School health promotion is advocated. Implementation studies on school health promotion are less often conducted as effectiveness studies and are mainly conducted conventionally by assessing fidelity of “one size fits all” interventions. However, interventions that allow for local adaptation are more appropriate and require a different evaluation approach. We evaluated a mutual adaptation physical activity and nutrition intervention implemented in eight primary schools located in low socioeconomic neighborhoods in the Netherlands, namely the KEIGAAF intervention. A qualitative, multiple-case study design was used to evaluate implementation and contextual factors affecting implementation. We used several qualitative data collection tools and applied inductive content analysis for coding the transcribed data. Codes were linked to the domains of the Consolidated Framework for Implementation Research. NVivo was used to support data analysis. The implementation process varied greatly across schools. This was due to the high level of bottom-up design of the intervention and differing contextual factors influencing implementation, such as differing starting situations. The mutual adaptation between top-down and bottom-up influences was a key element of the intervention. Feedback loops and the health promotion advisors played a crucial role by navigating between top-down and bottom-up. Implementing a mutual adaptation intervention is time-consuming but feasible.  Given the significant amount of time children spend at school, the school environment has an important influence on children’s energy balance-related behaviors (EBRBs), i.e., sedentary behavior, physical activity (PA), and nutrition behavior. The World Health Organization advocates school health promotion . HoweverTo understand why interventions succeeded or failed, insight into what really happens during implementation is indispensable . The numHowever, “one size fits all” evidence-based interventions do not take into account contextual differences between settings. In contrast, interventions which allow local adaptation to ensure contextual fit do take these differences in context into account and are considered to be more appropriate, implementable, effective, and ultimately sustainable ,16. It iIn this paper, we evaluated a mutual adaptation physical activity and nutrition intervention that was implemented in primary schools in the Netherlands , i.e., tTo study the implementation of KEIGAAF in the intervention schools, a qualitative, multiple-case study was conducted . This prEight intervention schools were recruited in April and May 2016 in Eindhoven, a city in the south of the Netherlands. These schools were located in low socioeconomic neighborhoods. Eligibility criteria and recruitment strategies are described in detail in the study protocol . The KEIGAAF intervention was not a prepackaged program, but an approach that consisted of an interplay between top-down and bottom-up influences reinforcing each other in order to optimize the implementation of school-based PA and nutrition activities by ensuring contextual fit ,24. The The top-down part of the KEIGAAF approach consisted of a steering committee of health behavioral experts and representatives of local organizations, who provided the basic principles of the intervention see  and suppThe working groups were encouraged to follow the steps proposed in the model by Van Kann et al.  which coThe working groups were advised on implementing a comprehensive and integrated set of PA and healthy nutrition-promoting activities. School health promotion is considered comprehensive and integrated when children’s health behaviors are promoted through health education, by the school’s physical and social environment, and beyond the school gates  by engaging families and the wider community ,25.The KEIGAAF intervention started in April 2016 and lasted until June 2019 . The intThe context of the intervention schools served as the study setting. By context, we mean “the set of circumstances or unique factors that surround a particular implementation effort”  (p. 52).In this study, the outer setting was considered the external context of the school that could influence implementation, for example, national and local policies or collaborations with external organizations. The inner setting was considered the school environment, for example, involvement of school staff and the principal. The individuals involved in the implementation of the intervention were the working group members, i.e., schoolteachers, external professionals, parents, and the HP advisor.In addition to the individuals involved in implementation, the study population consisted of all actors in the eight intervention schools, for example, schoolchildren, teachers and parents who were not involved in the working group but were part of the intervention setting. Observations focused on the entire context . Interviews were conducted with a selection of the study population and members of the steering committee (described below). Data were collected in and around the schools. Data collection started in September 2016 and ended in June 2019 . For thiFrom the start of the intervention until the end of the intervention, minutes were collected of each working group meeting (N = 113) and of the meetings of the steering committee (N = 8). Minutes of the working group meetings were mainly prepared by the HP advisor, and sometimes by another member of the working group . The minutes of these meetings provided in-depth information about the implementation plan ranging from informing the principals to developing and implementing plans and the (supporting) role of the steering committee in implementation.After each working group meeting, the HP advisor made notes about their observations of the meeting (N = 89). Notes could concern the process , interactions , or other contextual influences , but also included “soft” measurements, such as the atmosphere during meetings. These participatory observation notes were not shared with the working groups. In addition, a researcher regularly visited the participating schools to observe activities implemented there. Special attention was paid to contextual fit. These observations were recorded as notes. The participatory observation notes mainly served as secondary data to verify results found in the other data sources. They were used to give meaning and explanation to identified processes.At the start of the intervention, the starting situation of the schools concerning the promotion of PA and healthy nutrition was assessed. At the beginning of the preparation year (school year 2016 to 2017), the school principal or a teacher filled in a school scan, which was an online questionnaire. The questionnaire was based on theoretical frameworks concerning the comprehensiveness of primary schools’ efforts towards PA and healthy nutrition promotion ,28. The Initially, the working group members filled in a team climate checklist at the end of the preparation period to assess the climate for innovativeness within the working groups . The teaIn year three, a selective sample of principals (N = 5) and working group chairs (N = 4) was asked to participate in individual interviews to gain more insight into implementation at different levels  and factors influencing implementation. This sample was chosen based on the diversity in implementation of the KEIGAAF approach. Additionally, members of the steering committee (N = 5) were asked to participate in individual interviews. All participants agreed to participate. The interviews were scheduled at the convenience of the participant and took place at the participant’s place of work. Before conducting the interview, a semi-structured interview guide was developed using the CFIR  Supplem. The intRecorded data were transcribed verbatim. Inductive content analysis was performed when coding the data . Two resThe timeline of the implementation of the KEIGAAF intervention is outlined in At the beginning of the intervention period, the school principal and a physical education teacher was informed on the KEIGAAF intervention by the main researcher and the project leader. The school principal was instructed to form a working group. At the beginning, the working groups consisted mainly of teachers. Gradually, as the intervention developed, these teachers involved one, or more, parents in the working group. Four working groups did not succeed in involving a parent or involving a parent for a longer period of time. The working groups collaborated with one or more external professionals during the intervention period to implement activities. However, for four working groups, this collaboration with external professionals was minimal. Collaborations were primarily based on existing collaborations between school and an external organization. New collaborations between a school and external organizations were mainly initiated by the HP advisor or by the external organization after being informed about KEIGAAF by a member of the steering committee . Principal involvement in the working group differed between schools. Principals were either directly involved as a member (two working groups), or more indirectly involved (four working groups), or the (main) principal was not involved at all (two working groups). Overall, the composition and size of the working groups differed per school (ranging from three to ten members) and the working groups were highly dynamic during the entire intervention period. Nevertheless, in almost all working groups there was at least one member (besides the HP advisor) who was involved during the whole intervention. Additionally, all working groups, except for one, were supported by the same HP advisor for the entire intervention period. In the beginning, the HP advisor chaired the meetings of the working group and initiated the meetings. The HP advisor also ensured that needs were assessed at the beginning of the intervention period by brainstorming with the working group about needs and potential solutions. Additionally, the advisor discussed the results of the school scan and an environmental scan on the PA-friendliness of the school environment. The latter scan was conducted by the main researcher and a research assistant (more details about this scan can be found in the protocol paper ). The neAll working groups implemented PA and nutrition activities , but theThe working groups were advised to implement sustainable activities. In most cases, the HP advisor had to remind the working groups about this sustainable characteristic of activities and advised them to incorporate new practices into current practices. In addition to guaranteeing sustainability of the activities, the HP advisor also aimed to guarantee sustainability of the working group. Therefore, the HP advisor gradually handed over the role of chair to another working group member (a teacher). The readiness of a working group to continue independently of the HP advisor differed per school. For three working groups, the HP advisor was still the chair and initiator of the meetings at the end of the intervention period.We refer to The practical support of the HP advisor was considered a facilitating factor in implementation by most working groups. Although some working groups were intrinsically motivated to implement the intervention, other working groups required the guidance and encouragement of the HP advisor. The HP advisor sought the best strategy to guide and encourage a working group. A good match between these strategies and the needs of the working group facilitated implementation. School health promotion was considered important by the working groups, but not a priority. Four working groups considered the KEIGAAF budget provided to them as a supporting factor in the implementation. The feedback loops in the intervention supported implementation. Three working groups experienced that the timeline sessions were very helpful in deciding on or improving their activity plans. In contrast to the usefulness of the timeline sessions, the results of the behavioral measurements of the children were demotivating for some schools because, in the short term, the children did not improve in their behavioral outcomes. One working group wanted to share good results with the parents to show the effectiveness of their efforts. However, they decided not to do so as no improvements in EBRBs were found at the first follow-up measurement. In general, the schools used the enthusiasm of the children (and in some cases the reactions of parents and teachers) as an indicator of intervention success.Nutrition was considered a more difficult topic to address at school than physical activity. To promote healthy nutrition at school, support from multiple actors was needed. Especially parental support was considered important by the working groups, since parents provide the children’s snacks, lunch, drinks, and birthday treats. Support from school staff and principal support were also important for working group members to ensure that school nutrition policies and activities were implemented throughout school and in a consistent manner. However, parental and staff support was not self-evident in all schools, which inhibited implementation. At one school, not all parents supported the school’s policies concerning healthy nutrition, and thus gave the children sugar-sweetened beverages when they were expected to drink water. Some schools even felt unable to implement school nutrition policies because there was a lack of parental support. Staff support for nutrition policies and activities was lacking in three schools. In these schools, implementation of nutrition policies was delayed, nutrition activities were not implemented throughout the entire school, or there was no aim to promote healthy nutrition due to an expected lack of support. In schools where the principal perceived the children’s nutrition behavior to be the parents’ responsibility no nutrition policy was implemented. The principals of those schools did want to create awareness among the children about healthy nutrition, but this resulted in inconsistencies in healthy nutrition promotion by the teachers. In contrast, desirable nutritional changes among children were seen in the schools that implemented clear, formalized school nutrition policies.In the Netherlands, schools are stimulated to become a healthy school . To thisThe schools were governed by two different school boards, which were the two largest within the municipality. Seven intervention schools belonged to the same school board. Five years ago, this school board initiated a project to increase the children’s PA behavior by providing high-quality physical education. To this end, they employed qualified PE teachers at the schools. Additionally, the board financially supported schools in assigning a health coordinator within the school who was responsible for obtaining at least two HPS certificates. The school board’s demand to obtain the HPS certificates supported the KEIGAAF approach by accelerating the implementation of PA and nutrition-promoting activities. Six of the seven schools wanted to adhere to the school board’s demands concerning obtaining these certificates. As a result, these schools had obtained at least one HPS certificate at the end of the intervention period. The school that belonged to another school board did not feel this pressure to obtain one of the HPS certificates. They even believed that obtaining the HPS certificates was of no advantage to them. They were less active in the development of their activity plans and implementation. It took them longer to specify priorities.The intervention region is divided into seven districts. The participating schools were located in five different districts of the city. In the northern districts, there were different actors as compared with the southern district. Schools located in the northern districts perceived a lack of potential partners in health promotion in their neighborhood. Actors that were potential partners did not match the school’s working method. Even in regions with a potential partner, collaborations between school and potential partners were limited. As a result, most schools, implemented the activities only on the school premises, and the members of the school staff were the main implementer of the activities. In general, working group members lacked the capacity to form these collaborations or did not see the necessity to do so. Three schools did succeed in working together with local partners in the implementation of their intervention. This was because the principal, a parent, or the HP advisor initiated this collaboration. A lack of potential partners or limited collaborations between school and potential partners hindered the implementation of comprehensive PA and healthy nutrition promotion.The defined needs and the activity plans developed by the working groups were dependent on the school’s starting situation concerning PA and healthy nutrition promotion. A good starting situation for implementation was a situation in which the working group considered that the current situation had to change. This was mainly the case when there was limited PA or healthy nutrition promotion at school, while the working group perceived that the children needed to improve their EBRBs. When the working group considered that their school was already making much effort regarding PA and nutrition promotion, implementation was hindered. Hardly any of the schools focused on their own current practices concerning PA promotion with the aim to improve these practices; they were considered normal and consequently overlooked as a potential unit of change.All schools expressed that a lack of parental involvement in school activities  was a common problem. This low parental involvement was also evident in the number of parents participating in the working group; only four schools had at least one parent participating in the working group during the whole intervention period. Schools were hesitant to ask parents to participate in the working groups. School staff support facilitated the integration of activities and policies within the school. Some working group members motivated the school staff to support implementation. Creating school staff support was easier when the number of teachers in the working group was high relative to the total number of school staff. The support of the principal was also a facilitator in the implementation of the intervention. All initial principals decided to participate in the intervention. However, there was a high turnover in principals at most schools. In these schools, the new principal had not decided upon participation. This did not necessarily mean that implementation was hindered in these schools. Most of these new principals were very supportive of the intervention. The principals of the seven schools of the same school board were all instructed to obtain the HPS certificate by the school board, and most of them wanted to adhere to that obligation. The schools that were most active in implementation had a principal who supported the working group , agreed on decisions made by the working group, and demanded that the rest of the school staff support the implementation of this plan. To promote the feeling of ownership of KEIGAAF by the school staff, it was best if the principal was autonomy supportive instead of controlling. Besides a high turnover in school principals, all schools experienced employee turnover during the intervention period. This also resulted in working group members being replaced, added, or removed. At some schools, this employee turnover inhibited implementation because of poor communication between the leaving employee(s) and the new employee(s) or uncertainty about division of tasks. However, in most schools, the employee turnover facilitated the implementation of the intervention, because the new members were more proactive, had more decisional power, or because the changes could be more easily implemented given the new teachers’ unfamiliarity with the old practices.Misinterpretation of the intervention approach and the intervention objectives inhibited implementation. For example, one working group did not develop their own intervention plan, but waited for activities to be delivered and implemented by external organizations, and two working groups thought that they were expected to implement new things, while an objective could also be to bring about more coherence into the existing school PA and healthy nutrition promotion. The practice-oriented thinking of the working groups was considered inherent to the way of working in schools. This attribute of schools did not facilitate the development of a deliberated and sustainable plan, but it did facilitate implementation in most schools. A factor facilitating the integration of the activities within a school was the presence of a champion. This champion was characterized by enthusiasm, felt a great need to improve the children’s health behavior, quickly switched from a thinking mode to an acting mode, and focused on opportunities instead of obstacles. Primarily, the champion informed and involved other school staff. Three schools had clear champions. This was a teacher and the chair of the working group. Working groups that did not have a champion and did not feel an intrinsic need to improve the children’s health behavior but were more externally steered  to participate in the KEIGAAF working groups were less active throughout the intervention period. Good interaction between working group members, including constructive communication between the working group members and the HP advisor, facilitated the process of developing and implementing. Working groups that were characterized by enthusiastic, proactive members who felt a need to change things and invested time in this, collaborated well, and divided implementation tasks had more output as compared with working groups that were less enthusiastic or proactive. The KEIGAAF intervention was characterized by a high degree of adaptation and local tailoring. This facilitated the implementation of activities that were suitable for the local context. It also enhanced feelings of ownership and sustainability of the bottom-up approach . At the end of the intervention period, six schools decided to continue with KEIGAAF. Although the content of the intervention was very flexible, there was no flexibility in the application of working groups. The working groups were considered one of the main elements of the mutual adaptation intervention. The practice of working groups worked well for five schools but was less suitable for three schools. These schools preferred a more top-down approach. For example, one school required external organizations to offer an intervention, while the other school made all the decisions for the school’s PA promotion via the principal, who did not want to be actively involved in the working group. As a result, these working groups hardly developed an activity plan . We studied how a mutual adaptation intervention aimed at promoting children’s physical activity and nutrition behavior was implemented in eight primary schools located in low socioeconomic neighborhoods. Although the eight schools were located in the same municipality, the schools differed greatly in the implementation of PA and healthy nutrition-promoting activities. This was caused by the high level of bottom-up design of the intervention and differences in the contexts of the schools. Secondly, we studied which contextual factors influenced implementation. Schools had differing starting situations concerning PA and healthy nutrition promotion andthey differed in received parental support, staff and principal support, and in employee turnover. Moreover, differences in characteristics related to the working group members, i.e., interpretation of the approach, the degree of practice-oriented thinking, the presence of one or more champions, and the dynamics within the working group, but also the differing degrees of influence of factors within the outer setting  resulted in different implementation processes. Other studies also found these contextual factors to facilitate and hinder implementation of school health-promoting interventions ,39,40,41The implementation of the KEIGAAF intervention was the result of an interplay between top-down influences and bottom-up development and implementation which led to adaptation to the local context . This muInterestingly, the need for mutual adaptation between top-down intervention principles and bottom-up changes in school-based health promotion had already been acknowledged in 1976 . HoweverThere is currently no guidance on how to adapt evidence-based interventions for new contexts , but we This is one of the few studies examining the implementation of school-based PA and nutrition-promoting activities with a focus on context . The comThere are also some limitations to this study that should be mentioned. First, it was not possible to fully assess the implementation process  or to study every contextual factor  due to time and resource limitations. In addition, we aimed to minimize participant burden . Second,This study showed that a mutual adaptation physical activity and nutrition intervention was implemented differently in eight primary schools located in low socioeconomic neighborhoods in the same municipality due to the high level of bottom-up design of the intervention and the differences in influence of facilitating and hindering contextual factors. Important lessons were learned from implementation. One of these lessons was that implementation of this mutual adaptation intervention is time-consuming but feasible. Adaptation of key intervention principles to the school context and current practices is essential. Health promotion advisors play a crucial role in this adaptation by navigating the middle path between top-down and bottom-up influences in a particular school context, as well as feedback loops between other supporting activities and implementation.


The effects of flexibility exercise on the suicidal ideation in Korean adult women with depressive disorder presented the OR value of 0.682 . Based on the results, the participants who did flexibility exercises were likely to have less stress and suicidal ideation than the Korean adult women with depressive disorder who did not participate in flexibility exercise. In conclusion, the flexibility exercise has played an important role in reducing and preventing stress and suicidal ideation in Korean adult women with depressive disorder.Depressive disorder is common in many adult women in the world. It was found that depressive disorder was related to stress and suicidal ideation in Korean adult women with depressive disorder. Physical activities were effective to solve this mental disorder. Thus, the purpose of the study was to investigate the effects of physical activity (PA) on the stress and suicidal ideation of Korean adult women with depressive disorder. A sample of 1315 Korean adult women who have depressive disorder was collected, and the Korea National Health and Nutrition Examination Survey (KNHANES) was used to determine this purpose of the study. The complex samples in frequency analysis were used to identify the characteristics of the participants. The logistic regression in the complex sample design was conducted to investigate the effects of PA on the stress and suicidal ideation in Korean adult women with depressive disorder. The effects of flexibility exercise on the stress in Korean adult women with depressive disorder showed the odds ratio (OR) value of 1.434 (OR = 1.434, 95% CI = 1.043–1.973,  Depressive disorder is a serious mental disorder in the world. It is known that depressive disorder has negative influences on how a person feels, thinks, and behaves. It can cause a variety of physical and emotional troubles, such as feeling sad, obesity, loss of interest, sleeping, slowed movements, purposeless physical activity, and thoughts of suicide . AccordiIn South Korea, over 15% of people have experienced major depressive disorder during their lifetime . In addiParticularly, depressive disorder is common in adult women. Many adult women are under pressure that affects life stress. This life stress has been reported to be highly correlated with depression . FurtherEspecially, Korean adult women who have depressive disorder are more likely to attempt drug abuse or alcohol abuse, and over 10% of Korean adult women were reported to attempt suicide or have suicidal ideation . AlthougDepressive disorder is caused by a variety of factors and increases the suicidal ideation of women ,2,3. In n = 13), and LeCheminant et al. [n = 30). Furthermore, there was limited research to examine stress and suicidal ideation of adult women with depressive disorder [However, many researchers have focused on reducing or preventing depressive symptoms ,25,26 ort et al.  identifidisorder  even thoThis study determined the effects of PA on the stress and suicidal ideation in Korean adult women with depressive disorder by using the Korea National Health and Nutrition Examination Survey (KNHANES), which was conducted by the recommendations of the WHO . It has The purpose of the study was to determine the effects of PA  on the stress and suicidal ideation in Korean adult women with depressive disorder. This study used the data of KNHANES, which was conducted after the approval of the institutional review board (IRB) in Korea Centers for Disease Control and Prevention. In addition, it is represented as statistical data in South Korea, which is extracted every year by stratified, clustered, and systematic sampling. The KNHANES was conducted six times from 1988 to 2015.n. The weighted sample average is calculated as followsThe Korea Center for Disease Control and Prevention recommends that this raw data be reflected in the complex sampling because the sample design of the KNHANES was extracted using a two-stage stratified cluster sampling rather than a simple random sampling. The sampling framework of the KNHANES used the recent population, which is possible to extract a representative sample for the population over 19 years old living in South Korea. When using weights in the process of analyzing the data of the KNHANES, the inclusion errors, inequality extraction rates, and non-response errors of the surveyed participants were corrected according to the difference in the number of households and populations between the sample design time and the time of the survey. It was made to improve the accuracy of estimates related to the prevalence of chronic diseases, food, and nutrition. For instance, the population mean estimate  who completed questions in the KNHANES related depressive disorder were collected for the analysis. In this study, 1315 respondents have been maintained at least two weeks for a diagnosis of depression and diagnosed with depression by a specialist. The rest of the raw data were removed because it did not address questions in relation to depressive disorder. Further, the data collected from only common questions reduced the number of raw data since each KNHANES  contained several different questions in PA and the depressive disorder category. In The KNHANES was based on the International Physical Activity Questionnaire (IPAQ), which is a standardized questionnaire designed to measure and compare the level of PA of various populations (aged 16–65) around the world. In South Korea, the KNHANES has begun to collect data of the health level of people and evaluate the national health policy for the national health promotion project. The health behaviors of smoking, drinking, nutrition, and PA among the KNHANES contents are very important to prevent the health risk factors of Korean people. PA is the most cost-effective and highly efficient way of practicing health care for the prevention of chronic diseases, such as heart disease, hypertension, stroke, diabetes, colon cancer, breast cancer, and depression ,34. The In the IPAQ, specific examples for each country were used, and cultural diversity was considered to help understand the correct definition of PA . There iThe variables of this study were selected as type of PA, stress, and suicidal ideation for 1 year, and variables were categorized according to the purpose of this study by using the National Health and Nutrition Examination Guidelines . First, physical activity, which is an independent variable, was set as strength exercise, flexibility exercise, and walking. In the walking variable, there was a question, which was, “How many days did you walk at least 10 minutes at a time in the last week?” Further, a 7-point scale  was added to the walking question. These raw data were categorized as “1 = Never and 2 = Participation in walking” for this study. In the strength exercise variable, there was a question, which was, “How many days did you perform strength exercises such as push-up, sit-up, dumbbell, weight, and iron bar in the last week?” A 6-point scale  was used to the strength exercise question. The raw data of the strength exercise variable were classified as “1 = Never and 2 = Participation in strength exercise” for the study. In the flexibility exercise variable, there was a question, which was, “How many days did you do flexibility exercises such as stretching, bare-hand exercise, etc. in the last week?” A 6-point scale  was added to the flexibility exercise question. These raw data were categorized as “1 = Never and 2 = Participation in flexibility exercise.”The perception of stress, which is a dependent variable, was asked as “How much stress do you usually feel in your daily life?” A 2-point scale  was used for the perception of stress question. These raw data were used without modification. In the suicidal ideation variable, there was a question, “During the past 12 months, have you ever seriously thought about committing suicide?” A 2-point scale  was added to the suicidal ideation question. The raw data of suicidal ideation variable were used without change. In the process of restructuring the selected research variables, it was used for the analysis through review of previous studies and consultation among researchers.The purpose of this study was to investigate the effects of PA  on stress and suicidal ideation in Korean adult women with depressive disorder. In order to achieve the purpose of the study, researchers reflected the design of the complex sample recommended in the National Health and Nutrition Examination Guidelines . The strp < 0.05. After the user-missing value was changed to ‘valid values’, all data with the missing data were included for analysis, which was used to prevent the occurrence of bias in the dispersion estimation and the dispersion estimator. The SPSS 21.0 statistical package was used for all statistical analyzes.The complex samples in frequency analysis were used to identify the characteristics of the participants. Furthermore, the logistic regression in the complex sampling design was conducted to investigate the effects of PA on the stress and suicidal ideation in Korean adult women with depressive disorder. The significance level was p < 0.05). Therefore, Korean adult women were less likely to be stressed when participating in flexibility exercise.Logistic regression analysis was used to determine the effects of PA  on stress in Korean adult women with depressive disorder. As shown in p < 0.05). Therefore, Korean adult women with depressive disorder had less suicidal ideation when participating in flexibility exercise.Logistic regression analysis was used to identify the effects of PA  on suicidal ideation in Korean adult women with depressive disorder. In The purpose of the present study was to determine the effects of PA  on the stress and suicidal ideation in Korean adult women with depressive disorder. The logistic regression in the complex sample design was conducted to determine the purpose of the current study. Based on the findings, Korean adult women with depressive disorder who participated in flexibility exercise had less stress and suicidal ideation than those who did not. However, there were not significant effects of strength exercise and walking on stress and suicidal ideation in Korean adult women with depressive disorder.Adult women with depressive disorder might be associated with low physical condition and a sedentary lifestyle . Galper,In the current study, flexibility exercise contributed to reducing the stress and suicidal ideation in Korean adult women with depressive disorder. These results were related to findings by Esgalhado et al. , who repFurthermore, many researchers ,46,47 shOn the other hand, there were not significant effects of strength exercise and walking on stress and suicidal ideation in Korean adult women with depressive disorder. Even though there is no research investigating the effects of strength exercise and walking on stress and suicidal ideation in Korean adult women with depressive disorder, it might be deduced from several facts. The fifth and sixth KNHANES did not ask questions about moderate intensity strength exercise and walking. However, many Korean adults are doing moderate intensity strength exercise and walking. According to the Korea Ministry of Culture, Sports and Tourism , 44.7% KIn the study, there were some limitations. First, the results of the current study may not be generalizable to adult women with depressive disorder in other countries because many studies presented were related to South Korea. In addition, the participants were recruited in South Korea; therefore, the generalization of the findings should be restricted to Korean adult women with depressive disorder due to cultural differences. Future studies should consider providing evidence that can be generalized to other countries. Another limitation was that the KNHANES did not use structured and validated scales to determine stress and suicidal ideation. This may present an important limit to the validity and reliability of the KNHANES in stress and suicidal ideation. Future KNHANES should consider determining structured and validated scales for stress and suicidal ideation. The third limitation was that the study did not include a comparison sample of Korean adult women without depressive disorder because the difference in the number of samples between the two groups  was too big. Future research should include a comparison sample to determine the effects of PA on the stress and suicidal ideation in Korean adult women with and without depressive disorder. The fourth limitation was that this study showed a lot of risk factors for suicidal ideation in Korean adult women with depressive disorder . However, these risk factors were not analyzed in the present study. Hence, this study did not present ways to address risk factors for suicidal ideation in Korean adult women with depressive disorder. Future research should suggest ways to deal with risk factors for suicidal ideation in Korean adult women with depressive disorder. The final limitation was that the KNHANES did not show the examples of events by intensity of PA, and explanations of PA intensity were not appropriate. It can cause errors in the rate of PA by intensity. Future KNHANES items in PA need to be improved to meet the purpose of the survey and be understandable to respondents.Depressive disorder is common in many adult women in the world. It is linked to stress and suicidal ideation in Korean adult women with depressive disorder. PA is an effective way to resolve this mental disorder. The present study aimed to determine the effects of PA  on stress and suicidal ideation in Korean adult women with depressive disorder. The conclusions of this study were as follows: in this study, flexibility exercise played an important role in reducing and preventing stress and suicidal ideation in Korean adult women with depressive disorder. However, strength exercise and walking did not have significant effects on stress and suicidal ideation in Korean adult women with depressive disorder. Future studies need to consider determining which exercises aside from strength exercise, flexibility exercise, and walking are effective to reduce stress and suicidal ideation in women with depressive disorder.


Young children’s healthy development depends on nurturing care, which ensures health, nutrition, responsive caregiving, safety and security, and early learning. Infancy and childhood are characterized by rapid growth and development, and these two factors contribute largely to determining health status and well-being across the lifespan. Identification of modifiable risk factors and prognostic factors during the critical periods of life will contribute to the development of effective prevention and intervention strategies.NAscere e creSCere in ITAlia) study was created to evaluate physical, cognitive, and psychological development, health status and health resource utilization during the first six years of life in a cohort of newborns, and to evaluate potential associated factors.The NASCITA  will take place during the first routine well-child visit, which takes place at the office of the pediatrician assigned to them by the local health unit of residence, and which is scheduled for all newborns born in Italy within the first 45 days of their life.Data will be web-based and collected by the family pediatricians during each of the 7 standard well-child visits scheduled for all children during their first 6 years of life. Information on every contact with the enrolled children in addition to these prescheduled visits will be also recorded.https://coortenascita.marionegri.it.The NASCITA cohort study provides a framework in which children are followed from birth to six-years of age. NASCITA will broaden our understanding of the contribution of early-life factors to infant and child health and development. NASCITA provides opportunities to initiate new studies, also experimental ones, in parts of the cohort, and will contribute relevant information on determinants and health outcomes to policy and decision makers. Cohort details can be found on Clinicaltrials.gov: NCT03894566.Ethics committee approval: 6 February 2019, Verbale N 59. Childhood development is a maturational process resulting in an ordered progression of perceptual, motor, cognitive, language, socio-emotional, and self-regulation skills. The acquisition of skills throughout the life-cycle therefore builds on the foundational capacities established in early childhood.1 Multiple factors influence the acquisition of competencies and skills, including health, nutrition, security and safety, responsive caregiving, and early learning. All are necessary for nurturing care [As concisely and effectively reported in an excellent series of papers on early child development: ing care . Nurturiing care . Nurturiing care . Nurturiing care . The envInfancy and childhood are characterized by rapid growth and development, and are considered critical periods of development in life that strongly contribute to health status, well-being, and behavior across the lifespan . In factThe heterogeneity of the population in Italy is increasing, and sociodemographic and geographic differentials  have been associated with health disparities , 8. In oAlthough Italy has a public, universal healthcare system that should pose no legal or financial barriers to subgroups of the population, considerable health inequalities exist . DiffereLife course approaches show that a considerable part of these inequalities is determined by exposure, health status, and development in utero and in early childhood , 6. MoreNAscere e creSCere in ITAlia) is to improve the understanding of the health status of Italian children early on and how it is affected by social and health determinants. Like many other cohorts, it will address multiple research questions [Birth cohort studies are a powerful study design for medical and social research because they are designed to observe the impact of early exposures prospectively and at multiple time points during child development . A numbeuestions , 16. TheWe hypothesize that:- differences due to environmental, sociodemographic, and parental determinants, as well as to child characteristics and physician attitudes, exist between geographic areas in a population’s health and in the use of health resources in the first few years of life;- differences exist in the appropriateness of care provided by the National Health Service at different levels ;- differences exist between geographical settings in parental attitudes toward the recommendations concerning children’s health care and these differences may be a determinant of child development and well-being and health resource utilization;- the existing differences between geographical settings in the opportunities for children to access educational/socialization experiences (e.g. day-care centers) may have an impact on development.the relationship between child development and the domains that affect nurturing care during the preschool period: health (disease prevention and treatment), nutrition (breastfeeding and dietary approach), safety and security (care and early intervention for vulnerable children), responsive caregiving (caregiving routine), and early learning (home opportunities to explore and learn);the association between the well-being of children and parental adherence to the recommendations for better child care and development;the potential factors influencing child well-being and growth and development, including the acquisition of competences;the differences between geographical settings in educational and socialization opportunities available for young children and in the care provided by the family pediatricians and by the National Health Service for the same needs;The main aim of the NASCITA cohort is to evaluate physical, cognitive, and psychological development, and health status and health resource use during the first six years of life in a group of newborns, and to evaluate potential associated factors. The specific research questions are:Italy is located in southern Europe and comprises the long, boot-shaped Italian peninsula, the southern side of Alps, the large plain of the Po Valley and some islands including Sicily and Sardinia. Almost 40% of the Italian territory is mountainous, and there is a coastline of 7600 km on the Adriatic Sea, Ionian Sea, Tyrrhenian Sea, Ligurian Sea, Sea of Sardinia and Strait of Sicily. Italy is subdivided into 20 regions and is further divided into 14 metropolitan cities and 96 provinces, which in turn are subdivided into 7960 municipalities. A gaping North–South divide is a major factor of socio-economic weakness and can be noted by the huge difference in statistical income between the northern and southern regions and municipalities . Twenty-Italian healthcare is provided free or at a nominal charge through a network of Local Health Units (LHU). Each LHU consists of a number of healthcare districts, which are population-based territorial entities that aggregate different municipalities. Every Italian resident is registered with a family  practitioner. Children are assigned to a pediatrician until they are 6 years old; afterwards, the parents can choose to register a child with a general practitioner. All adolescents > 13 years old are assigned to a general practitioner. In Italy there are about 7500 family pediatricians, for an average of 450.000 births/year . About 6https://coortenascita.marionegri.it.NASCITA is an ongoing, dynamic, prospective, population-based birth cohort study. From the start of 2019, newborns will be continuously included in the study for (at least) an entire one-year period chosen by each participating family pediatrician and will be followed prospectively until at least the age of 6 years. Given the ongoing character of the study, no maximum number of inclusions has been set. Cohort details can also be found on The study population of the NASCITA cohort study will consist of all Italian children born during (at least) a one-year period who will be followed by participating pediatricians until the age of 6 years and whose parents agree to participate. Data on all newborns, including those with, e.g., congenital malformations, will be collected. We consider it valuable to have these data, also to be able to describe the epidemiological data more fully. The characteristics of this population will be evaluated separately in the analyses.The only inclusion criterion for participating in NASCITA is to be born in Italy during the period chosen by each pediatrician participating in the cohort study. Children whose parents do not agree to participate, or decide to withdraw, will be excluded from the study.NASCITA will be embedded in Italian pediatric primary care practice. The coordination center has collaborated over the years with a network of hundreds of family pediatricians, as documented by numerous collaborative publications –22, whicRecruitment of the newborns (and their parents) will take place during the first routine well child visit scheduled for all newborns within their first 45 days of life at the office of the pediatrician assigned to them by the LHU to which they belong. Parents will receive oral and written information about the purpose and methods of the study and will be invited to participate. If they agree to participate, they will be asked to sign an informed consent. Recruitment of newborns will begin in April 2019, while recruitment of pediatricians will begin in the preceding months.The NASCITA cohort is sized to have enough power to study relatively common child exposures and outcomes. Table With an expected minimum of 5000 newborns, representing about 1% of the newborns in Italy, and with an estimated 20% loss to follow-up, the resulting sample size of 4000 children will still give NASCITA enough power to study common childhood exposures and outcomes .With the parents’ consent, data on children withdrawing after 12 months of age will be considered in the analysis for the relevant time period of participation . Data will be deleted upon parents’ request.Before the start of the study, family pediatricians will be involved in training activities. Local coordinators will be trained by the research team, and will be responsible for the training of their peers at the local level. A case report form (CRF) was created in an online form with the contribution of local representatives of family pediatricians and scientific committee participants. During an initial phase, a group of family pediatricians tested the electronic CRF (eCRF), leading to improvements and adding the necessary questions to achieve an eCRF that would allow a more complete and simple collection of data. The eCRF will be available online before the start of the enrollment period in order to let participating family pediatricians familiarize with the information that needs to be collected.Central and local monitoring of the study will be scheduled with the aim to guarantee follow-up of the infants and the quality of data collected.Data considered for the basic CRF are part of those routinely collected by the family pediatricians at the 7 standard well-child care visits scheduled for all children during their first 6 years of life, and data collected during each contact with the enrolled children. See Fig. At the first visit (within 45 days of life of the newborn), parents will be asked about parental medical history, characteristics and lifestyle, indoor and outdoor environment, and circumstances during pregnancy and around birth. Pregnancy and perinatal data will be collected also through hospital discharge documents following delivery.The primary outcomes of the study are measures of health of the newborns/children from birth until (at least) the age of 6 years. Health outcomes of children aged 0–6 years will cover different fields including: physical development, mental/cognitive development, nutrition and allergies, environmental exposures, and preventable infectious diseases. Table The analysis plan for the NASCITA cohort entails the investigation of several exposures and outcomes in order to address numerous research questions.The main independent variables that will be tested are:Maternal/paternal age.Education level.Employment.Marital status.Parental health status.Parental lifestyle habits .A few examples of the dependent variables are:Vaccination in pregnancy.Folic acid prophylaxis.Birthweight.Duration of breastfeeding.Reading out loud.Sleep position.Overweight and obesity.Neurocognitive development.Prescription prevalence and appropriateness.Nursery school attendance.A few of these variables will be tested as both independent and dependent variables based on the kind of analyses .Examples of the NASCITA STUDY’S research questions are:- the relationship between mothers’ age, education level, and geographic area (independent variables) and vaccination in pregnancy (Influenza and Tdap vaccines) (dependent variable);- the association between maternal smoking in pregnancy (independent variable) and birthweight (dependent variable);- the relationship between pregnancy, perinatal, and newborn growth characteristics and occurrence of adverse outcomes ;- the relationship between parents’ educational level (independent variable) and duration of breastfeeding  (dependent variable);- the relationship between parents’ educational level (independent variable) and children’s weight and BMI/percentage of overweight/obese status (dependent variable);- the association between lifestyle factors and health inequalities and the trajectory of health in the preschool period;- the association between geographical setting and nursery school attendance;- the association between geographical setting and quality of care in terms of prevalence and appropriateness of drug prescriptions.In all of the of the analyses, the effect of the geographic and environmental setting will be evaluated.This type of general objective, involving numerous research questions, is similar to the goals of two Italian cohorts, the NINFEA  and the Migrant newborns will be included in special subgroup analyses.Mann Whitney U test for skewed continuous variables. Statistical significance will be evaluated using a 95% confidence interval and a two-tailed p-value of < 0.05. Multivariate analyses will also be performed based on the study designs and outcomes to be evaluated.Categorical variables will be summarized using proportions and associations tested using chi-square or Fisher’s exact text, where applicable. Continuous variables will be summarized using means and standard deviations for normally distributed data, while skewed data will be summarized using medians. One-way ANOVA  will be used to test difference of means for normally distributed continuous variables and the The coordination of the NASCITA study will be provided by the team of the Laboratory for Mother and Child Health of the Mario Negri Research Institute that integrates different expertise and competence with a long-standing experience in multicenter clinical research. The coordinating center will also carry out data collection, storage, management, and analysis. An independent scientific committee consisting of representatives of different disciplines and realities (including lay people) will monitor the development and results of the project. A network of local contacts (contact person per area) between pediatricians has been set up so that each node, representative of a setting, will act as a bridge to the coordinating center in conducting the study. An additional group of individual pediatricians has been identified to act as specialists in their area of expertise, e.g., environment, nutrition, and neurodevelopment.https://coortenascita.marionegri.it) to collect data, through a web-based form, and to provide findings and other information during the study period, also with the use of graphics on the analyses and data collected based on a successful approach already reported by the coordinating center [A specific web portal for the NASCITA cohort study was developed . A consent form for participation will be signed by the pediatricians upon their first access to the web site. A paper consent form will be signed by parents at the first visit. This form includes the consent to data collection at each contact with the pediatrician during the six-year study period (first 6 years of the child’s life). The filled in consent form will be stored by the pediatrician for ten years. Withdrawal from the study is guaranteed at any time both to pediatricians and parents. When consent is withdrawn, the child’s data collected up to that point will be kept in the analyses, but no further data will be collected. Standard procedures for the protection of confidential individual information will be applied according to national and international ethical recommendations and guidelines as well as national legal regulations. Data will be pseudonymized and all analyses will be conducted with fully anonymized data sets.A newsletter report will periodically be sent to the pediatricians and uploaded on the web site. During the study, different tools will be used to update the participating families. Ad-hoc information material will be created and will be disseminated to families through newsletters and the website. Collected data will be periodically analyzed according to the aims of the project, and findings reported to lay people and the scientific community.The coordinating center will provide the information, but the pediatricians will also be able to provide the families with information deriving from the cohort during their visits.When the enrolled children reach the age of 6 years, if not decided otherwise in the meantime, their personal files will no longer updated, but will be kept for another 10 years in the database.NASCITA proposes to be a resource for the research community, so data will be available to public researchers outside the NASCITA research group upon request for collaborative research initiatives, after approval by the scientific committee.The information gathered by the NASCITA birth cohort study will be valuable for child health care and public health policy making. Information concerning the children will be collected at specific ages that coincide with routine contact moments, so findings from NASCITA that can be translated into parental advice or other preventive measures can directly be incorporated into routine protocols and reach a large group of children and their parents at once. Furthermore, study results on (modifiable) risk factors, disease prognosis, and medication use may also be relevant for family pediatricians.Moreover, NASCITA findings may aid policy and decision makers, who need scientific evidence to develop and implement prevention and intervention strategies. NASCITA will progressively build on a database containing policy relevant information on a broad range of determinants and health outcomes that may be beneficial in responding to certain public health issues. NASCITA results may also contribute to the evidence towards the need to build up a permanent national observatory on child health and development.NASCITA is entirely embedded in the child health care practice foreseen by the National Health Service and provided by family pediatricians. Recruitment and follow-up coincide with routine contact moments, so broad participation and follow-up rates are expected. Collaboration with other cohorts is foreseen. The NASCITA cohort data will be linkable and integrable with other data sources, such as routinely collected health data or data from other projects, as part of scientific collaborations.High participation rates would allow an appropriate description and evaluation of all the different national territorial clusters. Moreover, NASCITA will provide opportunities to initiate new, experimental studies in subgroups of the cohort, and will contribute relevant information on determinants and health outcomes to policy and decision makers.Since loss to follow-up is always a cause for concern in cohort studies and should be minimized, efforts have been made to establish a close and trust-based relationship with all participants. These efforts involve the creation of ad-hoc information material, the website, and newsletters to keep in touch with the study participants and to apply health promotion measures within the cohort. The estimated 20% loss to follow-up would, in any case, lead to a sample size that is large enough to be able to study common childhood exposures and outcomes. With the parents’ consent, data on children withdrawing after 12 months of age will be considered in the analysis.A limit of the NASCITA study  is the possibility of selection bias in the study population. The pediatricians recruited represent a co-operative sample, not a random sample, and should not be considered to be representative of the population of family pediatricians. The pediatricians, for example, could be more sensitive to better care practices or recommendations, and could influence the parents accordingly, promoting, for example, reading out loud to children. The target population of the study, however, will be the newborns (and their families) who are assigned to the pediatricians by the LHU based on places that have been freed up with those pediatricians. No selection bias in the population should therefore occur.The rising number of migrant patients means increasing potential language barriers in the communication between a healthcare practitioner and a patient who speaks a different language, and miscommunication may occur in healthcare settings . Althoug


This work presents a novel five-fingered soft hand prototype actuated by Shape Memory Alloy (SMA) wires. The use of thin (100 μm diameter) SMA wire actuators, in conjunction with an entirely 3D printed hand skeleton, guarantees an overall lightweight and flexible structure capable of silent motion. To enable high forces with sufficiently high actuation speed at each fingertip, bundles of welded actuated SMA wires are used. In order to increase the compliance of each finger, flexible joints from superelastic SMA wires are inserted between each phalanx. The resulting system is a versatile hand prototype having intrinsically elastic fingers, which is capable to grasp several types of objects with a considerable force. The paper starts with the description of the finger hand design, along with practical considerations for the optimal placement of the superelastic SMA in the soft joint. The maximum achievable displacement of each finger phalanx is measured together with the phalanxes dynamic responsiveness at different power stimuli. Several force measurement are also realized at each finger phalanx. The versatility of the prototype is finally demonstrated by presenting several possible hand configurations while handling objects with different sizes and shapes. The design of a device able to reproduce all the functionalities of a human hand has been a challenge for many researchers since the late 1950'. Up to date, the most performant prototypes  are designed with a rigid structure, and driven by electric motors. Remarkable examples are represented by the “iLimb” , inevitably increases the weight of the overall prototype, thus it is unsuitable for portable devices. Recently, a number of researchers started using electric motors in combination with deformable finger joints to design soft prostheses. The biggest advantage of this technology, compared to pneumatics, is represented by its compactness. One relevant example is exposed in Hussain et al. , in whicShape memory alloys (SMA) represent an alternative actuation technology which can overcome several limitations of the previously described solutions, in terms of noise, weight, and structure simplicity. These active transducers, typically consisting of Ni–Ti alloys, undergo a phase transformation when exposed to heat ;several force measurements;systematic measurements of the motion range of each finger phalanx;a pulse method for high-speed activation of the SMA fingers;several hand grasping configurations while handling different size and shape object.The remainder of the paper is organized as follows. Section Design and Models describes the design of the full hand and its fingers. Section Fabrication provides information about the prototype fabrication procedure. In section Results and Discussion, several experiments are performed with the goal of evaluating the prototype performances in terms of force, motion, reactiveness, and grasping capabilities. Finally, in section Conclusions, some concluding remarks and future research directions are outlined.The hand is the most complex and articulated part of the human body. It is composed of a 27 bones and 17 articulations, resulting in an overall number of 23 degrees of freedom (DOF)   is applied. According to classical mechanics, a bending motion is generated at first. As soon as the overall load overcomes the critical load, each beam collapses in a buckling mode. This leads not only to an undesired top phalanx motion, but also to a permanent deformation of the superelastic wires   of one different phalanx.At the same time, this solution ensures a shorter wire length for each bundle. For a comparison, a single 300 mm long protagonist SMA wire and a single 500 mm long antagonist one would be required to allow full bending and stretching of the structure, respectively. With this design, the prototype size would have been unsuitable for prosthetic applications. Therefore, the bundle topology has been designed in order to achieve a trade-off between space constraints, desired motion range, and exerted force. The external structural pieces are mounted around the finger central parts, in order to protect the wires and the connections. In general, hand prostheses presented in literature have a quite complex structure, and their manual assembly often requires a significant effort , we decided to evaluate the force with a direct measurement of the load cell at the fingertip middle point.The choice of the force application point is motivated by the fact that, during daily grasping operations, objects are mostly handled by using the hand fingertips. It is pointed out that the measured force is not constant along each finger phalanx, but it increases as the load cell is moved closer to the phalanx center of rotation. In order to measure an average representative value, the fingertip middle point is chosen for force evaluation, represented by the second circle starting from the top designed at the fingertip front part see . The loaIn addition, since the proposed test rig is entirely composed of commercially available components, it can be easily reproduced by other researchers, and used for the systematic characterization of different hand prototypes. The tests results are depicted in In this section, the maximum achievable displacement of each phalanx of the finger prototype is experimentally evaluated. The experimental bench is very similar to the one showed in A custom electronic board is realized able to drive each bundle independently from the others. During each test, one channel of the NI 9472 is enabled at a time by the LabVIEW control logic, allowing to supply a desired power profile to the MOSFET connected to a corresponding bundle in the finger phalanx. In this way, each finger phalanx can be controlled independently of the other ones. In order to measure the finger motion, a Logitech webcamera is interfaced with LabVIEW and syncronized with the other NI module. At each sampling time, a video frame is recorded. The acquired video is then postprocessed with a MATLAB routine, and the signal describing the rotation angle over time is reconstructed. The antagonist SMA wires are activated at the beginning of each experiment, in such a way to ensure a fully straight initial configuration for each phalanx. Then, according to the desired input power signal designed in LabVIEW, the antagonist wires are deactivated while the protagonist SMA bundles are powered. The measured angles are displayed in As shown in In the previous section, the maximum displacement of each finger phalanx is investigated. During each experiment, conservative values of current and voltage are used to power each SMA bundle . Instead, the wire length influences the input voltage value .In the finger prototype, the bundles are composed of several SMAs having identical diameter, therefore each wire receives the same amount of input current. On the other hand, each group of bundles  are implemented in order drive each phalanx in a desired way. Prior to each experiment, the control strategy is manually tuned by the user. Starting from This design enables soft features in the hand structure, which are demonstrated in In ® collaborative robot arm. The robotic arm is programmed using the interface provided by the manufacturer, in order to reach the area where the object is positioned. At the same time, it is interfaced and synchronized with the microcontroller which drives the SMA hand.To test the SMA actuated soft hand in a robotic scenario, the hand is mounted at the end-effector flange of a UR5In this way, once the robotic arm reaches the desired position, it enables the microcontroller to drive each hand finger according to a predetermined trajectory, and grasp the desired object. Video sequences of the performed experiments can be seen in In the previous sections, the SMA Soft Hand performances have been described in terms of force, displacement, and reactiveness. In order to better clarify the advantages of the developed prototype, a performance benchmark with a number of recently developed myoelectric robotic hands is presented in this section. Pneumatic actuated prostheses are neglected from this comparative study, due to the structural disadvantage introduced by the technology (as discussed in the introduction section). In In this table, the iLimb, the Bebionic, and the Michelangelo hands are chosen among all the commercially available prostheses. Among all the myoelectric prototypes designed by research groups in recent years, the SmartHand (having stiff joints) and the Pisa/IIT Soft Hand (with soft joints) represent the most performing ones. In literature, the maximum weight of a human hand is quantified around 400 g , while, despite exhibiting smaller forces than the commercial prostheses (40 N), its grasping capabilities are sufficient to perform daily life operations. Note also that all of the described prostheses have a stiff structure, which ensures robustness but also exposes the user also to possible involuntary damages. The use of soft prostheses helps the interaction between the user and the device, preventing potential injuries . The shear force used for gripping also depends on the friction between hand and object, which is further affected by many factors like the type of object and the cover material used for the hand. The reported normal force measurement represents, thus, an intrinsic figure of performance of the novel SMA soft structure. Additional tests aimed at characterizing the gripping force for different objects and cover materials  would require a dedicated extensive investigation which lies beyond the scope of this paper.We remark how the force value of the SMA Soft Hand has been evaluated via blocking force experiments, rather than via gripping tests designed Nevertheless, even if this force value is large enough to fulfill daily life operations, it is still far from the grasping force demonstrated by the commercial prostheses. Big advantages over the other hand prototypes are represented by its completely silent activation, its low weight (300 g), and its simple structure without transmission mechanisms which favors a lower price and a systematic assembling procedure.In this work, a new design for a bioinspired SMA actuated hand prototype with soft features has been presented. The described prototype can be used in biomedicine as a human prosthesis well-suited for human-robot collaboration tasks. The modular finger structure uses superelastic SMA wires in the joint in order to enable soft features. These wires have been arranged according to a X-shaped pattern, in order to avoid undesired joint configurations under induced lateral moments. Bundles of actuated SMA wires have been systematically manufactured using a welding method, which ensures an identical behavior for each wire in the same bundle. The use of SMA wires as actuators permits the design of a compact, lightweight, and silent hand device. A protagonist-antagonist configuration has been chosen for the SMA bundles, to enable a higher prototype reactiveness. In addition, the modular structure permits a simple and fast replacement of possible damaged SMA actuator bundles, without requiring the replacement of the entire finger assembly.Several tests have been performed in order to demonstrate the prototype capabilities. Force measurements have been realized at the finger top phalanx, while activating all the protagonist bundles in the finger. A force of about 9 N per finger has been evaluated, which leads to an overall hand prototype force of about 45 N. Such a value is within the range of human hand force. The complete motion of each finger phalanx has also been recorded, showing also in this case values comparable with human fingers . Using a short pulse power excitation, a settling time between 0.2 and 0.3 s has been observed for both rising and falling phases of the finger rotation. The described method can be eventually used to enable better dynamic performances, provided that an adequate hardware is used. Objects with different sizes and shapes have been grasped by the SMA hand prototype, demonstrating its high gripping versatility. In relation to the state of the art, the presented prototype permits to achieve good performances in terms of force, reactiveness, and dexterity. At the same time, the use of SMA technology permits to manufacture low cost, lightweight, and silent prostheses. This fact allows to potentially increase the acceptance rate of the end user, especially in medical applications.These performances are achieved at the expense of high input power, which is about 27 W per finger in case of simultaneous activation of all the phalanxes. This value is a consequence of the low energy efficiency of SMA wire actuators.In future works, the thumb mechanism will be improved by adding also adduction/abduction and opposition movements in order to increase the hand dexterity. Additional experiments will then be performed to evaluate the handling capabilities when dealing with various types of daily life objects and hand payloads. Advanced dynamic models and simulation tools will also be developed. On the other hand, model-based control and self-sensing algorithms will be developed and implemented. In this way, we will be able to mimic the motion and gesture of a real human hand, to perform a more precise grasping of both fragile and small-size objects with a reduced sensory hardware, and eventually to exploit the material intrinsic hysteresis to further improve the energy efficiency (Riccardi et al., The raw data supporting the conclusions of this article will be made available by the authors, without undue reservation.FS: Design, manufacturing, and experimental results, GR, PM, and SS: Paper revision. All authors contributed to the article and approved the submitted version.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.