22 results on '"Dettweiler U"'
Search Results
2. Die Bewegungsaktivität von Schüler/innen im Draußenunterricht
- Author
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Becker, C., Kirsch, P., Simon, P., Mess, F., Dettweiler, U. and Becker, C., Kirsch, P., Simon, P., Mess, F., Dettweiler, U.
- Published
- 2016
3. A Bayesian Mixed-Methods Analysis of Basic Psychological Needs Satisfaction through Outdoor Learning and Its Influence on Motivational Behavior in Science Class.
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Dettweiler, U.; Lauterbach, G.; Becker, C.; Simon, P. and Dettweiler, U.; Lauterbach, G.; Becker, C.; Simon, P.
- Published
- 2016
4. The interdependence of substance use, satisfaction with life, and psychological distress: a dynamic structural equation model analysis.
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Moe FD, Erga A, Bjornestad J, and Dettweiler U
- Abstract
Introduction: Longitudinal studies with annual follow-up including psychological and social variables in substance use disorder recovery are scarce. We investigated whether levels of substance use, satisfaction with life, and psychological distress fluctuate across five years in relation to having drug-free friends., Methods: A prospective naturalistic cohort study of change trajectories in a cohort of people diagnosed with substance use disorder and using multiple substances with quarterly and annual follow-up over five years. Two-hundred-and-eight patients were recruited from substance use disorder treatment in Rogaland, Norway. Out of these, 164 participants fulfilled the inclusion criteria. We used Bayesian two-level dynamic structural equation modelling. The variable 'drug-free friends' was assessed by a self-reporting questionnaire, while psychological distress was assessed using the Symptoms Checklist 90 Revised. Satisfaction with life was assessed using the Satisfaction With Life Scale while drug use was assessed using the Drug Use Disorders Identification Test., Results: The main findings are that higher-than-average psychological distress at a three-month lag credibly predicts higher-than-normal substance use at the concurrent time point t. Substance use and satisfaction with life seem to have synchronous trajectories over time, i.e. as the first decreases the latter increases and vice versa. During the five years after treatment, the participants mainly experienced a decrease in substance use and increase in satisfaction with life., Conclusion: Since the participants experienced positive and negative fluctuations for several years after treatment, it seems crucial to establish a dialogue with treatment professionals in order to create functional solutions for maintaining motivation and aiding recovery., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Moe, Erga, Bjornestad and Dettweiler.)
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- 2024
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5. Compensatory behavior of physical activity in adolescents - a qualitative analysis of the underlying mechanisms and influencing factors.
- Author
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Beck F, Swelam BA, Dettweiler U, Krieger C, and Reimers AK
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- Male, Female, Humans, Adolescent, Child, Health Behavior, Qualitative Research, Exercise, Motor Activity
- Abstract
Introduction: Compensatory behavior of physical activity (PA) based on the ActivityStat hypothesis in adolescents is scarcely investigated, and existing studies showed inconclusive results. Understanding the compensatory behavior in a holistic way is important as this can help to improve intervention outcomes and thus, increase the PA levels in adolescents. Thus, the aim of the present study is to investigate the occurrence, direction, timeframe, and ratio of habitual activity compensation in adolescents. Furthermore, we want to identify the awareness of compensation and factors that influence compensatory behavior., Methods: The present qualitative study used a mixed methods crossover analysis design. Participants (N = 15, 8 boys and 7 girls) were adolescents aged 11-15 years (mean age 13.04 ± 1.28). They provided a habitual weekly schedule with habitual/regular activities and their intensity. Participants then kept an activity diary over one week to capture their actual behavior. After that, data were compared and deviations > ±20% were considered as compensation opportunities. On this basis, deviations were descriptively analyzed for compensatory behavior and were coded as positive and negative compensatory behavior. Further, for each compensation, the ratio of compensation (MET-minutes of the compensating activity/MET-minutes of the activity that was compensated) was calculated. Additionally, interviews were conducted to explore perceptions and influencing factors for (no) compensation., Results: Overall, 198 compensation opportunities were identified with deviations greater ± 20%. Of these, 109 opportunities were compensated overall (69 within-day, 40 between-day). Negative compensation took place in 57 opportunities and 52 opportunities were compensated positively. Most of the deviations were overcompensated (compensation/deviation > 100%). About half of the adolescents (N = 8) were not aware about their compensatory behavior, and only one boy was aware of all his compensatory behavior. The most mentioned influence for positive compensation were social support by friends and good weather. As influencing factors for negative compensation, tiredness as well as no need for movement were mentioned predominantly. No negative compensation occurred because adolescents wanted to stick to their routines or participated in hedonistic activities., Discussion: Summarizing the findings, the present study delivered new insights into the field of compensatory behavior in adolescents. Nevertheless, compensatory behavior was not consistently observed regarding the occurrence of compensation, direction, timeframe and ratio. However, social support appears to be an important factor to compensate positively or to avoid a negative compensatory behavior. Further, it seems to be helpful to support individuals in their search for hedonistic activities as well as in the establishment of routines., (© 2024. The Author(s).)
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- 2024
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6. Editorial: Nature-based learning and development: maximizing the returns on investment, volume II.
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Kuo M, Dettweiler U, Faber Taylor A, Jordan C, and Wells NM
- Abstract
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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- 2023
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7. Choice matters: Pupils' stress regulation, brain development and brain function in an outdoor education project.
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Dettweiler U, Gerchen M, Mall C, Simon P, and Kirsch P
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- Child, Humans, Hydrocortisone metabolism, Exercise physiology, Magnetic Resonance Imaging, Male, Female, Brain diagnostic imaging, Brain growth & development, Brain physiology, Students psychology, Students statistics & numerical data, Personal Autonomy, Stress, Physiological physiology, Education methods
- Abstract
Background: Education outside the classroom (EOtC) is considered beneficial to children's physical and mental health. Especially, stress resilience has been linked to nature experience., Aims: This study experimentally explored the effects of pupils' autonomy support (AUT) and physical activity (PA) on their biological stress responses and brain development in EOtC., Sample: The study comprised 48 fifth and sixth graders., Methods: The intervention consisted of one day/week taught in a forest over one school year. Structural magnetic resonance imaging (MRI) was conducted at the beginning and the end of the school year, functional MRI under a stress condition at the end. Regions of interest were amygdala, hippocampus and the anterior cingulate cortex (ACC). All other measures were obtained at the beginning, at mid-term and at the end of the school year. PA was measured using accelerometry. Cortisol levels were obtained three times during the examined school days. AUT was measured with a paper-based survey. Data were analysed using Bayesian multivariate models., Results: EOtC students exhibit more efficient regulation of biological stress-reactivity and show a reduction of cortisol over the day associated with light PA in the forest. Cortisol is further associated with amygdala activation in the stress condition. Cerebral structural change is best explained by age; however, AUT has a positive direct effect on the maturation of the ACC, which is stronger in EOtC., Conclusions: Our results support the idea that autonomy supportive teaching fosters cerebral maturation and that EOtC can have a positive effect on biological stress regulation., (© 2022 The Authors. British Journal of Educational Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.)
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- 2023
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8. Editorial: From "modern" to "postmodern" psychology: Is there a way past?
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Hanfstingl B, Uher J, Edelsbrunner PA, Dettweiler U, and Gnambs T
- Abstract
Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
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- 2023
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9. Compensation of overall physical activity in (pre)adolescent girls - the CReActivity project.
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Beck F, Dettweiler U, Sturm DJ, Demetriou Y, and Reimers AK
- Abstract
Background: According to the ActivityStat hypothesis more physical activity (PA) in one timespan is compensated by increased sedentary time (ST) in the following timespan and vice versa to maintain an overall stable PA level. Until now, existing literature revealed inconsistent results regarding compensatory behaviour across children and adolescents. Thus, the aim of the present study is (1) to investigate whether ST in the morning is compensated by active behaviour in the afternoon and (2) whether ST during the week is compensated by active behaviour during the weekend in (pre)adolescent girls. Additionally, we aimed to differentiate between positive and negative compensatory behaviour and examine whether it is moderated by socioeconomic status (SES), age or weight status., Methods: The participants were 370 sixth grade school girls (mean age 11.6 years) from Munich that participated in the CReActivity study, a school based intervention study aiming to identify the mechanisms of behavioural changes in PA among girls. ST and PA were measured over seven consecutive days using accelerometery. Descriptive determination of compensatory behaviour, as well as Bayesian multivariate multilevel analysis were conducted with data clustered on the individual (ID), class and school level., Results: Descriptive analysis revealed rather constant compensatory behaviour of about 60% for after-school days and weekends over all observation points. However, regarding all girls, compensation was predominantly negative. Differentiated analysis indicated that all girls with low ST levels in the morning or on weekdays, compensated for this behaviour with lower PA levels in the afternoon or on weekends. Multilevel covariate analysis indicated great variability between the participants. Furthermore, differences in compensatory behaviour can also be seen on class and school levels. Interestingly, PA compensatory behaviour is not associated with age, weight status or SES., Conclusion: Our findings could neither confirm nor reject the ActivityStat Hypothesis. Overall, due to the great variability across the girls, it seems that compensation depends on individual factors. In the future, to prevent negative compensation, school-based interventions that have the potential to provide opportunities to be physically active, should not neglect (pre)adolescents' leisure time behaviour., Trial Registration: DRKS00015723 (date of registration: 2018/10/22 retrospectively registered)., (© 2022. The Author(s).)
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- 2022
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10. Editorial: Epistemological and Ethical Aspects of Research in the Social Sciences.
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Dettweiler U, Hanfstingl B, and Schröter H
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- 2020
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11. The Rationality of Science and the Inevitability of Defining Prior Beliefs in Empirical Research.
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Dettweiler U
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- 2019
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12. Current Anti-Doping Crisis: The Limits of Medical Evidence Employing Inductive Statistical Inference.
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Simon P and Dettweiler U
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- Athletes, Humans, Doping in Sports, Performance-Enhancing Substances
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- 2019
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13. Benefits of Outdoor Sports for Society. A Systematic Literature Review and Reflections on Evidence.
- Author
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Eigenschenk B, Thomann A, McClure M, Davies L, Gregory M, Dettweiler U, and Inglés E
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- Europe, Humans, Exercise, Mental Health statistics & numerical data, Sports statistics & numerical data
- Abstract
The combination of physical activity and being in nature is recognized as providing a range of significant benefits. The objective of this literature review was to compile an overview of the social benefits and costs associated with outdoor sports within the academic literature and to reflect on the quality of underlying evidence that supports the relationship. A systematic review was carried out with seven partners from different European countries, including Bulgaria, France, Germany, United Kingdom, Italy, Portugal, and Spain. From a total of 17,560 studies identified, 133 studies were selected with relevant data extracted to standardized forms. The selected studies have been analyzed with qualitative research methods. A meta-analysis could not be conducted due to the heterogeneity of the study designs and outcome measures. As a result, the review gives an overview of the social impacts associated with outdoor sports which have been clustered to six broad categories: physical health, mental health and wellbeing, education and lifelong learning, active citizenship, crime reduction, and anti-social behavior, as well as additional benefits. The review furthermore revealed gaps in the evidence base which are especially notable in the long-term effects that outdoor sports can have on personal and social development.
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- 2019
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14. Children's Cortisol and Cell-Free DNA Trajectories in Relation to Sedentary Behavior and Physical Activity in School: A Pilot Study.
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Becker C, Schmidt S, Neuberger EWI, Kirsch P, Simon P, and Dettweiler U
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The worldwide prevalence of mental disorders in children and adolescents increased constantly. Additionally, the recommended amount of physical activity (PA) is not achieved by this age group. These circumstances are associated with negative impacts on their health status in later life and can lead to public health issues. The exposure to natural green environments (NGE) seems to be beneficial for human health. The compulsory school system offers great opportunities to reach every child with suitable health-related contents and interventions at an early stage. The concept of Education Outside the Classroom (EOtC) uses NGE and sets focus on PA. Therefore, EOtC might be a beneficial educational intervention to promote students health. The association between biological stress markers and sedentary behavior (SB) plus PA is insufficiently evaluated in school settings. This exploratory study aims to evaluate the association between students' cortisol, plus circulating cell-free deoxyribonucleic acid (cfDNA) levels, and their SB, light PA (LPA), and moderate-to-vigorous PA (MVPA). We assessed data from an EOtC program (intervention group [IG], n = 37; control group [CG], n = 11) in three seasons (fall/spring/summer) in outdoor lessons (IG) in a NGE and normal indoor lessons (CG). SB and PA were evaluated by accelerometry, and cortisol and cfDNA levels by saliva samples. Fitted Bayesian hierarchical linear models evaluated the association between cortisol and cfDNA, and compositional SB/LPA/MVPA. A steady decline of cortisol in the IG is associated with relatively high levels of LPA (posterior mean = -0.728; credible interval [CRI 95%]: -1.268; -0.190). SB and MVPA tended to exhibit a similar effect in the CG. A high amount of cfDNA is positively associated with a relatively high amount of SB in the IG (posterior mean, 1.285; CRI: 0.390; 2.191), the same association is likely for LPA and MVPA in both groups. To conclude, LPA seems to support a healthy cortisol decrease in children during outdoor lessons in NGEs. Associations between cfDNA and SB/PA need to be evaluated in further research. This study facilitates the formulation of straightforward and directed hypotheses for further research with a focus on the potential health promotion of EOtC.
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- 2019
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15. Individualized Web-Based Exercise for the Treatment of Depression: Randomized Controlled Trial.
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Haller N, Lorenz S, Pfirrmann D, Koch C, Lieb K, Dettweiler U, Simon P, and Jung P
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Background: Due to the high prevalence of depressive disorders, it is mandatory to develop therapeutic strategies that provide universal access and require limited financial and human resources. Web-based therapeutic approaches fulfill these conditions., Objective: The objective of our study was to assess the feasibility, acceptability, and efficacy of a supervised, individualized 8-week Web-based exercise intervention conducted for patients with moderate to severe depression., Methods: We recruited 20 patients with unipolar depression and randomly assigned them into 2 groups (intervention, exercise program group, n=14, and control, treatment-as-usual group, n=6). At baseline, depressive symptoms were rated via the Quick Inventory of Depressive Symptomatology (QIDS) by patients themselves (QIDS-self-report, QIDS-SR) and by a blinded psychiatrist (QIDS-clinician rating, QIDS-C). In addition, performance diagnostics (lactate analysis, spiroergometry during a treadmill walking test) were conducted. Quality of life was assessed via the Short Form-36 questionnaire (SF-36) and self-efficacy via the General Self-Efficacy scale (GSE). In addition, habitual physical activity (HPA) was determined via the Baecke questionnaire. Participants of the intervention group received exercise schedules once weekly with endurance and strength training instructions. Rating of depressive symptoms was repeated after 6-12 days and 8 weeks; performance diagnostics and the completion of all the questionnaires were repeated after 8 weeks only., Results: The severity of depression subsided significantly in the intervention group after 8 weeks (median change in QIDS-SR: -5; interquartile range, IQR: -2 to -10), although it was already evident within the first 6-12 days (median change in QIDS-SR: -6; IQR: -2 to -8). During the intervention, participants undertook a median of 75 (IQR: 63 to 98) minutes of endurance training per week or 84% (16 [IQR: 9 to 19] of 19 [IQR: 15 to 21]) recommended endurance units in total. In addition, 9 (IQR: 4 to 12) of 10 (IQR: 8 to 13) recommended strength training exercise units were conducted during the 8 weeks. Performance diagnostics revealed a substantial increase in the maximum output in Watt for the intervention group after 8 weeks. Moreover, the intervention showed a favorable effect on SF-36 items "emotional well-being" and "social functioning" as well as on GSE and HPA scores., Conclusions: Our individualized Web-based exercise intervention for moderate to severe depression was highly accepted by the patients and led to a significant and clinically relevant improvement of depressive symptoms., Trial Registration: ClinicalTrials.gov NCT02874833; https://clinicaltrials.gov/ct2/show/NCT02874833 (Archived by WebCite at http://www.webcitation.org/72ZUUR4tE)., (©Nils Haller, Sonja Lorenz, Daniel Pfirrmann, Cora Koch, Klaus Lieb, Ulrich Dettweiler, Perikles Simon, Patrick Jung. Originally published in JMIR Mental Health (http://mental.jmir.org), 12.10.2018.)
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- 2018
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16. A Bayesian Mixed-Methods Analysis of Basic Psychological Needs Satisfaction through Outdoor Learning and Its Influence on Motivational Behavior in Science Class.
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Dettweiler U, Lauterbach G, Becker C, and Simon P
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Research has shown that outdoor educational interventions can lead to students' increased self-regulated motivational behavior. In this study, we searched into the satisfaction of basic psychological needs (BPN), i.e., autonomy support, the learners' experience of competence, and relatedness, both within the peer group and with their teachers, through outdoor learning. From 2014 to 2016, n = 281 students attended "research weeks" at a Student Science Lab in the Alpine National Park Berchtesgaden (Germany). The program is a curriculum-based one-week residential course, centered on a 2-day research expedition. Both before and after the course, students completed a composite questionnaire addressing BPN-satisfaction and overall motivational behavior in relation to the Self-Determination Index (SDI). At the latter time-point, students also reported on their experiences during the intervention. Questionnaire data was analyzed using a set of Bayesian General Linear Models with random effects. Those quantitative measures have been complemented by and contextualized with a set of qualitative survey methods. The results showed that the basic psychological needs influence the motivational behavior in both contexts equally, however on different scale levels. The basic needs satisfaction in the outdoor context is decisively higher than indoors. Moreover, the increment of competence-experience from the school context to the hands-on outdoor program appears to have the biggest impact to students' increased intrinsic motivation during the intervention. Increased autonomy support, student-teacher relations, and student-student relations have much less or no influence on the overall difference of motivational behavior. Gender does not influence the results. The contextualization partly supports those results and provide further explanation for the students' increased self-regulation in the outdoors. They add some explanatory thrust to the argument that outdoor teaching, be it during a residential week, or during occasional but regular sessions as integral part of the "normal" teaching, fosters intrinsic motivational behavior in science with lower secondary students.
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- 2017
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17. Effects of Regular Classes in Outdoor Education Settings: A Systematic Review on Students' Learning, Social and Health Dimensions.
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Becker C, Lauterbach G, Spengler S, Dettweiler U, and Mess F
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- Curriculum, Emotional Intelligence, Exercise, Health Status, Humans, Mental Health, Learning, Schools organization & administration
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Background: Participants in Outdoor Education Programmes (OEPs) presumably benefit from these programmes in terms of their social and personal development, academic achievement and physical activity (PA). The aim of this systematic review was to identify studies about regular compulsory school- and curriculum-based OEPs, to categorise and evaluate reported outcomes, to assess the methodological quality, and to discuss possible benefits for students., Methods: We searched online databases to identify English- and German-language peer-reviewed journal articles that reported any outcomes on a student level. Two independent reviewers screened studies identified for eligibility and assessed the methodological quality., Results: Thirteen studies were included for analysis. Most studies used a case-study design, the average number of participants was moderate (mean valued (M) = 62.17; standard deviation (SD) = 64.12), and the methodological quality was moderate on average for qualitative studies (M = 0.52; SD = 0.11), and low on average for quantitative studies (M = 0.18; SD = 0.42). Eight studies described outcomes in terms of social dimensions, seven studies in learning dimensions and four studies were subsumed under additional outcomes, i.e., PA and health. Eleven studies reported positive, one study positive as well as negative, and one study reported negative effects. PA and mental health as outcomes were underrepresented., Conclusion: Tendencies were detected that regular compulsory school- and curriculum-based OEPs can promote students in respect of social, academic, physical and psychological dimensions. Very little is known concerning students' PA or mental health. We recommend conducting more quasi-experimental design and longitudinal studies with a greater number of participants, and a high methodological quality to further investigate these tendencies.
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- 2017
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18. Stress in School. Some Empirical Hints on the Circadian Cortisol Rhythm of Children in Outdoor and Indoor Classes.
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Dettweiler U, Becker C, Auestad BH, Simon P, and Kirsch P
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- Child, Environment, Female, Germany epidemiology, Humans, Linear Models, Longitudinal Studies, Male, Prospective Studies, Saliva chemistry, Stress, Psychological etiology, Teaching, Circadian Rhythm, Hydrocortisone metabolism, Stress, Psychological epidemiology, Students psychology
- Abstract
This prospective longitudinal survey compared the stress levels of students taught using an outdoor curriculum in a forest, with children in a normal school setting. We were especially interested in the effect outdoor teaching might have on the children's normal diurnal cortisol rhythm. 48 children (mean age = 11.23; standard deviation (SD) = 0.46) were enrolled, with 37 in the intervention group (IG), and 11 in the control group (CG). The intervention consisted of one full school day per week in the forest over the school year. Stress levels were measured in cortisol with three samples of saliva per day. Furthermore, the data allowed for statistical control of physical activity (PA) values. For data analysis, we used a linear mixed-effects model (LMM) with random intercept and general correlation matrix for the within-unit residuals. The LMM yields that IG have expected greater decline of cortisol compared to CG; rate 0.069 µg/L vs. 0.0102 µg/L (log-units/2 h), p = 0.009. PA does not show a statistically significant interaction with cortisol ( p = 0.857), despite being higher in the intervention group ( p < 0.001). The main effect in our measures was that the IG had a steady decline of cortisol during the school day. This is in accordance with a healthy child's diurnal rhythm, with a significant decline of cortisol from morning to noon. This effect is constant over the school year. The CG does not show this decline during either measurement day. Further research is needed to fully explain this interesting phenomenon.
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- 2017
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19. MOTIVATION INTERNALIZATION AND SIMPLEX STRUCTURE IN SELF-DETERMINATION THEORY.
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Ünlü A and Dettweiler U
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- Child, Female, Germany, Humans, Male, Psychometrics, Surveys and Questionnaires, Achievement, Defense Mechanisms, Internal-External Control, Motivation, Psychological Theory, Self Concept
- Abstract
Self-determination theory, as proposed by Deci and Ryan, postulated different types of motivation regulation. As to the introjected and identified regulation of extrinsic motivation, their internalizations were described as "somewhat external" and "somewhat internal" and remained undetermined in the theory. This paper introduces a constrained regression analysis that allows these vaguely expressed motivations to be estimated in an "optimal" manner, in any given empirical context. The approach was even generalized and applied for simplex structure analysis in self-determination theory. The technique was exemplified with an empirical study comparing science teaching in a classical school class versus an expeditionary outdoor program. Based on a sample of 84 German pupils (43 girls, 41 boys, 10 to 12 years old), data were collected using the German version of the Academic Self-Regulation Questionnaire. The science-teaching format was seen to not influence the pupils' internalization of identified regulation. The internalization of introjected regulation differed and shifted more toward the external pole in the outdoor teaching format. The quantification approach supported the simplex structure of self-determination theory, whereas correlations may disconfirm the simplex structure.
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- 2015
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20. Investigating the motivational behavior of pupils during outdoor science teaching within self-determination theory.
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Dettweiler U, Ünlü A, Lauterbach G, Becker C, and Gschrey B
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This paper presents data from a mixed-method pilot study (n = 84) searching into learning psychological aspects of an outdoor science teaching program. We use data from qualitative explorations into the pupils' learning motivation during field observation, a group interview, and open questionnaires, in order to understand quantitative measures from the Self-Determination Index (SDI), and the Practical Orientation (PO) of the program. Our data suggest that lower self-regulated pupils in "normal" science classes show a significantly higher self-regulated learning motivational behavior in the outdoor educational setting (p < 10(-4)), and that the outdoor-teaching has generally been perceived as more practical than teaching at the normal school context (p < 10(-4)), irrespective of gender or school culture. We are going to provide in-depth analyses of all quantitative findings with our qualitative data and thus explain the findings logically, with respect to the direction of the statistical interpretation, and substantially, with respect to the meaning of the discoveries. We conclude that outdoor programming appears to be a suitable tool to trigger interest in science in youngsters, especially for less motivated pupils.
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- 2015
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21. Human experimentation. Legal regulation and ethical justification in Germany.
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Knoepffler N and Dettweiler U
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- Adult, Child, Constitution and Bylaws, Embryo Research ethics, Embryo Research legislation & jurisprudence, Ethics, Research, European Union, Female, Germany, Human Experimentation ethics, Human Rights legislation & jurisprudence, Humans, Informed Consent legislation & jurisprudence, Pregnancy, Third-Party Consent ethics, Third-Party Consent legislation & jurisprudence, Human Experimentation legislation & jurisprudence
- Published
- 2002
22. Points to consider for ethics committees in human gene therapy trials.
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Dettweiler U and Simon P
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- Clinical Trials as Topic standards, Conflict of Interest, Humans, Informed Consent, Researcher-Subject Relations, Genetic Therapy adverse effects, Human Experimentation, Risk Assessment
- Abstract
Recent political developments and disclosures of serious adverse events in human gene therapy (HGT) with the death of 18-year old Jesse Gelsinger in the USA have shown that the clinical application of HGT raises some severe ethical issues. These have either been neglected or not yet been discussed to a satisfactory extent. In this paper, we will address this deficiency and develop strategies for a safer application of HGT. Such a study must first look closely at the science of HGT itself. We will evaluate the latest preclinical research, especially data on the viruses that are used as vectors and on modes of administration of vectors. We will put forward new arguments concerning the toxicity assessment of so-called 'gene drugs', the tissue and cell type specificity of the vectors, and the duration and on-set of gene expression. Secondly, we will look at procedural aspects of applied research ethics on the way to clinical application of HGT. There, informed consent (IC) and the patient-researcher relationship are of utmost concern. Furthermore, we will explore the problem of expertise in risk assessment and will show how current regulations foster conflicts on interests that create dilemma situations even for those researchers who act in the best interest of the patients. We will conclude the article with a set of questions for ethicists who have to decide about the quality of HGT protocols. This may contribute to the safety of patients participating in HGT trials and to achieving the aim of efficient application of HGT.
- Published
- 2001
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