Study is a prospective, stratified, cluster-randomized, and longitudinal study with two groups (intervention group and control group). Measurements were taken at the beginning of the academic years 2010/2011 and 2011/2012. Efficacy of the intervention is being assessed using three main outcomes: changes in waist circumference, skinfold thickness and 6 minutes run. Stratified cluster-randomization (according to class grade level) was performed for primary schools; pupils, teachers/principals, and parents were investigated. An approximately balanced number of classes in intervention group and control group could be reached by stratified randomization and was maintained at follow-up.</p> <p>Discussion</p> <p>At present, "Komm mit in das Gesunde Boot - Grundschule" is the largest school-based health promotion program in Germany. Comparative objective main outcomes are used for the evaluation of efficacy. Simulations showed sufficient power with the existing sample size. Therefore, the results will show whether the promotion of a healthier lifestyle in primary school children is possible using a relatively low effort within a school-based program involving children, teachers and parents. The research team anticipates that not only efficacy will be proven in this study but also expects many other positive effects of the program.</p> <p>Trial registration</p> <p>German Clinical Trials Register (DRKS), DRKS-ID: DRKS00000494</p

Allergen-specific immunotherapy provides immediate, long-term and preventive clinical effects in children and adults: the effects of immunotherapy can be categorised by level of benefit -the centenary of allergen specific subcutaneous immunotherapy

Allergen Specific Immunotherapy (SIT) for respiratory allergic diseases is able to significantly improve symptoms as well as reduce the need for symptomatic medication, but SIT also has the capacity for long-term clinical effects and plays a protective role against the development of further allergies and symptoms. The treatment acts on basic immunological mechanisms, and has the potential to change the pathological allergic immune response. In this paper we discuss some of the most important achievements in the documentation of the benefits of immunotherapy, over the last 2 decades, which have marked a period of extensive research on the clinical effects and immunological background of the mechanisms involved. The outcome of immunotherapy is described as different levels of benefit from early reduction in symptoms over progressive clinical effects during treatment to long-term effects after discontinuation of the treatment and prevention of asthma. The efficacy of SIT increases the longer it is continued and immunological changes lead to potential long-term benefits. SIT alone and not the symptomatic treatment nor other avoidance measures has so far been documented as the therapy with long-term or preventive potential. The allergic condition is driven by a subset of T-helper lymphocytes (Th2), which are characterised by the production of cytokines like IL-4, and IL-5. Immunological changes following SIT lead to potential curative effects. One mechanism whereby immunotherapy suppresses the allergic response is through increased production of IgG4 antibodies. Induction of specific IgG4 is able to influence the allergic response in different ways and is related to immunological effector mechanisms, also responsible for the reduced late phase hyperreactivity and ongoing allergic inflammation. SIT is the only treatment which interferes with the basic pathophysiological mechanisms of the allergic disease, thereby creating the potential for changes in the long-term prognosis of respiratory allergy. SIT should not only be recognised as first-line therapeutic treatment for allergic rhinoconjunctivitis but also as secondary preventive treatment for respiratory allergic diseases

Subsequent Event Risk in Individuals with Established Coronary Heart Disease:Design and Rationale of the GENIUS-CHD Consortium

BACKGROUND: The "GENetIcs of sUbSequent Coronary Heart Disease" (GENIUS-CHD) consortium was established to facilitate discovery and validation of genetic variants and biomarkers for risk of subsequent CHD events, in individuals with established CHD. METHODS: The consortium currently includes 57 studies from 18 countries, recruiting 185,614 participants with either acute coronary syndrome, stable CHD or a mixture of both at baseline. All studies collected biological samples and followed-up study participants prospectively for subsequent events. RESULTS: Enrollment into the individual studies took place between 1985 to present day with duration of follow up ranging from 9 months to 15 years. Within each study, participants with CHD are predominantly of self-reported European descent (38%-100%), mostly male (44%-91%) with mean ages at recruitment ranging from 40 to 75 years. Initial feasibility analyses, using a federated analysis approach, yielded expected associations between age (HR 1.15 95% CI 1.14-1.16) per 5-year increase, male sex (HR 1.17, 95% CI 1.13-1.21) and smoking (HR 1.43, 95% CI 1.35-1.51) with risk of subsequent CHD death or myocardial infarction, and differing associations with other individual and composite cardiovascular endpoints. CONCLUSIONS: GENIUS-CHD is a global collaboration seeking to elucidate genetic and non-genetic determinants of subsequent event risk in individuals with established CHD, in order to improve residual risk prediction and identify novel drug targets for secondary prevention. Initial analyses demonstrate the feasibility and reliability of a federated analysis approach. The consortium now plans to initiate and test novel hypotheses as well as supporting replication and validation analyses for other investigators

Association of Chromosome 9p21 with Subsequent Coronary Heart Disease events:A GENIUS-CHD study of individual participant data

BACKGROUND:Genetic variation at chromosome 9p21 is a recognized risk factor for coronary heart disease (CHD). However, its effect on disease progression and subsequent events is unclear, raising questions about its value for stratification of residual risk. METHODS:A variant at chromosome 9p21 (rs1333049) was tested for association with subsequent events during follow-up in 103,357 Europeans with established CHD at baseline from the GENIUS-CHD Consortium (73.1% male, mean age 62.9 years). The primary outcome, subsequent CHD death or myocardial infarction (CHD death/MI), occurred in 13,040 of the 93,115 participants with available outcome data. Effect estimates were compared to case/control risk obtained from CARDIoGRAMPlusC4D including 47,222 CHD cases and 122,264 controls free of CHD. RESULTS:Meta-analyses revealed no significant association between chromosome 9p21 and the primary outcome of CHD death/MI among those with established CHD at baseline (GENIUS-CHD OR 1.02; 95% CI 0.99-1.05). This contrasted with a strong association in CARDIoGRAMPlusC4D OR 1.20; 95% CI 1.18-1.22; p for interaction Conclusions: In contrast to studies comparing individuals with CHD to disease free controls, we found no clear association between genetic variation at chromosome 9p21 and risk of subsequent acute CHD events when all individuals had CHD at baseline. However, the association with subsequent revascularization may support the postulated mechanism of chromosome 9p21 for promoting atheroma development

Morphological responses of the Wax Lake Delta, Louisiana, to Hurricanes Rita

This study examines the morphodynamic response of a deltaic system to extreme weather events. The Wax Lake Delta (WLD) in Louisiana, USA, is used to illustrate the impact of extreme events (hurricanes) on a river-dominated deltaic system. Simulations using the open source Delft3D model reveal that Hurricane Rita, which made landfall 120 km to the west of WLD as a Category 3 storm in 2005, caused erosion on the right side and deposition on the left side of the hurricane eye track on the continental shelf line (water depth 10 m to 50 m). Erosion over a wide area occurred both on the continental shelf line and in coastal areas when the hurricane moved onshore, while deposition occurred along the Gulf coastline (water depth < 5 m) when storm surge water moved back offshore. The numerical model estimated that Hurricane Rita’s storm surge reached 2.5 m, with maximum currents of 2.0 m s–1, and wave heights of 1.4 m on the WLD. The northwestern-directed flow and waves induced shear stresses, caused erosion on the eastern banks of the deltaic islands and deposition in channels located west of these islands. In total, Hurricane Rita eroded more than 500,000 m3 of sediments on the WLD area. Including waves in the analysis resulted in doubling the amount of erosion in the study area, comparing to the wave-excluding scenario. The exclusion of fluvial input caused minor changes in deltaic morphology during the event. Vegetation cover was represented as rigid rods in the model which add extra source terms for drag and turbulence to influence the momentum and turbulence equations. Vegetation slowed down the floodwater propagation and decreased flow velocity on the islands, leading to a 47% reduction in the total amount of erosion. Morphodynamic impact of the hurricane track relative to the delta was explored. Simulations indicate that the original track of Hurricane Rita (landfall 120 km west of the WLD) produced twice as much erosion and deposition at the delta compared to a hurricane of a similar intensity that made landfall directly on the delta. This demonstrates that the wetlands located on the right side of a hurricane track experience more significant morphological changes than areas located directly on the hurricane track

Sinking deltas due to human activites

Many of the world's largest deltas are densely populated and heavily farmed. Yet many of their inhabitants are becoming increasingly vulnerable to flooding and conversions of their land to open ocean. The vulnerability is a result of sediment compaction from the removal of oil, gas and water from the delta's underlying sediments, the trapping of sediment in reservoirs upstream and floodplain engineering in combination with rising global sea level. Here we present an assessment of 33 deltas chosen to represent the world's deltas. We find that in the past decade, 85% of the deltas experienced severe flooding, resulting in the temporary submergence of 260,000 km2. We conservatively estimate that the delta surface area vulnerable to flooding could increase by 50% under the current projected values for sea-level rise in the twenty-first century. This figure could increase if the capture of sediment upstream persists and continues to prevent the growth and buffering of the delta

Modelling feedbacks between human and natural processes in the land system

Abstract. The unprecedented use of Earth's resources by humans, in combination with the increasing natural variability in natural processes over the past century, is affecting evolution of the Earth system. To better understand natural processes and their potential future trajectories requires improved integration with and quantification of human processes. Similarly, to mitigate risk and facilitate socio-economic development requires a better understanding of how the natural system (e.g., climate variability and change, extreme weather events, and processes affecting soil fertility) affects human processes. To capture and formalize our understanding of the interactions and feedback between human and natural systems a variety of modelling approaches are used. While integrated assessment models are widely recognized as supporting this goal and integrating representations of the human and natural system for global applications, an increasing diversity of models and corresponding research have focused on coupling models specializing in specific human (e.g., decision-making) or natural (e.g., erosion) processes at multiple scales. Domain experts develop these specialized models with a greater degree of detail, accuracy, and transparency, with many adopting open-science norms that use new technology for model sharing, coupling, and high performance computing. We highlight examples of four different approaches used to couple representations of the human and natural system, which vary in the processes represented and in the scale of their application. The examples illustrate how groups of researchers have attempted to overcome the lack of suitable frameworks for coupling human and natural systems to answer questions specific to feedbacks between human and natural systems. We draw from these examples broader lessons about system and model coupling and discuss the challenges associated with maintaining consistency across models and representing feedback between human and natural systems in coupled models