Understanding for whom, under what conditions and how smoking cessation services for pregnant women in the United Kingdom work-a rapid realist review.

BACKGROUND: Maternal smoking in pregnancy is associated with several adverse maternal and infant health outcomes including increased risk of miscarriage, stillbirth, low birth weight, preterm birth, and asthma. Progress to reduce rates of smoking at time of delivery in England have been slow and over the last decade, less than half of pregnant women who accessed services went onto report having quit. This realist review was undertaken to improve the understanding of how smoking cessation services in pregnancy work and to understand the heterogeneity of outcomes observed. METHODS: The initial programme theory was developed using the National Centre for Smoking Cession and Training Standard Treatment Programme for Pregnant Women and the National Institute for Health and Care Excellence guidance on treating tobacco dependency. A search strategy and inclusion criteria were developed. Four databases were searched to identify published papers and four websites were hand searched to identify any unpublished literature that could contribute to theory building. Realist logic was applied to the analysis of papers to identify the contexts in which the intended behaviour change mechanism(s) were triggered, or not, and towards what outcomes to develop context mechanism outcome configurations. RESULTS: The review included 33 papers. The analysis produced 19 context mechanism outcome configurations structured under five closely interconnected domains (i) articulating harm, (ii) promoting support, (iii) managing cravings, (iv) maintaining commitment and (v) building self-efficacy. This review identifies two key processes involved in how services achieve their effects: how material resources are implemented and relationships. Of the two key processes identified, more existing literature was available evidencing how material resources are implemented. However, the review provides some evidence that non-judgemental and supportive relationships with healthcare workers where regular contact is provided can play an important role in interrupting the social cues and social practice of smoking, even where those around women continue to smoke. CONCLUSIONS: This review clarifies the range of interconnected and bi-directional relationships between services and the personal and social factors in women's lives. It underscores the importance of aligning efforts across the models five domains to strengthen services' ability to achieve smoking cessation.

A Qualitative Exploration of Patient and Staff Experiences of the Receipt and Delivery of Specialist Weight Management Services in the UK.

BACKGROUND: Addressing the increasing prevalence of obesity is a global public health priority. Severe obesity (body mass index > 40) reduces life expectancy, due to its association with people developing complications (e.g. diabetes, cancer, cardiovascular disease), and greatly impairs quality of life. The National Health Service (NHS) in the UK provides specialist weight management services (SWMS) for people with severe obesity, but key uncertainties remain around patient access to and engagement with weight management services, as well as pathways beyond the service. METHODS: In this multiple methods study, using online forum data and semi-structured interviews, stakeholders' experiences of delivering and receiving SWMS were explored. Using the web search engine Google with keywords and web address (URL) identifiers, relevant public online platforms were sourced with snowball sampling and search strings used to identify threads related to people's experiences of accessing SWMS (n = 57). Interviews were conducted with 24 participants (nine patients, 15 staff), and data from all sources were analysed thematically using the framework approach. RESULTS: Six themes related to access to and engagement with SWMS emerged during data analysis: (1) making the first move, (2) uncertainty and confusion, (3) resource issues, (4) respect and understanding, (5) mode of delivery, and (6) desire for ongoing support. CONCLUSION: There is a mixed and varied picture of SWMS provision across the UK. The service offered is based on local clinical decision making and available resources, resulting in a range of patient experiences and perspectives. Whilst service capacity issues and patient anxiety were seen as barriers to accessing care, peer support and positive clinical and group interactions (connectedness between individuals) were considered to increase engagement.

A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol.

BACKGROUND: Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist 'Tier 3' Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity. METHODS: This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted. DISCUSSION: This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients. TRIAL REGISTRATION: ISRCTN number 22088800.

Enablers and barriers English secondary schools face in promoting healthy diet and physical activity behaviours.

This study sought to understand the current challenges mainstream secondary schools in England face in creating a health promoting school culture for diet and physical activity behaviours. An in-depth qualitative case study of two purposely selected state-funded schools, including interviews with teachers, observations of school activities including meal breaks and a qualitative survey with parents was done. Inductive thematic analysis was used to explore emerging themes. Additional interviews with the leadership team from four further schools were used to develop and refine emerging themes. Four main themes emerged from the data: competing pressures, school environment, personnel and policy. Results demonstrate that schools recognize they have role to play in promoting healthy lifestyle behaviours to pupils; however, several significant barriers were identified such as lack of government support and regulation, school structures and organization, focus on core subjects, business-run canteens and lack of family and community engagement. Given the importance of maintaining a healthy weight throughout the life course, schools have an important role to play in creating healthy environments in which students can easily make a healthy choice. Future school promotion initiatives need to consider addressing the barriers that schools face by working with them and the communities in which they are embedded.

There has been little research done in secondary schools to understand how to promote healthy lifestyle behaviours to adolescents (secondary schools provide secondary education for students aged 11­18 years). COVID-19 has brought the importance of maintaining a healthy weight back into sharp focus and schools are an ideal setting to educate and support young people in making healthy diet and activity choices. This research sought to understand how important school staff thought creating a health-promoting culture in schools was, how they could create such a culture and what support they had or needed to do so. From interviews with school staff, observing school activities and a questionnaire to parents, we found that schools and parents believe that schools have a role to play in supporting healthy diet and physical activity behaviours although they identified many pressures that prevent making health promotion a priority; these include time and resources as well as a lack of government policy. The importance of having a head teacher with a belief in the benefits of a healthy lifestyle was recognized. The way secondary schools are structured in England makes a joined-up approach difficult and requires central planning and coordination. More support, including resources and policy commitments, are needed to support secondary schools to create a healthy school environment.

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation.

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.

Induction of protective immunity against Schistosoma mansoni via DNA priming and boosting with the large subunit of calpain (Sm-p80): adjuvant effects of granulocyte-macrophage colony-stimulating factor and interleukin-4.

Considerable morbidity and mortality result from schistosomiasis, an affliction affecting an estimated 200 million people. Although schistosomicidal drugs and other control measures (including public hygiene and snail control) exist, the advent of an efficacious vaccine remains the most potentially powerful means for controlling this disease. We have targeted a vaccine candidate (large subunit of calpain, Sm-p80) because of its consistent immunogenicity, protective potential, and integral role in surface membrane biogenesis of schistosomes. Since surface membrane renewal appears to be one of the major phenomena employed by schistosomes to evade the host's immune system; an immune response directed against Sm-p80 should render the parasite susceptible to immune clearance from the host by both providing a focus of attack and by potentially impairing the membrane repair process. In the present study, we have employed DNA immunization protocols using Sm-p80 with plasmids encoding granulocyte-macrophage colony-stimulating factor (GM-CSF) and interleukin-4 (IL-4). Sm-p80 by itself provided 39% protection (P = < or =0.0001) against challenge infection in C57BL/6 mice. This protection was increased to 44% (P = < or =0.0001) when the plasmid encoding GM-CSF was coadministered with Sm-p80 DNA. Coinjection of plasmid DNA encoding IL-4 with Sm-p80 DNA yielded a protection level of 42% (P = < or =0.0001). Statistically, the protection conferred by including GM-CSF, but not IL-4, was significantly greater than that when only Sm-p80 was used. Sm-p80 DNA by itself elicited strong responses that include IgG2A and IgG2B antibody isotypes. The introduction of GM-CSF DNA with Sm-p80 DNA led to distinct increases in total IgG and IgG1 titers, whereas the coadministration of IL-4 DNA with Sm-p80 DNA resulted in a slight elevation of IgG1 and IgG3 titers and in some reduction of IgG2A and IgG2B titers. Our data again indicate that Sm-p80 can be an excellent candidate for a schistosomiasis vaccine.