Furthering Scientific Inquiry for Weight Loss Maintenance: Assessing the Psychological Processes Impacted by a Low intensity Technology-Assisted Intervention (NULevel Trial).

BACKGROUND: NULevel was a randomized control trial to evaluate a technology-assisted weight loss maintenance (WLM) program in the UK. The program included: (a) a face-to-face goal-setting session; (b) an internet platform, a pedometer, and wirelessly connected scales to monitor and report diet, physical activity, and weight, and; (c) regular automated feedback delivered by mobile phone, tailored to participants' progress. Components were designed to target psychological processes linked to weight-related behavior. Though intervention participants showed increased physical activity, there was no difference in WLM between the intervention and control groups after 12 months (Sniehotta FF, Evans EH, Sainsbury K, et al. Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity: A randomized controlled trial in the UK (NULevel Trial). PLoS Med. 2019; 16(5):e1002793. doi:10.1371/journal.pmed.1002793). It is unclear whether the program failed to alter targeted psychological processes, or whether changes in these processes failed to influence WLM. PURPOSE: We evaluate whether the program influenced 16 prespecified psychological processes (e.g., self-efficacy and automaticity toward diet and physical activity), and whether these processes (at 6 months) were associated with successful WLM (at 12 months). METHODS: 288 adults who had previously lost weight were randomized to the intervention or control groups. The control group received wireless scales and standard advice via newsletters. Assessments occurred in person at 0, 6, and 12 months. RESULTS: The intervention significantly altered 10 of the 16 psychological processes, compared with the control group. However, few processes were associated with WLM, leading to no significant indirect effects of the intervention via the processes on WLM. CONCLUSIONS: Changes in targeted processes were insufficient to support WLM. Future efforts may more closely examine the sequence of effects between processes, behavior, and WLM.

Many tools exist to help people lose weight, but it is common for people to regain that weight over time. Thus, understanding how to support the maintenance of weight loss remains a priority. The NULevel program was a 12-month weight loss maintenance (WLM) intervention for individuals who had recently lost weight. It promoted psychological factors, shown to be tied to weight-related behaviors, using face-to-face and technology-based (e.g., mobile phone feedback) elements. For example, the program encouraged making plans to improve lifestyles (e.g., exercise, better diet) and promoted people's confidence in these behaviors. However, the program was not more successful than a control condition in maintaining weight loss. We sought to understand why this occurred. We found that the program was indeed successful in influencing most of the psychological factors it targeted. Instead, it was the psychological factors that failed to predict WLM. Were the psychological factors insufficient to impact behavior? Or did the promoted behaviors fail to aid WLM? Future research should focus on answering such questions. Doing so would inform whether interventions should target different psychological factors to change behaviors, or choose different sets of behaviors to support WLM.

'I Do It All Alone': The Burdens and Benefits of Being Diagnosed With, and Treated for, Colorectal Cancer During the Covid-19 Pandemic.

INTRODUCTION: The Covid-19 pandemic dramatically altered the way cancer care services were accessed and delivered, including for colorectal cancer (CRC). In the United Kingdom, patients were discouraged from presenting in primary care, many consultations took place remotely, investigative procedures and screening programmes were temporarily suspended, and fewer operations and treatments were delivered. People had to face the practical consequences of having cancer during a pandemic and navigate never before seen pathways, often alone. We examined the experience of being diagnosed and treated for CRC during the pandemic, and the implications of this on people's cancer journeys. METHODS: Semi-structured interviews were undertaken with people diagnosed with CRC during the Covid-19 pandemic (January 2020-May 2021), in the North East of England. An iterative topic guide was used during interviews, which took place remotely (telephone or Zoom), were audio recorded, pseudo-anonymised and transcribed. Initial transcripts were independently coded by two researchers, and a code 'bank' developed for application across transcripts. Development of themes and overarching analytical constructs was undertaken collaboratively by the research team. RESULTS: Interviews were conducted with 19 participants, analysed and four key themes identified: (1) The relative threats of Covid-19 and Cancer were not comparable, with cancer seen as posing a far greater risk than Covid-19; (2) Remote consultations were problematic, affecting patients' abilities to build rapport and trust with clinicians, assess nonverbal communication, and feel able to disclose, comprehend and retain information; (3) Stoma follow-up care was seen to be lacking, with long wait times for stoma reversal experienced by some; Finally, (4) Being alone during consultations negatively impacted some peoples' abilities to absorb information, and left them without the support of loved ones at an emotionally vulnerable time. However, some participants preferred being alone at certain points in their pathways, including receiving a diagnosis, and most frequently when receiving in-patient treatment. CONCLUSION: Being alone brought unexpected benefits, absolving people from undertaking emotions work for others, and instead focus on their recovery, however, remote consultations negatively impacted patients' experiences. This study highlights the complex benefits and burdens of pandemic-located cancer journeys, including how these shifted at different points across cancer pathways. PATIENT OR PUBLIC CONTRIBUTION: Lorraine Angell, a cancer survivor, has been central to this study from idea conception, contributing to: development of study focus and design; securing funding; production of patient-facing materials; development of interview topic guides; analysis and interpretation of data; and drafting of key findings and manuscripts.

Understanding supported self-management for people living with a lower-grade glioma: Implementation considerations through the lens of normalisation process theory.

BACKGROUND: Supported self-management can improve clinical and psychosocial outcomes in people with cancer; the considerations required to implement self-management support (SMS) for people living with a lower-grade glioma (LGG)-who often have complex support needs-are not known. We aimed to identify and understand these implementation considerations through the lens of normalisation process theory (NPT), from the perspectives of healthcare professionals (HCP) and people with LGG. METHODS: We conducted semistructured interviews with HCPs who support adults with brain tumours (n = 25; 12 different healthcare professions), and people with LGG who had completed primary treatment (n = 28; male n = 16, mean age 54.6 years, mean time since diagnosis 8.7 years), from across the United Kingdom. Interviews were transcribed and inductive open coding conducted, before deductively mapping to constructs of NPT. We first mapped HCP data, then integrated data from people with LGG to explore alignment in experiences and perspectives. RESULTS: We generated supporting evidence for all four NPT constructs and related subconstructs, namely: 'Coherence', 'Cognitive participation', 'Collective action' and 'Reflexive monitoring'. Data from HCPs and people with LGG clearly demonstrated that effective SMS constitutes a collective activity. Key implementation considerations included: ensuring awareness of, and access to, support; building strong HCP-support recipient relationships; and careful inclusion of close family and friends. We identified pertinent challenges, such as identifying support needs (influenced by the extent to which those with LGG engage in help-seeking), resistance to support (e.g., technology literacy), training for HCPs and HCP cooperation. CONCLUSIONS: This study demonstrates the collective nature of, and provides insight into the individual roles within, supported self-management. We outline considerations to operationalise, sustain and appraise the implementation of SMS for people with LGG. PATIENT OR PUBLIC CONTRIBUTION: People with brain tumours, and informal caregivers, were involved in the development of information materials and topic guides to ensure accessibility and pertinence. They also had opportunities to comment on interview findings.

'A Constant Black Cloud': The Emotional Impact of Informal Caregiving for Someone With a Lower-Grade Glioma.

Those closest to people with lower-grade gliomas (LGGs) often assume the role of informal caregiver (IC). The additional responsibilities mean ICs of people with cancer can experience adverse impacts on their own lives. We explored the emotional impact of informal caregiving for people with LGGs. This was a descriptive qualitative study within the multi-method Ways Ahead project. We conducted semi-structured interviews with individuals from the United Kingdom, who currently, or in the past 5 years, informally cared for someone with an LGG. Interviews encompassed experiences of emotional impact as a consequence of caregiving for someone with an LGG. Inductive thematic analysis was undertaken. We interviewed 19 ICs (mean age 54.6 years; 14 females, 5 males). Participants reported substantial emotional impact. Four themes and associated subthemes were generated: Emotional responses to the illness (e.g. feeling helpless), Emotional responses to the unknown (e.g. anxiety about future uncertainty), Emotional consequences of care recipient changes (e.g. challenges of changed relationship dynamics), and Emotional weight of the responsibility (e.g. feeling burnout). Emotional impact in one area often exacerbated impact in another (e.g. future uncertainty impacted feelings of helplessness). Participants detailed the factors that helped them manage the emotional impact (e.g. being resilient). ICs of people with LGGs can experience wide-ranging emotional responses to and impacts of the illness, uncertain prognosis, care recipient changes, and the toll of caregiving. Adjustment and resilience are key protective factors, though further consideration of ways to identify and fulfil the emotional support needs of ICs of people with LGGs is required.

Thinking Health-related Behaviors in a Climate Change Context: A Narrative Review.

BACKGROUND: Human activities have changed the environment so profoundly over the past two centuries that human-induced climate change is now posing serious health-related threats to current and future generations. Rapid action from all scientific fields, including behavioral medicine, is needed to contribute to both mitigation of, and adaption to, climate change. PURPOSE: This article aims to identify potential bi-directional associations between climate change impacts and health-related behaviors, as well as a set of key actions for the behavioral medicine community. METHODS: We synthesized the existing literature about (i) the impacts of rising temperatures, extreme weather events, air pollution, and rising sea level on individual behaviors (e.g., eating behaviors, physical activity, sleep, substance use, and preventive care) as well as the structural factors related to these behaviors (e.g., the food system); and (ii) the concurrent positive and negative roles that health-related behaviors can play in mitigation and adaptation to climate change. RESULTS: Based on this literature review, we propose a first conceptual model of climate change and health-related behavior feedback loops. Key actions are proposed, with particular consideration for health equity implications of future behavioral interventions. Actions to bridge the fields of behavioral medicine and climate sciences are also discussed. CONCLUSIONS: We contend that climate change is among the most urgent issues facing all scientists and should become a central priority for the behavioral medicine community.

Health-related quality of life in adults with low-grade gliomas: a systematic review.

PURPOSE: Low-grade glioma (LGG) patients may face health-related quality-of-life (HRQoL) impairments, due to the tumour, treatment and associated side-effects and prospects of progression. We systematically identified quantitative studies assessing HRQoL in adult LGG patients, for: aspects of HRQoL impacted; comparisons with non-cancer controls (NCC) and other groups; temporal trends; and factors associated with HRQoL. METHODS: MEDLINE, CINAHL, Embase, PubMed, and PsycINFO were systematically searched from inception to 14th September 2021. Following independent screening of titles and abstracts and full-texts, population and study characteristics, and HRQoL findings were abstracted from eligible papers, and quality appraised. Narrative synthesis was conducted. RESULTS: Twenty-nine papers reporting 22 studies (cross-sectional, n = 13; longitudinal, n = 9) were identified. Papers were largely good quality, though many excluded patients with cognitive and communication impairments. Comparators included high-grade gliomas (HGG) (n = 7); NCCs (n = 6) and other patient groups (n = 3). Nineteen factors, primarily treatment (n = 8), were examined for association with HRQoL. There was substantial heterogeneity in HRQoL instruments used, factors and aspects of HRQoL assessed and measurement timepoints. HRQoL, primarily cognitive functioning and fatigue, in adult LGG patients is poor, and worse than in NCCs, though better than in HGG patients. Over time, HRQoL remained low, but stable. Epilepsy/seizure burden was most consistently associated with worse HRQoL. CONCLUSION: LGG patients experience wide-ranging HRQoL impairments. HRQoL in those with cognitive and communication impairments requires further investigation. These findings may help clinicians recognise current supportive care needs and inform types and timings of support needed, as well as inform future interventions.

Identifying the psychosocial predictors of ultraviolet exposure to the face in patients with xeroderma pigmentosum: a study of the behavioural factors affecting clinical outcomes in this genetic disease.

BACKGROUND: For patients with xeroderma pigmentosum (XP), the main means of preventing skin and eye cancers is extreme protection against ultraviolet radiation (UVR), particularly for the face. We have recently developed a methodology for objectively measuring photoprotection behaviour ('UVR dose to facial skin') and have found that the degree of photoprotection varies greatly between patients with XP. We have previously identified factors affecting photoprotection behaviour in XP using a subjective measure of photoprotection. Here, we have used this objective methodology to identify the factors which determine photoprotection behaviour in XP. METHODS: We studied 29 psychological, social, demographic and clinical variables in 36 patients with XP. We have previously objectively measured UVR protection (by measuring the dose of UVR reaching the skin of the face over a 3-week period) in these patients. Here, we use linear mixed-effects model analysis to identify the factors which lead to the differences in degree of photoprotection observed in these patients. RESULTS: Psychosocial factors accounted for as much of the interindividual variation in photoprotection behaviour (29%) as demographic and clinical factors (24%). Psychosocial factors significantly associated with worse UVR protection included: automaticity of the behaviours, and a group of beliefs and perceptions about XP and photoprotection known to associate with poor treatment adherence in other diseases. CONCLUSIONS: We have identified factors contributing to poor photoprotection in XP. Identifying these potentially reversible psychosocial features has enabled us to design an intervention to improve photoprotection in patients with XP, aiming to prevent skin and eye cancers in these patients.

Promoting regular dental attendance in problem-orientated dental attenders: A systematic review of potential interventions.

BACKGROUND: Problem-orientated dental attenders account for around one-third of the UK population, these being patients who do not seek regular dental care, instead only attending with dental pain. In order to develop intervention(s) to encourage regular dental attendance in these patients, any previous intervention development should be identified to aid idea generation or retrofitting of interventions. OBJECTIVE: To identify previous interventions which have been developed targeted at problem-orientated dental attenders to facilitate the development and co-design of a new intervention. METHODS: Eight electronic databases were searched for studies which included an intervention targeted at adult problem-orientated or irregular dental attenders to encourage regular dental attendance. Data on the intervention design mapped to the theoretical domains framework were extracted, alongside effectiveness and patient views where available. RESULTS: Three studies fitted the inclusion criteria for the review. Interventions identified were attendance at a dental anxiety clinic, and a large advertising campaign promoting a free dental update where members of the public could visit local dental practices to look around and meet the dentists. One study looked at the effect of policy change by introducing free dental check-ups in Scotland. Interventions were poorly reported, with significant omissions in their description and a lack of clear identification of what composed the intervention. CONCLUSION: There are very few interventions developed targeted at problem-orientated dental attendance, but important areas to consider in future intervention development include the following: dentist communication; dentist-patient relationship; increasing the awareness of need; the effect of free dental check-ups.

Facial photoprotection in xeroderma pigmentosum (XP) patients: Validation of a new self-reported questionnaire of adherence.

BACKGROUND/PURPOSE: Adherence to photoprotection is the only way to prevent skin cancers and eye disease in xeroderma pigmentosum (XP). No validated self-report questionnaire exists for assessing adherence to photoprotection practices in individuals with XP. We sought to validate a self-reported measure of adherence to face photoprotection in this population. METHODS: Sixty six XP patients recruited from the patient list of the XP specialist service in London, UK, completed a questionnaire of adherence to specific photoprotection behaviours. We measured objective ultraviolet radiation (UVR) exposure to the face continuously for 21 days with a wristworn UVR electronic dosimeter combined with a daily photoprotection diary. Reliability and convergent validity of the questionnaire were tested in relation to overall UVR exposure, UVR dose to the face, daily photoprotection activities, other self-reported photoprotection practices and clinical ratings of patient's protection. RESULTS: Internal consistency of the questionnaire was satisfactory. Questionnaire total scores were concordant with objective UVR exposure and UVR dose to the face. However, not all participants who reported good/excellent face photoprotection on the questionnaire recorded high levels of photoprotection in the daily diary. Correlations between the questionnaire and other practices and the clinical rating ranged from small to large in size. There was no correlation between the level of face photoprotection and self-reported avoidance of going outside. CONCLUSIONS: Our questionnaire was reliable and had good convergent validity with other indicators of photoprotection. This questionnaire could assist clinicians to detect low levels of adherence, and the methodology used to develop validated questionnaires for other photosensitive conditions.

Acceptability of a cessation intervention for pregnant smokers: a qualitative study guided by Normalization Process Theory.

BACKGROUND: Smoking during pregnancy has serious consequences for maternal and child health. An intervention package to embed National Institute for Health and Care Excellence guidance (babyClear©) was delivered across maternity and stop smoking services (SSS) within an English region, to support pregnant women to stop smoking. We aimed to ascertain acceptability among pregnant smokers receiving the intervention. METHODS: Pregnant smokers who received the intervention and participated in the study were interviewed, first at around 16 weeks of pregnancy (n = 17) and again several weeks later (n = 8) or postpartum (n = 3). Interview schedules were informed by Normalization Process Theory (NPT) and Theoretical Domains Framework; interviews were audio-recorded, transcribed and analysed thematically, using the Framework method and NPT. Findings are grouped according to the four NPT concepts. RESULTS: Coherence: Carbon monoxide monitoring appeared to make sense; women were motivated to quit by being monitored. Cognitive participation: When linked to a professional discourse of caring and concern, some women were prompted to engage with the SS message. Women were more guarded in their reaction to initial contact from the SSS; reporting attending appointments successfully, or in some cases, experiencing problems that decreased engagement and made quitting harder. Collective action: Where women continued to smoke or failed to attend SSS appointments, an extra intervention was delivered, the Risk Perception Tool (RPT), which often prompted pregnant women to act. Reflexive monitoring: Most women accepted the need for a hard-hitting approach (RPT) and, while it distressed them at the time, they claimed they were subsequently grateful for it. SSS intervention post-RPT was seen as supportive, partly because it often involved home visits. Aspects of family inclusion in babyClear© were reported as beneficial. In Trusts where women experienced services as less focused on prioritising the stop smoking message, less well integrated or reported maternity staff as less adept at delivering the RPT, women found babyClear© less acceptable overall. CONCLUSIONS: The babyClear© package was acceptable to pregnant smokers interviewed during and shortly after pregnancy and, in some cases, to promote quitting. However, some contexts were more optimal than others, leading to variation in acceptability overall.

Integrating Health Technologies in Health Services for Syrian Refugees in Lebanon: Qualitative Study.

BACKGROUND: Lebanon currently hosts around one million Syrian refugees. There has been an increasing interest in integrating eHealth and mHealth technologies into the provision of primary health care to refugees and Lebanese citizens. OBJECTIVE: We aimed to gain a deeper understanding of the potential for technology integration in primary health care provision in the context of the protracted Syrian refugee crisis in Lebanon. METHODS: A total of 17 face-to-face semistructured interviews were conducted with key informants (n=8) and health care providers (n=9) involved in the provision of health care to the Syrian refugee population in Lebanon. Interviews were audio recorded and directly translated and transcribed from Arabic to English. Thematic analysis was conducted. RESULTS: Study participants indicated that varying resources, primarily time and the availability of technologies at primary health care centers, were the main challenges for integrating technologies for the provision of health care services for refugees. This challenge is compounded by refugees being viewed by participants as a mobile population thus making primary health care centers less willing to invest in refugee health technologies. Lastly, participant views regarding the health and technology literacies of refugees varied and that was considered to be a challenge that needs to be addressed for the successful integration of refugee health technologies. CONCLUSIONS: Our findings indicate that in the context of integrating technology into the provision of health care for refugees in a low or middle income country such as Lebanon, some barriers for technology integration related to the availability of resources are similar to those found elsewhere. However, we identified participant views of refugees' health and technology literacies to be a challenge specific to the context of this refugee crisis. These challenges need to be addressed when considering refugee health technologies. This could be done by increasing the visibility of refugee capabilities and configuring refugee health technologies so that they may create spaces in which refugees are empowered within the health care system and can work toward debunking the views discovered in this study.

The Recognition-Response Gap in Acute Stroke: Examining the Relationship between Stroke Recognition and Response in a General Population Survey.

BACKGROUND: Benefits of reperfusion therapies in acute ischemic stroke are highly time-dependent. It is crucial that people who witness the onset of symptoms call emergency medical services (EMS) immediately. The aim of this study was to examine whether there is a gap between recognition of stroke and responding correctly by calling EMS using a scenario-based measure. METHODS: Population-based survey of 1406 individuals from Newcastle upon Tyne, UK, examining stroke recognition and response knowledge using 12 scenario-based vignettes. The response rate was 32% out of 5000 contacted individuals. In total, 16,574 responses to scenarios were examined to investigate whether respondents would recognise stroke symptoms and indicate to call EMS immediately. RESULTS: In 16% of cases people recognised stroke but did not correctly respond by indicating to call EMS. In 49% of responses people recognised stroke and would respond correctly, while in 31% of cases people both failed to correctly recognise and failed to identify the correct response to the stroke scenario. In 5% of cases stroke was not identified but a correct response was indicated. When stroke was recognised, in 25% of responses people indicated that they would not call EMS. Recognition self-efficacy and response self-efficacy were associated with correct response. CONCLUSIONS: A recognition-response gap was identified among UK adults in hypothetical scenarios concerning stroke. Both recognition and translation to adequate EMS response should be explicitly addressed in interventions aiming to improve witness response to stroke. Self-efficacy may be a promising target to close the recognition-response gap.

Behavioural intervention for weight loss maintenance versus standard weight advice in adults with obesity: A randomised controlled trial in the UK (NULevel Trial).

BACKGROUND: Scalable weight loss maintenance (WLM) interventions for adults with obesity are lacking but vital for the health and economic benefits of weight loss to be fully realised. We examined the effectiveness and cost-effectiveness of a low-intensity technology-mediated behavioural intervention to support WLM in adults with obesity after clinically significant weight loss (≥5%) compared to standard lifestyle advice. METHODS AND FINDINGS: The NULevel trial was an open-label randomised controlled superiority trial in 288 adults recruited April 2014 to May 2015 with weight loss of ≥5% within the previous 12 months, from a pre-weight loss BMI of ≥30 kg/m2. Participants were self-selected, and the majority self-certified previous weight loss. We used a web-based randomisation system to assign participants to either standard lifestyle advice via newsletter (control arm) or a technology-mediated low-intensity behavioural WLM programme (intervention arm). The intervention comprised a single face-to-face goal-setting meeting, self-monitoring, and remote feedback on weight, diet, and physical activity via links embedded in short message service (SMS). All participants were provided with wirelessly connected weighing scales, but only participants in the intervention arm were instructed to weigh themselves daily and told that they would receive feedback on their weight. After 12 months, we measured the primary outcome, weight (kilograms), as well as frequency of self-weighing, objective physical activity (via accelerometry), psychological variables, and cost-effectiveness. The study was powered to detect a between-group weight difference of ±2.5 kg at follow-up. Overall, 264 participants (92%) completed the trial. Mean weight gain from baseline to 12 months was 1.8 kg (95% CI 0.5-3.1) in the intervention group (n = 131) and 1.8 kg (95% CI 0.6-3.0) in the control group (n = 133). There was no evidence of an effect on weight at 12 months (difference in adjusted mean weight change from baseline: -0.07 [95% CI 1.7 to -1.9], p = 0.9). Intervention participants weighed themselves more frequently than control participants and were more physically active. Intervention participants reported greater satisfaction with weight outcomes, more planning for dietary and physical activity goals and for managing lapses, and greater confidence for healthy eating, weight loss, and WLM. Potential limitations, such as the use of connected weighing study in both trial arms, the absence of a measurement of energy intake, and the recruitment from one region of the United Kingdom, are discussed. CONCLUSIONS: There was no difference in the WLM of participants who received the NULevel intervention compared to participants who received standard lifestyle advice via newsletter. The intervention affected some, but not all, process-related secondary outcomes of the trial. TRIAL REGISTRATION: This trial is registered with the ISRCTN registry (ISRCTN 14657176; registration date 20 March 2014).

Feasibility and acceptability of a Takeaway Masterclass aimed at encouraging healthier cooking practices and menu options in takeaway food outlets.

OBJECTIVE: To evaluate the feasibility and acceptability of the Takeaway Masterclass, a three-hour training session delivered to staff of independent takeaway food outlets that promoted healthy cooking practices and menu options. DESIGN: A mixed-methods study design. All participating food outlets provided progress feedback at 6 weeks post-intervention. Baseline and 6-week post-intervention observational and self-reported data were collected in half of participating takeaway food outlets. SETTING: North East England. PARTICIPANTS: Independent takeaway food outlet owners and managers. RESULTS: Staff from eighteen (10 % of invited) takeaway food outlets attended the training; attendance did not appear to be associated with the level of deprivation of food outlet location. Changes made by staff that required minimal effort or cost to the business were the most likely to be implemented and sustained. Less popular changes included using products that are difficult (or expensive) to source from suppliers, or changes perceived to be unpopular with customers. CONCLUSION: The Takeaway Masterclass appears to be a feasible and acceptable intervention for improving cooking practices and menu options in takeaway food outlets for those who attended the training. Further work is required to increase participation and retention and explore effectiveness, paying particular attention to minimising adverse inequality effects.

What helped and hindered implementation of an intervention package to reduce smoking in pregnancy: process evaluation guided by normalization process theory.

BACKGROUND: Smoking in pregnancy causes harm to mother and baby. Despite evidence from trials of what helps women quit, implementation in the real world has been hard to achieve. An evidence-based intervention, babyClear©, involving staff training, universal carbon monoxide monitoring, opt-out referral to smoking cessation services, enhanced follow-up protocols and a risk perception tool was introduced across North East England. This paper presents the results of the qualitative analyses, reporting acceptability of the system changes to staff, as well as aids and hindrances to implementation and normalization of this complex intervention. METHODS: Process evaluation was used to complement an effectiveness study. Interviews with maternity and smoking cessation services staff and observations of training were undertaken. Normalization Process Theory (NPT) was used to frame the interview guides and analysis. NPT is an empirically-derived theory, developed by sociologists, that uses four concepts to understand the process of routinising new practices. RESULTS: Staff interviews took place across eight National Health Service trusts at a time of widespread restructuring in smoking cessation services. Principally interviewees worked in maternity (n = 63) and smoking cessation services (n = 35). Five main themes, identified inductively, influenced the implementation: 1) initial preparedness of the organisations; 2) staff training; 3) managing partnership working; 4) resources; 5) review and planning for sustainability. CONCLUSIONS: NPT was used to show that the babyClear© package was acceptable to staff in a range of organisations. Illustrated in Themes 1, 2 & 3, staff welcomed ways to approach pregnant women about their smoking, without damaging their professional relationship with them. Predicated on producing individual behaviour change in women, the intervention does this largely through reorganising and standardising healthcare systems that are required to implement best practice guidelines. Changing organisational systems requires belief and commitment from staff, so that they set up and maintain practical adjustments to their practice and are reflective about adapting themselves and the work context as new challenges are encountered. The ongoing challenge is to identify and maintain the elements of the intervention package which are essential for its effectiveness and how to tailor them to local circumstances and resources without compromising its core ingredients.

Developing Behavior Change Interventions for Self-Management in Chronic Illness: An Integrative Overview.

More people than ever are living longer with chronic conditions such as obesity, type 2 diabetes, and heart disease. Behavior change for effective self-management can improve health outcomes and quality of life in people living with such chronic illnesses. The science of developing behavior change interventions with impact for patients aims to optimize the reach, effectiveness, adoption, implementation, and maintenance of interventions and rigorous evaluation of outcomes and processes of behavior change. The development of new services and technologies offers opportunities to enhance the scope of delivery of interventions to support behavior change and self-management at scale. Herein, we review key contemporary approaches to intervention development, provide a critical overview, and integrate these approaches into a pragmatic, user-friendly framework to rigorously guide decision-making in behavior change intervention development. Moreover, we highlight novel emerging methods for rapid and agile intervention development. On-going progress in the science of intervention development is needed to remain in step with such new developments and to continue to leverage behavioral science's capacity to contribute to optimizing interventions, modify behavior, and facilitate self-management in individuals living with chronic illness.

Evaluation of a complex healthcare intervention to increase smoking cessation in pregnant women: interrupted time series analysis with economic evaluation.

OBJECTIVES: To evaluate the effectiveness of a complex intervention to improve referral and treatment of pregnant smokers in routine practice, and to assess the incremental costs to the National Health Service (NHS) per additional woman quitting smoking. DESIGN: Interrupted time series analysis of routine data before and after introducing the intervention, within-study economic evaluation. SETTING: Eight acute NHS hospital trusts and 12 local authority areas in North East England. PARTICIPANTS: 37 726 records of singleton delivery including 10 594 to mothers classified as smoking during pregnancy. INTERVENTIONS: A package of measures implemented in trusts and smoking cessation services, aimed at increasing the proportion of pregnant smokers quitting during pregnancy, comprising skills training for healthcare and smoking cessation staff; universal carbon monoxide monitoring with routine opt-out referral for smoking cessation support; provision of carbon monoxide monitors and supporting materials; and an explicit referral pathway and follow-up protocol. MAIN OUTCOME MEASURES: Referrals to smoking cessation services; probability of quitting smoking during pregnancy; additional costs to health services; incremental cost per additional woman quitting. RESULTS: After introduction of the intervention, the referral rate increased more than twofold (incidence rate ratio=2.47, 95% CI 2.16 to 2.81) and the probability of quitting by delivery increased (adjusted OR=1.81, 95% CI 1.54 to 2.12). The additional cost per delivery was £31 and the incremental cost per additional quit was £952; 31 pregnant women needed to be treated for each additional quitter. CONCLUSIONS: The implementation of a system-wide complex healthcare intervention was associated with significant increase in rates of quitting by delivery.

The challenges of interventions to promote healthier food in independent takeaways in England: qualitative study of intervention deliverers' views.

BACKGROUND: Much of the food available from takeaways, pubs and restaurants particularly that sold by independent outlets, is unhealthy and its consumption is increasing. These food outlets are therefore important potential targets for interventions to improve diet and thus prevent diet related chronic diseases. Local authorities in England have been charged with delivering interventions to increase the provision of healthy food choices in independent outlets, but prior research shows that few such interventions have been rigorously developed or evaluated. We aimed to learn from the experiences of professionals delivering interventions in independent food outlets in England to identify the operational challenges and their suggestions for best practice. METHODS: We used one-to-one semi-structured qualitative interviews to explore the views and experiences of professionals who were either employees of, or contracted by, a local authority to deliver interventions to increase the provision of healthier food choices in independent food outlets. Purposive sampling was used to recruit a sample which included men and women, from a range of professional roles, across different areas of England. Interviews were informed by a topic guide, and proceeded until no new themes emerged. Interviews were recorded, transcribed verbatim and analysed using the Framework method. RESULTS: We conducted 11 individual interviews. Participants focussed on independent takeaways and their unhealthy food offerings, and highlighted the advantages and disadvantages of intervention delivery methods, their evaluation and impact. The main barriers to implementation of interventions in independent takeaways were identified as limited funding and the difficulties of engaging the food outlet owner/manager. Engagement was thought to be facilitated by delivering intensive, interactive and tailored interventions, clear and specific information, and incentives, whilst accounting for practical, primarily financial, constraints of food businesses. Alternative intervention approaches, targeting suppliers or customers, were suggested. CONCLUSIONS: Participants emphasised independent takeaways as particularly challenging, but worthwhile intervention targets. Participants perceived that interventions need to take account of the potentially challenging operating environment, particularly the primacy of the profit motive. Upstream interventions, engaging suppliers, as well as those that drive consumer demand, may be worth exploring. Rigorous, evidence-informed development and evaluation of such interventions is needed.

Support needs of patients with obesity in primary care: a practice-list survey.

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.

Liver triacylglycerol content and gestational diabetes: effects of moderate energy restriction.

AIMS/HYPOTHESIS: Women with a history of gestational diabetes mellitus (GDM) have raised liver triacylglycerol. Restriction of energy intake in type 2 diabetes can normalise glucose control and liver triacylglycerol concentration but it is not known whether similar benefits could be achieved in GDM. The aim of this work was to examine liver triacylglycerol accumulation in women with GDM and the effect of modest energy restriction. METHODS: Sixteen women with GDM followed a 4 week diet (5 MJ [1200 kcal]/day). Liver triacylglycerol, before and after diet and postpartum, was measured by magnetic resonance. Insulin secretion and sensitivity were assessed before and after diet. Twenty-six women who underwent standard antenatal care for GDM (matched for age, BMI, parity and ethnicity) were used as a comparator group. RESULTS: Fourteen women, who completed the study, achieved a weight loss of 1.6 ± 1.7 kg over the 4 week dietary period. Mean weight change was -0.4 kg/week in the study group vs +0.3 kg/week in the comparator group (p = 0.002). Liver triacylglycerol level was normal but decreased following diet (3.7% [interquartile range, IQR 1.2-6.1%] vs 1.8% [IQR 0.7-3.1%], p = 0.004). There was no change in insulin sensitivity or production. Insulin was required in six comparator women vs none in the study group (eight vs two required metformin). Blood glucose control was similar for both groups. The hypo-energetic diet was well accepted. CONCLUSIONS/INTERPRETATION: Liver triacylglycerol in women with GDM was not elevated, unlike observations in non-pregnant women with a history of GDM. A 4 week hypo-energetic diet resulted in weight loss, reduced liver triacylglycerol and minimised pharmacotherapy. The underlying pathophysiology of glucose metabolism appeared unchanged.