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'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism.

ABSTRACT: INTRODUCTION:Individuals with autism spectrum disorder (ASD) have difficulties in communication and social interaction resulting from atypical perceptual and cognitive information processing, leading to an accumulation of anxiety. Extreme overloading experienced internally may not be externally visible. Identifying stressful situations at an early stage may avoid socially problematic behaviour from occurring, such as self-injurious behaviour. Activation of the autonomous nervous system (ANS) is involved in the response to anxiety, which can be measured through heart rate variability and skin conductance with the use of portable devices, non-intrusively and pain-free. Thus, developing innovative analysis of signal perception and reaction is necessary, mainly for non-communicative individuals with autism. METHODS AND ANALYSIS:The protocol will take place in real life (home and social environments). We aim to associate modifications of the ANS with external events that will be recorded in a synchronous manner through a specific design (spy glasses with video/audio recording). Four phases will be carried out on ASD participants and aged-matched controls: (1) 24-hour baseline pre-experiment (physical activity, sleep), (2) 2?h in a real life situation, (3) 30?min in a quiet environment, interrupted by a few seconds of stressful sound, (4) an interview to record feelings about events triggering anxiety. ASD and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events. The novelty will be to apply time-series analyses (which led to several Nobel Prizes in quantitative finance) on ANS series (heart rate, heart rate variability, skin conductance) and wrist motion. ETHICS AND DISSEMINATION:Ethical approval has been obtained from Ethics Committee of Clermont-Ferrand (South-East I), France (2014-A00611-46). Trial findings will be disseminated via open-access peer-reviewed publications, conferences, clinical networks, public lectures and our websites. TRIAL REGISTRATION NUMBER:ClinicalTrials identifier NCT02275455.

SUBMITTER: Dutheil F

PROVIDER: S-EPMC4336464 | biostudies-literature | 2015 Feb

REPOSITORIES: biostudies-literature

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'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism.

Dutheil Frédéric F Chambres Patrick P Hufnagel Cédric C Auxiette Catherine C Chausse Pierre P Ghozi Raja R Paugam Guillaume G Boudet Gil G Khalfa Nadia N Naughton Geraldine G Chamoux Alain A Mermillod Martial M Bertrand Pierre Raphael PR

BMJ open 20150220 2

<h4>Introduction</h4>Individuals with autism spectrum disorder (ASD) have difficulties in communication and social interaction resulting from atypical perceptual and cognitive information processing, leading to an accumulation of anxiety. Extreme overloading experienced internally may not be externally visible. Identifying stressful situations at an early stage may avoid socially problematic behaviour from occurring, such as self-injurious behaviour. Activation of the autonomous nervous system ( ...[more]

PMID: 25710916

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Project description:IntroductionAustralian Aboriginal and/or Torres Strait Islander (hereafter referred to as 'Aboriginal') adolescents (10-24 years) experience multiple challenges to their health and well-being. However, limited evidence is available on factors influencing their health trajectories. Given the needs of this group, the young age profile of the Aboriginal population and the long-term implications of issues during adolescence, reliable longitudinal data are needed.Methods and analysisThe 'Next Generation: Youth Well-being Study' is a mixed-methods cohort study aiming to recruit 2250 Aboriginal adolescents aged 10-24 years from rural, remote and urban communities in Central Australia, Western Australia and New South Wales. The study assesses overall health and well-being and consists of two phases. During phase 1, we qualitatively explored the meaning of health and well-being for adolescents and accessibility of health services. During phase 2, participants are being recruited into a longitudinal cohort. Recruitment is occurring mainly through community networks and connections. At baseline, participants complete a comprehensive survey and undertake an extensive age relevant clinical assessment. Survey and clinical data will be linked to various databases including those relating to health services; medication; immunisation; hospitalisations and emergency department presentations; death registrations; education; child protection and corrective services. Participants will receive follow-up surveys approximately 2 years after their baseline visit. The 'Next Generation' study will fill important evidence gaps by providing longitudinal data on the health and social well-being of Aboriginal adolescents supplemented with narratives from participants to provide context.Ethics and disseminationEthics approvals have been sought and granted. Along with peer-reviewed publications and policy briefs, research findings will be disseminated via reports, booklets and other formats that will be most useful and informative to the participants and community organisations.

Project description:IntroductionOver 30% of Canadians between the ages of 16 and 24 years attend university. This period of life coincides with the onset of common mental illnesses. Yet, data to inform university-based mental health prevention and early intervention initiatives are limited. The U-Flourish longitudinal study based out of Queen's University, Canada and involving Oxford University in the UK, is a student informed study funded by the Canadian Institute for Health Research Strategy for Patient Oriented Research (CIHR-SPOR). The primary goal of U-Flourish research is to examine the contribution of risk and resiliency factors to outcomes of well-being and academic success in first year students transitioning to university.Methods and analysisThe study is a longitudinal survey of all first-year undergraduate students entering Queen's University in the fall term of 2018 (and will launch at Oxford University in fall of 2019). In accordance with the CIHR-SPOR definitions, students represent the target population (ie, patient equivalent). Student peer health educators were recruited to inform the design, content and implementation of the study. Baseline surveys of Queen's first year students were completed in the fall of 2018, and follow-up surveys at the end of first year in the spring of 2019. Extensive student-led engagement campaigns were used to maximise participation rates. The baseline survey included measures of personal factors, family factors, environmental factors, psychological and emotional health, and lifestyle factors. Main outcomes include self-reported indicators of mental health at follow-up and mental health service access, as well as objective measures of academic success through linkage to university administrative and academic databases. A combination of mixed effects regression techniques will be employed to determine associations between baseline predictive factors and mental health and academic outcomes.Ethics and disseminationEthical approval was obtained by the Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (HSREB) (#6023126) at Queen's University. Findings will be disseminated through international and national peer-reviewed scientific articles and other channels including student-driven support and advocacy groups, newsletters and social media.

Project description:Stroke is a major public health threat globally. Psychosocial well-being may be affected following stroke. Depressive symptoms, anxiety, general psychological distress and social isolation are prevalent. Approximately one third report depressive symptoms and 20% report anxiety during the first months or years after the stroke. Psychosocial difficulties may impact significantly on long-term functioning and quality of life, reduce the effects of rehabilitation services and lead to higher mortality rates. The aim of the study is to evaluate the effect of a previously developed and feasibility tested dialogue-based psychosocial intervention aimed at promoting psychosocial well-being and coping following stroke among stroke survivors with and without aphasia.The study will be conducted as a multicenter, randomized, single blind controlled trial with one intervention and one control arm. It will include a total of 330 stroke survivors randomly allocated into either an intervention group (dialogue-based intervention to promote psychosocial well-being) or a control group (usual care). Participants in the intervention group will receive eight individual sessions of supported dialogues in their homes during the first six months following an acute stroke. The primary outcome measure will be psychosocial well-being measured by the General Health Questionnaire (GHQ). Secondary outcome measures will be quality of life (SAQoL), sense of coherence (SOC), and depression (Yale). Process evaluation will be conducted in a longitudinal mixed methods study by individual qualitative interviews with 15-20 participants in the intervention and control groups, focus group interviews with the intervention personnel and data collectors, and a comprehensive analysis of implementation fidelity.The intervention described in this study protocol is based on thorough development and feasibility work, guided by the UK medical research council framework for developing and testing complex interventions. It combines classical effectiveness evaluation with a thorough process evaluation. The results from this study may inform the development of further trials aimed at promoting psychosocial well-being following stroke as well as inform the psychosocial follow up of stroke patients living at home.NCT02338869 ; registered 10/04/2014 (On-going trial).

Project description:IntroductionThe rapid increase in apartment construction in Australia has raised concerns about the impacts of poorly designed and located buildings on resident health and well-being. While apartment design policies exist, their content varies across jurisdictions and evidence on their impact on health and well-being is lacking. This cross-sectional observational study (2017-2021) aims to generate empirical evidence to guide policy decisions on apartment development and help to create healthy, equitable higher-density communities. Objectives include to benchmark the implementation of health-promoting apartment design requirements and to identify associations between requirements and resident health and well-being outcomes.Methods and analysisEligible buildings in three Australian cities with different apartment design guidelines will be stratified by area disadvantage and randomly selected (~n=99). Building architects, developers and local governments will be approached to provide endorsed development plans from which apartment and building design features will be extracted. Additional data collection includes a resident survey (~n=1000) to assess environmental stressors and health and well-being impacts and outcomes, and geographic information systems measures of the neighbourhood. The study has 85% power to detect a difference of 0.5 SD in the primary outcome of mental well-being (Warwick-Edinburgh Mental Well-being Scale) at a 5% level of significance. Analyses will compare policy compliance and health-promoting design features between cities and area disadvantage groups. Regression models will test whether higher policy compliance (overall and by design theme) is associated with better health and well-being, and the relative contribution of the neighbourhood context.Ethics and disseminationHuman Research Ethics Committees of RMIT University (CHEAN B 21146-10/17) and the University of Western Australia (RA/4/1/8735) approved the study protocol. In addition to academic publications, the collaboration will develop specific health-promoting indicators to embed into the monitoring of apartment design policy implementation and impact, and co-design research dissemination materials to facilitate uptake by decision makers.

Project description:IntroductionStress at work and psychosocial risks are a major public health problem. Sophrology and neurolinguistic programming (NLP) have demonstrated benefits in terms of mental, physical and social health, both in the general population and in patients, and both in and out of hospital settings. However, these approaches have never been provided at the hospital for the benefit of health professionals at risk of suffering at work. In general, we aim to demonstrate the effectiveness of a hospital sophrology/NLP intervention for health care professionals at risk of stress-related disorders. The secondary objectives are to study (i) within-group, and (ii) between-group): (1) effects on mental, physical, and social health; (2) persistence of effect; (3) relationships between job perception and mental, physical, and social health; (4) intervention success factors (personality and job perception, attendance and practice, other); (5) effects on other stress biomarkers (other measures of autonomic nervous system activity, DHEAS, cortisol, etc.).MethodsOur study will be a randomized controlled prospective study (research involving the human person of type 2). The study will be proposed to any health-care workers (HCW) or any non-HCW (NHCW) from a healthcare institution (such as CHU of Clermont-Ferrand, other hospitals, clinics, retirement homes). Participants will benefit from NLP and sophrology interventions at the hospital. For both groups: (i) heart rate variability, skin conductance and saliva biomarkers will be assessed once a week during the intervention period (6 to 8 sophrology sessions) and once by month for the rest of the time; (ii) the short questionnaire will be collected once a week during the whole protocol (1-2 min); (iii) the long questionnaire will be assessed only 5 times: at baseline (M0), month 1 (M1), month 3 (M3), month 5 (M5) and end of the protocol (M7).Ethics and disseminationThe protocol, information and consent form had received the favorable opinion from the Ethics Committee. Notification of the approval of the Ethics Committee was sent to the study sponsor and the competent authority (ANSM). The study is registered in ClinicalTrials.gov under the identification number NCT05425511 after the French Ethics Committee's approval. The results will be reported according to the CONSORT guidelines.Strengths and limitations of this studyThe psychological questionnaires in this study are self-assessed. It is also possible that responses suffer from variation. For the study, participants need to attend 6 to 8 sophrology sessions and one visit per month for 7 months, which might seem demanding. Therefore, to make sure that participants will complete the protocol, two persons will be fully in charge of the participants' follow-up.

Project description:BACKGROUND:Childhood obesity is one of the greatest public health problems facing advanced societies, and Spain is one of the countries with the highest incidence. There are many studies that monitor at the national level, but given the lack of specificity, lack of updating and scarcity of epidemiological data on overweight, obesity, physical condition and well-being of children and adolescents in Extremadura, it seems necessary to create a Well-being, Obesity and Motricity Observatory in Childhood and Youth (WOMO) in Extremadura in order to follow up on the evolution of this problem and to propose strategies to combat it. Therefore, this project aims (1) to obtain information on the physical condition, body composition and well-being of children and youth in Extremadura every year and (2) to evaluate the relationship between obesity, overweight, physical condition, well-being, self-perceived physical fitness, physical activity adherence, physical literacy, health-related quality of life (HRQoL), happiness and satisfaction with life, connection with nature, barriers to sports practice, self-concept and bullying in children and youth. METHODS:An annual monitoring cross-sectional and follow-up study will be performed. Primary outcome measures will be (1) personal data and anthropometric measurements, (2) family and school information, (3) physical condition, (4) obesity and overweight level, and (5) well-being. Secondary outcome measures will be (1) self-perceived physical fitness, (2) physical activity adherence, (3) physical literacy, (4) HRQoL, (5) happiness and satisfaction with life, (6) connection with nature, (7) barriers to sports practice, (8) self-concept and (9) bullying. DISCUSSION:This project will provide valuable information to adopt appropriate strategies to reduce the level of overweight and obesity in children and youth. Furthermore, orientations will be given to transfer the results obtained to the business sector or to the public sector to evaluate or change the policies adopted.

Dataset Information

'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism.

Publications

'Do Well B.': Design Of WELL Being monitoring systems. A study protocol for the application in autism.

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