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Background: Adolescents and their communities in Ebonyi State, Nigeria have poor attitudes and beliefs towards adolescent sexual and reproductive health (SRH). This paper reports on the effects of a community-embedded intervention that focused on creating positive changes in the attitudes and beliefs of adolescents and community members to enhance adolescents' access to SRH information and services. Methods: This study adopted the Qualitative Impact Assessment approach to evaluate the changes in attitudes and beliefs about the SRH of adolescents from the perspectives of the beneficiaries of a community-embedded intervention namely, adolescents, parents, school teachers, and community leaders. The intervention was implemented in six local government areas in Ebonyi State, southeast Nigeria and the evaluation was undertaken four months after the implementation of the interventions commenced. Eighteen (18) interviews were conducted with 82 intervention beneficiaries including: (i) six in-depth interviews with school teachers; (ii) two sex-disaggregated FGDs with parents; (iii) two sex-disaggregated FGDs with community leaders; and (iv) eight sex-disaggregated FGDs with in school and out of school adolescents. A thematic analysis of data was performed with the aid of NVivo software, version 12. Results: The community-embedded intervention led to changes in individual attitudes and beliefs, as well as changes in community norms and values concerning adolescent SRH. Adolescents reported that following the community-embedded SRH intervention, they have become more comfortable discussing openly SRH issues with their peers, and they could more easily approach their parents and initiate SRH discussions. The parents of adolescents reported that following the intervention, they have become more willing to discuss sensitive SRH issues with adolescents, and frequently make out time to do so. It was also reported that parents no longer use euphemisms to describe sexual body parts, and community leaders now believe that it is all right to discuss SRH with adolescents. Hence, initiating or having SRH discussions with adolescents is no longer misconceived as encouraging sex, and menstruation in unmarried adolescents is no longer viewed as a sign of promiscuity. Respondents also highlighted changes in community norms of, (i) gendered parental communication of SRH matters, as both mothers and fathers have started discussing SRH issues with their adolescent boys and girls; and (ii) public shaming and discipline of pregnant teenage girls are on the decline. Conclusion: The community-based intervention had a positive impact on individual attitudes and beliefs, as well as community and societal values and norms about adolescent SRH. Interventions that take into account community norms and values regarding adolescent SRH should be prioritized to enable the achievement of the SRH-related target of SDG 3. Plain language summary: Adolescents face significant sexual and reproductive health (SRH) challenges which makes it difficult for them to access and utilize SRH services as a result of negative community norms and values. These norms discourage discussions relating to sex and sexuality in Nigeria because sexuality matters are regarded as taboo for young people, and sex is regarded as sacred and the exclusive reserve of the married. This qualitative study explored the views of adolescents, parents, and community leaders on the impact of a community-based intervention on their attitudes and beliefs concerning SRH issues. Using focus group discussions, the community members described the impact of the intervention on the beliefs and attitudes of adolescents, parents/guardians, and the community. Following the SRH intervention, parents started to make out time to discuss SRH issues with adolescents. They became more approachable and willing to discuss sensitive SRH issues with adolescents. Both mothers and fathers started to take up the role of communicating SRH matter with their adolescent boys and girls. Adolescents also started initiating SRH discussions with parents and could openly discuss SRH issues with their peers. In the community, adolescent girls were no longer publicly shamed for engaging in pre-marital sex. There were changes in community leaders' attitudes to teenage pregnancy and they no longer misconceive adolescent SRH issues. Considering the positive changes in individual attitudes, social values, and norms, there is a need for the community-embedded SRH intervention to be sustained and scaled up to other parts of the state by program managers. [ABSTRACT FROM AUTHOR]

Background: Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group.Methods: This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity.Results: A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures.Discussion: If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners.Trial Registration: This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 19, 2014. The registration ID is NCT02290808 . [ABSTRACT FROM AUTHOR]

Background: The enrichment of information technology has impacted traditional teaching modes. The emergence of virtual simulation class experimental teaching software has effectively improved the quality of nursing experiment teaching. The learning experience of virtual simulation class experiment teaching and learning based on the perspective of nursing students is explored to provide a basis for improving related learning effects in the future. Methods: Fourteen undergraduate nursing students were selected using the purposive sampling method for semi-structured interviews. The Colaizzi seven-step analysis method was used to collate and analyse the interview data. Results: Two themes and six sub-themes were considered during the data analysis. The two themes were positive experiences and negative experiences. In the positive learning experience, undergraduate nursing students showed a deep memory of authentic and diverse scenes, which presented knowledge in a clearly logical, visualised and stereoscopic manner. Negative experiences are manifested as significantly different learning efficiencies in different grades and subjects, and timing the delivery of teaching feedback is difficult. Conclusion: Virtual simulation experimental teaching can promote the subjective initiative of nursing students' learning and promote better coordination and unity in their image and theoretical thinking. Some advantages can be augmented by following the national educational policy, strengthening the information construction, combining the construction of virtual simulation experiments with the discipline's characteristics and optimising the resources. This paper provides a reference for the future exploration of nursing education and further improving the construction of virtual simulation experimental teaching tools and resources. [ABSTRACT FROM AUTHOR]

Background: While there is extensive published evidence regarding the effectiveness of the Care Group Approach in promoting community-wide health behavior change, there is no published evidence regarding its empowering effect on its participants. Our study aimed to understand if the Care Group Approach as applied in the Curamericas/Guatemala Maternal and Child Health Project in isolated rural mountainous communities in Guatemala produced evidence of empowerment among the female participants. This is the seventh of 10 papers describing the expanded Census-Based, Impact-Oriented (CBIO+) Approach in improving the health and well-being of mothers and children in the rural highlands of the Department of Huehuetenango, Guatemala. Methods: We conducted semi-structured individual and group interviews with 96 female Care Group participants –including Level-1 Care Group Promoters, Care Group Volunteers, and Self-Help Group participants. The participants were from six communities – two from each of the three municipalities making up the Project Area. Data were analyzed both using deductive thematic and by exploring the following social constructs: perceived social status, self-efficacy, decision-making autonomy, and formation of social capital. Results: The findings supported the hypothesis that Care Group participation was an empowering process. The primary themes that emerged included increased respect accorded to women in the community, women's willingness and ability to make decisions and their confidence in making those decisions, and the development of stronger bonds among Care Group members, with other community members, and with community leaders. Conclusion: Through increased theoretical and practical knowledge about important maternal and child health matters and through the social experience of obtaining this knowledge and sharing it with other community members, participation in the Care Group Approach empowered participants to make positive health behavior changes for themselves and for their children and families. This, in turn, led many participants to become more engaged in community activities for improved health and beyond, thereby enhancing social capital in the community. We conclude that the Care Group Approach, as applied in this setting, has made it possible for marginalized indigenous women living in a male-dominated society to become more empowered. [ABSTRACT FROM AUTHOR]

Background: Sustainable shifts in population behaviours require system-level implementation and embeddedness of large-scale health interventions. This paper aims to understand how different contexts of scaling up interventions affect mechanisms to produce intended and unintended scale up outcomes. Methods: A mixed method study combining a realist perspective and systems analysis (causal loop diagrams) of scaled-up physical activity and/or nutrition interventions implemented at a state/national level in Australia (2010–18). The study involved four distinct phases: Phase 1 expert consultation, database and grey literature searches to identify scaled-up interventions; Phase 2 generating initial Context-Mechanism-Outcome configurations (CMOs) from the WHO ExpandNet framework for scaling up; Phase 3 testing and refining CMOs via online surveys and realist interviews with academics, government and non-government organisations (NGOs) involved in scale up of selected interventions (Phase 1); and Phase 4 generating cross-case mid-range theories represented in systems models of scaling up; validated by member checking. Descriptive statistics were reported for online survey data and realist analysis for interview data. Results: Seven interventions were analysed, targeting nutrition (n = 1), physical activity (n = 1), or a combination (n = 5). Twenty-six participants completed surveys; 19 completed interviews. Sixty-three CMO pathways underpinned successful scale up, reflecting 36 scale up contexts, 8 key outcomes; linked via 53 commonly occurring mechanisms. All five WHO framework domains were represented in the systems models. Most CMO pathways included 'intervention attributes' and led to outcomes 'community sustainability/embeddedness' and 'stakeholder buy-in/perceived value'. Irrespective of interventions being scaled in similar contexts (e.g., having political favourability); mechanisms still led to both intended and unintended scale up outcomes (e.g., increased or reduced sustainability). Conclusion: This paper provides the first evidence for mechanisms underpinning outcomes required for successful scale up of state or nationally delivered interventions. Our findings challenge current prerequisites for effective scaling suggesting other conditions may be necessary. Future scale up approaches that plan for complexity and encourage iterative adaptation throughout, may enhance scale up outcomes. Current linear, context-to-outcome depictions of scale up oversimplify what is a clearly a complex interaction between perceptions, worldviews and goals of those involved. Mechanisms identified in this study could potentially be leveraged during future scale up efforts, to positively influence intervention scalability and sustainability. [ABSTRACT FROM AUTHOR]

Background: This paper presents the mixed methods process evaluation of the randomised controlled trial (RCT) of the Structured Health Intervention For Truckers (SHIFT), a multi-component intervention targeting physical activity and positive lifestyle behaviours in a cohort of 382 truck drivers in the UK. The SHIFT RCT found a significant difference in daily steps between intervention and control groups at 6-months in favour of the intervention participants. Methods: SHIFT was evaluated within a cluster-RCT and involved 25 transport sites (12 intervention and 13 control sites). Intervention components included an education session, Fitbit, text messages, and cab workout equipment. Participants completed questionnaires at baseline and 6-months follow-up. Semi-structured focus groups/interviews were conducted with drivers (n = 19) and managers (n = 18) from each site, after completion of the final follow-up health assessment (16-18 months post-randomisation). Questionnaires and interviews collected information on fidelity, dose, context, implementation, barriers, sustainability, and contamination. Results: Questionnaire and interview data from intervention participants indicated favourable attitudes towards SHIFT, specifically towards the Fitbit with a high proportion of drivers reporting regularly using it (89.1%). 79.2% of intervention participants attended the education session, which was deemed useful for facilitating improvements in knowledge and behaviour change, dietary changes were predominantly recalled. Despite not being part of the intervention, participants reported that feedback from the health assessments motivated them to change aspects of their lifestyle (intervention = 91.1%, control = 67.5%). The cab workout equipment was used less and spoken unfavourably of in the interviews. The main barriers to a healthy lifestyle at work were reported as long hours and irregular shift patterns. The most suggested improvement for the intervention was more frequent contact with drivers. Managers were positive about the objectives of SHIFT, however almost all mentioned the challenges related to implementation, specifically in smaller sites. Conclusions: Overall, SHIFT was predominantly implemented as intended, with minimal discrepancies seen between the delivery and protocol. Having said this, transport sites each have distinct characteristics, which may require adaptations to individual settings to encourage participation. Managers and drivers reported enthusiasm and necessity for SHIFT to be included in future Certificate of Professional Competence training. Trial registration: ISRCTN10483894 (date registered: 01/03/2017). [ABSTRACT FROM AUTHOR]

Background: Sustainability of evidence-based health promotion interventions has received increased research attention in recent years. This paper reports sustainability data from Project HEAL (Health through Early Awareness and Learning) a cancer communication implementation trial about early detection, based in African American churches. In this paper, we used a framework by Scheirer and Dearing (Am J Publ Health 101:2059-2067, 2011) to evaluate multiple dimensions of sustainability from Project HEAL.Methods: We examined the following dimensions of sustainability: (a) continued benefits for intervention recipients, (b) continuation of intervention activities, c) maintaining community partnerships, (d) changes in organizational policies or structures, (e) sustained attention to the underlying issues, (f) diffusion to additional sites, or even (g) unplanned consequences of the intervention. Project HEAL provided a three-workshop cancer educational series delivered by trained lay peer community health advisors (CHAs) in their churches. Multiple sources of sustainability were collected at 12 and 24 months after the intervention that reflect several levels of analysis: participant surveys; interviews with CHAs; records from the project's management database; and open-ended comments from CHAs, staff, and community partners.Results: Outcomes differ for each dimension of sustainability. For continued benefit, 39 and 37% of the initial 375 church members attended the 12- and 24-month follow-up workshops, respectively. Most participants reported sharing the information from Project HEAL with family or friends (92% at 12 months; 87% at 24 months). For continuation of intervention activities, some CHAs reported that the churches held at least one additional cancer educational workshop (33% at 12 months; 24% at 24 months), but many more CHAs reported subsequent health activities in their churches (71% at 12 months; 52% at 24 months). No church replicated the original series of three workshops. Additional data confirm the maintenance of community partnerships, some changes in church health policies, and continued attention to health issues by churches and CHAs.Conclusions: The multiple dimensions of sustainability require different data sources and levels of analysis and show varied sustainability outcomes in this project. The findings reinforce the dynamic nature of evidence-based health interventions in community contexts. [ABSTRACT FROM AUTHOR]

Background: Despite the growing popularity of mixed-methods studies and considerable emphasis on the potential value of qualitative research to the trial endeavour, there remains a dearth of published studies reporting on actual contribution. This paper presents a critically reflective account of our experience of the actual value of undertaking qualitative research alongside a pilot cluster randomised controlled trial of a guided e-learning intervention for managers in an NHS Mental Health Trust to improve employee wellbeing and reduce sickness absence. For the qualitative study we undertook 36 in-depth interviews with key informants, managers and employees. We observed and took in-depth field notes of 10 meetings involving managers and employees at the Trust, and the two qualitative researchers acted as participant observers at steering committee and monthly research team meetings. We adopted a narrative methodological orientation alongside a thematic approach to data analysis, eliciting a rich account of the complexities of managing stress at work.Results: We identified two key overarching roles played by the qualitative research: 'problematising' and 'contextualising'. Specifically, the qualitative data revealed and challenged assumptions embedded in the trial about the nature of the learning process, and exposed the slippery and contested nature of abstracted variables, on which a trial depends. The qualitative data challenged the trial's logic model, and provided a rich understanding of the context within which the trial and intervention took place.Conclusions: While acknowledging the ever-present tension in mixed-methods research between the requirements of quantitative research to represent the social world as abstracted variables, and the goal of qualitative research to explore and document the complexity of social phenomena, we adopted a pragmatic position that enabled us to engage with this tension in a productive and partially integrative way. Our critically reflective account of the praxis of integration illuminated opportunities and challenges for maximising the value of qualitative research to a trial. This paper sets out tangible illustrative lessons for other mixed-methods researchers endeavouring to get the most from qualitative research.Trial Registration: This study is registered as ISRCTN58661009 . Registration was submitted on 22 April 2013 and completed on 17 June 2013. [ABSTRACT FROM AUTHOR]

Background: Physical inactivity levels are rising worldwide with major implications for the health of the population and the prevalence of non-communicable diseases. Exercise referral schemes (ERS) continue to be a popular intervention utilised by healthcare practitioners to increase physical activity. We undertook a systematic review of views studies in order to inform guidance from the UK National Institute of Health and Care Excellence (NICE) on exercise referral schemes to promote physical activity. This paper reports on the participant views identified, to inform those seeking to refine schemes to increase attendance and adherence.Methods: Fifteen databases and a wide range of websites and grey literature sources were searched systematically for publications from 1995 to June 2013. In addition, a range of supplementary methods including, a call for evidence by NICE, contacting authors, reference list checking and citation tracking were utilised to identify additional research. Studies were included where they detailed schemes for adults aged 19 years or older who were 'inactive' (i.e. they are not currently meeting UK physical activity guidelines). Study selection was conducted independently in duplicate. Quality assessment was undertaken by one reviewer and checked by a second, with 20 % of papers being considered independently in duplicate. Papers were coded in qualitative data analysis software Atlas.ti. This review was reported in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement).Results: Evidence from 33 UK-relevant studies identified that support from providers, other attendees and family was an important facilitator of adherence and 'making exercise a habit' post programme, as was the variety and personalised nature of sessions offered. Barriers to attendance included the inconvenient timing of sessions, their cost and location. An intimidating gym atmosphere, a dislike of the music and TV and a lack of confidence in operating gym equipment were frequently reported.Conclusions: These findings provide valuable insights that commissioners and providers should consider. The main themes were consistent across a large number of studies and further research should concentrate on programmes that reflect these findings. [ABSTRACT FROM AUTHOR]

Background: The No Germs on Me (NGoM) Social Marketing Campaign to promote handwashing with soap to reduce high rates of infection among children living in remote Australian Aboriginal communities has been ongoing since 2007. Recently three new television commercials were developed as an extension of the NGoM program. This paper reports on the mass media component of this program, trialling an evaluation design informed by the Theory of Planned Behaviour (TPB).Methods: A survey questionnaire taking an ecological approach and based on the principals and constructs of the TPB was developed. Surveys were completed in six discrete Aboriginal communities immediately before and on completion of four weeks intensive televising of the three new commercials.Results: Across the six communities access in the home to a television that worked ranged from 49 to 83 % (n = 415). Seventy-seven per cent (n = 319) of participants reported having seen one or more of the new commercials. Levels of acceptability and comprehension of the content of the commercials was high (97 % n = 308). Seventy-five per cent (n = 651) of participants reported they would buy more soap, toilet paper and facial tissues if these were not so expensive in their communities. For TPB constructs demonstrated to have good internal reliability the findings were mixed and these need to be interpreted with caution due to limitations in the study design.Conclusions: Cultural, social-economic and physical barriers in remote communities make it challenging to promote adults and children wash their hands with soap and maintain clean faces such that these behaviours become habit. Low levels of access to a television in the home illustrate the extreme level of disadvantage experienced in these communities. Highlighting that social marketing programs have the potential to increase disadvantage if expensive items such as television sets are needed to gain access to information. This trial of a theory informed evaluation design allowed for new and rich information to be obtained about community members' beliefs, attitudes and intentions towards teaching and assisting children so safe hygiene behaviours become habit. Findings will support an evidence-based approach is taken to plan future NGoM program activities. [ABSTRACT FROM AUTHOR]

Background: Binge-drinking in adolescents is a highly prevalent healthcare problem that associates physical and mental health complications with community implications. This paper describes the design, implementation and evaluation of the first web-based computer tailored intervention aimed at the prevention of binge drinking in Spanish adolescents.Methods: The Alerta Alcohol program is based on the I-Change Model. First, feedback from focus and Delphi groups are used for cultural adaptation and to obtain further information on the items to be included on the program. A pilot study is then conducted to assess feasibility and to identify strengths and weaknesses. Second, a Cluster Randomized Controlled Trial is conducted to test the effectiveness of Alerta Alcohol in students aged 16 to 18 years. The study is performed in 16 high schools from Andalusia (southern Spain), which are randomized either to the experimental or the control condition (EC and CC). The EC receives the Alerta Alcohol intervention, which consists of four sessions at school (baseline questionnaire, two sessions in three scenarios: at home, celebrations, and public places, and a final evaluation). The adolescents are provided with answers related to their views of each scenario; this information is used to provide highly specific feedback regarding their knowledge, risk perception, self-esteem, attitude, social influence, and self-efficacy. In addition, two booster sessions are given at home to reinforce the previous messages. The CC just completes the baseline and the final evaluation questionnaires and then they are allowed to receive the intervention as well (as a waiting list). Evaluation takes place after four months. The primary endpoint is binge drinking within 30 days prior to the evaluation and alcohol use in the previous week. It is expected that Alerta Alcohol reduce the prevalence of binge drinking by 10%. Follow up analyses are carried out to determine the differences in effectiveness according to the compliance of the program (quality of the implementation).Discussion: The results are expected to be applicable and may incorporate improvements in the practice of the Healthcare and Education Systems. If the program proves to be effective, regional and eventual national implementation should be considered.Trial Registration: Trial registration number (ClinicalTrials.gov): NCT03288896 . This study was retrospectively registered on 19/09/2017. [ABSTRACT FROM AUTHOR]

Background: Overweight and obese adolescents are reported to be less physically active than their peers. Research-based knowledge about their views may contribute to a better understanding of key factors that may foster or undermine motivation for physical activity, and provide knowledge for the future development of interventions. This paper explores experiences of physical activity among overweight adolescents, age 13-14 years, participants in Young & Active, a web-based controlled trial intervention to increase physical activity (ClinicalTrials.gov NCT01700309). The theoretical perspective is based on Self-Determination Theory.Methods: Two qualitative post-intervention research interviews, with a nine-month interval, were conducted with 21 adolescents, 15 girls and 6 boys to study short-term and long-term changes. The informants were recruited from a total of 84 participants from the Young & Active intervention group. Data were analyzed using qualitative content analysis.Results: The participants associated physical activity with organized sports and physical education classes at school, and as a means of promoting good health and attractive bodies. A majority of the adolescents said that they experienced their health as poorer than other youths, and expressed worries about their fitness and future health. Mastering a physical activity, being together with friends and having fun promoted motivation to perform sports. Not mastering an activity, or not knowing the others made them less motivated. None of the adolescents highlighted the importance of informal active living when asked about their understanding and experiences of physical activity. Consistency was found between the first and second interviews.Conclusion: This study adds to limited research on overweight and obese adolescents' experiences of physical activity. The participants' views reflect opinions in society about physical activity, and its importance for health. Viewing physical activity as conducted within organized sports makes it necessary to look into how these are organized, structured and led, and what can be done to support self-esteem, autonomous motivation and participation. The ability to choose among available, affordable and desirable physical activities, together with friends, may promote participation and maintenance. [ABSTRACT FROM AUTHOR]

Background: About 30 million individuals in the United States are living with a rare disease, which by definition have a prevalence of 200,000 or fewer cases in the United States ([National Organization for Rare Disorders], [About NORD], [2016]). Disease heterogeneity and geographic dispersion add to the difficulty of completing robust studies in small populations. Improving the ability to conduct research on rare diseases would have a significant impact on population health. The purpose of this paper is to raise awareness of methodological approaches that can address the challenges to conducting robust research on rare diseases.Approach: We conducted a landscape review of available methodological and analytic approaches to address the challenges of rare disease research. Our objectives were to: 1. identify algorithms for matching study design to rare disease attributes and the methodological approaches applicable to these algorithms; 2. draw inferences on how research communities and infrastructure can contribute to the efficiency of research on rare diseases; and 3. to describe methodological approaches in the rare disease portfolio of the Patient-Centered Outcomes Research Institute (PCORI), a funder promoting both rare disease research and research infrastructure.Results: We identified three algorithms for matching study design to rare disease or intervention characteristics (Gagne, et.al, BMJ 349:g6802, 2014); (Gupta, et.al, J Clin Epidemiol 64:1085-1094, 2011); (Cornu, et. al, Orphet J Rare Dis 8:48,2012) and summarized the applicable methodological and analytic approaches. From this literature we were also able to draw inferences on how an effective research infrastructure can set an agenda, prioritize studies, accelerate accrual, catalyze patient engagement and terminate poorly performing studies. Of the 24 rare disease projects in the PCORI portfolio, 11 are randomized controlled trials (RCTs) using standard designs. Thirteen are observational studies using case-control, prospective cohort, or natural history designs. PCORI has supported the development of 9 Patient-Powered Research Networks (PPRNs) focused on rare diseases.Conclusion: Matching research design to attributes of rare diseases and interventions can facilitate the completion of RCTs that are adequately powered. An effective research infrastructure can improve efficiency and avoid waste in rare disease research. Our review of the PCORI research portfolio demonstrates that it is feasible to conduct RCTs in rare disease. However, most of these studies are using standard RCT designs. This suggests that use of a broader array of methodological approaches to RCTs --such as adaptive trials, cross-over trials, and early escape designs can improve the productivity of robust research in rare diseases. [ABSTRACT FROM AUTHOR]

Background: Aboriginal people in Australia experience significant health burden from chronic disease. There has been limited research to identify effective healthy lifestyle programs to address risk factors for chronic disease among Aboriginal people.Methods: The Knockout Health Challenge is a community-led healthy lifestyle program for Aboriginal communities across New South Wales, Australia. An evaluation of the 2013 Knockout Health Challenge was undertaken. Participants' self-reported physical activity and diet were measured at four time points - at the start and end of the Challenge (via paper form), and 5 and 9 months after the Challenge (via telephone survey). Participants' weight was measured objectively at the start and end of the Challenge, and self-reported (via telephone survey) 5 and 9 months after the Challenge. Changes in body composition, physical activity and diet between time points were analysed using linear mixed models. As part of the telephone survey participants were also asked to identify other impacts of the Challenge; these were analysed descriptively (quantitative items) and thematically (qualitative items).Results: A total of 586 people registered in 22 teams to participate in the Challenge. The mean weight at the start was 98.54kg (SD 22.4), and 94% of participants were overweight or obese. Among participants who provided data at all four time points (n=122), the mean weight loss from the start to the end of the Challenge was 2.3kg (95%CI -3.0 to -1.9, p<0.001), and from the start to 9 months after the Challenge was 2.3kg (95%CI -3.3 to -1.3, p<0.001). Body mass index decreased by an average of 0.9kg/m2 (95%CI -1.0 to -0.7, p<0.001) from the start to the end of the Challenge, and 0.8kg/m2 (95%CI -1.2 to -0.4, p<0.001) 9 months after. At the end of the Challenge, participants reported they were more physically active and had increased fruit and vegetable consumption compared with the start of the Challenge, and identified a range of other positive impacts.Conclusions: The Challenge was effective in reducing weight and promoting healthy lifestyles among Aboriginal people across New South Wales, and has potential to contribute to closing the health gap between Aboriginal and non-Aboriginal people. [ABSTRACT FROM AUTHOR]

Background: Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale.Methods: The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016.Results: Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project.Conclusions: Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs explored in an RCT are inadequate in describing the enablers and barriers of upscaled community program implementation. Methods for data collection, analysis and reporting also require consideration. We present a number of experiential reflections and suggestions for the successful evaluation of future upscaled community programs which are scarcely reported in the literature.Trials Registration: PEACH™ QLD was retrospectively registered with the Australian New Zealand Clinical Trials Registry on 28 February 2017 (ACTRN12617000315314). [ABSTRACT FROM AUTHOR]

Background: The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. Methods: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. Results: All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. Conclusion: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. Trial registration: ISRCTN15811706. [ABSTRACT FROM AUTHOR]

Background: Diarrhoea is a leading cause of child death in Zambia. As elsewhere, the disease burden could be greatly reduced through caregiver uptake of existing prevention and treatment strategies. We recently reported the results of the Komboni Housewives intervention which tested a novel strategy employing motives including affiliation and disgust to improve caregiver practice of four diarrhoea control behaviours: exclusive breastfeeding; handwashing with soap; and correct preparation and use of oral rehydration salts (ORS) and zinc. The intervention was delivered via community events (women's forums and road shows), at health clinics (group session) and via radio. A cluster randomised trial revealed that the intervention resulted in a small improvement in exclusive breastfeeding practices, but was only associated with small changes in the other behaviours in areas with greater intervention exposure. This paper reports the findings of the process evaluation that was conducted alongside the trial to investigate how factors associated with intervention delivery and receipt influenced caregiver uptake of the target behaviours.Methods: Process data were collected from the eight peri-urban and rural intervention areas throughout the six-month implementation period and in all 16 clusters 4-6 weeks afterwards. Intervention implementation (fidelity, reach, dose delivered and recruitment strategies) and receipt (participant engagement and responses, and mediators) were explored through review of intervention activity logs, unannounced observation of intervention events, semi-structured interviews, focus groups with implementers and intervention recipients, and household surveys. Evaluation methods and analyses were guided by the intervention's theory of change and the evaluation framework of Linnan and Steckler.Results: Intervention reach was lower than intended: 39% of the surveyed population reported attending one or more face-to-face intervention event, of whom only 11% attended two or more intervention events. The intervention was not equally feasible to deliver in all settings: fewer events took place in remote rural areas, and the intervention did not adequately penetrate communities in several peri-urban sites where the population density was high, the population was slightly higher socio-economic status, recruitment was challenging, and numerous alternative sources of entertainment existed. Adaptations made by the implementers affected the fidelity of implementation of messages for all target behaviours. Incorrect messages were consequently recalled by intervention recipients. Participants were most receptive to the novel disgust and skills-based interactive demonstrations targeting exclusive breastfeeding and ORS preparation respectively. However, initial disgust elicitation was not followed by a change in associated psychological mediators, and social norms were not measurably changed.Conclusions: The lack of measured behaviour change was likely due to issues with both the intervention's content and its delivery. Achieving high reach and intensity in community interventions delivered in diverse settings is challenging. Achieving high fidelity is also challenging when multiple behaviours are targeted for change. Further work using improved tools is needed to explore the use of subconscious motives in behaviour change interventions. To better uncover how and why interventions achieve their measured effects, process evaluations of complex interventions should develop and employ frameworks for investigation and interpretation that are structured around the intervention's theory of change and the local context.Trial Registration: The study was registered as part of the larger trial on 5 March 2014 with ClinicalTrials.gov: NCT02081521 . [ABSTRACT FROM AUTHOR]

Background This paper explores the nature of food and plants and their meanings in a British Bengali urban context. It focuses on the nature of plants and food in terms of their role in home making, transnational connections, generational and concepts of health. Methods An ethnographic approach to the research was taken, specific methods included participant observation, focus group discussions and semi-structured interviews. Thirty women of Bengali origin were mostly composed of "mother" and "daughter" pairs. The mothers were over 45 years old and had migrated from Bangladesh as adults and their grown-up daughters grew up in the UK. Results Food and plants play an important role in the construction of home "here" (London) while continuing to connect people to home "there" (Sylhet). This role, however, changes and is redefined across generations. Looking at perceptions of "healthy" and "unhealthy" food, particularly in the context of Bengali food, multiple views of what constitutes "healthy" food exist. However, there appeared to be little two-way dialogue about this concept between the research participants and health professionals. This seems to be based on "cultural" and power differences that need to be addressed for a meaningful dialogue to occur. Conclusion In summary, this paper argues that while food is critical to the familial spaces of home (both locally and globally), it is defined by a complex interplay of actors and wider meanings as illustrated by concepts of health and what constitutes Bengali food. Therefore, we call for greater dialogue between health professionals and those they interact with, to allow for an enhanced appreciation of the dynamic nature of food and plants and the diverse perceptions of the role that they play in promoting health. [ABSTRACT FROM AUTHOR]

Background: Many teenagers are insufficiently active despite the health benefits of physical activity (PA). There is strong evidence to show that inactivity and low fitness levels increase the risk of non-communicable diseases such as coronary heart disease (CHD), type 2 diabetes and breast and colon cancers (Lee et al. Lancet 380:219-29, 2012). A major barrier facing adolescents is accessibility (e.g. cost and lack of local facilities). The ACTIVE project aims to tackle this barrier through a multi-faceted intervention, giving teenagers vouchers to spend on activities of their choice and empowering young people to improve their fitness and PA levels.Design: ACTIVE is a mixed methods randomised control trial in 7 secondary schools in Swansea, South Wales. Quantitative and qualitative measures including PA (cooper run test (CRT), accelerometery over 7 days), cardiovascular (CV) measures (blood pressure, pulse wave analysis) and focus groups will be undertaken at 4 separate time points (baseline, 6 months,12 months and follow-up at 18 months). Intervention schools will receive a multi-component intervention involving 12 months of £20 vouchers to spend on physical activities of their choice, a peer mentor scheme and opportunities to attend advocacy meetings. Control schools are encouraged to continue usual practice. The primary aim is to examine the effect of the intervention in improving cardiovascular fitness.Discussion: This paper describes the protocol for the ACTIVE randomised control trial, which aims to increase fitness, physical activity and socialisation of teenagers in Swansea, UK via a voucher scheme combined with peer mentoring. Results can contribute to the evidence base on teenage physical activity and, if effective, the intervention has the potential to inform future physical activity interventions and policy.Trial Registration: ISRCTN75594310 (Assigned 06/03/2017). [ABSTRACT FROM AUTHOR]

Background: Self-monitoring using pedometers is an effective behaviour change technique to support increased physical activity (PA). However, the ways in which pedometers operate as motivational tools in adoption and maintenance of PA is not well understood. This paper investigates men's experiences of pedometers as motivational tools both during and after their participation in a 12-week group-based, weight management programme for overweight/obese men, Football Fans in Training (FFIT). Methods: Semi-structured telephone interviews were conducted with 28 men, purposively sampled to include men who did and did not achieve 5% weight loss during the programme. Data were analysed thematically utilising the framework approach, using Self-Determination Theory (SDT) - namely concepts of behavioural regulation and the basic needs of relatedness, competence and autonomy - as an analytical lens. Results: During the programme, FFIT's context and fellow participants supported relatedness and encouraged use of the pedometer. The pedometer was seen to provide tangible proof of progress, thus increasing competence for change, whilst the ability to monitor one's own progress and take remedial action supported autonomy; these men portrayed the pedometer as an 'ally'. However, a minority found the pedometer 'dispiriting' or controlling when it evidenced their inability to meet their PA targets. After the programme, some men no longer used the device as they had fully internalised their motivations for increased PA. In contrast, others continued to use pedometers or progressed to other self-monitoring technologies because it was enjoyable and facilitated maintenance of their increased PA. However, the minority of men who experienced the pedometer as controlling no longer used it. They were less successful in achieving 5% weight loss and appeared reliant on external factors, including support from coach and group members, to maintain motivation. Conclusion: These findings show how self-monitoring using pedometers and associated goal setting supported the development of autonomous motivation for PA, during and after participation in a group-based programme. They also suggest that programmes could focus on early identification of participants who remain motivated by extrinsic factors or express negative experiences of self-monitoring tools, to offer greater support to identify the benefits of PA based on a person's own values. [ABSTRACT FROM AUTHOR]

Background: Regular physical activity (PA) promotes and excessive sedentary behavior (SB) deteriorates health. Yet the Finnish working-aged population spends most of the day sitting. A 1-year Moving To Business (MTB) -intervention supported small and medium-size workplaces to combat sedentariness. This paper reports the changes in employees' PA and SB from before MTB (baseline) to 1 year after baseline (follow-up).Methods: Twelve workplaces with a total of 396 employees participated. Each workplace nominated a team to promote PA and reduce SB at organizational, working unit and employee level. The teams were mentored regionally through meetings, workshop and tools. Changes in PA and SB were assessed with a questionnaire and an accelerometer. Wald Confidence Interval (Cl) for a difference of proportions with matched pairs was used in the questionnaire data (%-points with 95% CI) and linear mixed model in the accelerometer data (minutes and % of wear-time with 95% CI).Results: The mean age of the respondents to the questionnaire (N = 296; 75%) was 42.6 (SD 10.9), 64% were women, 95% had some education after high school, 74% worked in the day shift, 71% did sedentary work and 51% were overweight. The mean number of actions implemented in the workplaces was 6.8 and the multilevel approach was fully applied in 6 workplaces. Based on the questionnaire the time spent in SB decreased from baseline to follow-up 16% (95% CI -29 to -3) in total and 22% (-41 to -3) at work. The accelerometer showed daily increases of 33.7 min (15.3 to 52.1) and 6.8% (3.1 to 10.4) in total PA, 30.9 min (15.3 to 46.5) and 6.1% (2.9 to 9.2) in light PA and 673 (209 to 1139) more steps at work. Daily SB at work decreased 44.9 min (-68.0 to -21.8) and 7.6% (-11.9 to -3.2). Daily leisure PA declined 11.0 min (-24.9 to 2.9) and 3.2% (-6.2 to -0.2). Number of levels or actions had no effect on changes.Conclusions: Employees' PA increased and SB reduced at work during the intervention. At the same time leisure PA decreased slightly. Workplaces can achieve meaningful changes in employees' PA and SB if assisted systematically. Controlled studies are needed to confirm the present findings.Trial Registration: NCT01999205 , registration date 11/01/2013. [ABSTRACT FROM AUTHOR]

Background: We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial.Methods: Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months.Results: At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day.Conclusion: We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status.Trial Registration: ISRCTN15811706 (1/05/2012). [ABSTRACT FROM AUTHOR]

Background: Use of technology is increasing in health promotion and has continued growth potential in intervention research. Guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, this paper reports on the adoption, reach, and implementation of Project HEAL (Health through Early Awareness and Learning)-a community-based implementation trial of a cancer educational intervention in 14 African American churches. We compare adoption, reach, and implementation at the organizational and participant level for churches in which lay peer community health advisors (CHAs) were trained using traditional classroom didactic methods compared with a new online system.Methods: Fifteen churches were randomized to one of two study groups in which two CHAs per church were trained through either classroom ("Traditional"; n = 16 CHAs in 8 churches) or web-based ("Technology"; n = 14 CHAs in 7 churches) training methods. Once trained and certified, all CHAs conducted a series of three group educational workshops in their churches on cancer early detection (breast, prostate, and colorectal). Adoption, reach, and implementation were assessed using multiple data sources including church-level data, participant engagement in the workshops, and study staff observations of CHA performance.Results: The project had a 41% overall adoption rate at the church level. In terms of reach, a total of 375 participants enrolled in Project HEAL-226 participants in the Traditional group (43% reach) and 149 in the Technology group (21% reach; p < .10). Implementation was evaluated in terms of adherence, dosage, and quality. All churches fully completed the three workshops; however, the Traditional churches took somewhat longer (M = 84 days) to complete the workshop series than churches in the Technology group (M = 64 days). Other implementation outcomes were comparable between both the Traditional and Technology groups (p > .05).Conclusions: Overall, the Project HEAL intervention had reasonable adoption, though reach could have been better. Implementation was strong across both study groups, suggesting the promise of using web-based methods to disseminate and implement evidence-based interventions in faith-based settings and other areas where community health educators work to eliminate health disparities. [ABSTRACT FROM AUTHOR]

An essential, but often overlooked part of health promotion and development support to achieve self-sufficiency in developing countries is the concomitant need to build and strengthen research capacity. This is even more challenging and critical in the area of sexual and reproductive health because of diverse interplay of socio cultural, religious, economic factors in relation to reproductive health. This paper presents the case study of HRP's efforts to build research capacity in Latin America by studying and analyzing the 5-year history of institutional development support to an institution in Paraguay. In reviewing the efforts, we identify the strengths in the approaches used by HRP, the challenges and outcomes of the process and we present recommendations for future efforts to strengthen research capacity to improve sexual and reproductive health. The authors call for greater support from and collaborative efforts of developmental partners and governments to strengthen research capacity in low and middle-income countries to improve sexual and reproductive health. [ABSTRACT FROM AUTHOR]

Background: In June 2015, an expert consensus guidance statement was published recommending that office workers accumulate 2-4 h of standing and light activity daily and take regular breaks from prolonged sitting. This paper describes public responses to media coverage of the guidance, so as to understand public acceptability of the recommendations within the guidance, and perceptions of sitting and standing as health behaviours.Methods: UK news media websites that had reported on the sedentary workplace guidance statement, and permitted viewers to post comments responding to the story, were identified. 493 public comments, posted in a one-month period to one of six eligible news media websites, were thematically analysed.Results: Three themes were extracted: (1) challenges to the credibility of the sedentary workplace guidance; (2) challenges to the credibility of public health; and (3) the guidance as a spur to knowledge exchange. Challenges were made to the novelty of the guidance, the credibility of its authors, the strength of its evidence base, and its applicability to UK workplaces. Public health was commonly mistrusted and viewed as a tool for controlling the public, to serve a paternalistic agenda set by a conspiracy of stakeholders with hidden non-health interests. Knowledge exchanges focused on correcting others' misinterpretations, raising awareness of historical or scientific context, debating current workplace health policies, and sharing experiences around sitting and standing.Conclusions: The guidance provoked exchanges of health-promoting ideas among some, thus demonstrating the potential for sitting reduction messages to be translated into everyday contexts by lay champions. However, findings also demonstrated confusion, misunderstanding and misapprehension among some respondents about the health value of sitting and standing. Predominantly unfavourable, mistrusting responses reveal significant hostility towards efforts to displace workplace sitting with standing, and towards public health science more broadly. Concerns about the credibility and purpose of public health testify to the importance of public engagement in public health guidance development. [ABSTRACT FROM AUTHOR]

Background: Obesity and other nutrition-related chronic disease rates are high in American Indian (AI) populations, and an urgent need exists to identify evidence-based strategies for prevention and treatment. Multi-level, multi-component (MLMC) interventions are needed, but there are significant knowledge gaps on how to deliver these types of interventions in low-income rural AI communities.Methods: OPREVENT2 is a MLMC intervention targeting AI adults living in six rural reservations in New Mexico and Wisconsin. Aiming to prevent and reduce obesity in adults by working at multiple levels of the food and physical activity (PA) environments, OPREVENT2 focuses on evidence-based strategies known to increase access to, demand for, and consumption of healthier foods and beverages, and increase worksite and home-based opportunities for PA. OPREVENT2 works to create systems-level change by partnering with tribal stakeholders, multiple levels of the food and PA environment (food stores, worksites, schools), and the social environment (children as change agents, families, social media). Extensive evaluation will be conducted at each level of the intervention to assess effectiveness via process and impact measures.Discussion: Novel aspects of OPREVENT2 include: active engagement with stakeholders at many levels (policy, institutional, and at multiple levels of the food and PA system); use of community-based strategies to engage policymakers and other key stakeholders (community workshops, action committees); emphasis on both the built environment (intervening with retail food sources) and the social environment. This paper describes the design of the intervention and the evaluation plan of the OPREVENT2.Trial Registration: Clinical Trial Registration: NCT02803853 (June 10, 2016). [ABSTRACT FROM AUTHOR]

Background: The worksite cafeteria is a suitable setting for interventions focusing on changing eating behavior, because a lot of employees visit the worksite cafeteria regularly and a variety of interventions could be implemented there. The aim of this paper is to describe the intervention development and design of the evaluation of an intervention to make the purchase behavior of employees in the worksite cafeteria healthier. The developed intervention called "the worksite cafeteria 2.0" consists of a set of 19 strategies based on theory of nudging and social marketing (marketing mix). The intervention will be evaluated in a real-life setting, that is Dutch worksite cafeterias of different companies and with a number of contract catering organizations.Methods/design: The study is a randomized controlled trial (RCT), with 34 Dutch worksite cafeterias randomly allocated to the 12-week intervention or to the control group. Primary outcomes are sales data of selected products groups like sandwiches, salads, snacks and bread topping. Secondary outcomes are satisfaction of employees with the cafeteria and vitality.Discussion: When executed, the described RCT will provide better knowledge in the effect of the intervention "the worksite cafeteria 2.0" on the purchasing behavior of Dutch employees in worksite cafeterias.Trial Registration: Dutch Trial register: NTR5372 . [ABSTRACT FROM AUTHOR]

Background: Obstructive sleep apnoea is a common disorder with under-rated clinical impact, which is increasingly being recognised as having a major bearing on global disease burden. Men are especially vulnerable and become a priority group for preventative interventions. However, there is limited information on prevalence of the condition in Australia, its co-morbidities, and potential risk factors.Methods: We used data from 13,423 adult men included in the baseline wave of Ten to Men, an Australian national study of the health of males, assembled using stratified cluster sampling with oversampling from rural and regional areas. Those aged 18-55 years self-completed a paper-based questionnaire that included a question regarding health professional-diagnosed sleep apnoea, physical and mental health status, and health-related behaviours. Sampling weights were used to account for the sampling design when reporting the prevalence estimates. Odds ratios were used to describe the association between health professional-diagnosed sleep apnoea and potential correlates while adjusting for age, country of birth, and body-mass index (BMI).Results: Prevalence of self-reported health professional-diagnosed sleep apnoea increased from 2.2 % in age 18-25 years to 7.8 % in the age 45-55 years. Compared with those without sleep apnoea, those with sleep apnoea had significantly poorer physical, mental, and self-rated health as well as lower subjective wellbeing and poorer concentration/remembering (p < 0.001 for all). Sleep apnoea was significantly associated with older age (p < 0.001), unemployment (p < 0.001), asthma (p = 0.011), chronic obstructive pulmonary disease/chronic bronchitis (p = 0.002), diabetes (p < 0.001), hypercholesterolemia (p < 0.001), hypertension (p < 0.001), heart attack (p < 0.001), heart failure (p < 0.001), angina (p < 0.001), depression (p < 0.001), post-traumatic stress disorder (p < 0.001), other anxiety disorders (p < 0.001), schizophrenia (p = 0.002), overweight/obesity (p < 0.001), insufficient physical activity (p = 0.006), smoking (p = 0.005), and high alcohol consumption (p < 0.001).Conclusion: Health professional-diagnosed sleep apnoea is relatively common, particularly in older males. Associations between sleep apnoea and cardiovascular, metabolic, respiratory, and psychiatric disorders have important clinical and public health implications. As men are especially vulnerable to sleep apnoea as well as some of its chronic co-morbidities, they are potentially a priority group for health interventions. Modifiable lifestyle related factors such as smoking, alcohol consumption, level of physical activity and BMI are possible key foci for interventions. [ABSTRACT FROM AUTHOR]

Background: Coordinated, multi-component school-based interventions can improve health behaviors in children, as well as parents, and impact the weight status of students. By leveraging a unique collaboration between Texas AgriLife Extension (a federal, state and county funded educational outreach organization) and the University of Texas School of Public Health, the Texas Grow! Eat! Go! Study (TGEG) modeled the effectiveness of utilizing existing programs and volunteer infrastructure to disseminate an enhanced Coordinated School Health program. The five-year TGEG study was developed to assess the independent and combined impact of gardening, nutrition and physical activity intervention(s) on the prevalence of healthy eating, physical activity and weight status among low-income elementary students. The purpose of this paper is to report on study design, baseline characteristics, intervention approaches, data collection and baseline data.Methods: The study design for the TGEG study consisted of a factorial group randomized controlled trial (RCT) in which 28 schools were randomly assigned to one of 4 treatment groups: (1) Coordinated Approach to Child Health (CATCH) only (Comparison), (2) CATCH plus school garden intervention [Learn, Grow, Eat & Go! (LGEG)], (3) CATCH plus physical activity intervention [Walk Across Texas (WAT)], and (4) CATCH plus LGEG plus WAT (Combined). The outcome variables include student's weight status, vegetable and sugar sweetened beverage consumption, physical activity, and sedentary behavior. Parents were assessed for home environmental variables including availability of certain foods, social support of student health behaviors, parent engagement and behavior modeling.Results: Descriptive data are presented for students (n = 1369) and parents (n = 1206) at baseline. The sample consisted primarily of Hispanic and African American (53 % and 18 %, respectively) and low-income (i.e., 78 % eligible for Free and Reduced Price School Meals program and 43 % food insecure) students. On average, students did not meet national guidelines for vegetable consumption or physical activity. At baseline, no statistical differences for demographic or key outcome variables among the 4 treatment groups were observed.Conclusions: The TGEG study targets a population of students and parents at high risk of obesity and related chronic conditions, utilizing a novel and collaborative approach to program formulation and delivery, and a rigorous, randomized study design. [ABSTRACT FROM AUTHOR]

Background: Overweight and obesity are prevalent among young women and are greater among minority and low-income women. The postpartum period is critical in women's weight trajectories as many women do not lose their pregnancy weight, and others lose some and then plateau or experience weight gain. Excess weight puts women at greater risk of chronic disease and thus weight loss in the postpartum period may be key to the long-term health of young women. This paper describes the design and methods of a randomized clinical trial of Fresh Start, an innovative narrative-based group intervention aimed at promoting postpartum weight loss among low-income, diverse women.Methods/design: Study participants were recruited from the five sites of the Women, Infants and Children (WIC) program in central Massachusetts. Participants were English-speaking, age ≥ 18 years, 6 weeks to 6 months postpartum, with a body mass index (BMI) ≥ 27 kg/m(2). The Fresh Start postpartum weight loss intervention, adapted from the Diabetes Prevention Program (DPP) in collaboration with WIC staff and clients, consisted of an 8-week group-based curriculum followed by nine monthly telephone calls. It included a narrative component (i.e., storytelling), group discussions, print materials and access to exercise facilities. The study is a two-arm randomized controlled trial. The control condition included print materials and access to exercise facilities. In-person assessments were conducted at baseline and at 6 and 12 months following the eight-week intervention phase.Discussion: The Fresh Start intervention translated key elements of an evidence-based weight loss protocol into a format that is hypothesized to be relevant, acceptable and effective for the target audience of low-SES postpartum women. This novel intervention was developed in collaboration with WIC to be sustainable within the context of its clinics, which reach approximately 9 million individuals per year across the U.S. via 10,000 clinics.Trial Registration: clinicaltrials.gov NCT02176915 . Registered 25 June 2014. [ABSTRACT FROM AUTHOR]

Background: Despite expanding international commitment to community health worker (CHW) deployment, little is known about how such workers actually use their time. This paper investigates this issue for paid CHWs named "Community Health Agents," which in Swahili is "Wawezeshaji wa Afya ya Jamii" ("WAJA"), trained for 9 months in primary health care service delivery and deployed to villages as subjects of a randomized trial of their impact on childhood survival in three rural districts of Tanzania.Methods: To capture information about time allocation, 30 WAJA were observed during conventional working hours by research assistants for 5 days each over a period of 4 weeks. Results were presented in term of percentage time allocation for direct client treatment, documentation activities, health education, health promotion non-work-related activities and personal activities.Results: During routine 8-h workdays, 59.5 % of WAJA time was spent on the provision of health services and other work-related activities. Overall, WAJA spent 27.8 % of their work on traveling from home to home, 33.1 % on health education, 9.9 % of health promotion and only 12.3 % on direct patient care. Other activities related to documentation (7.8 %) and supervision (2.5 %).Conclusions: Results reflect the pressing obligations of WAJA to engage in activities other than direct work responsibilities during routine work hours. Time spent on work activities is primarily used for health education, promotion, moving between households, and direct patient care. However, greater effort should be directed to strengthening supervisory systems and follow-up of challenges WAJAs facing in order to increase proportion of working hours. [ABSTRACT FROM AUTHOR]

Background: Osteoporosis is a debilitating disease. Adequate calcium consumption and physical activity are the two major modifiable risk factors. This paper describes the major outcomes and efficacy of a workplace-based targeted behaviour change intervention to improve the dietary and physical activity behaviours of working women in sedentary occupations in Singapore.Methods: A cluster-randomized design was used, comparing the efficacy of a tailored intervention to standard care. Workplaces were the units of randomization and intervention. Sixteen workplaces were recruited from a pool of 97, and randomly assigned to intervention and control arms (eight workplaces in each). Women meeting specified inclusion criteria were then recruited to participate. Workplaces in the intervention arm received three participatory workshops and organization-wide educational activities. Workplaces in the control/standard care arm received print resources. Outcome measures were calcium intake (milligrams/day) and physical activity level (duration: minutes/week), measured at baseline, 4 weeks and 6 months post intervention. Adjusted cluster-level analyses were conducted comparing changes in intervention versus control groups, following intention-to-treat principles and CONSORT guidelines.Results: Workplaces in the intervention group reported a significantly greater increase in calcium intake and duration of load-bearing moderate to vigorous physical activity (MVPA) compared with the standard care control group. Four weeks after intervention, the difference in adjusted mean calcium intake was 343.2 mg/day (95 % CI = 337.4 to 349.0, p < .0005) and the difference in adjusted mean load-bearing MVPA was 55.6 min/week (95 % CI = 54.5 to 56.6, p < .0005). Six months post intervention, the mean differences attenuated slightly to 290.5 mg/day (95 % CI = 285.3 to 295.7, p < .0005) and 50.9 min/week (95 % CI =49.3 to 52.6, p < .0005) respectively.Conclusion: This workplace-based intervention substantially improved calcium intake and load-bearing moderate to vigorous physical activity 6 months after the intervention began.Trial Registration: Australia New Zealand Clinical Trial Registry ACTRN12616000079448 . Registered 25 January 2016 (retrospectively registered). [ABSTRACT FROM AUTHOR]

Background: It is currently unknown if school-based social norms interventions are effective in preventing harmful alcohol consumption and other drug use among adolescents in Denmark. This paper describes the social norms-based programme The GOOD life and the design of a cluster-randomized controlled trial to test its effectiveness.Methods/design: The intervention The GOOD life is composed of three social norms components representing three different communication channels, namely face-to-face communication (normative feedback session), print communication (posters) and interactive media (web application). The intervention period of 8 weeks is preceded and followed by data collection, with the follow-up taking place 3 months after baseline. Public schools in the Region of Southern Denmark with grades 8 and 9 are invited to participate in the study and participating schools are randomly allocated to either intervention or control schools. The aim is to recruit a total of 39 schools and a sample of 1.400 pupils for the trial. An online questionnaire is conducted to examine the use of alcohol, tobacco and marijuana as well as the perceived frequency of use among peers of their own grade, which is measured before and after the intervention. Baseline data is used to develop social norms messages which are included in the three intervention components. Primary outcomes are binge drinking (more than 5 units at one occasion) and perceived frequency of binge drinking among peers, while smoking, marijuana use and alcohol-related harm will be assessed as secondary outcomes.Discussion: The GOOD life study will provide necessary insights on descriptive and injunctive norms regarding alcohol and other drug use among Danish adolescents. In addition, it will provide new knowledge and insight on the feasibility, implementation context and effectiveness of a newly developed social norms intervention in the Danish school context.Trial Registration: Date of registration: 17 February 2016 (retrospectively registered) at Current Controlled Trials with study ID ISRCTN27491960. [ABSTRACT FROM AUTHOR]

Background: Lifestyle interventions targeting physical activity, sedentary time and dietary behaviours have the potential to initiate and support behavioural change and result in public health gain. Although men have often been reluctant to engage in such lifestyle programs, many are at high risk of several chronic conditions. We have developed an evidence and theory-based, gender sensitised, health and lifestyle program (European Fans in Training (EuroFIT)), which is designed to attract men through the loyalty they feel to the football club they support. This paper describes the study protocol to evaluate the effectiveness and cost-effectiveness of the EuroFIT program in supporting men to improve their level of physical activity and reduce sedentary behaviour over 12 months.Methods: The EuroFIT study is a pragmatic, two-arm, randomised controlled trial conducted in 15 football clubs in the Netherlands, Norway, Portugal and the UK (England). One-thousand men, aged 30 to 65 years, with a self-reported Body Mass Index (BMI) ≥27 kg/m(2) will be recruited and individually randomised. The primary outcomes are objectively-assessed changes in total physical activity (steps per day) and total sedentary time (minutes per day) at 12 months after baseline assessment. Secondary outcomes are weight, BMI, waist circumference, resting systolic and diastolic blood pressure, cardio-metabolic blood biomarkers, food intake, self-reported physical activity and sedentary time, wellbeing, self-esteem, vitality and quality of life. Cost-effectiveness will be assessed and a process evaluation conducted. The EuroFIT program will be delivered over 12 weekly, 90-minute sessions that combine classroom discussion with graded physical activity in the setting of the football club. Classroom sessions provide participants with a toolbox of behaviour change techniques to initiate and sustain long-term lifestyle changes. The coaches will receive two days of training to enable them to create a positive social environment that supports men in engaging in sustained behaviour change.Discussion: The EuroFIT trial will provide evidence on the effectiveness and cost-effectiveness of the EuroFIT program delivered by football clubs to their male fans, and will offer insight into factors associated with success in making sustained changes to physical activity, sedentary behaviour, and secondary outcomes, such as diet.Trial Registration: Isrctn: 81935608 . Registered 16 June 2015. [ABSTRACT FROM AUTHOR]

Background: Process evaluation studies are recommended to improve our understanding of underlying mechanisms related to clinicians, patients, context and intervention delivery that may impact on trial or program results and on their potential transferability to practice. This paper aims to document the translation of a type-2 diabetes (T2D) prevention program into the routine context of several primary care centers, assessing process indicators related to clinician adoption, patient recruitment, exposure to the intervention components and baseline characteristics.Methods: An observational descriptive process evaluation study was conducted of the 2.5-year implementation of the Prevention of Diabetes in Euskadi cluster randomized trial in 14 primary care centers of the Basque Health Service (Osakidetza). The clinical intervention consisted of three components: (1) risk screening, (2) an educational intervention promoting healthy lifestyles, and (3) remote support (follow-up). A passive dissemination strategy of providing training and materials was used to translate the intervention into practice. All non-diabetic patients aged 45 to 70 years who were identified as being at high risk of developing T2D were eligible for study inclusion. The RE-AIM framework guided the process evaluation.Results: Overall, 31.4 % of family physicians and 57.6 % of nurses participated in the study, while 4170 out of 67,293 (6.2 %) targeted patients who attended the centers during the implementation period were reached through the screening. Around half of the screened patients were identified as being at high risk of developing T2D (FINDRISC score ≥14). The rate of refusal to participate and the proportion of women were higher in the intervention group. Finally, 634 and 454 non-diabetic 45- to 70-year-old patients who were at high risk of T2D were included in the control and intervention group centers (intervention reach = 48 %). Significant variability in most process indicators was observed at center level.Conclusion: The passive dissemination strategy has produced modest process indicators related to the adoption, reach and implementation of the intervention program, and reduced the possibility of its standardized application in heterogeneous contexts. The resulting different procedures and strategies used by the centers were associated with process outcomes. Context-specific variability and possible confounding will require rigorous procedures for analysis of the intervention effects.Trial Registration: The trial was registered in ClinicalTrials.gov (identifier: NCT01365013 ). Registered on June 2011. [ABSTRACT FROM AUTHOR]

Background: The Medical Research Council (MRC) Framework for complex interventions highlights the need to explore interactions between components of complex interventions, but this has not yet been fully explored within complex, non-pharmacological interventions. This paper draws on the process evaluation data of a suicide prevention programme implemented in four European countries to illustrate the synergistic interactions between intervention levels in a complex programme, and to present our method for exploring these.Methods: A realist evaluation approach informed the process evaluation, which drew on mixed methods, longitudinal case studies. Data collection consisted of 47 semi-structured interviews, 12 focus groups, one workshop, fieldnoted observations of six programme meetings and 20 questionnaires (delivered at six month intervals to each of the four intervention sites). Analysis drew on the framework approach, facilitated by the use of QSR NVivo (v10). Our qualitative approach to exploring synergistic interactions (QuaSIC) also developed a matrix of hypothesised synergies that were explored within one workshop and two waves of data collection.Results: All four implementation countries provided examples of synergistic interactions that added value beyond the sum of individual intervention levels or components in isolation. For instance, the launch ceremony of the public health campaign (a level 3 intervention) in Ireland had an impact on the community-based professional training, increasing uptake and visibility of training for journalists in particular. In turn, this led to increased media reporting of OSPI activities (monitored as part of the public health campaign) and also led to wider dissemination of editorial guidelines for responsible reporting of suicidal acts. Analysis of the total process evaluation dataset also revealed the new phenomenon of the OSPI programme acting as a catalyst for externally generated (and funded) activity that shared the goals of suicide prevention.Conclusions: The QuaSIC approach enabled us to develop and refine our definition of synergistic interactions and add the innovative concept of catalytic effects. This represents a novel approach to the evaluation of complex interventions. By exploring synergies and catalytic interactions related to a complex intervention or programme, we reveal the added value to planned activities and how they might be maximised. [ABSTRACT FROM AUTHOR]

Background: China has the biggest population in the world, and has been experiencing the largest migration in history, and its rapid urbanization has profound and lasting impacts on local and national public health. Under these conditions, a systems understanding on the correlation among urbanization, environmental change and public health and to devise solutions at national, local and individual levels are in urgent need.Methods: In this paper, we provide a comprehensive review of recent studies which have examined the relationship between urbanization, urban environmental changes and human health in China. Based on the review, coupled with a systems understanding, we summarize the challenges and opportunities for promoting the health and wellbeing of the whole nation at national, local, and individual levels.Results: Urbanization and urban expansion result in urban environmental changes, as well as residents' lifestyle change, which can lead independently and synergistically to human health problems. China has undergone an epidemiological transition, shifting from infectious to chronic diseases in a much shorter time frame than many other countries. Environmental risk factors, particularly air and water pollution, are a major contributing source of morbidity and mortality in China. Furthermore, aging population, food support system, and disparity of public service between the migrant worker and local residents are important contributions to China's urban health.Conclusions: At the national level, the central government could improve current environmental policies, food safety laws, and make adjustments to the health care system and to demographic policy. At the local level, local government could incorporate healthy life considerations in urban planning procedures, make improvements to the local food supply, and enforce environmental monitoring and management. At the individual level, urban residents can be exposed to education regarding health behaviour choices while being encouraged to take responsibility for their health and to participate in environmental monitoring and management. [ABSTRACT FROM AUTHOR]

Background: Health system guidance (HSG) provides recommendations aimed to address health system challenges. However, there is a paucity of methods to direct, appraise, and report HSG. Earlier research identified 30 candidate criteria (concepts) that can be used to evaluate the quality of HSG and guide development and reporting requirements. The objective of this paper was to describe two studies aimed at evaluating the importance of these 30 criteria, design a draft HSG appraisal tool, and test its usability.Methods: This study involved a two-step survey process. In step 1, respondents rated the 30 concepts for appropriateness to, relevance to, and priority for health system decisions and HSG. This led to a draft tool. In step 2, respondents reviewed HSG documents, appraised them using the tool, and answered a series of questions. Descriptive analyses were computed.Results: Fifty participants were invited in step 1, and we had a response rate of 82 %. The mean response rates for each concept within each survey question were universally favorable. There was also an overall agreement about the need for a high-quality tool to systematically direct the development, appraisal, and reporting of HSG. Qualitative feedback and a consensus process by the team led to refinements to some of the concepts and the creation of a beta (draft) version of the HSG tool. In step 2, 35 participants were invited and we had a response rate of 74 %. Exploratory analyses showed that the quality of the HSGs reviewed varied as a function of the HSG item and the specific document assessed. A favorable consensus was reached with participants agreeing that the HSG items were easy to understand and easy to apply. Moreover, the overall agreement was high for the usability of the tool to systematically direct the development (85 %), appraisal (92 %), and reporting (81 %) of HSG. From this process, version 1.0 of the HSG appraisal tool was generated complete with 32 items (and their descriptions) and 4 domains.Conclusions: The final tool, named the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS) (version 1), defines expectations of HSG and facilitates informed decisions among policymakers on health system delivery, financial, and governance arrangements. [ABSTRACT FROM AUTHOR]

Background: Interventions on adolescents' lifestyle are important, but the main mechanisms that explain the changes (mediating variables) on lifestyle are unclear. This paper presents the rationale and methods of an intervention program focused on promoting active and healthy lifestyles (especially physical activity [PA] practice and reducing screen time) among Brazilian students-the Fortaleça sua Saúde program (Portuguese for "strengthen your health").Methods/design: This is a school-based cluster-randomized controlled trial. Three intervention and three control (no intervention) full-time public schools were randomly selected in Fortaleza, northeastern Brazil. Students (n = 1,272) from classes in Grades 7-9 were eligible, and 1,085 (548 in the intervention and 537 in control schools) completed the baseline and follow-up measures. The program duration was approximately four months and took place in 2014. Intervention strategies focused on teacher training, activities on health in the curriculum, active opportunities in the school environment (the availability of equipment for PA), and health education (health materials for students and parents). Data collection was undertaken before and immediately after the intervention. The primary variables included the practice of PA (weekly PA volume, PA behavior change stage and preference for PA during leisure-time) and screen time (TV and computer/video games). Potential intrapersonal, interpersonal and environmental mediators of PA and screen time were evaluated by a standardized questionnaire. Other lifestyle components (e.g., eating habits, substance use), psychological (e.g., self-rated health, body satisfaction) and biological (general and abdominal obesity) aspects, as well as academic performance were also evaluated in the total sample. Depressive symptoms, eating disorders, sleep quality, objectively-measured PA, and sedentary time were evaluated in obese students.Discussion: If effective, this program will contribute to the development of public policies for the promotion of active and healthy lifestyles in youth, especially those from low- and middle-income countries. The main intrapersonal, interpersonal and/or environmental mediators of PA and screen time may also be indicated. Finally, we anticipate that the proposed strategies may be adaptable to public schools and may even be extended to the entire school system.Trial Registration: ClinicalTrials.Gov: NCT02439827 . Registration date: May 3, 2015. [ABSTRACT FROM AUTHOR]

Background: With regard to the global childhood obesity epidemic, it is imperative that effective lifestyle interventions are devised to combat childhood obesity. This paper describes the development and implementation of a comprehensive (a combination of diet and physical activity (PA)), social cognitive behaviour modification intervention using accelerometry and a dietary diary to tackle child overweight and obesity. The comprehensive intervention effect was evaluated in a comparison with diet only, PA only and a no-treatment control group.Methods: A pilot study was conducted with a non-randomized cluster design. Four hundred thirty-eight overweight and obese children aged 7-12 years from ten primary schools in Beijing were recruited to receive a one-year intervention. Participants were allocated into one of four groups: the comprehensive intervention group; the PA only group (Happy 10 program); the diet only group (nutrition education program); and a control group. The effects of intervention on adiposity, blood pressure, and biochemical indicators were assessed by examining 2-way interactions (time × intervention) in linear mixed models. Means and 95 % confidence intervals (CI) for the adjusted changes between post-intervention and baseline relative to changes in the control group were calculated and reported as effect sizes.Results: The percentage of body fat in the comprehensive intervention group showed a significant relative decrease (adjusted change: -1.01 %, 95 % CI: (-1.81, -0.20) %) compared with the PA only, diet only or control groups (P < 0.001). Systolic blood pressure significantly decreased in the comprehensive intervention group (adjusted change: -4.37 mmHg, 95 % CI: (-8.42, -0.33) mmHg), as did diastolic blood pressure (adjusted change: -5.50 mmHg, 95 % CI (-8.81, -2.19) mmHg) (P < 0.05). Compared with the other two intervention groups and the control group, positive adjusted changes in fasting glucose in the comprehensive group were found, although not for the biochemical lipid metabolism indicators. Positive but non-significant adjusted changes in body mass index and waist circumference were observed.Conclusions: Compared with the diet or PA only intervention groups, the current comprehensive program had superior positive effects on body fat percentage and blood pressure but not on the biochemical lipid metabolism indicators in Chinese overweight and obese children. Future randomized controlled trials and long-term follow-up studies are required to elaborate the findings of the current intervention.Trial Registration: ClinicalTrials.gov identifier: NCT02228434. [ABSTRACT FROM AUTHOR]

Background: Active for Life Year 5 (AFLY5) is an educational programme for Year 5 children (aged 9-10) designed to increase children's physical activity, decrease sedentary behaviour and increase fruit and vegetable intake. This paper reports findings from a process evaluation embedded within a randomised controlled trial evaluating the programme's effectiveness. It considers the fidelity of implementation of AFLY5 with a focus on three research questions: 1. To what extent was the intervention delivered as planned? 2. In what ways, if any, did the teachers amend the programme? and 3. What were the reasons for any amendments? Methods: Mixed methods were used including data collection via observation of the intervention delivery, questionnaire, teacher's intervention delivery log and semi-structured interviews with teachers and parents. Qualitative data were analysed thematically and quantitative data were summarised using descriptive statistics. Results: Following training, 42 of the 43 intervention school teachers/teaching staff (98 %) were confident they could deliver the nutrition and physical activity lessons according to plan. The mean number of lessons taught was 12.3 (s.d. 3.7), equating to 77 % of the intervention. Reach was high with 95 % of children in intervention schools receiving lessons. A mean of 6.2 (s.d. 2.6) out of 10 homeworks were delivered. Median lesson preparation time was 10 min (IQR 10-20) and 28 % of lessons were reported as having been amended. Qualitative findings revealed that those who amended the lessons did so to differentiate for student ability, update them for use with new technologies and to enhance teacher and student engagement. Teachers endorsed the aims of the intervention, but some were frustrated with having to adapt the lesson materials. Teachers also a reported tendency to delegate the physical activity lessons to other staff not trained in the intervention. Conclusions: Fidelity of intervention implementation was good but teachers' enthusiasm for the AFLY5 programme was mixed despite them believing that the messages behind the lessons were important. This may have meant that the intervention messages were not delivered as anticipated and explain why the intervention was found not to be effective. Trial registration: ISRCTN50133740. [ABSTRACT FROM AUTHOR]

Background: The promotion of health equity, the absence of avoidable and unfair differences in health outcomes, is a global imperative. Systematic reviews are an important source of evidence for health decision-makers, but have been found to lack assessments of the intervention effects on health equity. The Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) is a 27 item checklist intended to improve transparency and reporting of systematic reviews. We developed an equity extension for PRISMA (PRISMA-E 2012) to help systematic reviewers identify, extract, and synthesise evidence on equity in systematic reviews. Methods and findings: In this explanation and elaboration paper we provide the rationale for each extension item. These items are additions or modifications to the existing PRISMA Statement items, in order to incorporate a focus on equity. An example of good reporting is provided for each item as well as the original PRISMA item. Conclusions: This explanation and elaboration document is intended to accompany the PRISMA-E 2012 Statement and the PRISMA Statement to improve understanding of the reporting guideline for users. The PRISMA-E 2012 reporting guideline is intended to improve transparency and completeness of reporting of equity-focused systematic reviews. Improved reporting can lead to better judgement of applicability by policy makers which may result in more appropriate policies and programs and may contribute to reductions in health inequities. To encourage wide dissemination of this article it is accessible on the International Journal for Equity in Health, Journal of Clinical Epidemiology, and Journal of Development Effectiveness web sites. [ABSTRACT FROM AUTHOR]

Background: The teenage birth rate in the USA has considerably decreased in recent decades; however, more innovative, collaborative approaches are needed to promote adolescent health and prevent teenage pregnancy at the community level. Despite literature on the promising results of the collective impact (CI) model for health promotion, there is limited literature on the model's ability to reduce teenage pregnancies in a community. The Central Oklahoma Teen Pregnancy Prevention Collaboration is applying the CI model to foster collaboration among multiple stakeholders with the goal of increasing community and organizational capacity to improve adolescent health outcomes. This paper reports the findings from the initiative's implementation evaluation, which sought to understand whether the CI model improved collaboration among organizations and understand barriers and facilitators that affected program delivery.Methods: Program implementers and evaluators jointly developed research questions to guide the intervention and evaluation design. The Consolidated Framework for Implementation Research (CFIR) was used to assess program components including the intervention characteristics, organization setting, community setting, facilitator characteristics, and the process of implementation. Primary sources of data included performance measures, meeting observations (n = 11), and semi-structured interviews (n = 10). The data was thematically analyzed using CFIR constructs, community capacity domains, and the five constructs of CI.Results: Key findings include the need for shortened meeting times for meaningful engagement, opportunities for organizations to take on more active roles in the Collaboration, and enhanced community context expertise (i.e., those with lived experience) in all Collaboration initiatives. We identified additional elements to the core constructs of CI that are necessary for successful implementation: distinct role identification for partner organizations and incorporation of equity and inclusivity into collaboration processes and procedures.Conclusions: Results from this implementation evaluation provide valuable insights into implementation fidelity, participant experience, and implementation reach of an innovative, systems-level program. Findings demonstrate the context and requirements needed to successfully implement this innovative program approach and CI overall. Additional core elements for CI are identified and contribute to the growing body of literature on successful CI initiatives. [ABSTRACT FROM AUTHOR]

Background: This paper examines the opportunity and need for lifestyle interventions for patients attending generalist community nursing services in Australia. This will help determine the scope for risk factor management within community health care by generalist community nurses (GCNs). Methods: This was a quasi-experimental study conducted in four generalist community nursing services in NSW, Australia. Prior to service contacts, clients were offered a computer-assisted telephone interview to collect baseline data on socio-demographics, health conditions, smoking status, physical activity levels, alcohol consumption, height and weight, fruit and vegetable intake and ‘readiness-to-change’ for lifestyle risk factors. Results: 804 clients participated (a response rate of 34.1%). Participants had higher rates of obesity (40.5% vs 32.1%) and higher prevalence of multiple risk factors (40.4% vs 29.5%) than in the general population. Few with a SNAPW (Smoking-Nutrition-Alcohol-Physical-Activity-Weight) risk factor had received advice or referral in the previous 3 months. The proportion of clients identified as at risk and who were open to change (i.e. contemplative, in preparation or in action phase) were 65.0% for obese/overweight; 73.8% for smokers; 48.2% for individuals with high alcohol intake; 83.5% for the physically inactive and 59.0% for those with poor nutrition. Conclusions: There was high prevalence of lifestyle risk factors. Although most were ready to change, few clients recalled having received any recent lifestyle advice. This suggests that there is considerable scope for intervention by GCNs. The results of this trial will shed light on how best to implement the lifestyle risk factor management in routine practice. [ABSTRACT FROM AUTHOR]

Background: Childhood obesity is a global health concern. Early intervention to help parents adopt best practice for infant feeding and physical activity is critical for maintaining healthy weight. Australian governments provide universal free primary healthcare from child and family health nurses (CFHNs) to support families with children aged up to five years and to provide evidence-based advice to parents. This paper aims to examine factors influencing the child obesity prevention practices of CFHNs and to identify opportunities to support them in promoting healthy infant growth. Methods: This mixed methods study used a survey (n = 90) and semi-structured interviews (n = 20) with CFHNs working in two local health districts in Sydney, Australia. Survey data were analysed descriptively; interview transcripts were coded and analysed iteratively. Survey and interview questions examined how CFHNs addressed healthy infant feeding practices, healthy eating, active play and limiting sedentary behaviour during routine consultations; factors influencing such practices; and how CFHNs could be best supported. Results: CFHNs frequently advised parents on breastfeeding, introducing solid foods, and techniques for settling infants. They spent less time providing advice on evidence-based formula feeding practices or encouraging physical activity in young children. Although nurses frequently weighed and measured children, they did not always use growth charts to identify those at risk of becoming overweight or obese. Nurses identified several barriers to promoting healthy weight gain in infants and young children, including limited parental recognition of overweight in their children or motivation to change diet or lifestyle; socioeconomic factors (such as the cost of healthy food); and beliefs and attitudes about infant weight and the importance of breastfeeding and physical activity amongst parents and family members. Conclusions: CFHNs require further education and support for their role in promoting optimal child growth and development, especially training in behaviour change techniques to increase parents' understanding of healthy infant weight gain. Parent information resources should be accessible and address cultural diversity. Resources should highlight the health effects of childhood overweight and obesity and emphasise the benefits of breastfeeding, appropriate formula feeding, suitable first foods, responsiveness to infant feeding cues, active play and limiting screen time. [ABSTRACT FROM AUTHOR]

Background: Self-care practice within the palliative care workforce is often discussed, yet seemingly under-researched. While palliative care professionals are required to implement and maintain effective self-care strategies, there appears little evidence to guide them. Moreover, there is an apparent need to clarify the meaning of self-care in palliative care practice. This paper reports qualitative findings within the context of a broader mixed-methods study. The aim of the present study was to explore the meaning and practice of self-care as described by palliative care nurses and doctors. Methods: A purposive sample of 24 palliative care nurses and doctors across Australia participated in semi-structured, in-depth interviews. Interviews were digitally recorded and transcribed prior to inductive qualitative content analysis, supported by QSR NVivo data management software. Results: Three overarching themes emerged from the analysis: (1) A proactive and holistic approach to promoting personal health and wellbeing to support professional care of others; (2) Personalised self-care strategies within professional and non-professional contexts; and (3) Barriers and enablers to self-care practice. Conclusions: The findings of this study provide a detailed account of the context and complexity of effective self-care practice previously lacking in the literature. Self-care is a proactive, holistic, and personalised approach to the promotion of health and wellbeing through a variety of strategies, in both personal and professional settings, to enhance capacity for compassionate care of patients and their families. This research adds an important qualitative perspective and serves to advance knowledge of both the context and effective practice of self-care in the palliative care workforce. [ABSTRACT FROM AUTHOR]

Background: In the light of demographic developments health promotion interventions for older people are gaining importance. In addition to methodological challenges arising from the economic evaluation of health promotion interventions in general, there are specific methodological problems for the particular target group of older people. There are especially four main methodological challenges that are discussed in the literature. They concern measurement and valuation of informal caregiving, accounting for productivity costs, effects of unrelated cost in added life years and the inclusion of 'beyond-health' benefits. This paper focuses on the question whether and to what extent specific methodological requirements are actually met in applied health economic evaluations. Methods: Following a systematic review of pertinent health economic evaluations, the included studies are analysed on the basis of four assessment criteria that are derived from methodological debates on the economic evaluation of health promotion interventions in general and economic evaluations targeting older people in particular. Results: Of the 37 studies included in the systematic review, only very few include cost and outcome categories discussed as being of specific relevance to the assessment of health promotion interventions for older people. The few studies that consider these aspects use very heterogeneous methods, thus there is no common methodological standard. Conclusion: There is a strong need for the development of guidelines to achieve better comparability and to include cost categories and outcomes that are relevant for older people. Disregarding these methodological obstacles could implicitly lead to discrimination against the elderly in terms of health promotion and disease prevention and, hence, an age-based rationing of public health care. [ABSTRACT FROM AUTHOR]

Background: PEACH™QLD translated the PEACH™ Program, designed to manage overweight/obesity in primary school-aged children, from efficacious RCT and small scale community trial to a larger state-wide program. This paper describes the lessons learnt when upscaling to universal health coverage.Methods: The 6-month, family-focussed program was delivered in Queensland, Australia from 2013 to 2016. Its implementation was planned by researchers who developed the program and conducted the RCT, and experienced project managers and practitioners across the health continuum. The intervention targeted parents as the agents of change and was delivered via parent-only group sessions. Concurrently, children attended fun, non-competitive activity sessions. Sessions were delivered by facilitators who received standardised training and were employed by a range of service providers. Participants were referred by health professionals or self-referred in response to extensive promotion and marketing. A pilot phase and a quality improvement framework were planned to respond to emerging challenges.Results: Implementation challenges included engagement of the health system; participant recruitment; and engagement. A total of 1513 children (1216 families) enrolled, with 1122 children (919 families) in the face-to-face program (105 groups in 50 unique venues) and 391 children (297 families) in PEACH™ Online. Self-referral generated 68% of enrolments. Unexpected, concurrent and, far-reaching public health system changes contributed to poor program uptake by the sector (only 56 [53%] groups delivered by publicly-funded health organisations) requiring substantial modification of the original implementation plan. Process evaluation during the pilot phase and an ongoing quality improvement framework informed program adaptations that included changing from fortnightly to weekly sessions aligned with school terms, revision of parent materials, modification of eligibility criteria to include healthy weight children and provision of services privately. Comparisons between pilot versus state-wide waves showed comparable prevalence of families not attending any sessions (25% vs 28%) but improved number of sessions attended (median = 5 vs 7) and completion rates (43% vs 56%).Conclusions: Translating programs developed in the research context to enable implementation at scale is complex and presents substantial challenges. Planning must ensure there is flexibility to accommodate and proactively manage the system changes that are inevitable over time.Trial Registration: ACTRN12617000315314 . This trial was registered retrospectively on 28 February, 2017. [ABSTRACT FROM AUTHOR]

Background: January 2016 saw the publication of proposed revisions to the UK's lower risk drinking guidelines but no sustained promotional activity. This paper aims to explore the impact of publishing guidelines without sustained promotional activity on reported guideline exposure and determinants of behaviour (capability, opportunity and motivation) proposed by the COM-B model.Methods: Data were collected by a monthly repeat cross-sectional survey of adults (18+) resident in England over 15 months between November 2015 and January 2017 from a total of 16,779 drinkers, as part of the Alcohol Toolkit Study. Trends and associated 95% confidence intervals were described in the proportion of reported exposure to guidelines in the past month and measures of the capability, opportunity and motivation to consume alcohol within drinking guidelines.Results: There was a rise in reported exposure to drinking guidelines in January 2016 (57.6-80.6%) which did not reoccur in January 2017. Following the increase in January 2016, reported exposure reduced slowly but remained significantly higher than in December 2015. In February 2016, there was an increase in measures of capability (31.1% reported tracking units of alcohol consumption and 87.8% considered it easier to drink safely) and opportunity (84.0% perceived their lifestyle as conducive to drinking within guidelines). This change was not maintained in subsequent months. Other measures showed marginal changes between January and February 2016 with no evidence of change in subsequent months.Conclusions: Following the publication of revised drinking guideline in January 2016, there was a transient increase in exposure to guidelines, and capability and opportunity to drink within the guidelines that diminished over time. The transience and size of the changes indicate that behaviour change is unlikely. Well-designed, theory-based promotional campaigns may be required for drinking guidelines to be an effective public health intervention. [ABSTRACT FROM AUTHOR]

Background: In 2009, after many delays and changes, India introduced a single pictorial health warning label (HWL) on smokeless tobacco (SLT) packing-a symbolic image of a scorpion covering 40% of the front surface. In 2011, the scorpion was replaced with 4 graphic images. This paper tested the effectiveness of SLT HWLs in India and whether the 2011 change from symbolic to graphic images increased their effectiveness.Methods: Data were from a cohort of 4733 adult SLT users (age15+) of the Tobacco Control Project (TCP) India Survey from 4 states. The surveys included key indicators of health warning effectiveness, including warning salience, and cognitive, emotional, and behavioral responses to the warnings.Results: The HWL change from symbolic to graphic did not result in significant increases on any of the HWL outcome indicators. A substantial minority of SLT users were unaware that SLT packages contained HWLs (27% at both waves). Noticing the warnings was also remarkably low at both waves (W1 = 34.3%, W2 = 28.1%). These effects carried over to the cognitive and behavioural measures, where among those who noticed HWLs, about one-third reported forgoing SLT at least once because of the HWLs, and fewer than 20% reported that HWLs made them think about SLT risks or about quitting SLT. Even fewer reported avoiding HWLs (8.1 to 11.6%). Among those who quit using SLT by post-policy, awareness that SLT packaging contained HWLs was significantly greater at post-policy (86.8%) compared to pre-policy (77.8%, p = 0.02). Quitters were also significantly more aware of the post-policy HWLs compared to those who continued to use SLT (p < 0.001).Conclusions: Health warnings on SLT packages in India are low in effectiveness, and the change from the symbolic warning (pre-policy) to graphic HWLs (post-policy) did not lead to significant increases of effectiveness on any of the HWL indicators among those who continued to use SLT products, thus suggesting that changing an image alone is not enough to have an impact. There is a critical need to implement SLT HWLs in India that are more salient (large in size and on the front and back of the package) and impactful, which following from studies of HWLs on cigarette packaging, would have strong potential to increase awareness of the harms of SLT and to motivate quitting. [ABSTRACT FROM AUTHOR]