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Abstract Background The path of a complaint and patient satisfaction with complaint resolution is often dependent on the responses of healthcare professionals (HCPs). It is therefore important to understand the influences shaping HCP behaviour. This systematic review aimed to (1) identify the key actors, behaviours and factors influencing HCPs’ responses to complaints, and (2) apply behavioural science frameworks to classify these influences and provide recommendations for more effective complaints handling behaviours. Methods A systematic literature review of UK published and unpublished (so-called grey literature) studies was conducted (PROSPERO registration: CRD42022301980). Five electronic databases [Scopus, MEDLINE/Ovid, Embase, Cumulated Index to Nursing and Allied Health Literature (CINAHL) and Health Management Information Consortium (HMIC)] were searched up to September 2021. Eligibility criteria included studies reporting primary data, conducted in secondary and tertiary care, written in English and published between 2001 and 2021 (studies from primary care, mental health, forensic, paediatric or dental care services were excluded). Extracted data included study characteristics, participant quotations from qualitative studies, results from questionnaire and survey studies, case studies reported in commentaries and descriptions, and summaries of results from reports. Data were synthesized narratively using inductive thematic analysis, followed by deductive mapping to the Theoretical Domains Framework (TDF). Results In all, 22 articles and three reports met the inclusion criteria. A total of 8 actors, 22 behaviours and 24 influences on behaviour were found. Key factors influencing effective handling of complaints included HCPs’ knowledge of procedures, communication skills and training, available time and resources, inherent contradictions within the role, role authority, HCPs’ beliefs about their ability to handle complaints, beliefs about the value of complaints, managerial and peer support and organizational culture and emotions. Themes mapped onto nine TDF domains: knowledge, skills, environmental context and resources, social/professional role and identity, social influences, beliefs about capability, intentions and beliefs about consequences and emotions. Recommendations were generated using the Behaviour Change Wheel approach. Conclusions Through the application of behavioural science, we identified a wide range of individual, social/organizational and environmental influences on complaints handling. Our behavioural analysis informed recommendations for future intervention strategies, with particular emphasis on reframing and building on the positive aspects of complaints as an underutilized source of feedback at an individual and organizational level.

Abstract Background Pregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives’ implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures. Methods GLOWING was a multi-centre parallel-group pilot cluster RCT comparing the delivery of a behaviour change intervention for midwives (delivered as training workshops) with usual practice. The clusters were four NHS Trusts in Northeast England, randomised to intervention or control arms. Blinding of allocation was not possible due to the nature of the intervention. We aimed to deliver the intervention to all eligible midwives in the intervention arm, in groups of 6 midwives per workshop, and to pilot questionnaire data collection for a future definitive trial. Intervention arm midwives’ acceptability of GLOWING content and delivery was assessed using a mixed methods questionnaire, and pregnant women’s acceptability of trial procedures by interviews. Quantitative data were analysed descriptively and qualitative data thematically. Results In intervention arm Trusts, 100% of eligible midwives (n = 67) were recruited to, and received, the intervention; however, not all workshops had the planned number of attendees (range 3–8). The consent rate amongst midwives randomised (n = 100) to complete questionnaires was 74% (n = 74) (95% CI 65%, 83%), and overall completion rate 89% (n = 66) (95% CI 82%, 96%). Follow-up response rate was 66% (n = 49) (95% CI 55%, 77%), with a marked difference between intervention (39%, n = 15) and control (94%, n = 34) groups potentially due to the volume of research activities. Overall, 64% (n = 47) (95% CI 53%, 75%) completed both baseline and follow-up questionnaires. Midwives viewed the intervention as acceptable and directly relevant to routine practice. The least popular components related to scripted role-plays. Pregnant women viewed the recruitment and trial processes to be acceptable. Conclusions This rigorously conducted pilot study demonstrated feasibility intervention delivery and a high level of acceptability amongst participants. It has provided information required to refine the intervention and trial protocol, enhancing confidence that a definitive trial could be carried out. Trial registration ISRCTN46869894; retrospectively registered 25th May 2016, www.isrctn.com/ISRCTN46869894 .

Background: UK local authority public health teams (LAPHT) supported delivery of the Covid-19 vaccination programme, particularly to disadvantaged populations. We explored the challenges encountered and lessons learnt by LAPHTs in tackling low Covid-19 vaccine uptake. The aim of this study was to understand what works, and how, in addressing local inequalities in relation to uptake of the Covid-19 vaccination with a view to generalising insights to building back fairer after the pandemic and into the future. Study design: Qualitative. Method: We conducted in-depth on-line interviews with Directors of Public Health or their representatives from 21 English local authorities covering a total population of over 8 million people. Data were analysed thematically. Results: Accessing the requisite (and accurate) data, engaging with communities, and working with National Health Service (NHS) organisations presented challenges in delivering initiatives to improve vaccine uptake, particularly for disadvantaged groups. LAPHT's assets beneficial to the programme - in-depth knowledge and experience of their communities and locality - were not considered in the national vaccination programme. Community engagement and relationships with local NHS featured heavily in the majority of LAPHTs responses to improving vaccine uptake rates. Conclusions: Incorporating local public health infrastructure, expertise and existing relationships into national vaccination planning during epidemics or pandemics is crucial. Community engagement and good relationships with NHS staff help to reach and serve disadvantaged populations. How these can be developed and maintained in the longer term without future investment was a concern. Future research should explore the design and implementation of PH and NHS joint service delivery models to tackle health inequalities, informed by experiences of the Covid-19 vaccination programme and with input from community partners.

Abstract During the COVID-19 pandemic, lateral flow tests (LFTs) were used to regulate access to work, education, social activities, and travel. However, falsification of home LFT results was a concern. Falsification of test results during an ongoing pandemic is a sensitive issue. Consequently, respondents may not answer truthfully to questions about LFT falsification behaviours (FBs) when asked directly. Indirect questioning techniques such as the Extended Crosswise model (ECWM) can provide more reliable prevalence estimates of sensitive behaviors than direct questioning. Here we report the prevalence of LFT FBs in a representative sample in England (n = 1577) using direct questioning (DQ) and the ECWM. We examine the role of demographic and psychological variables as predictors of LFT FBs. We show that the prevalence estimates of the FBs in the DQ condition were significantly lower than the ECWM estimates, e.g., reporting a negative result without conducting a test: 5.7% DQ vs 18.4% ECWM. Moral norms, subjective norms, anticipated regret, perception of risk to self, and trust in government predicted some of the FBs. Indirect questioning techniques can help provide more realistic and higher quality data about compliance with behavioural regulations to government and public health agencies.

Abstract Background The Identifying Child Anxiety Through Schools-identification to intervention (iCATS-i2i) trial is being conducted to establish whether ‘screening and intervention’, consisting of usual school practice plus a pathway comprising screening, feedback and a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety), bring clinical and health economic benefits compared to usual school practice and assessment only — ‘usual school practice’, for children aged 8–9 years in the following: (1) the ‘target population’, who initially screen positive for anxiety problems according to a two-item parent-report child anxiety questionnaire — iCATS-2, and (2) the ‘total population’, comprising all children in participating classes. This article describes the detailed statistical analysis plan for the trial. Methods and design iCATS-i2i is a definitive, superiority, pragmatic, school-based cluster randomised controlled trial (with internal pilot), with two parallel groups. Schools are randomised 1:1 to receive either screening and intervention or usual school practice. This article describes the following: trial objectives and outcomes; statistical analysis principles, including detailed estimand information necessary for aligning trial objectives, conduct, analyses and interpretation when there are different analysis populations and outcome measures to be considered; and planned main analyses, sensitivity and additional analyses. Trial registration ClinicalTrials.gov ISRCTN76119074. Registered on 4 January 2022

Abstract Purpose Preventing weight regain can only be achieved by sustained changes in energy balance-related behaviors that are associated with weight, such as diet and physical activity. Changes in motivation and self-regulatory skills can support long-term behavioral changes in the context of weight loss maintenance. We propose that experiencing a supportive climate care is associated with enhanced satisfaction of basic psychological needs, intrinsic goals, and autonomous motivation. These factors are expected to be associate with the utilization of self-regulation skills, leading to more sustained behavior changes and ultimately preventing weight regain. This hypothesis was tested in this ancillary analysis of the NoHoW trial, where the study arms were pooled and followed for 12 months. Methods The NoHoW was a three-center, large-scale weight regain prevention full factorial trial. In this longitudinal study, data were collected in adults who lost > 5% weight in the past year (N = 870, complete data only, 68.7% female, 44.10 ± 11.86 years, 84.47 ± 17.03 kg) during their participation in a 12-month digital behavior change intervention. Weight and validated measures of motivational- and self-regulatory skills-related variables were collected at baseline, six- and 12 months. Change variables were used in Mplus’ path analytical models informed by NoHoW’s logic model. Results The bivariate correlations confirmed key mediators’ potential effect on weight outcomes in the expected causal direction. The primary analysis showed that a quarter of the variance (r2 = 23.5%) of weight regain prevention was achieved via the mechanisms of action predicted in the logic model. Specifically, our results show that supportive climate care is associated with needs satisfaction and intrinsic goal content leading to better weight regain prevention via improvements in self-regulatory skills and exercise-controlled motivation. The secondary analysis showed that more mechanisms of action are significant in participants who regained or maintained their weight. Conclusions These results contribute to a better understanding of the mechanisms of action leading to behavior change in weight regain prevention. The most successful participants used only a few intrinsic motivation-related mechanisms of action, suggesting that habits may have been learned. While developing a digital behavior change intervention, researchers and practitioners should consider creating supportive climate care to improve needs satisfaction and intrinsic goal contents. Trial registration ISRCTN, ISRCTN88405328 , registered 12/22/2016.

Abstract Background Systematically screening for child anxiety problems, and offering and delivering a brief, evidence-based intervention for children who are identified as likely to benefit would minimise common barriers that families experience in accessing treatment. We have developed a short parent-report child anxiety screening questionnaire, and procedures for administering screening questionnaires, sharing screening outcomes with families, and offering and delivering a brief parent-led online intervention (OSI: Online Support and Intervention for child anxiety) through schools. This trial aims to evaluate clinical and health economic outcomes for (1) children (aged 8–9) who screen positive for anxiety problems at baseline (target population) and (2) the wider population of all children in participating classes (total population) in schools randomly allocated to receive identification-to-intervention procedures and usual school practice (‘screening and intervention’), compared to assessment and usual school practice only (‘usual school practice’). Methods The trial design is a parallel-group, superiority cluster randomised controlled trial, with schools (clusters) randomised to ‘screening and intervention’ or ‘usual school practice’ arms in a 1:1 ratio stratified according to the level of deprivation within the school. We will recruit schools and participants in two phases (a pilot phase (Phase 1) and Phase 2), with progression criteria assessed prior to progressing to Phase 2. In total, the trial will recruit 80 primary/junior schools in England, and 398 children (199 per arm) who screen positive for anxiety problems at baseline (target population). In schools allocated to ‘screening and intervention’: (1) parents/carers will complete a brief parent-report child anxiety screening questionnaire (at baseline) and receive feedback on their child’s screening outcomes (after randomisation), (2) classes will receive a lesson on managing fears and worries and staff will be provided with information about the intervention and (3) parents/carers of children who screen positive for anxiety problems (target population) will be offered OSI. OSI will also be available for any other parents/carers of children in participating classes (total population) who request it. We will collect child-, parent- and teacher-report measures for the target population and total population at baseline (before randomisation), 4 months, 12 months and 24 months post-randomisation. The primary outcome will be the proportion of children who screen positive for anxiety problems at baseline (target population) who screen negative for anxiety problems 12 months post-randomisation. Discussion This trial will establish if systematic screening for child anxiety problems, sharing screening outcomes with families and delivering a brief parent-led online intervention through schools is effective and cost-effective. Trial registration ISRCTN registry ISRCTN76119074. Prospectively registered on 4.1.2022.

IntroductionPlace-based public health evaluations are increasingly making use of natural experiments. This scoping review aimed to provide an overview of the design and use of natural experiment evaluations (NEEs), and an assessment of the plausibility of the as-if randomization assumption.MethodsA systematic search of three bibliographic databases (Pubmed, Web of Science and Ovid-Medline) was conducted in January 2020 to capture publications that reported a natural experiment of a place-based public health intervention or outcome. For each, study design elements were extracted. An additional evaluation of as-if randomization was conducted by 12 of this paper's authors who evaluated the same set of 20 randomly selected studies and assessed ‘as-if ' randomization for each.Results366 NEE studies of place-based public health interventions were identified. The most commonly used NEE approach was a Difference-in-Differences study design (25%), followed by before-after studies (23%) and regression analysis studies. 42% of NEEs had likely or probable as-if randomization of exposure (the intervention), while for 25% this was implausible. An inter-rater agreement exercise indicated poor reliability of as-if randomization assignment. Only about half of NEEs reported some form of sensitivity or falsification analysis to support inferences.ConclusionNEEs are conducted using many different designs and statistical methods and encompass various definitions of a natural experiment, while it is questionable whether all evaluations reported as natural experiments should be considered as such. The likelihood of as-if randomization should be specifically reported, and primary analyses should be supported by sensitivity analyses and/or falsification tests. Transparent reporting of NEE designs and evaluation methods will contribute to the optimum use of place-based NEEs.

Abstract Background Anxiety disorders are common among primary-school aged children, but few affected children receive evidence-based treatment. Identifying and supporting children who experience anxiety problems through schools would address substantial treatment access barriers that families and school staff often face. We have worked with families and school staff to co-design procedures that incorporate screening, feedback for parents, and the offer of a brief intervention in primary schools. This study sets out to assess the feasibility of a subsequent school-based cluster randomised controlled trial to evaluate these procedures. Our objectives are to ensure our procedures for identifying and supporting children with anxiety difficulties through primary schools are acceptable and there are no negative impacts, to estimate recruitment and retention rates, and to identify any changes needed to study procedures or measures. Methods We will recruit six primary/junior schools in England (2 classes per school), and invite all children (aged 8–9) (n = 360) and their parent/carer and class teacher in participating classes to take part. Children, parents and class teachers will complete questionnaires at baseline and 12-week follow-up. Children who ‘screen positive’ on a 2-item parent-report child anxiety screen at baseline will be the target population (expected n = 43). Parents receive feedback on screening questionnaire responses, and where the child screens positive the family is offered support (OSI: Online Support and Intervention for child anxiety). OSI is a brief, parent-led online intervention, supported by short telephone sessions with a Children’s Wellbeing Practitioner. Participants’ experiences of study procedures will be assessed through qualitative interviews/discussion groups. Discussion Evidence-based procedures for identifying and supporting children with anxiety difficulties through primary schools would improve children’s access to timely, effective intervention for anxiety difficulties. Trial registration ISRCTN registry: ISRCTN30032471 . Retrospectively registered on 18 May 2021.

Abstract Background Shared medical appointments (SMAs) or group consultations have been promoted in primary care to improve workload pressures, resource-use efficiency and patient self-management of long-term conditions (LTCs). However, few studies have explored stakeholders’ perspectives of this novel care delivery model in the English NHS context, particularly patients’ views and experiences of SMAs. Method Semi-structured interviews were used to explore the perspectives of stakeholders (21 patients, 17 primary care staff, 2 commissioners and 2 SMA training providers) with and without SMA experience from a range of geographical and socio-economic backgrounds in the North East and North Cumbrian region of England. Thematic analysis was conducted to examine perceptions around impact on patient care and outcomes and barriers and facilitators to implementation. Results Three main themes were identified: ‘Value of sharing’, ‘Appropriateness of group setting’, ‘Implementation processes’. Patients experiences and perceptions of SMAs were largely positive yet several reported reservations about sharing personal information, particularly in close-knit communities where the risk of breaching confidentiality was perceived to be greater. SMAs were considered by patients and staff to be inappropriate for certain personal conditions or for some patient groups. Staff reported difficulties engaging sufficient numbers of patients to make them viable and having the resources to plan and set them up in practice. Whilst patients and staff anticipated that SMAs could deliver high quality care more efficiently than 1:1 appointments, none of the practices had evaluated the impact SMAs had on patient health outcomes or staff time. Conclusion Stakeholder experiences of SMA use in English primary care are largely similar to those reported in other countries. However, several important cultural barriers were identified in this setting. Further work is needed to better understand how patient and staff perceptions, experiences and engagement with SMAs change with regular use over time. Concerns regarding staff capacity, additional resource requirements and numbers of eligible patients per practice suggest SMAs may only be feasible in some smaller practices if facilitated by primary care networks. Further mixed-method evaluations of SMAs are needed to inform the evidence base regarding the effectiveness, efficiency and feasibility of SMAs long-term and subsequently their wider roll-out in English primary care.

Preconception obesity is associated with adverse pregnancy outcomes and deprivation. The postnatal period provides an opportunity for preconception intervention. There is a lack of published postnatal behaviour and weight data to inform intervention needs. Secondary analysis of the GLOWING study explored postnatal diet, physical activity (PA) and weight among women living with obesity in deprivation. Thirty-nine women completed food frequency and PA questionnaires and provided weight measurement(s) between 3–12 months postnatal. Women’s diet and PA fell short of national guidelines, especially for fruit/vegetables (median 1.6–2.0 portions/day) and oily fish (0–4 g/day). PA was predominantly light intensity. Patterns in weight change across time points indicated postnatal weight loss compared with 1st (median −0.8 to −2.3 kg) and 3rd-trimester weights (−9.0 to −11.6 kg). Weight loss was higher among women without excessive gestational weight gain (GWG) (−2.7 to −9.7 kg) than those with excessive GWG (2.3 to −1.8 kg), resulting in postnatal weight measurements lower than their 1st trimester. These pilot data suggest preconception interventions should commence in pregnancy with a focus on GWG, and postnatal women need early support to achieve guideline-recommendations for diet and PA. Further research in a larger population could inform preconception intervention strategies to tackle inequalities in maternal obesity and subsequent pregnancy outcomes.

Abstract Background Letters are regularly sent by healthcare organisations to healthcare professionals to encourage them to take action, change practice or implement guidance. However, whether letters are an effective tool in delivering a change in healthcare professional behaviour is currently uncertain. In addition, there are currently no evidence-based guidelines to support health providers and authorities with advice on how to formulate the communication, what information and behaviour change techniques to include in order to optimise the potential effect on the behaviour of the receivers. To address this research gap, we seek to inform such guidance through this systematic review, which aims to provide comprehensive evidence of the effectiveness of personal letters to healthcare professionals in changing their professional behaviours. Methods/design A comprehensive literature search of published and unpublished studies (the grey literature) in electronic databases will be conducted to identify randomised controlled trials (RCTs) that meet our inclusion criteria. We will include RCTs evaluating the effectiveness of personal letters to healthcare professionals in changing professional behaviours. The primary outcome will be behavioural change. The search will be conducted in five electronic databases (from their inception onwards): MEDLINE, Embase, PsycINFO, the Cochrane Library and CINAHL. We will also conduct supplementary searches in Google Scholar, hand search relevant journals, and conduct backward and forward citation searching for included studies and relevant reviews. A systematic approach to searching, screening, reviewing and data extraction will be applied in accordance with the process recommended by the Cochrane Collaboration. Two researchers will examine titles, abstracts, full-texts for eligibility independently. Risk of bias will be assessed using the Cochrane Risk of Bias 2 (RoB 2) tool for randomised controlled trials. Disagreements will be resolved by a consensus procedure. Discussion Health policy makers across government are expected to benefit from being able to increase compliance in clinical settings by applying theories of behaviour to design of policy communications. The synthesised findings will be disseminated through peer-reviewed publication. Systematic review registration PROSPERO CRD42020167674

Background: Effective interventions and commercial programmes for weight loss (WL) are widely available, but most people regain weight. Few effective WL maintenance (WLM) solutions exist. The most promising evidence-based behaviour change techniques for WLM are self-monitoring, goal setting, action planning and control, building self-efficacy, and techniques that promote autonomous motivation (e.g., provide choice). Stress management and emotion regulation techniques show potential for prevention of relapse and weight regain. Digital technologies (including networked-wireless tracking technologies, online tools and smartphone apps, multimedia resources, and internet-based support) offer attractive tools for teaching and supporting long-term behaviour change techniques. However, many digital offerings for weight management tend not to include evidence-based content and the evidence base is still limited. The Project: First, the project examined why, when, and how many European citizens make WL and WLM attempts and how successful they are. Second, the project employed the most up-to-date behavioural science research to develop a digital toolkit for WLM based on 2 key conditions, i.e., self-management (self-regulation and motivation) of behaviour and self-management of emotional responses for WLM. Then, the NoHoW trial tested the efficacy of this digital toolkit in adults who achieved clinically significant (≥5%) WL in the previous 12 months (initial BMI ≥25). The primary outcome was change in weight (kg) at 12 months from baseline. Secondary outcomes included biological, psychological, and behavioural moderators and mediators of long-term energy balance (EB) behaviours, and user experience, acceptability, and cost-effectiveness. Impact: The project will directly feed results from studies on European consumer behaviour, design and evaluation of digital toolkits self-management of EB behaviours into development of new products and services for WLM and digital health. The project has developed a framework and digital architecture for interventions in the context of EB tracking and will generate results that will help inform the next generation of personalised interventions for effective self-management of weight and health.

There is substantial evidence documenting the effects of behavioural interventions on weight loss (WL). However, behavioural approaches to initial WL are followed by some degree of longer-term weight regain, and large trials focusing on evidence-based approaches to weight loss maintenance (WLM) have generally only demonstrated small beneficial effects. The current state-of-the-art in behavioural interventions for WL and WLM raises questions of (i) how we define the relationship between WL and WLM, (ii) how energy balance (EB) systems respond to WL and influence behaviours that primarily drive weight regain, (iii) how intervention content, mode of delivery and intensity should be targeted to keep weight off, (iv) which mechanisms of action in complex interventions may prevent weight regain and (v) how to design studies and interventions to maximise effective longer-term weight management. In considering these issues a writing team within the NoHoW Consortium was convened to elaborate a position statement, and behaviour change and obesity experts were invited to discuss these positions and to refine them. At present the evidence suggests that developing the skills to self-manage EB behaviours leads to more effective WLM. However, the effects of behaviour change interventions for WL and WLM are still relatively modest and our understanding of the factors that disrupt and undermine self-management of eating and physical activity is limited. These factors include physiological resistance to weight loss, gradual compensatory changes in eating and physical activity and reactive processes related to stress, emotions, rewards and desires that meet psychological needs. Better matching of evidence-based intervention content to quantitatively tracked EB behaviours and the specific needs of individuals may improve outcomes. Improving objective longitudinal tracking of energy intake and energy expenditure over time would provide a quantitative framework in which to understand the dynamics of behaviour change, mechanisms of action of behaviour change interventions and user engagement with intervention components to potentially improve weight management intervention design and evaluation.

Abstract Background The National Health Service diabetes prevention programme in England, (NHS DPP) aims to identify people at high risk of type 2 diabetes (T2D) and offer them a face-to-face, group-based, behaviour change intervention for at least 9 months. The NHS DPP was rolled out in phases. We aimed to elicit stakeholders’ perceptions and experiences of the factors influencing implementation of, and participation in, the programme during the development phase. Methods Individual, semi-structured telephone interviews were conducted with 50 purposively sampled stakeholders: service users (n = 20); programme commissioners (n = 7); referrers (n = 8); and intervention deliverers (n = 15). Topic guides were structured using a pragmatic, theory-informed approach. Analysis employed the framework method. Results We identified factors that influenced participation: Risk communication at referral - stakeholders identified point of referral as a window of opportunity to offer brief advice, to provide an understanding of T2D risk and information about the programme; Perceived impact of the NHS DPP - service users highlighted the positive perceived impact on their behaviour change, the peer support provided by participating in the programme, the option to involve a relative, and the ‘knock on’ effect on others. Service users also voiced disappointment when blood test results still identified them at high risk after the programme; and Behavioural maintenance - participants highlighted the challenges linked to behavioural maintenance (e.g. discontinuation of active support). Factors influencing implementations were also identified: Case finding – stakeholders suggested that using community involvement to identify service users could increase reach and ensure that the workload was not solely on GP practices; Adaptability: intervention deliverers acknowledged the need to tailor advice to service users’ preferences and needs; Accountability – the need to acknowledge who was responsible for what at different stages of the NHS DPP pathway; and Fidelity – stakeholders described procedures involved in monitoring service users’ satisfaction, outcome data collection and quality assurance assessments. Conclusions The NHS DPP offers an evidence-informed behavioural intervention for T2D prevention. Better risk communication specification could ensure consistency at the referral stage and improve participation in the NHS DPP intervention. Cultural adaptations and outreach strategies could ensure the NHS DPP contributes to reducing health inequalities.

Abstract Background Tobacco smoking is a major risk factor for several oral diseases, including periodontitis, and electronic cigarettes (e-cigarettes) are increasingly being used for smoking cessation. This study aimed to assess the viability of delivering and evaluating an e-cigarette intervention for smoking cessation within the dental setting, prior to a definitive study. Methods A feasibility study, comprising a pilot randomised controlled trial and qualitative process evaluation, was conducted over 22 months in the Newcastle upon Tyne Hospitals NHS Dental Clinical Research Facility, UK. The pilot trial comprised a two-armed, parallel group, individually randomised, controlled trial, with 1:1 allocation. Participant eligibility criteria included being a tobacco smoker, having periodontitis and not currently using an e-cigarette. All participants received standard non-surgical periodontal therapies and brief smoking cessation advice. The intervention group additionally received an e-cigarette starter kit with brief training. Proposed outcomes for a future definitive trial, in terms of smoking behaviour and periodontal/oral health, were collected over 6 months to assess data yield and quality and estimates of parameters. Analyses were descriptive, with 95% confidence intervals presented, where appropriate. Results Eighty participants were successfully recruited from a range of dental settings. Participant retention was 73% (n = 58; 95% CI 62–81%) at 6 months. The e-cigarette intervention was well received, with usage rates of 90% (n = 36; 95% CI 77–96%) at quit date. Twenty percent (n = 8; 95% CI 11–35%) of participants in the control group used an e-cigarette at some point during the study (against advice). The majority of the outcome measures were successfully collected, apart from a weekly smoking questionnaire (only 30% of participants achieved ≥ 80% completion). Reductions in expired air carbon monoxide over 6 months of 6 ppm (95% CI 1–10 ppm) and 12 ppm (95% CI 8–16 ppm) were observed in the control and intervention groups, respectively. Rates of abstinence (carbon monoxide-verified continuous abstinence for 6 months) for the two groups were 5% (n = 2; 95% CI 1–17%; control group) and 15% (n = 6; 95% CI 7–29%; intervention group). Conclusions Data suggest that a definitive trial is feasible and that the intervention may improve smoking quit rates. Insights were gained into how best to conduct the definitive trial and estimates of parameters to inform design were obtained. Trial registration ISRCTN, ISRCTN17731903; registered 19 September 2016 http://www.isrctn.com/ISRCTN17731903.

Abstract Background The implementation of new medical interventions into routine care involves healthcare professionals adopting new clinical behaviours and changing existing ones. Whilst theory-based approaches can help understand healthcare professionals’ behaviours, such approaches often focus on a single behaviour and conceptualise its performance in terms of an underlying reflective process. Such approaches fail to consider the impact of non-reflective influences (e.g. habit and automaticity) and how the myriad of competing demands for their time may influence uptake. The current study aimed to apply a dual process theoretical approach to account for reflective and automatic determinants of healthcare professional behaviour while integrating a multiple behaviour approach to understanding the implementation and use of a new self-management tool by healthcare professionals in the context of diabetes care. Methods Following Diabetes UK’s national release of the ‘Information Prescription’ (DUK IP; a self-management tool targeting the management of cholesterol, blood pressure and HbA1c) in January 2015, we conducted semi-structured interviews with 13 healthcare professionals (general practitioners and nurses) who had started to use the DUK IP during consultations to provide self-management advice to people with type 2 diabetes. A theory-based topic guide included pre-specified constructs from a previously developed logic model. We elicited healthcare professionals’ views on reflective processes (outcome expectations, self-efficacy, intention, action and coping planning), automatic processes (habit), and multiple behaviour processes (goal priority, goal conflict and goal facilitation). All interviews were audio recorded and transcribed verbatim and all transcripts were independently double coded and analysed using content analysis. Results The majority of healthcare professionals interviewed reported strong intentions to use the DUK IP and having formed a habit of using them after a minimum of one month continuous use. Pop-up cues in the electronic patient records were perceived to facilitate the use of the tool. Factors that conflicted with the use of the DUK IP included existing pathways of providing self-management advice. Conclusion Data suggests that constructs from dual process and multiple behaviour approaches are useful to provide supplemental understanding of the implementation of new self-management tools such as the DUK IP and may help to advance behavioural approaches to implementation science.

Abstract Objective The National Health Service (NHS) in England planned a national diabetes prevention programme (NHS DPP) with phased implementation. Evidence-based guidelines and service specifications support efficient and effective translation of research into practice. We aimed to evaluate the use of a structured mapping exercise to appraise how evidence, service specification and early phase practice could inform recommendations to guide subsequent implementation of the NHS DPP. Results The mapping exercise facilitated comparison and appraisal of key components from different documentary sources (evidence-based NICE guidelines, service specification, and provider documents). Key components were categorised into (A) pathways into programmes, (B) intervention content (C) inequalities and (D) quality assurance and staff training. We identified where key components were the same (accordance), where they varied (discrepancies) and where they were lacking (discontinuities), across the documentary sources. For example there was discrepancy in intervention duration and discontinuity in intervention enrolment procedures. This mapping exercise was useful to compare the fidelity in translation of evidence-based guidance into service specification and programme documents, thus identifying where future service implementation might be improved. This method may be applicable for use with other health conditions where research evidence requires translation into real world population programmes.

Abstract Background Socially disadvantaged men are at high risk of suffering from alcohol-related harm. Disadvantaged groups are less likely to engage with health promotion. There is a need for interventions that reach large numbers at low cost and which promote high levels of engagement with the behaviour change process. The aim of this study was to design a theoretically and empirically based text message intervention to reduce binge drinking by socially disadvantaged men. Results Following MRC guidance, the intervention was developed in four stages. Stage 1 developed a detailed behaviour change strategy based on existing literature and theory from several areas. These included the psychological theory that would underpin the intervention, alcohol brief interventions, text message interventions, effective behaviour change techniques, narratives in behaviour change interventions and communication theory. In addition, formative research was carried out. A logic model was developed to depict the pathways between intervention inputs, processes and outcomes for behaviour change. Stage 2 created a narrative which illustrated and modelled key steps in the strategy. Stage 3 rendered the intervention into a series of text messages and ensured that appropriate behavioural change techniques were incorporated. Stage 4 revised the messages to ensure comprehensive coverage of the behaviour change strategy and coherence of the narrative. It also piloted the intervention and made final revisions to it. Conclusions The structured, systematic approach to design created a narrative intervention which had a strong theoretical and empirical basis. The use of a narrative helped make the intervention realistic and allowed key behaviour change techniques to be modelled by characters. The narrative was intended to promote engagement with the intervention. The intervention was rendered into a series of short text messages, and subsequent piloting showed they were acceptable in the target group. Delivery of an intervention by text message offers a low-cost, low-demand method that can reach large numbers of people. This approach provides a framework for the design of behaviour change interventions which could be used for interventions to tackle other health behaviours.

Abstract Background National diabetes audits in the UK show room for improvement in the quality of care delivered to people with type 2 diabetes in primary care. Systematic reviews of quality improvement interventions show that such approaches can be effective but there is wide variability between trials and little understanding concerning what explains this variability. A national cohort study of primary care across 99 UK practices identified modifiable predictors of healthcare professionals’ prescribing, advising and foot examination. Our objective was to evaluate the effectiveness of an implementation intervention to improve six guideline-recommended health professional behaviours in managing type 2 diabetes in primary care: prescribing for blood pressure and glycaemic control, providing physical activity and nutrition advice and providing updated diabetes education and foot examination. Methods Two-armed cluster randomised trial involving 44 general practices. Primary outcomes (at 12 months follow-up): from electronic medical records, the proportion of patients receiving additional prescriptions for blood pressure and insulin initiation for glycaemic control and having a foot examination; and from a patient survey of a random sample of 100 patients per practice, reported receipt of updated diabetes education and physical activity and nutrition advice. Results The implementation intervention did not lead to statistically significant improvement on any of the six clinical behaviours. 1,138,105 prescriptions were assessed. Intervention (29% to 37% patients) and control arms (31% to 35%) increased insulin initiation relative to baseline but were not statistically significantly different at follow-up (IRR 1.18, 95%CI 0.95–1.48). Intervention (45% to 53%) and control practices (45% to 50%) increased blood pressure prescription from baseline to follow-up but were not statistically significantly different at follow-up (IRR 1.05, 95%CI 0.96 to 1.16). Intervention (75 to 78%) and control practices (74 to 79%) increased foot examination relative to baseline; control practices increased statistically significantly more (OR 0.84, 95%CI 0.75–0.94). Fewer patients in intervention (33%) than control practices (40%) reported receiving updated diabetes education (OR = 0.74, 95%CI 0.57–0.97). No statistically significant differences were observed in patient reports of having had a discussion about nutrition (intervention = 73%; control = 72%; OR = 0.98, 95%CI 0.59–1.64) or physical activity (intervention = 57%; control = 62%; OR = 0.79, 95%CI 0.56–1.11). Development and delivery of the intervention cost £1191 per practice. Conclusions There was no measurable benefit to practices’ participation in this intervention. Despite widespread use of outreach interventions worldwide, there is a need to better understand which techniques at which intensity are optimally suited to address the multiple clinical behaviours involved in improving care for type 2 diabetes. Trial registration ISRCTN, ISRCTN66498413. Registered April 4, 2013

Abstract Background Weight management in pregnancy guidelines exist, although dissemination alone is an ineffective means of implementation. Midwives identify the need for support to overcome complex barriers to practice. An evaluation of an intervention to support midwives’ guideline implementation would require a large-scale cluster randomised controlled trial. A pilot study is necessary to explore the feasibility of delivery and evaluation prior to a definitive trial. The GestationaL Obesity Weight management: Implementation of National Guidelines (GLOWING) trial aims to test whether it is feasible and acceptable to deliver a behaviour change intervention to support midwives’ implementation of weight management guidelines. Methods GLOWING is a multi-centre parallel group pilot cluster randomised controlled trial comparing the delivery of a behaviour change intervention for midwives versus usual practice. Four NHS Trusts (clusters) will be randomised to intervention and control arms, stratified by size of maternity services. The intervention uses social cognitive theory and consists of face-to-face midwifery training plus information resources for routine practice. The main outcomes are whether the intervention and trial procedures are feasible and acceptable to participants and the feasibility of recruitment and data collection for a definitive trial. Target recruitment involves all eligible midwives in the intervention arm recruited to receive the intervention, 30 midwives and pregnant women per arm for baseline and outcome questionnaire data collection and 20 midwives and women to provide qualitative data. All quantitative and qualitative analyses will be descriptive with the purpose of informing the development of the definitive trial. Discussion This pilot study has been developed to support community midwives’ implementation of guidelines. Community midwives have been selected as they usually carry out the booking appointment which includes measuring and discussing maternal body mass index. A cluster design is the gold standard in implementation research as there would be a high risk of contamination if randomisation was at individual midwife level: community midwives usually work in locality-based teams, interact on a daily basis, and share care of pregnant women. The results of the pilot trial will be used to further develop and refine GLOWING prior to a definitive trial to evaluate effectiveness and cost-effectiveness. Trial registration ISRCTN46869894; retrospectively registered 25th May 2016.

Abstract Background UK guidelines recommend that patients with obesity in primary care receive opportunistic weight loss advice from health care professionals, but there is a lack of research into the characteristics and existing weight management practices of these patients. The aim of this study was to characterise primary care patients with obesity in England, to inform the screening, support, and referral options appropriate to this group. Methods We surveyed 1309 patients registered at 15 GP practices in North East England, aged ≥18 years and with objectively recorded obesity (BMI ≥ 30 kg/m2). Study participants reported their weight history, health status, past and current weight loss activities, motivating factors, weight loss strategies used, professional support received, and perceived barriers to weight loss. Results 62% of participants were actively trying to lose weight, and a further 15% had attempted and discontinued weight loss in the last 12 months. Only 20% of the sample had sought GP support for weight loss in the last 12 months; instead, most efforts to lose weight were self-guided and did not use evidence-based strategies. Those who sought GP weight loss support were likely to use it and find it motivating. Participants had attempted weight loss on multiple previous occasions and overall felt less confident and successful at maintaining weight loss than losing it. Participants at greatest clinical risk (higher BMI and more health conditions) reported particularly low confidence and multiple barriers to weight loss, but were nevertheless highly motivated to lose weight and keep it off. Conclusions We identified the need for informational, structural, and weight loss maintenance-specific support for GP patients with objectively-recorded obesity. Study participants were motivated to lose weight and keep it off, but lacked the confidence and understanding of effective strategies required to do this. GP weight loss support was acceptable and useful but underutilised, indicating that screening and brief referral interventions to structured programmes may augment patients’ current weight management activities and meet key support needs whilst optimising limited primary care resources.

Abstract Background Existing evidence about the impact of retirement on physical activity (PA) has primarily focused on the average change in PA level after retirement in group-based studies. It is unclear whether findings regarding the direction of PA change after retirement from group-based studies apply to individuals. This study aimed to explore changes in PA, PA determinants and their inter-relationships during the retirement transition at the individual level. Methods A series of n-of-1 natural experiments were conducted with seven individuals who were aged 55–76 years and approaching retirement. PA was measured by tri-axial accelerometry. Twice-daily self-report and ecological momentary assessments of evidence- and theory-based determinants of PA (e.g. sleep length/quality, happiness, tiredness, stress, time pressure, pain, intention, perceived behavioural control, priority, goal conflict and goal facilitation) were collected via a questionnaire for a period of between 3 and 7 months, which included time before and after the participant’s retirement date. A personalised PA determinant was also identified by each participant and measured daily for the duration of the study. Dynamic regression models for discrete time binary data were used to analyse data for each individual participant. Results Two participants showed a statistically significant increase in the probability of engaging in PA bouts after retirement and two participants showed a significant time trend for a decrease and increase in PA bouts over time during the pre- to post-retirement period, respectively. There was no statistically significant change in PA after retirement for the remaining participants. Most of the daily questionnaire variables were significantly associated with PA for one or more participants but there were no consistent pattern of PA predictors across participants. For some participants, the relationship between questionnaire variables and PA changed from pre- to post-retirement. Conclusions The findings from this study demonstrate the impact of retirement on individual PA trajectories. Using n-of-1 methods can provide information about unique patterns and determinants of individual behaviour over time, which has been obscured in previous research. N-of-1 methods can be used as a tool to inform personalised PA interventions for individuals within the retirement transition.

Background: There has been a rapid increase in the number of, and demand for, organisations offering behavioural science advice to government over the last ten years. Yet we know little of the state of science and the experiences of these evidence providers. Aims and objectives: To identify current practice in this emerging field and the factors that impact on the production of high-quality and policy-relevant research. Methods: A qualitative study using one-to-one interviews with representatives from a purposeful sample of 15 units in the vanguard of international behavioural science research in policy. The data were analysed thematically. Findings: Relationships with policymakers were important in the inception of units, research conduct, implementation and dissemination of findings. Knowledge exchange facilitated a shared understanding of policy issues/context, and of behavioural science. Sufficient funding was crucial to maintain critical capacity in the units' workforces, build a research portfolio beneficial to policymakers and the units, and to ensure full and transparent dissemination. Discussion and conclusion: Findings highlight the positive impact of strong evidence-provider/user relationships and the importance of governments' commitment to co-produced research programmes to address policy problems and transparency in the dissemination of methods and findings. From the findings we have created a framework, 'STEPS' (Sharing, Transparency, Engagement, Partnership, Strong relationships), of five recommendations for units working with policymakers. These findings will be of value to all researchers conducting research on behalf of government.

Abstract Background Cross-sectional relationships between physical activity and health have been explored extensively, but less is known about how physical activity changes with time in older people. The aim of this study was to assess baseline predictors of how objectively measured physical activity changes with time in older people. Methods Longitudinal cohort study using data from the Physical Activity Cohort Scotland. A sample of community-dwelling older people aged 65 and over were recruited in 2009–2011, then followed up 2–3 years later. Physical activity was measured using Stayhealthy RT3 accelerometers over 7 days. Other data collected included baseline comorbidity, health-related quality of life (SF-36), extended Theory of Planned Behaviour Questionnaire and Social Capital Module of the General Household Survey. Associations between follow-up accelerometer counts and baseline predictors were analysed using a series of linear regression models, adjusting for baseline activity levels and follow-up time. Results Follow up data were available for 339 of the original 584 participants. The mean age was 77 years, 185 (55%) were female and mean follow up time was 26 months. Mean activity counts fell by between 2% per year (age 80, deprivation decile 5–10) from baseline values. In univariate analysis age, sex, deprivation decile, most SF-36 domains, most measures of social connectedness, most measures from the extended Theory of Planned Behaviour, hypertension, diabetes mellitus, chronic pain and depression score were significantly associated with adjusted activity counts at follow-up. In multivariate regression age, satisfactory friend network, SF-36 physical function score, and the presence of diabetes mellitus were independent predictors of activity counts at follow up after adjustment for baseline count and duration of follow up. Conclusions Health status and social connectedness, but not extended Theory of Planned Behaviour measures, independently predicted changes in physical activity in community dwelling older people.

After weight loss, most individuals regain lost weight. Interventions to support the transition from successful loss to weight loss maintenance (WLM), regardless of the method of prior weight loss, are needed. The aims of this study were to (1) develop a face-to-face behavioural intervention session to support overweight and obese individuals who have recently lost a clinically significant amount of weight in the transition to WLM; (2) to assess the single-session intervention for acceptability and feasibility prior to its use in a larger, 12-month, multi-component trial; and (3) to optimise the intervention session for future use based on participant feedback. Participants with a Body Mass Index of ≥25 kg/m2 prior to a ≥5% weight loss in the previous 12 months were recruited via the local government authority and community-based advertisements. Each attended the one-hour session with a trained facilitator, which focused on setting maintenance-relevant weight, eating, and physical activity goals. Semi-structured interviews were carried out immediately post-session to obtain feedback on the acceptability of this intervention component. Data were used to generate recommendations for changes to the session, which were discussed by the team, and used to optimise the session. Seventeen participants (13 female; median WL = 13%) were recruited. All participants evaluated the intervention session positively; 11 participants suggested improvements including reducing information provision in favour of greater focus on identifying and coping with barriers, and the inclusion of practical examples. The systematic refinement and optimisation process resulted in an acceptable and feasible face-to-face behavioural intervention session (described here), which will be tested as part of a multi-component intervention. We anticipate the session could be used to supplement existing support including online services, and has the potential to benefit people who have lost a clinically significant amount of weight to achieve WLM over the long term.

Background: This article presents an exploratory study, aiming to explore the correspondence between knowledge, motivation and sun-protection practices during holidays. Methods: Seventeen participants aged 21–62 years old, recruited from community settings took part in individual face-to-face semi-structured interviews, completed sun sensitivity questions and an objective assessment of sunscreen use. Holidaymakers’ knowledge about sun-safe messages, intentions and perceptions of barriers and facilitators for sun-protection were assessed. Qualitative data were analysed using thematic analysis and integrated with quantitative data, using a pragmatic theory-informed approach to synthesise the findings. Results: Participants were well informed about sun-safe messages, highly motivated to protect themselves from solar UV radiation (UVR) and they perceived themselves as well protected. However, they did not seem to use effective protective practices. Sunscreen was the preferred method of sun-protection, but most participants used considerably less than the recommended amount and significantly overestimated the amount of time they could be safely exposed. Seeking shade was the least used method of sun-protection and covering-up strategies were mostly implemented as a partial protection (i.e. hats or sunglasses). The desire to reach an optimal balance between getting a tan and using sun-protection to avoid sunburns was preeminent. Several additional barriers and facilitators for sun-protection were identified. Conclusions: Holidaymakers might have a false sense of security when it comes to sun-exposure. They are aware of the need to protect from solar UVR, but the motive for a safe tan, the overreliance on sunscreen, the overestimation of the safe sun-exposure time for their skin type and the insufficient application of sunscreen leaves holidaymakers motivated to protect their skin at significant risk of overexposure, sunburn and skin cancer. Public health messages need to address how to implement effective sun-safe strategies.

Abstract Background Providing financial incentives contingent on healthy behaviours is one way to encourage healthy behaviours. However, there remains substantial concerns with the acceptability of health promoting financial incentives (HPFI). Previous research has studied acceptability of HPFI to the public, recipients and practitioners. We are not aware of any previous work that has focused particularly on the views of public health policymakers. Our aim was to explore the views of public health policymakers on whether or not HPFI are acceptable; and what, if anything, could be done to maximise acceptability of HPFI. Methods We recruited 21 local, regional and national policymakers working in England via gatekeepers and snowballing. We conducted semi-structured in-depth interviews with participants exploring experiences of, and attitudes towards, HPFI. We analysed data using the Framework approach. Results Public health policymakers working in England acknowledged that HPFI could be a useful behaviour change tool, but were not overwhelmingly supportive of them. In particular, they raised concerns about effectiveness and cost-effectiveness, potential ‘gaming’, and whether or not HPFI address the underlying causes of unhealthy behaviours. Shopping voucher rewards, of smaller value, targeted at deprived groups were particularly acceptable to policymakers. Participants were particularly concerned about the response of other stakeholders to HPFI – including the public, potential recipients, politicians and the media. Overall, the interviews reflected three tensions. Firstly, a tension between wanting to trust individuals and promote responsibility; and distrust around the potential for ‘gaming the system’. Secondly, a tension between participants’ own views about HPFI; and their concerns about the possible views of other stakeholders. Thirdly, a tension between participants’ personal distaste of HPFI; and their professional view that they could be a valuable behaviour change tool. Conclusions There are aspects of design that influence acceptability of financial incentive interventions to public health policymakers. However, it is not clear that even interventions designed to maximise acceptability would be acceptable enough to be recommended for implementation. Further work may be required to help policymakers understand the potential responses of other stakeholder groups to financial incentive interventions.

Abstract Background Physical activity (PA) has been shown to decline during adolescence, and those with lower education have lower levels of activity already at this age, calling for targeted efforts for them. No previous study has demonstrated lasting effects of school-based PA interventions among older adolescents. Furthermore, these interventions have rarely targeted sedentary behaviour (SB) despite its relevance to health. The Let’s Move It trial aims to evaluate the effectiveness and the cost-effectiveness of a school-based, multi-level intervention, on PA and SB, among vocational school students. We hypothesise that the intervention is effective in increasing moderate-to-vigorous-intensity physical activity (MVPA), particularly among those with low or moderate baseline levels, and decreasing SB among all students. Methods The design is a cluster-randomised parallel group trial with an internal pilot study. The trial is conducted in six vocational schools in the Helsinki Metropolitan area, Finland. The intervention is carried out in 30 intervention classes, and 27 control classes retain the standard curriculum. The randomisation occurs at school-level to avoid contamination and to aid delivery. Three of the six schools, randomly allocated, receive the ‘Let’s Move It’ intervention which consists of 1) group sessions and poster campaign targeting students’ autonomous PA motivation and self-regulation skills, 2) sitting reduction in classrooms via alterations in choice architecture and teacher behaviour, and 3) enhancement of PA opportunities in school, home and community environments. At baseline, student participants are blind to group allocation. The trial is carried out in six batches in 2015–2017, with main measurements at pre-intervention baseline, and 2-month and 14-month follow-ups. Primary outcomes are for PA, MVPA measured by accelerometry and self-report, and for SB, sedentary time and breaks in sedentary time (accelerometry). Key secondary outcomes include measured body composition, self-reported well-being, and psychological variables. Process variables include measures of psychosocial determinants of PA (e.g. autonomous motivation) and use of behaviour change techniques. Process evaluation also includes qualitative interviews. Intervention fidelity is monitored. Discussion The study will establish whether the Let’s Move It intervention is effective in increasing PA and reducing SB in vocational school students, and identify key processes explaining the results. Trial registration ISRCTN10979479 . Registered: 31.12.2015