Comparison of different mobile health applications for intervention in children and adolescent with overweight: a protocol for systematic review with meta-analysis and trial sequential analysis.

INTRODUCTION: Overweight in children is increasing worldwide. Innovative smartphone health applications (mHealth apps) have either sought to deliver single or multi-component interventions for the management of overweight in children. However, the clinical effects of these apps are poorly explored. The objective of the review will be to compare the benefits and harms of different categories of mHealth apps for intervention of overweight in children. METHODS AND ANALYSIS: We will include randomised clinical trials irrespective of publication type, year, status or language. Children and adolescents between 0 to 18 years will be referred to as children in the remaining part of the paper. Children with all degrees of overweight included obesity and morbidly obese in the remaining part of the paper will be referred to as overweight. We plan to classify different apps according to type of intervention, measurement device, coaching and reward system. The following databases will be used: Cochrane Library, Excerpta Medica database (Embase), PsycINFO, PubMed, IEEE Explore and Web of Science, CINAHL and LILACS. Primary outcomes will be body mass index z-score, quality of life and serious adverse event. Secondary outcomes will be body weight, self-efficacy, anxiety, depression and adverse event not considered serious. Study inclusion, data extraction and bias risk assessment will be conducted independently by at least two authors. We will assess the risk of bias through eight domains and control risks of random errors with Trial Sequential Analysis. The quality of the evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation Tool (GRADE). ETHICS AND DISSEMINATION: As the protocol is for a systematic reviews, we have not included any patient data and we do not require ethical approval. This review will be published in a peer-reviewed journal. PROSPERO REGISTRATION NUMBER: CRD42019120266.

A Mobile Phone Intervention to Improve Obesity-Related Health Behaviors of Adolescents Across Europe: Iterative Co-Design and Feasibility Study.

BACKGROUND: Promotion of physical activity, healthy eating, adequate sleep, and reduced sedentary behavior in adolescents is a major priority globally given the current increase in population health challenges of noncommunicable diseases and risk factors such as obesity. Adolescents are highly engaged with mobile technology, but the challenge is to engage them with mobile health (mHealth) technology. Recent innovations in mobile technology provide opportunities to promote a healthy lifestyle in adolescents. An increasingly utilized approach to facilitate increased engagement with mHealth technology is to involve potential users in the creation of the technology. OBJECTIVE: This study aimed to describe the process of and findings from co-designing and prototyping components of the PEGASO Fit for Future (F4F) mHealth intervention for adolescents from different cultural backgrounds. METHODS: A total of 74 adolescents aged 13 to 16 years from Spain, Italy, and the United Kingdom participated in the co-design of the PEGASO F4F technology. In 3 iterative cycles over 12 months, participants were involved in the co-design, refinement, and feasibility testing of a system consisting of diverse mobile apps with a variety of functions and facilities to encourage healthy weight-promoting behaviors. In the first iteration, participants attended a single workshop session and were presented with mock-ups or early-version prototypes of different apps for user requirements assessment and review. During the second iteration, prototypes of all apps were tested by participants for 1 week at home or school. In the third iteration, further developed prototypes were tested for 2 weeks. Participants' user experience feedback and development ideas were collected through focus groups and completion of questionnaires. RESULTS: For the PEGASO F4F technology to be motivating and engaging, participants suggested that it should (1) allow personalization of the interface, (2) have age-appropriate and easy-to-understand language (of icons, labels, instructions, and notifications), (3) provide easily accessible tutorials on how to use the app or navigate through a game, (4) present a clear purpose and end goal, (5) have an appealing and self-explanatory reward system, (6) offer variation in gamified activities within apps and the serious game, and (7) allow to seek peer support and connect with peers for competitive activities within the technology. CONCLUSIONS: Incorporating adolescents' preferences, the PEGASO F4F technology combines the functions of a self-monitoring, entertainment, advisory, and social support tool. This was the first study demonstrating that it is possible to develop a complex mobile phone-based technological system applying the principles of co-design to mHealth technology with adolescents across 3 countries. The findings from this study informed the development of an mHealth system for healthy weight promotion to be tested in a controlled multinational pilot trial.

Health apps targeting children with overweight-a protocol for a systematic review with meta-analysis and Trial Sequential Analysis of randomised clinical trials.

BACKGROUND: The prevalence of overweight is increasing worldwide in children. Multi-component interventions incorporating diet, physical activity, and behavioural change have been shown to reduce body mass index (BMI). Whilst many children have their own smartphone, the clinical effects of using smartphone applications (apps) for overweight are unknown. This systematic review aims to ascertain the effects of mHealth apps in children with overweight. METHODS: We will include randomised clinical trials irrespective of publication type, year, status, or language. Children between 0 and 18 years with overweight will be included. We will compare apps targeting overweight versus sham app, no app, or usual intervention. No distinction about operative system will be considered (i.e. Android, iOS, and Window Mobile will be included). The following databases will be searched: The Cochrane Library, Excerpta Medica database (Embase), PsycINFO, PubMed, IEEE Explore, Web of Science, CINAHL, and LILACS. Primary outcomes will be body weight, quality of life, and serious adverse event. Secondary outcomes will be self-efficacy, anxiety, depression, and adverse event not considered serious. Trial inclusion, data extraction, and bias risk assessment will be conducted independently by at least two authors. We will assess risk of bias through eight domains and control risks of random errors with Trial Sequential Analysis. The quality of the evidence will be assessed using Grading of Recommendations Assessment, Development and Evaluation Tool (GRADE). DISCUSSION: We will provide evidence of the beneficial and harmful effects of smartphone apps for children with overweight and highlight any gaps in the evidence in order to shape future potential interventions. By only including randomised clinical trials, we know that we bias our review towards benefits. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019120210.

Teenagers' Usage of a Mobile-Wearable-Cloud Platform to Promote Healthy Lifestyles: the PEGASO Experience.

In contemporary society, non-communicable diseases linked to unhealthy lifestyles, such as obesity, are on the rise with a major impact on global deaths. Prevention is the new frontier, promising to increase life expectancy and quality, while reducing costs related to healthcare. The PEGASO project developed a mobile ecosystem where the digital Companion aims at empowering teenagers in the adoption of healthy lifestyles. The pilot study conducted in three European countries (Spain, UK and Italy) shows a good acceptance of the system and that teenagers are keen to use mobile technology to improve their lifestyle, although wearable devices did not engage the young users.

Pilot Test of a New Personal Health System Integrating Environmental and Wearable Sensors for Telemonitoring and Care of Elderly People at Home (SMARTA Project).

BACKGROUND: The increase in life expectancy is accompanied by a growing number of elderly subjects affected by chronic comorbidities, a health issue which also implies important socioeconomic consequences. Shifting from hospital or community dwelling care towards a home personalized healthcare paradigm would promote active aging with a better quality of life, along with a reduction in healthcare-related costs. OBJECTIVE: The aim of the SMARTA project was to develop and test an innovative personal health system integrating standard sensors as well as innovative wearable and environmental sensors to allow home telemonitoring of vital parameters and detection of anomalies in daily activities, thus supporting active aging through remote healthcare. METHODS: A first phase of the project consisted in the definition of the health and environmental parameters to be monitored (electrocardiography and actigraphy, blood pressure and oxygen saturation, weight, ear temperature, glycemia, home interaction monitoring - water tap, refrigerator, and dishwasher), the feedbacks for the clinicians, and the reminders for the patients. It was followed by a technical feasibility analysis leading to an iterative process of prototype development, sensor integration, and testing. Once the prototype had reached an advanced stage of development, a group of 32 volunteers - including 15 healthy adult subjects, 13 elderly people with cardiac diseases, and 4 clinical operators - was recruited to test the system in a real home setting, in order to evaluate both technical reliability and user perception of the system in terms of effectiveness, usability, acceptance, and attractiveness. RESULTS: The testing in a real home setting showed a good perception of the SMARTA system and its functionalities both by the patients and by the clinicians, who appreciated the user interface and the clinical governance system. The moderate system reliability of 65-70% evidenced some technical issues, mainly related to sensor integration, while the patient's user interface showed excellent reliability (100%). CONCLUSIONS: Both elderly people and clinical operators considered the SMARTA system a promising and attractive tool for improving patients' healthcare while reducing related costs and preserving quality of life. However, the moderate reliability of the system should prompt further technical developments in terms of sensor integration and usability of the clinical operator's user interface.

A Smart Wearable Sensor System for Counter-Fighting Overweight in Teenagers.

PEGASO is a FP7-funded project whose goal is to develop an ICT and mobile-based platform together with an appropriate strategy to tackle the diffusion of obesity and other lifestyle-related illnesses among teenagers. Indeed, the design of an engaging strategy, leveraging a complementary set of technologies, is the approach proposed by the project to promote the adoption of healthy habits such as active lifestyle and balanced nutrition and to effectively counter-fight the emergence of overweight and obesity in the younger population. A technological key element of such a strategy sees the adoption of wearable sensors to monitor teenagers' activities, which is at the basis of developing awareness about the current lifestyle. This paper describes the experience carried out in the framework of the PEGASO project in developing and evaluating wearable monitoring systems addressed to adolescents. The paper describes the methodological approach based on the co-designing of such a wearable system and the main results that, in the first phase, involved a total of 407 adolescents across Europe in a series of focus groups conducted in three countries for the requirements definition phase. Moreover, it describes an evaluation process of signal reliability during the usage of the wearable system. The main results described here are: (a) a prototype of the standardized experimental protocol that has been developed and applied to test signal reliability in smart garments; (b) the requirements definition methodology through a co-design activity and approach to address user requirements and preferences and not only technological specifications. Such co-design approach is able to support a higher system acceptance and usability together with a sustained adoption of the solution with respect to the traditional technology push system development strategy.

Defining Requirements and Related Methods for Designing Sensorized Garments.

Designing smart garments has strong interdisciplinary implications, specifically related to user and technical requirements, but also because of the very different applications they have: medicine, sport and fitness, lifestyle monitoring, workplace and job conditions analysis, etc. This paper aims to discuss some user, textile, and technical issues to be faced in sensorized clothes development. In relation to the user, the main requirements are anthropometric, gender-related, and aesthetical. In terms of these requirements, the user's age, the target application, and fashion trends cannot be ignored, because they determine the compliance with the wearable system. Regarding textile requirements, functional factors-also influencing user comfort-are elasticity and washability, while more technical properties are the stability of the chemical agents' effects for preserving the sensors' efficacy and reliability, and assuring the proper duration of the product for the complete life cycle. From the technical side, the physiological issues are the most important: skin conductance, tolerance, irritation, and the effect of sweat and perspiration are key factors for reliable sensing. Other technical features such as battery size and duration, and the form factor of the sensor collector, should be considered, as they affect aesthetical requirements, which have proven to be crucial, as well as comfort and wearability.

Clinical gait analysis for amputees: innovation wishlist and the perspectives offered by the outwalk protocol.

Clinical gait analysis (CGA) has shown potentials for the prosthetics field and has been found effective for scientific purposes and to design general rehabilitation models. However, intrinsic limitations of the "artificial" laboratory environment usually result in recording performances not representative patients' real-life gait. In order to promote the diffusion of CGA in the clinical decision-making process, a framework for developing novel, more ecological CGA applications is presented. Moreover, the Outwalk protocol, based on wearable sensors and developed within this framework guidelines, is described and validated for its inter-rater agreement on a population of transtibial amputees walking in a real-life scenario. Results show the possibility of drawing precise conclusions over different aspects of amputees' gait and prostheses' performance in every-day life conditions.

Assessment of lower limb prosthesis through wearable sensors and thermography.

This study aimed to explore the application of infrared thermography in combination with ambulatory wearable monitoring of temperature and relative humidity, to assess the residual limb-to-liner interface in lower-limb prosthesis users. Five male traumatic transtibial amputees were involved, who reported no problems or discomfort while wearing the prosthesis. A thermal imaging camera was used to measure superficial thermal distribution maps of the stump. A wearable system for recording the temperature and relative humidity in up to four anatomical points was developed, tested in vitro and integrated with the measurement set. The parallel application of an infrared camera and wearable sensors provided complementary information. Four main Regions of Interest were identified on the stump (inferior patella, lateral/medial epicondyles, tibial tuberosity), with good inter-subject repeatability. An average increase of 20% in hot areas (P < 0.05) is shown after walking compared to resting conditions. The sensors inside the cuff did not provoke any discomfort during recordings and provide an inside of the thermal exchanges while walking and recording the temperature increase (a regime value is ~+1.1 ± 0.7 °C) and a more significant one (~+4.1 ± 2.3%) in humidity because of the sweat produced. This study has also begun the development of a reference data set for optimal socket/liner-stump construction.

Wearable monitoring devices for assistive technology: case studies in post-polio syndrome.

The correct choice and customization of an orthosis are crucial to obtain the best comfort and efficiency. This study explored the feasibility of a multivariate quantitative assessment of the functional efficiency of lower limb orthosis through a novel wearable system. Gait basographic parameters and energetic indexes were analysed during a Six-Minute Walking Test (6-MWT) through a cost-effective, non-invasive polygraph device, with a multichannel wireless transmission, that carried out electro-cardiograph (ECG); impedance-cardiograph (ICG); and lower-limb accelerations detection. Four subjects affected by Post-Polio Syndrome (PPS) were recruited. The wearable device and the semi-automatic post-processing software provided a novel set of objective data to assess the overall efficiency of the patient-orthosis system. Despite the small number of examined subjects, the results obtained with this new approach encourage the application of the method thus enlarging the dataset to validate this promising protocol and measuring system in supporting clinical decisions and out of a laboratory environment.

Wearable monitoring systems in pre-term newborns care.

In the last decade, the trends in the development and management of healthcare services are focused on the personalization of prevention, diagnosis and treatment. This paper presents an example of the development of wearable technology for biosignal monitoring in the field of pre-term newborns care. The system was validated by an in-hospital pre-clinical test demonstrating efficiency, reliability and quality.

Sport monitoring with smart wearable system.

This work presents a new system for sport monitoring. The system was composed of a t-shirt with two textile electrodes and two devices for the acquisition, storage, processing and visualization of the signals. The systems allows monitoring both ECG signal (raw and processed heart-rate) and 3 axial acceleration (raw and step counter). The systems were tested in different conditions during some races; we report the results on three subjects during a skyrunning race.

Ergonomics and design for sustainability in healthcare: ambient assisted living and the social-environmental impact of patients lifestyle.

This work presents considerations on Ergonomics and Design for Sustainability in the healthcare field based on research experiences of the Technology and Design for Healthcare (TeDH) research group of INDACO (Industrial design, communication, arts and fashion) department of Politecnico di Milano. In order to develop a multidisciplinary approach to design able to answer to specific user needs such as elderly in an environmental sustainable way (1) this paper shows the results we achieved concerning ergonomics and environmental impact in product development (2), the extension of this approach to interior and home design and the advantage of the application of Information Communication Technologies (ICT). ICT can help people with special needs to make their everyday life easier and more safe, at the same time, ICT can make social-environmental impact of everyday behavior evident and can be applied to manage sustainability. The specific theme is thus to integrate ergonomics and sustainability competences in the development of Ambient Assisted Living through a Product- Service System approach. The concept of product service system has the potential to improve product performances and services, establish new relations and networks with different actors in order to satisfy user needs and apply a systems approach considering environmental, social and economic factors in the users' environment.

Automatic detection of tic activity in the Tourette Syndrome.

This study presents a simple decision-support system for the detection of tic events during the Tourette Syndrome (TS). The system is based on a triaxial accelerometer placed on the patient's trunk. TS is a neurological disorder that emerges during childhood and that is characterized by a large spectrum of involuntary/compulsive movements and sounds. 12 subjects with chronic TS participated in the study and the tic events were both measured by the proposed device and visually classified through video recording. 3D-acceleration timeseries were combined through a module operator and their noise was eliminated by a median filter. Signal to noise ratio was improved by a nonlinear energy operator. Finally, a time-variant threshold was used to detect tic events. The automatic tic recognition showed a performance around 80 % in terms of sensitivity, specificity and accuracy. In conclusion, this simple, automatic and unobtrusive method offers an alternative approach to quantitatively assess the tic events in clinical and non clinical environments. This overcomes the limitations of the current motor tic evaluation which is done by clinical observation and/or video-inspection in specialized neurological centres.

Prototype of a wearable system for remote fetal monitoring during pregnancy.

Fetal Heart Rate (FHR) monitoring gives important information about the fetus health state during pregnancy. This paper presents a new prototype for remote fetal monitoring. The device will allow to monitor FHR in a domiciliary context and to send fetal ECG traces to a hospital facility, where clinicians can interpret them. In this way the mother could receive prompt feedback about fetal wellbeing. The system is characterized by two units: (i) a wearable unit endowed with textile electrodes for abdominal ECG recordings and with a Field Programmable Gate Array (FPGA) board for fetal heart rate (FHR) extraction; (ii) a dock station for the transmission of the data through the telephone line. The system will allow to reduce costs in fetal monitoring, improving the assessment of fetal conditions. The device is actually in development state. In this paper, the most crucial aspects behind its fulfillment are discussed.

A novel automatic method for monitoring Tourette motor tics through a wearable device.

The aim of this study was to propose a novel automatic method for quantifying motor-tics caused by the Tourette Syndrome (TS). In this preliminary report, the feasibility of the monitoring process was tested over a series of standard clinical trials in a population of 12 subjects affected by TS. A wearable instrument with an embedded three-axial accelerometer was used to detect and classify motor tics during standing and walking activities. An algorithm was devised to analyze acceleration data by: eliminating noise; detecting peaks connected to pathological events; and classifying intensity and frequency of motor tics into quantitative scores. These indexes were compared with the video-based ones provided by expert clinicians, which were taken as the gold-standard. Sensitivity, specificity, and accuracy of tic detection were estimated, and an agreement analysis was performed through the least square regression and the Bland-Altman test. The tic recognition algorithm showed sensitivity = 80.8% ± 8.5% (mean ± SD), specificity = 75.8% ± 17.3%, and accuracy = 80.5% ± 12.2%. The agreement study showed that automatic detection tended to overestimate the number of tics occurred. Although, it appeared this may be a systematic error due to the different recognition principles of the wearable and video-based systems. Furthermore, there was substantial concurrency with the gold-standard in estimating the severity indexes. The proposed methodology gave promising performances in terms of automatic motor-tics detection and classification in a standard clinical context. The system may provide physicians with a quantitative aid for TS assessment. Further developments will focus on the extension of its application to everyday long-term monitoring out of clinical environments.

A robust and self-paced BCI system based on a four class SSVEP paradigm: algorithms and protocols for a high-transfer-rate direct brain communication.

In this paper, we present, with particular focus on the adopted processing and identification chain and protocol-related solutions, a whole self-paced brain-computer interface system based on a 4-class steady-state visual evoked potentials (SSVEPs) paradigm. The proposed system incorporates an automated spatial filtering technique centred on the common spatial patterns (CSPs) method, an autoscaled and effective signal features extraction which is used for providing an unsupervised biofeedback, and a robust self-paced classifier based on the discriminant analysis theory. The adopted operating protocol is structured in a screening, training, and testing phase aimed at collecting user-specific information regarding best stimulation frequencies, optimal sources identification, and overall system processing chain calibration in only a few minutes. The system, validated on 11 healthy/pathologic subjects, has proven to be reliable in terms of achievable communication speed (up to 70 bit/min) and very robust to false positive identifications.

Pervasive technology in Neonatal Intensive Care Unit: a prototype for newborns unobtrusive monitoring.

Pervasive computing research is introducing new perspectives in a wide range of applications, including healthcare domain. In this study we explore the possibility to realize a prototype of a system for unobtrusive recording and monitoring of multiple biological parameters on premature newborns hospitalized in the Neonatal Intensive Care Unit (NICU). It consists of three different units: a sensitized belt for Electrocardiogram (ECG) and chest dilatation monitoring, augmented with extrinsic transducers for temperature and respiratory activity measure, a device for signals pre-processing, sampling and transmission through Bluetooth(R) (BT) technology to a remote PC station and a software for data capture and post-processing. Preliminary results obtained by monitoring babies just discharged from the ward demonstrated the feasibility of the unobtrusive monitoring on this kind of subjects and open a new scenario for premature newborns monitoring and developmental cares practice in NICU.

A Wearable Home BCI system: preliminary results with SSVEP protocol.

This paper presents and discusses the realization and the performances of a wearable system for EEG-based BCI applications. The system (called Kimera) consists of a two-layer hardware architecture (the wireless acquisition and transmission board based on a Bluetooth ® ARM chip, and a low power miniaturized biosignal acquisition analog front end) together with a software suite (called Bellerophonte) for the Graphic User Interface management, protocol execution, data recording, transmission and processing. The implemented BCI system was based on the SSVEP protocol, applied to a two state selection by using standards display/monitor with a couple of high efficiency LEDs. The frequency features of the signal were computed and used in the intention detection. The BCI algorithm is based on a supervised classifier implemented through a multi-class Canonical Discriminant Analysis (CDA) with a continuous realtime feedback based on the mahalanobis distance parameter. Five healthy subjects participated in the first phase for a preliminary device validation. The obtained results are very interesting and promising, being lined out to the most recent performance reported in literature with a significant improvement both in system and in classification capabilities. The user-friendliness and low cost of the Kimera& Bellerophonte platform make it suitable for the development of home BCI applications.

The densitometric physical fractionator for counting neuronal populations: application to a mouse model of familial amyotrophic lateral sclerosis.

The method of the 'densitometric physical fractionator' presented here realizes an accurate and reproducible stereological quantification, not requiring a motorized or controlled z-axis, of cell populations. It includes a special software for the calibration of the optics alignment of the microscope and a semi-automatic procedure that integrates specific densitometric functions for image analysis, to identify the reference volume and the particle profiles. This improves the identification of the cells significantly, reduces variability in the subjective choice of the particles by the operators, and allows a consistent saving of time during the analysis. The method is proved to be unbiased and the accuracy and reproducibility of the results has been validated through intra- and inter-operator analyses. Furthermore, it has been applied to calculate the loss of spinal motor neurons during pathology progression in transgenic mice for superoxide-dismutase Cu/Zn dependent (SOD1) mutants, a model of amyotrophic lateral sclerosis (ALS).