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The consumption of vegetables is vitally important for children’s health and development. However, in many Westernised countries, most children do not eat sufficient quantities of vegetables and consume many energy-dense and high-sugar foods; a health behaviour associated with the onset of non-communicable diseases. To address this important public health concern, it is necessary to think ‘outside the box’ and consider innovative and pragmatic ways to increase children’s daily vegetable intake. In many countries, caregivers implementing best-practice child feeding methods typically offer children vegetables at lunch, dinner and for snacks. It is unusual for children to be routinely offered vegetables for breakfast, yet there is no nutritional, physiological or medical reason why vegetables should not be eaten at breakfast. Indeed, in some countries, children frequently consume vegetables for breakfast. Increasing children’s exposure to vegetables at breakfast from an early age would allow for the development of a positive association between eating vegetables and breakfast, thus providing another opportunity in the day where vegetables might be regularly consumed by children. In this paper, we propose a rationale for why vegetables should be routinely offered to young children at breakfast time in countries where this may not be the norm. Future research assessing the feasibility and acceptability of such a public health intervention would provide health policy agencies with evidence about a potentially effective and easily implementable approach for increasing children’s vegetable intake, thus improving their overall nutritional status, as well as their heath and development.

Background After childbirth, most women do not lose the extra weight gained during pregnancy. This is important because postnatal weight retention contributes to the development of obesity in later life. Research shows that postnatal women living with overweight would prefer to weigh less, are interested in implementing weight loss strategies, and would like support. Without evidence for the benefit of weight management interventions during pregnancy, postnatal interventions are increasingly important. Research has focused on intensive weight loss programmes, which cannot be offered to all postnatal women. Instead, we investigated the feasibility of a brief intervention delivered to postnatal women at child immunisation appointments. This qualitative study explored the views of women who received the intervention and healthcare professionals who delivered it. Methods The intervention was delivered within the context of the national child immunisation programme. The intervention group were offered brief support encouraging self-management of weight when attending general practices to have their child immunised at two, three and four months of age. The intervention involved motivation and support from practice nurses to encourage women to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme. Nurses provided external accountability for weight loss. Women were asked to weigh themselves weekly and record this on a weight record card. Nested within this trial, semi-structured interviews explored the experiences of postnatal women who received the intervention and nurses who delivered it. Results The intervention was generally acceptable to participants and child immunisation appointments considered a suitable intervention setting. Nurses were hesitant to discuss maternal weight, viewing the postnatal period as a vulnerable time. Whilst some caveats to implementation were discussed by nurses, they felt the intervention was easy to deliver and would motivate postnatal women to lose weight. Conclusions Participants were keen to lose weight after childbirth. Overall, they reported that the intervention was acceptable, convenient, and, appreciated support to lose weight after childbirth. Although nurses, expressed concerns about raising the topic of weight in the early postnatal period, they felt the intervention was easy to deliver and would help to motivate women to lose weight.

Objective Patients with ANCA-associated vasculitis (AAV) experience high levels of fatigue, despite disease remission. This study assessed the feasibility and acceptability of a definitive randomized controlled trial of a behavioural-based physical activity intervention to support fatigue self-management in AAV patients. Methods AAV patients in disease remission with fatigue (Multidimensional Fatigue Inventory-20 general fatigue domain ≥14) were randomly allocated to intervention or standard care in this single-centre open-label randomized controlled feasibility study. The intervention lasted 12 weeks and comprised eight face-to-face physical activity sessions with a facilitator and 12 weekly telephone calls. Participants were encouraged to monitor their physical activity using a tracker device (Fitbit). Standard care involved sign-posting to fatigue websites. The primary outcome was feasibility of a phase III trial assessed against three stop/go traffic light criteria, (recruitment, intervention adherence and study withdrawal). A qualitative study assessed participant views about the intervention. Results A total of 248 patients were screened and 134 were eligible to participate (54%). Stop/go criteria were amber for recruitment; 43/134 (32%, 95% CI: 24, 40) eligible participants randomized, amber for adherence; 73% of participants attended all eight physical activity sessions, but only 11/22 (50%, 95% CI: 29, 71%) completed the intervention as per the intended schedule, and green for study withdrawal; 2/43 participants withdrew before 24 weeks (5%, 95% CI: 0, 11). Qualitative results suggested the intervention was acceptable. Conclusion This study suggests a behavioural-based physical activity intervention targeting fatigue self-management was acceptable to patients with AAV, although recruitment and protocol adherence will need modification prior to a definitive trial. Clinical Trial Registration Number ISRCTN11929227.

BackgroundMore men than women in the UK are living with overweight or obesity, but men are less likely to engage with weight loss programmes. Healthy Dads, Healthy Kids is an effective Australian weight management programme that targets fathers, who participate with their primary school-aged children. Behavioural interventions do not always transfer between contexts, so an adaptation of the Healthy Dads, Healthy Kids programme to an ethnically diverse UK setting was trialled.ObjectivesTo adapt and test the Australian Healthy Dads, Healthy Kids programme for delivery to men in an ethnically diverse, socioeconomically disadvantaged UK setting.DesignPhase 1a studied the cultural adaptation of the Healthy Dads, Healthy Kids programme and was informed by qualitative data from fathers and other family members, and a theoretical framework. Phase 1b was an uncontrolled feasibility trial. Phase 2 was a randomised controlled feasibility trial.SettingTwo ethnically diverse, socioeconomically disadvantaged UK cities.ParticipantsIn phase 1a, participants were parents and family members from black and minority ethnic groups and/or socioeconomically deprived localities. In phases 1b and 2, participants were fathers with overweight or obesity and their children aged 4–11 years.InterventionsThe adapted Healthy Dads, Healthy Kids intervention comprised nine sessions that targeted diet and physical activity and incorporated joint father–child physical activity. Healthy Dads, Healthy Kids was delivered in two programmes in phase 1b and four programmes in phase 2. Those in the comparator arm in phase 2 received a family voucher to attend a local sports centre.Main outcome measuresThe following outcomes were measured: recruitment to the trial, retention, intervention fidelity, attendance, feasibility of trial processes and collection of outcome data.ResultsForty-three fathers participated (intervention group,n = 29) in phase 2 (48% of recruitment target), despite multiple recruitment locations. Fathers’ mean body mass index was 30.2 kg/m2(standard deviation 5.1 kg/m2); 60.2% were from a minority ethnic group, with a high proportion from disadvantaged localities. Twenty-seven (63%) fathers completed follow-up at 3 months. Identifying sites for delivery at a time that was convenient for the families, with appropriately skilled programme facilitators, proved challenging. Four programmes were delivered in leisure centres and community venues. Of the participants who attended the intervention at least once (n = 20), 75% completed the programme (attended five or more sessions). Feedback from participants rated the sessions as ‘good’ or ‘very good’ and participants reported behavioural change. Researcher observations of intervention delivery showed that the sessions were delivered with high fidelity.ConclusionsThe intervention was well delivered and received, but there were significant challenges in recruiting overweight men, and follow-up rates at 3 and 6 months were low. We do not recommend progression to a definitive trial as it was not feasible to deliver the Healthy Dads, Healthy Kids programme to fathers living with overweight and obesity in ethnically diverse, socioeconomically deprived communities in the UK. More work is needed to explore the optimal ways to engage fathers from ethnically diverse socioeconomically deprived populations in research.Trial registrationCurrent Controlled Trials ISRCTN16724454.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 8, No. 2. See the NIHR Journals Library website for further project information.

Background Chronic obstructive pulmonary disease is a major contributor to morbidity, mortality and health service costs but is vastly underdiagnosed. Evidence on screening and how best to approach this is not clear. There are also uncertainties around the natural history (prognosis) of chronic obstructive pulmonary disease and how it impacts on work performance. Objectives Work package 1: to evaluate alternative methods of screening for undiagnosed chronic obstructive pulmonary disease in primary care, with clinical effectiveness and cost-effectiveness analyses and an economic model of a routine screening programme. Work package 2: to recruit a primary care chronic obstructive pulmonary disease cohort, develop a prognostic model [Birmingham Lung Improvement StudieS (BLISS)] to predict risk of respiratory hospital admissions, validate an existing model to predict mortality risk, address some uncertainties about natural history and explore the potential for a home exercise intervention. Work package 3: to identify which factors are associated with employment, absenteeism, presenteeism (working while unwell) and evaluate the feasibility of offering formal occupational health assessment to improve work performance. Design Work package 1: a cluster randomised controlled trial with household-level randomised comparison of two alternative case-finding approaches in the intervention arm. Work package 2: cohort study – focus groups. Work package 3: subcohort – feasibility study. Setting Primary care settings in West Midlands, UK. Participants Work package 1: 74,818 people who have smoked aged 40–79 years without a previous chronic obstructive pulmonary disease diagnosis from 54 general practices. Work package 2: 741 patients with previously diagnosed chronic obstructive pulmonary disease from 71 practices and participants from the work package 1 randomised controlled trial. Twenty-six patients took part in focus groups. Work package 3: occupational subcohort with 248 patients in paid employment at baseline. Thirty-five patients took part in an occupational health intervention feasibility study. Interventions Work package 1: targeted case-finding – symptom screening questionnaire, administered opportunistically or additionally by post, followed by diagnostic post-bronchodilator spirometry. The comparator was routine care. Work package 2: twenty-three candidate variables selected from literature and expert reviews. Work package 3: sociodemographic, clinical and occupational characteristics; occupational health assessment and recommendations. Main outcome measures Work package 1: yield (screen-detected chronic obstructive pulmonary disease) and cost-effectiveness of case-finding; effectiveness of screening on respiratory hospitalisation and mortality after approximately 4 years. Work package 2: respiratory hospitalisation within 2 years, and barriers to and facilitators of physical activity. Work package 3: work performance – feasibility and acceptability of the occupational health intervention and study processes. Results Work package 1: targeted case-finding resulted in greater yield of previously undiagnosed chronic obstructive pulmonary disease than routine care at 1 year [n = 1278 (4%) vs. n = 337 (1%), respectively; adjusted odds ratio 7.45, 95% confidence interval 4.80 to 11.55], and a model-based estimate of a regular screening programme suggested an incremental cost-effectiveness ratio of £16,596 per additional quality-adjusted life-year gained. However, long-term follow-up of the trial showed that at ≈4 years there was no clear evidence that case-finding, compared with routine practice, was effective in reducing respiratory admissions (adjusted hazard ratio 1.04, 95% confidence interval 0.73 to1.47) or mortality (hazard ratio 1.15, 95% confidence interval 0.82 to 1.61). Work package 2: 2305 patients, comprising 1564 with previously diagnosed chronic obstructive pulmonary disease and 741 work package 1 participants (330 with and 411 without obstruction), were recruited. The BLISS prognostic model among cohort participants with confirmed airflow obstruction (n = 1894) included 6 of 23 candidate variables (i.e. age, Chronic Obstructive Pulmonary Disease Assessment Test score, 12-month respiratory admissions, body mass index, diabetes and forced expiratory volume in 1 second percentage predicted). After internal validation and adjustment (uniform shrinkage factor 0.87, 95% confidence interval 0.72 to 1.02), the model discriminated well in predicting 2-year respiratory hospital admissions (c-statistic 0.75, 95% confidence interval 0.72 to 0.79). In focus groups, physical activity engagement was related to self-efficacy and symptom severity. Work package 3: in the occupational subcohort, increasing dyspnoea and exposure to inhaled irritants were associated with lower work productivity at baseline. Longitudinally, increasing exacerbations and worsening symptoms, but not a decline in airflow obstruction, were associated with absenteeism and presenteeism. The acceptability of the occupational health intervention was low, leading to low uptake and low implementation of recommendations and making a full trial unfeasible. Limitations Work package 1: even with the most intensive approach, only 38% of patients responded to the case-finding invitation. Management of case-found patients with chronic obstructive pulmonary disease in primary care was generally poor, limiting interpretation of the long-term effectiveness of case-finding on clinical outcomes. Work package 2: the components of the BLISS model may not always be routinely available and calculation of the score requires a computerised system. Work package 3: relatively few cohort participants were in paid employment at baseline, limiting the interpretation of predictors of lower work productivity. Conclusions This programme has addressed some of the major uncertainties around screening for undiagnosed chronic obstructive pulmonary disease and has resulted in the development of a novel, accurate model for predicting respiratory hospitalisation in people with chronic obstructive pulmonary disease and the inception of a primary care chronic obstructive pulmonary disease cohort for longer-term follow-up. We have also identified factors that may affect work productivity in people with chronic obstructive pulmonary disease as potential targets for future intervention. Future work We plan to obtain data for longer-term follow-up of trial participants at 10 years. The BLISS model needs to be externally validated. Our primary care chronic obstructive pulmonary disease cohort is a unique resource for addressing further questions to better understand the prognosis of chronic obstructive pulmonary disease. Trial registration Current Controlled Trials ISRCTN14930255. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 13. See the NIHR Journals Library website for further project information.

BackgroundOccupational sitting is associated with negative health outcomes. Sit–stand workstations have been shown to reduce sitting time in office workers, although there is no evidence on whether this change to practice would be acceptable to GPs.AimTo investigate GPs views about the use of sit–stand desks within general practice and the potential impact they may have on the nature and quality of consultations with adult patients.Design & settingObservational study involving GPs located across the UK.MethodAn online survey was emailed to members of the Royal College of General Practitioners (RCGP) and shared on social media. Only GPs working in the UK were eligible. The survey included questions on socio-demographics, GPs views about the use of sit–stand desks within their work, their levels of physical activity, total time spent sitting at work each day, and time spent at work.Results14 142 surveys were sent by the RCGP to their members with 810 GPs responding, with a further 33 responding via social media. 60.6% of GPs would like a sit–stand desks in their consultation room, while 19.2% already had one. Most GPs thought sit–stand desks could be used for telephone consultations (91.9%) and administration tasks (92.3%). There was less agreement about whether they could be used during face-to-face consultations (35.0% agreed), with the potential impact on the doctor–patient relationship raised as the primary concern.ConclusionThe implementation of sit–stand desks had support from GPs, but their possible impact on the doctor–patient relationship should be considered in future research.

Traditional weight management interventions typically involve people making large changes to their energy intake and/or expenditure and can be effective in the short term, but weight regain is common. An alternative strategy is a small change approach, which asks people to make small(er) changes to their diet and/or physical activity behaviors (e.g., 100-kcal reduction or increases of 1000 steps/day). This approach may lead to sustained weight management because such energy-deficit goals are easier for people to integrate into their lives and then maintain. This systematic review and meta-analysis of randomized and quasi-randomized controlled trials assessed the effectiveness of a small change approach for weight management; 21 trials were included. In weight gain prevention trials with adults, the mean difference in weight change between groups was -0.7 kg (95% CI -1.0 to -0.4, 95% PI -1.1 to -0.3) at program-end and -0.9 kg (95% CI -1.5 to -0.3, 95% PI -3.1 to 1.3) at last follow-up, favoring small change interventions. A small change approach was not effective for weight loss. Only 2/21 trials had a low risk of bias. Initial evidence supports the effectiveness of a small change approach for weight gain prevention but not weight loss. Further high-quality trials with longer follow-up are required.

Background Pregnancy is a high-risk time for excessive weight gain. The rising prevalence of obesity in women, combined with excess weight gain during pregnancy, means that there are more women with obesity in the postnatal period. This can have adverse health consequences for women in later life and increases the health risks during subsequent pregnancies. Objective The primary aim was to produce evidence of whether or not a Phase III trial of a brief weight management intervention, in which postnatal women are encouraged by practice nurses as part of the national child immunisation programme to self-monitor their weight and use an online weight management programme, is feasible and acceptable. Design The research involved a cluster randomised controlled feasibility trial and two semistructured interview studies with intervention participants and practice nurses who delivered the intervention. Trial data were collected at baseline and 3 months later. The interview studies took place after trial follow-up. Setting The trial took place in Birmingham, UK. Participants Twenty-eight postnatal women who were overweight/obese were recruited via Birmingham Women’s Hospital or general practices. Nine intervention participants and seven nurses were interviewed. Interventions The intervention was delivered in the context of the national child immunisation programme. The intervention group were offered brief support that encouraged self-management of weight when they attended their practice to have their child immunised at 2, 3 and 4 months of age. The intervention involved the provision of motivation and support by nurses to encourage participants to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme. The role of the nurse was to provide regular external accountability for weight loss. Women were asked to weigh themselves weekly and record this on a record card in their child’s health record (‘red book’) or using the online programme. The behavioural goal was for women to lose 0.5–1 kg per week. The usual-care group received a healthy lifestyle leaflet. Main outcome measures The primary outcome was the feasibility of a Phase III trial to test the effectiveness of the intervention, as assessed against three traffic-light stop–go criteria (recruitment, adherence to regular self-weighing and registration with an online weight management programme). Results The traffic-light criteria results were red for recruitment (28/80, 35% of target), amber for registration with the online weight loss programme (9/16, 56%) and green for adherence to weekly self-weighing (10/16, 63%). Nurses delivered the intervention with high fidelity. In the qualitative studies, participants indicated that the intervention was acceptable to them and they welcomed receiving support to lose weight at their child immunisation appointments. Although nurses raised some caveats to implementation, they felt that the intervention was easy to deliver and that it would motivate postnatal women to lose weight. Limitations Fewer participants were recruited than planned. Conclusions Although women and practice nurses responded well to the intervention and adherence to self-weighing was high, recruitment was challenging and there is scope to improve engagement with the intervention. Future work Future research should focus on investigating other methods of recruitment and, thereafter, testing the effectiveness of the intervention. Trial registration Current Controlled Trials ISRCTN12209332. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 49. See the NIHR Journals Library website for further project information.

Physical activity has many physical, mental, and social health benefits. Interventions can be successful at helping people initiate participation, but there is a lack of evidence about the ability of these interventions to help adults maintain their physical activity. This systematic review and meta-analysis aims to address this evidence gap. We investigated the extent to which successful physical activity interventions with demonstrated success within randomized controlled trials result in maintenance of device-measured physical activity (at least 3 months post-intervention end). Five databases were searched, and 8919 titles and abstracts were screened for eligibility, and 29 trials met the inclusion criteria. Of these, 22 were included in the meta-analysis. We found that 60% to 80% of physical activity behavior was maintained, as equivalent to an additional 45 min/week of moderate-to-vigorous physical activity and 945 steps per day compared with comparators. We also examined trials that randomized participants to maintenance interventions after an initial physical activity intervention (n = 7) and we found small effects (standardized mean difference 0.14, 95% confidence interval [CI] 0.1 to 0.27). The evidence suggests that most (60%-80%) of the increases in physical activity in successful programs are maintained for at least 3 months and there are small effects from providing a maintenance intervention to the public. Registration: CRD42019144585.

Evidence demonstrates that participation in regular physical activity (PA) reduces the risk of morbidity and mortality. However, current PA guidelines are focused on weekly accumulation of 150 min of moderate intensity PA as a threshold. Although recent developments of this guidance have discussed the merits of short bouts of physical activity, guidance that sets large behavioural goals for PA has not been successful in supporting the public to become sufficiently physically active and a ‘one-size fits all’ approach to PA guidelines may not be optimal. A complementary ‘whole day’ approach to PA promotion (i.e. incorporating PA throughout the day) that could motivate the population to be more physically active, is a concept we have called ‘Snacktivity™’. The Snacktivity™ approach promotes small or ‘bite’ size bouts (e.g. 2–5 min) of PA accumulated throughout the whole day. Snacktivity™ is consistent with the small change approach which suggest that behaviour change and habit formation are best achieved through gradual building of task self-efficacy, celebrating small successes. Snacktivity™ also offers opportunities to “piggyback” on to existing behaviours/habits, using them as prompts for Snacktivity™. Moreover, small behaviour changes are easier to initiate and maintain than larger ones. A plethora of evidence supports the hypothesis that Snacktivity may be a more acceptable and effective way to help the public reach, or exceed current PA guidelines. This paper outlines the evidence to support the Snacktivity™ approach and the mechanisms by which it may increase population levels of physical activity. Future research directions for Snacktivity™ are also outlined.

PACE food labelling seeks to provide kilocalorie information with an interpretation of what the kilocalorie content of the food item or meal means for energy expenditure. For example, "the kilocalories in this pizza require 110 minutes of walking to expend". Displaying calorie content in an easily understandable format is important given evidence indicating that the public consistently underestimate the energy content of food when labelling is not provided. Evidence from systematic reviews and trials testing the effects of PACE labelling point to the possible benefits of inclusion on food labels and menus. However, several criticisms of this labelling system have been raised. This commentary explores both the issues and opportunities related to PACE food labelling, arguing that the benefits of implementation outweigh potential unintended consequences.

Abstract Recently revised public health guidelines acknowledge the health benefits of regular intermittent bouts of vigorous intensity incidental physical activity done as part of daily living, such as carrying shopping bags, walking uphill, and stair climbing. Despite this recognition and the advantages such lifestyle physical activity has over continuous vigorous intensity structured exercise, a scoping review we conducted revealed that current research in this area is, at best, rudimentary. Key gaps include the absence of an empirically-derived dose specification (e.g., minimum duration of lifestyle physical activity required to achieve absolute or relative vigorous intensity), lack of acceptable measurement standards, limited understanding of acute and chronic (adaptive) effects of intermittent vigorous bouts on health, and paucity of essential information necessary to develop feasible and scalable interventions (e.g., acceptability of this kind of physical activity by the public). To encourage collaboration and research agenda alignment among groups interested in this field, we propose a research framework to further understanding of vigorous intermittent lifestyle physical activity (VILPA). This framework comprises four pillars aimed at the development of: (a) an empirical definition of VILPA, (b) methods to reliably and accurately measure VILPA, (c) approaches to examine the short and long-term dose–response effects of VILPA, and (d) scalable and acceptable behavioural VILPA-promoting interventions. Graphic Abstract

Weight loss programmes appeal mainly to women, prompting calls for gender-specific programmes. In the United Kingdom, general practitioners (GPs) refer nine times as many women as men to community weight loss programmes. GPs endorsement and offering programmes systematically could reduce this imbalance. In this trial, consecutively attending patients in primary care with obesity were invited and 1882 were enrolled and randomized to one of two opportunistic 30-second interventions to support weight loss given by GPs in consultations unrelated to weight. In the support arm, clinicians endorsed and offered referral to a weight loss programme and, in the advice arm, advised that weight loss would improve health. Generalized linear mixed effects models examined whether gender moderated the intervention. Men took effective weight loss action less often in both arms (support: 41.6% vs 60.7%; advice: 12.1% vs 18.3%; odds ratio (OR) = 0.38, 95% confidence interval (CI), 0.27, 0.52, P

Background Women commonly seek medical advice about menopausal symptoms. Although menopausal hormone therapy is the most effective treatment, many women prefer non-pharmacological treatments, such as physical activity. The effectiveness of physical activity has been inconclusive when assessed by randomised controlled trials, and it remains unclear how women feel about it as a possible treatment approach. The aim of the study was to explore symptomatic menopausal women’s views and experiences of physical activity as a treatment for vasomotor and other menopausal symptoms. Methods An in-depth qualitative study was embedded within a randomised controlled trial that assessed the effectiveness of physical activity as a treatment for vasomotor menopausal symptoms in previously inactive vasomotor symptomatic women. Participants were randomised to one of two physical activity interventions or a usual care group. Both physical activity interventions involved two one-to-one consultations, plus either supporting materials or access to physical activity support groups, over 6 months. Semi-structured interviews were conducted with 17 purposively selected participants from all three trial groups after they had completed trial follow-up. Interviews were audio recorded, transcribed verbatim, and analysed by constant comparison. Results All participants talked positively about physical activity as a treatment for their menopausal symptoms, with most reporting participation had improved their hot flushes and night sweats. They reported that they had experienced improved sleep, physical health and psychological well-being. Those who received the physical activity plus social-support intervention reported their ability to cope with their menopausal symptoms had improved. Many participants commented that they would prefer doctors to discuss physical activity as a possible treatment for their hot flushes and night sweats, before offering medication. Conclusions Based on the views and experiences of the women who participated in this study, healthcare professionals should continue discussing physical activity as a potential first treatment option with menopausal women. Furthermore, healthcare professionals should ensure they prepare, support, and encourage these women both physically and emotionally. Trial registration ISRCTN ISRCTN06495625 Registered 10/11/2010

Background The prevalence of obesity in women continues to rise and pregnancy is a high-risk time for excessive weight gain. The period after childbirth represents an opportunity to offer women support to manage their weight. The primary aim here was to investigate the acceptability and feasibility of delivering a self-management intervention to postnatal women to support weight loss, embedded within the national child immunisation programme. Methods The research involved a randomised controlled cluster feasibility trial. Data were collected at baseline and 3 months later. Twenty-eight postnatal women living with overweight or obesity were recruited via Birmingham Women Hospital or general practices. Babies are routinely immunised at 2, 3 and 4 months of age; the intervention was embedded within these appointments. The intervention involved brief motivation/support by practice nurses to encourage participants to make healthier lifestyle choices through self-monitoring of weight and signposting to an online weight management programme, when they attended their practice to have their child immunised. The role of the nurse was to provide external accountability for weight loss. Participants were asked to weigh themselves weekly and record this on a record card or using the online programme. The weight goal was for participants to lose 0.5 to 1 kg per week. Usual care received a healthy lifestyle leaflet. The primary outcome was the feasibility of a phase III trial to test the subsequent effectiveness of the intervention, as assessed against three stop-go traffic light criteria (recruitment, adherence to regular self-weighing and registration with an online weight management programme). Results The traffic light stop-go criteria results were red for recruitment (28/80, 35% of target), amber for registration with the online weight loss programme (9/16, 56%) and green for adherence to weekly self-weighing (10/16, 63%). Nurses delivered the intervention with high fidelity. Discussion Whilst participants and nurses followed the trial protocol well and adherence to self-weighing was acceptable, recruitment was challenging and there is scope to improve engagement with the online weight management programme component of the intervention. Trial registration ISRCTN 12209332. Registration date is 04/12/18.

BackgroundExercise is recommended as a treatment for premenstrual syndrome (PMS) in clinical guidelines, but this is currently based on poor-quality trial evidence.AimTo systematically review the evidence for the effectiveness of exercise as a treatment for PMS.Design & settingThis systematic review searched eight major databases, including MEDLINE, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL), and two trial registries from inception until April 2019.MethodRandomised controlled trials (RCTs) comparing exercise interventions of a minimum of 8-weeks duration with non-exercise comparator groups in women with PMS were included. Mean change scores for any continuous PMS outcome measure were extracted from eligible trials and standardised mean differences (SMDs) were calculated where possible. Random-effects meta-analysis of the effect of exercise on global PMS symptoms was the primary outcome. Secondary analyses examined the effects of exercise on predetermined clusters of psychological, physical, and behavioural symptoms.ResultsA total of 436 non-duplicate returns were screened, with 15 RCTs eligible for inclusion (n = 717). Seven trials contributed data to the primary outcome meta-analysis (n = 265); participants randomised to an exercise intervention reported reduced global PMS symptom scores (SMD = -1.08; 95% confidence interval [CI] = -1.88 to -0.29) versus comparator, but with substantial heterogeneity (I2 = 87%). Secondary results for psychological (SMD = -1.67; 95% CI = -2.38 to -0.96), physical (SMD = -1.62; 95% CI = -2.41 to -0.83) and behavioural (SMD = -1.94; 95% CI = -2.45 to -1.44) symptom groupings displayed similar findings. Most trials (87%) were considered at high risk of bias.ConclusionBased on current evidence, exercise may be an effective treatment for PMS, but some uncertainty remains.

IntroductionOn average women retain 5 to 9 kg 1 year after giving birth which can increase the risk of later obesity and chronic diseases. Some previous trials in this population have been effective in reducing weight, but are too intensive and costly to deliver at scale. There is a need for low-cost interventions to facilitate weight loss in this population.Methods and analysisThe primary aim is to assess the feasibility of delivering a weight management intervention for overweight/obese postnatal women within child immunisation appointments. We will conduct a randomised controlled cluster feasibility trial with a nested qualitative study to assess study recruitment and acceptability of the intervention. General practitioner practice (cluster) will be the unit of randomisation, with practices randomised to offer usual care plus the intervention or usual care only. Eighty women will be recruited. The intervention group will be offered brief support that encourages self-management of weight when attending child immunisation appointments. Practice nurses will encourage women to weigh themselves weekly and record this, and to make healthy lifestyle choices through using an online weight management programme. Women will be advised to aim for 0.5 to 1 kg/week weight loss. At each child immunisation the nurse will assess progress by weighing women. The comparator group will receive a healthy lifestyle leaflet. Data on weight, body fat, depression, anxiety, body image, eating behaviours and physical activity will be collected at baseline and follow-up. Women and nurses will be interviewed to ascertain their views about the intervention. The decision to proceed to the phase III trial will be based on prespecified stop-go criteria.Ethics and disseminationData will be stored securely at the University of Birmingham. Results will be disseminated through academic publications and presentations and will inform a possible phase III trial. The National Research Ethics Committee approved the study protocol.Trial registration numberNCT12209332

BackgroundThere is limited evidence that nutritional labelling on food/drinks is changing eating behaviours. Physical activity calorie equivalent (PACE) food labelling aims to provide the public with information about the amount of physical activity required to expend the number of kilocalories in food/drinks (eg, calories in this pizza requires 45 min of running to burn), to encourage healthier food choices and reduce disease.ObjectiveWe aimed to systematically search for randomised controlled trials and experimental studies of the effects of PACE food labelling on the selection, purchase or consumption of food/drinks.MethodsPACE food labelling was compared with any other type of food labelling or no labelling (comparator). Reports were identified by searching electronic databases, websites and social media platforms. Inverse variance meta-analysis was used to summarise evidence. Weighted mean differences (WMD) and 95% CIs were used to describe between-group differences using a random effects model.Results15 studies were eligible for inclusion. When PACE labelling was displayed on food/drinks and menus, significantly fewer calories were selected, relative to comparator labelling (WMD=−64.9 kcal, 95% CI −103.2 to −26.6, p=0.009, n=4606). Presenting participants with PACE food labelling results in the consumption of significantly fewer calories (WMD=−80.4 kcal, 95% CI−136.7 to −24.2, p=0.005, n=486) relative to comparator food labelling.ConclusionBased on current evidence PACE food labelling may reduce the number of kilocalories selected from menus and decrease the number of kilocalories/grams of food consumed by the public, compared with other types of food labelling/no labelling.Trial registration numberCRD42018088567.

Contains fulltext : 220990.pdf (Publisher’s version ) (Closed access) PURPOSE: Fatigue is a common and potentially disabling symptom in patients with cancer. It can often be effectively reduced by exercise. Yet, effects of exercise interventions might differ across subgroups. We conducted a meta-analysis using individual patient data of randomized controlled trials (RCT) to investigate moderators of exercise intervention effects on cancer-related fatigue. METHODS: We used individual patient data from 31 exercise RCT worldwide, representing 4366 patients, of whom 3846 had complete fatigue data. We performed a one-step individual patient data meta-analysis, using linear mixed-effect models to analyze the effects of exercise interventions on fatigue (z score) and to identify demographic, clinical, intervention- and exercise-related moderators. Models were adjusted for baseline fatigue and included a random intercept on study level to account for clustering of patients within studies. We identified potential moderators by testing their interaction with group allocation, using a likelihood ratio test. RESULTS: Exercise interventions had statistically significant beneficial effects on fatigue (beta = -0.17; 95% confidence interval [CI], -0.22 to -0.12). There was no evidence of moderation by demographic or clinical characteristics. Supervised exercise interventions had significantly larger effects on fatigue than unsupervised exercise interventions (betadifference = -0.18; 95% CI -0.28 to -0.08). Supervised interventions with a duration

Exercise effects in cancer patients often appear modest, possibly because interventions rarely target patients most in need. This study investigated the moderator effects of baseline values on the exercise outcomes of fatigue, aerobic fitness, muscle strength, quality of life (QoL), and self-reported physical function (PF) in cancer patients during and post-treatment. Methods: Individual patient data from 34 randomized exercise trials (n = 4519) were pooled. Linear mixed-effect models were used to study moderator effects of baseline values on exercise intervention outcomes and to determine whether these moderator effects differed by intervention timing (during vs post-treatment). All statistical tests were two-sided. Results: Moderator effects of baseline fatigue and PF were consistent across intervention timing, with greater effects in patients with worse fatigue (Pinteraction = .05) and worse PF (Pinteraction = .003). Moderator effects of baseline aerobic fitness, muscle strength, and QoL differed by intervention timing. During treatment, effects on aerobic fitness were greater for patients with better baseline aerobic fitness (Pinteraction = .002). Post-treatment, effects on upper (Pinteraction < .001) and lower (Pinteraction = .01) body muscle strength and QoL (Pinteraction < .001) were greater in patients with worse baseline values. Conclusion: Although exercise should be encouraged for most cancer patients during and post-treatments, targeting specific subgroups may be especially beneficial and cost effective. For fatigue and PF, interventions during and post-treatment should target patients with high fatigue and low PF. During treatment, patients experience benefit for muscle strength and QoL regardless of baseline values; however, only patients with low baseline values benefit post-treatment. For aerobic fitness, patients with low baseline values do not appear to benefit from exercise during treatment. Sin financiación 13.757 JCR (2018) Q1, 6/196 Oncology 5.827 SJR (2018) Q1, 6/226 Cancer Research, 10/381 Oncology No data IDR 2018 UEM

Background - Fatigue is one of the most common and disabling complaints in patients with breast cancer and can effectively be reduced by physical exercise, with small to moderate effect sizes. To identify heterogeneity in responses to exercise and to further personalize exercise prescriptions, moderators of exercise effects on fatigue should be investigated. However, most randomized controlled trials (RCTs) are not adequately powered for such analyses. Therefore we conducted meta-analyses using the individual patient data of several exercise RCTs. The aim is to investigate the effect and moderators of physical exercise on cancer-related fatigue in patients with breast cancer. Methods - Within the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium, principal investigators of 34 exercise RCTs worldwide have shared their individual patient data. Twenty-two of these RCTs included patients with breast cancer with a total sample size of 3,061. Different questionnaires to assess level of fatigue were used, which was acknowledged by using z-scores in the analysis. A one-step individual patient data meta-analysis, using a linear mixed-effect model adjusted for baseline fatigue, with a random intercept on study (to account for study clustering) was undertaken to investigate effect of exercise on fatigue. The result, a between-group difference in z-scores, corresponds to a Cohen's d effect size. An interaction term was included in the model to assess potential moderators including demographic (age, marital status, education), clinical (body mass index, presence of distant metastasis), intervention-related (intervention timing, delivery mode and duration), and exercise-related (exercise type, frequency, intensity, duration) characteristics. Results – Exercise significantly reduced fatigue reported by women with breast cancer (β= -0.15, 95% CI -0.21;-0.09). This effect did not differ significantly between patients with different demographic and clinical characteristics (p-valuesinteraction >0.05). Also, neither timing (during or post-treatment) and duration of the intervention, nor exercise-related factors moderated intervention effects on fatigue. Supervised exercise had significantly larger effects on fatigue than unsupervised exercise (βdifference= -0.17, 95%CI -0.28;-0.05). Compared to the control group, supervised exercise significantly improved fatigue (β = -0.21, 95%CI = -0.28;-0.14), while unsupervised exercise did not (β = -0.04, 95%CI = -0.14;0.06). Conclusion – Exercise significantly reduces fatigue in patients with breast cancer across subgroups formed on the basis of age, marital status, education level, body mass index, and presence of distant metastasis. The effect of exercise is significantly larger when performed under supervision. Hence, exercise, and preferably supervised exercise, represents a viable intervention for the prevention and treatment of fatigue among patients with breast cancer. Citation Format: van Vulpen JK, Sweegers MG, Kalter J, Peeters PH, Courneya KS, Newton RU, Aaronson NK, Jacobsen PB, Steindorf K, Stuiver MM, Hayes S, Mesters I, Knoop H, Goedendorp M, Mutrie N, Thorsen L, Schmidt M, Sonke GS, Bohus M, James EL, Oldenburg HS, Velthuis MJ, Nollet F, Wenzel J, Wiskemann J, Galvão DA, Chinapaw MJ, Irwin ML, Griffith KA, van Weert E, Daley AJ, McConnachie A, Schulz K-H, Short CE, Plotnikoff RC, Potthoff K, van Beurden M, van Harten WH, Schmitz KH, Winters-Stone KM, Taaffe DR, van Mechelen W, Kersten M-J, Verdonck-de Leeuw IM, Brug J, Buffart LM, May AM. Effect and moderators of exercise on fatigue in patients with breast cancer: Meta-analysis of individual patient data [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr P6-12-06.

BackgroundThere is currently no specific guidance on the role of exercise in managing postpartum depression in the UK and US, and international guidance is inconsistent.AimTo assess the effectiveness of aerobic exercise on postpartum depressive symptoms.Design and settingSystematic review and meta-analysis. There was no restriction to study site or setting.MethodThe databases MEDLINE, EMBASE, Cochrane Library, PsycINFO, SportDiscus, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform were searched. Titles and abstracts, then full-text articles, were screened against inclusion criteria: RCTs measuring depressive symptoms in mothers ≤1 year postpartum; and interventions designed to increase aerobic exercise compared with usual care or other comparators. Included studies were assessed using the Cochrane Collaboration’s risk of bias tool. Meta-analysis was conducted. Pre-planned subgroup analyses explored heterogeneity.ResultsThirteen RCTs were included, with 1734 eligible participants. Exercise significantly reduced depressive symptoms when all trials were combined (standardised mean difference −0.44; 95% confidence interval = −0.75 to −0.12). Exploration of heterogeneity did not find significant differences in effect size between women with possible depression and in general postpartum populations; exercise only and exercise with co-interventions; and group exercise and exercise counselling.ConclusionThis systematic review provides support for the effectiveness of exercise in reducing postpartum depressive symptoms. Group exercise, participant-chosen exercise, and exercise with co-interventions all may be effective interventions. These results should be interpreted with caution because of substantial heterogeneity and risk of bias.

BackgroundAlthough behavioural weight loss treatments can be effective, long-term maintenance of this weight loss remains a critical challenge because the vast majority of people will regain their lost weight over time. The period after initial weight loss is the time when people are at the highest risk of weight regain.ObjectiveThe primary aim of this study was to evaluate the effectiveness and cost-effectiveness of a brief behavioural intervention delivered by non-specialist call centre staff to promote regular self-weighing to prevent weight regain after intentional weight loss.DesignRandomised controlled trial.SettingWest Midlands, UK.ParticipantsAdults were recruited if they had attended a local authority-funded weight management programme and had lost ≥ 5% of their starting weight by the end of their weight loss programme.InterventionsThe intervention group received three brief support telephone calls, delivered by non-specialist call centre staff (from a third-sector community organisation), that encouraged setting a weight maintenance target of ≤ 1 kg of weight gain from current weight, which was to be assessed by daily self-weighing and recording weight on a record card, together with regular text messages. Participants were asked to return to their weight loss plan if they gained > 1 kg above their target weight. The usual-care group received a standard weight maintenance leaflet, the infographic EatWell Plate and a list of useful websites pertaining to weight management.Main outcome measuresThe primary outcome was the difference between the groups in mean weight change (kg) from baseline to 12 months. The secondary outcomes included the proportion of participants in each group who had regained ResultsA total of 813 potential participants were screened, 583 of whom were eligible and randomised (usual care,n = 292; intervention,n = 291). A total of 94% and 89% of participants completed follow-up at 3 and 12 months, respectively. At 12 months, the mean unadjusted weight change was +0.39 kg for the intervention group and –0.17 kg for the usual-care group, an adjusted difference of 0.53 kg [95% confidence interval (CI) –0.64 to 1.71 kg]. At 12 months, 134 (45.9%) and 130 (44.7%) participants regained ≤ 1 kg of their baseline weight in the usual-care and intervention groups, respectively (odds ratio 0.96, 95% CI 0.69 to 1.33). As the intervention was ineffective, we did not pursue a cost-effectiveness analysis.ConclusionsBrief behavioural telephone support delivered by non-specialist workers to promote target-setting and daily self-weighing and recording of weight does not prevent weight regain after intentional weight loss. Specifically, as target-setting and daily self-weighing did not increase conscious cognitive restraint, people may need more intensive interventions to promote the use of behavioural techniques that help people maintain lost weight.Trial registrationCurrent Controlled Trials ISRCTN52341938.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 7, No. 7. See the NIHR Journals Library website for further project information.

Increased stair climbing reduces cardiovascular disease risk. While signage interventions for workplace stair climbing offer a low-cost tool to improve population health, inconsistent effects of intervention occur. Pedestrian movement within the built environment has major effects on stair use, independent of any health initiative. This paper used pooled data from UK and Spanish workplaces to test the effects of signage interventions when pedestrian movement was controlled for in analyses. Automated counters measured stair and elevator usage at the ground floor throughout the working day. Signage interventions employed previously successful campaigns. In the UK, minute-by-minute stair/elevator choices measured effects of momentary pedestrian traffic at the choice-point (n = 426,605). In Spain, aggregated pedestrian traffic every 30 min measured effects for &lsquo, busyness&rsquo, of the building (n = 293,300). Intervention effects on stair descent (3 of 4 analyses) were more frequent than effects on stair climbing, the behavior with proven health benefits (1 of 4 analyses). Any intervention effects were of small magnitude relative to the influence of pedestrian movement. Failure to control for pedestrian movement compromises any estimate for signage effectiveness. These pooled data provide limited evidence that signage interventions for stair climbing at work will enhance population health.

At least half of those with COPD are undiagnosed, but current guidelines do not recommend screening partly because evidence of clinical benefit is not available. We previously conducted the TargetCOPD trial demonstrating that yield from active case-finding was significantly higher compared to routine practice (OR=7.45). We now report on clinical outcomes at 4yr follow up. We obtained data through NHS Digital on mortality and hospitalisations (all-cause and respiratory) for 74,693 participants from all 54 practices in the TargetCOPD case-finding trial. Cox proportional hazard models, using random effects, adjusted for potential confounding factors were used to model time to event outcomes (first respiratory hospital admission, first all cause hospital admission and death) in the case-finding and routine arms. Time to event was censored at death or data extraction (Sept17) if no event occurred. Analyses were adjusted for a range of potential confounders, including age, sex, ethnicity and baseline values for lung function, comorbidities and smoking status. Of the 32,743 participants in the case-finding arm, 1,557 had a respiratory hospitalisation compared to 1,899/ 41,950 in the routine arm over a mean follow up of 4.3 years (adjusted hazard ratio (HR) 1.04; 95% CI: 0.73, 1.47). The corresponding HR for all cause hospitalisation and mortality were 1.06 (0.66, 1.71) and 1.15 (0.82, 1.61) respectively. Thus despite screening resulting in higher yield, there were no differences in clinical outcomes at 4 years. Further research is needed to understand the process of management following screening and the effectiveness of existing treatments in case-found patients.

Prognostic scores could be used to guide management of COPD patients and reduce risk of hospital admission but existing scores do not perform well enough and are not practical for primary care. Using data from the Birmingham primary care COPD cohort we developed and internally validated the new BLISS prognostic score from 23 candidate variables. 1558 patients on COPD registers of 71 GP practices and 331 newly-identified patients from a linked case-finding trial were included and their self-reported and clinical data were combined with routine hospital episode statistics. Primary outcome was the record of at least one respiratory admission within 2 years of cohort entry. The model was developed using backward elimination. Missing data were imputed using chained equations. Discrimination and calibration were assessed. Bootstrapping was used for internal validation. Median (min, max) follow up was 2.9 years (1.8, 3.8). 6 variables were retained in the final model: age, CAT score, respiratory admissions previous 12m, BMI, diabetes, FEV1% predicted. After adjustment for optimism, the model performed well in predicting 2yr respiratory admissions (c statistic=0.75 (95%CI 0.72, 0.79). The BLISS score showed better performance in predicting respiratory admissions than existing published scores. All 6 variables are readily available in primary care records or would be easy to collect, and a simple computer programme could calculate the score. Important next steps are external validation, proposing/evaluating a model of use to guide patient management and exploration of the best ways to implement the score in primary care practice.

ObjectivesTo assess the effectiveness of a brief behavioural intervention based on routine antenatal weighing to prevent excessive gestational weight gain (defined by US Institute of Medicine).DesignRandomised controlled trial.SettingAntenatal clinic in England.ParticipantsWomen between 10+0and 14+6weeks gestation, not requiring specialist obstetric care.InterventionsParticipants were randomised to usual antenatal care or usual care (UC) plus the intervention. The intervention involved community midwives weighing women at antenatal appointments, setting maximum weight gain limits between appointments and providing brief feedback. Women were encouraged to monitor and record their own weight weekly to assess their progress against the maximum limits set by their midwife. The comparator was usual maternity care.Primary and secondary outcome measuresExcessive gestational weight gain, depression, anxiety and physical activity.ResultsSix hundred and fifty-six women from four maternity centres were recruited: 329 women were randomised to the intervention group and 327 to UC. We found no evidence that the intervention decreased excessive gestational weight gain. At 38 weeks gestation, the proportions gaining excessive gestational weight were 27.6% (81/305) versus 28.9% (90/311) (adjusted OR 0.84, 95% CI: 0.53 to 1.33) in the intervention and UC group, respectively. There were no significant difference between the groups in anxiety or depression scores (anxiety: adjusted mean −0.58, 95% CI:−1.25 to –0.8; depression: adjusted mean −0.60, 95% CI:−1.24 to –0.05). There were no significant differences in physical activity scores between the groups.ConclusionsA behavioural intervention delivered by community midwives involving routine weighing throughout pregnancy, setting maximum weight gain targets and encouraging women to weigh themselves each week to check progress did not prevent excessive gestational weight gain. There was no evidence of psychological harm.Trial registration numberISRCTN67427351

Introduction‘One-off’ systematic case-finding for COPD using a respiratory screening questionnaire is more effective and cost-effective than routine care at identifying new cases. However, it is not known whether early diagnosis and treatment is beneficial in the longer term. We estimated the long-term cost-effectiveness of a regular case-finding programme in primary care.MethodsA Markov decision analytic model was developed to compare the cost-effectiveness of a 3-yearly systematic case-finding programme targeted to ever smokers aged ≥50 years with the current routine diagnostic process in UK primary care. Patient-level data on case-finding pathways was obtained from a large randomised controlled trial. Information on the natural history of COPD and treatment effects was obtained from a linked COPD cohort, UK primary care database and published literature. The discounted lifetime cost per quality-adjusted life-year (QALY) gained was calculated from a health service perspective.ResultsThe incremental cost-effectiveness ratio of systematic case-finding versus current care was £16 596 per additional QALY gained, with a 78% probability of cost-effectiveness at a £20 000 per QALY willingness-to-pay threshold. The base case result was robust to multiple one-way sensitivity analyses. The main drivers were response rate to the initial screening questionnaire and attendance rate for the confirmatory spirometry test.DiscussionRegular systematic case-finding for COPD using a screening questionnaire in primary care is likely to be cost-effective in the long-term despite uncertainties in treatment effectiveness. Further knowledge of the natural history of case-found patients and the effectiveness of their management will improve confidence to implement such an approach.

Background The Brief Intervention for Weight Loss Trial enrolled 1882 consecutively attending primary care patients who were obese and participants were randomised to physicians opportunistically endorsing, offering, and facilitating a referral to a weight loss programme (support) or recommending weight loss (advice). After one year, the support group lost 1.4 kg more (95%CI 0.9 to 2.0): 2.4 kg versus 1.0 kg. We use a cohort simulation to predict effects on disease incidence, quality of life, and healthcare costs over 20 years. Methods Randomly sampling from the trial population, we created a virtual cohort of 20 million adults and assigned baseline morbidity. We applied the weight loss observed in the trial and assumed weight regain over four years. Using epidemiological data, we assigned the incidence of 12 weight-related diseases depending on baseline disease status, age, gender, body mass index. From a healthcare perspective, we calculated the quality adjusted life years (QALYs) accruing and calculated the incremental difference between trial arms in costs expended in delivering the intervention and healthcare costs accruing. We discounted future costs and benefits at 1.5% over 20 years. Results Compared with advice, the support intervention reduced the cumulative incidence of weight-related disease by 722/100,000 people, 0.33% of all weight-related disease. The incremental cost of support over advice was £2.01million/100,000. However, the support intervention reduced health service costs by £5.86 million/100,000 leading to a net saving of £3.85 million/100,000. The support intervention produced 992 QALYs/100,000 people relative to advice. Conclusions A brief intervention in which physicians opportunistically endorse, offer, and facilitate a referral to a behavioural weight management service to patients with a BMI of at least 30 kg/m2 reduces healthcare costs and improves health more than advising weight loss.

Background Guidelines recommend that clinicians should make brief opportunistic behavioural interventions to patients who are obese to increase the uptake of effective weight loss programmes. The objective was to assess the effect of this policy on socioeconomic equity. Methods One thousand eight hundred eighty-two consecutively attending patients with obesity and who were not seeking support for weight loss from their GP were enrolled in a trial. Towards the end of each consultation, GPs randomly assigned participants to one of two 30-s interventions. In the active intervention (support arm), the GP offered referral to a weight management group. In the control intervention (advice arm), the GP advised the patient that their health would benefit from weight loss. Agreement to attend a behavioural weight loss programme, attendance at the programme and weight loss at 12 months were analysed by socioeconomic status, measured by postcode using the Index of Multiple Deprivation (IMD). Results Mean weight loss was 2.43 kg (sd 6.49) in the support group and 1.04 kg (sd 5.50) for the advice only group, but these effects were moderated by IMD (p = 0.039 for the interaction). In the support arm, weight loss was greater in higher socioeconomic groups. Participants from lower socioeconomic backgrounds were more likely to accept the offer and equally likely to attend a weight loss referral but attended fewer sessions. Adjusting for these sequentially reduced the gradient for the association of socioeconomic status with weight loss from + 0.035 to − 0.001 kg/IMD point. In the advice only arm, 10% took effective action to promote weight loss. The decision to seek support for weight loss outside of the trial did not differ by socioeconomic status, but weight loss among deprived participants who used external support was greater than among more affluent participants (p = 0.025). Conclusion Participants’ responses to GPs’ brief opportunistic interventions to promote weight loss differed by socioeconomic status and trial arm. In the support arm, more deprived people lost less weight because they attended fewer sessions at the programme. In the advice arm, more deprived people who sought and paid for support for weight loss themselves lost more weight than more affluent people who sought support. Trial registration This trial is registered with the ISRCTN registry, number ISRCTN26563137. Date of registration: January 3, 2013; date of first participant recruited: June 4, 2014 Electronic supplementary material The online version of this article (10.1186/s12916-019-1284-y) contains supplementary material, which is available to authorized users.

This individual patient data meta-analysis aimed to evaluate the effects of exercise on quality of life (QoL) and physical function (PF) in patients with cancer, and to identify moderator effects of demographic (age, sex, marital status, education), clinical (body mass index, cancer type, presence of metastasis), intervention-related (intervention timing, delivery mode and duration, and type of control group), and exercise-related (exercise frequency, intensity, type, time) characteristics. Relevant published and unpublished studies were identified in September 2012 via PubMed, EMBASE, PsycINFO, and CINAHL, reference checking and personal communications. Principle investigators of all 69 eligible trials were requested to share IPD from their study. IPD from 34 randomised controlled trials (n = 4519 patients) that evaluated the effects of exercise compared to a usual care, wait-list or attention control group on QoL and PF in adult patients with cancer were retrieved and pooled. Linear mixed-effect models were used to evaluate the effects of the exercise on post-intervention outcome values (z-score) adjusting for baseline values. Moderator effects were studies by testing interactions. Exercise significantly improved QoL (β = 0.15, 95%CI = 0.10;0.20) and PF (β = 0.18, 95%CI = 0.13;0.23). The effects were not moderated by demographic, clinical or exercise characteristics. Effects on QoL (βdifference_in_effect = 0.13, 95%CI = 0.03;0.22) and PF (βdifference_in_effect = 0.10, 95%CI = 0.01;0.20) were significantly larger for supervised than unsupervised interventions. In conclusion, exercise, and particularly supervised exercise, effectively improves QoL and PF in patients with cancer with different demographic and clinical characteristics during and following treatment. Although effect sizes are small, there is consistent empirical evidence to support implementation of exercise as part of cancer care. Alpe d’HuZes foundation/Dutch Cancer Society (VU 2011-5045) 8.122 JCR (2017) Q1, 21/222 Oncology 3.420 SJR (2017) Q1, 62/2878 Medicine (miscellaneous), 19/378 Oncology, 6/344 Radiology, Nuclear Medicine and Imaging No data IDR 2017 UEM

Introduction Fatigue is a major cause of morbidity, limiting quality of life, in patients with antineutrophil cytoplasmic antibody-associated vasculitis (AAV). The aetiology of fatigue is multifactorial; biological and psychosocial mediators, such as sleep deprivation, pain and anxiety and depression, are important and may be improved by increasing physical activity. Current self-management advice is based on expert opinion and is poorly adhered to. This study aims to investigate the feasibility of increasing physical activity using a programme of direct contact and telephone support, to provide patient education, encourage behaviour self-monitoring and the development of an individual change plan with defined goals and feedback to treat fatigue compared with standard of care to inform the design of a large randomised controlled trial to test the efficacy and cost effectiveness of this programme. Methods and analysis Patients with AAV and significant levels of fatigue (patient self-report using multidimensional fatigue index score questionnaire ≥14) will be randomised in a 1:1 ratio to the physical activity programme supported by behavioural change techniques or standard of care. The intervention programme will consist of 8 visits of supervised activity sessions and 12 telephone support calls over 12 weeks with the aim of increasing physical activity to the level advised by government guidelines. Assessment visits will be performed at baseline, 12, 24 and 52 weeks. The study will assess the feasibility of recruitment, retention, the acceptability, adherence and safety of the intervention, and collect data on various assessment tools to inform the design of a large definitive trial. A nested qualitative study will explore patient experience of the trial through focus groups or interviews. Ethics and dissemination All required ethical and regulatory approvals have been obtained. Findings will be disseminated through conference presentations, patient networks and academic publications. Trial registration number ISRCTN11929227.

This systematic review of systematic reviews investigated the effectiveness of lifestyle weight management interventions for postnatal women. We systematically reviewed Medline (PubMed), Embase, CINAHL Plus, The Cochrane Library, and Scopus from 2000 until January 2018, to identify systematic reviews of randomized controlled trials that evaluated the effectiveness of behavioural lifestyle interventions for weight management in postnatal women. Results were summarized both descriptively and statistically using a mega meta-analysis of data from randomized controlled trials included in previous systematic reviews. Nine systematic reviews met our inclusion criteria. Overall the reviews concluded that lifestyle interventions involving physical activity and/or dietary changes resulted in a reduction in postnatal weight. Results from the overall mega meta-analysis confirmed this finding with a mean difference of −1.7 kg (95% CI, −2.3 to −1.1). Findings for subgroup analyses gave mean differences of −1.9 kg (95% CI, −2.9 to −1.0) for combined diet and physical activity interventions, −1.6 kg (95% CI, −2.1 to −1.2) for physical activity–only interventions, and −9.3 kg (95% CI, −16.5 to −2.1) for diet-only interventions (one study). Heterogeneity varied from 0% to 68%. Interventions involving lifestyle interventions appeared to be effective in reducing weight in postnatal women, although these findings should be interpreted with some caution due to statistical heterogeneity.

ObjectiveTo optimally target exercise interventions for patients with cancer, it is important to identify which patients benefit from which interventions.DesignWe conducted an individual patient data meta-analysis to investigate demographic, clinical, intervention-related and exercise-related moderators of exercise intervention effects on physical fitness in patients with cancer.Data sourcesWe identified relevant studies via systematic searches in electronic databases (PubMed, Embase, PsycINFO and CINAHL).Eligibility criteriaWe analysed data from 28 randomised controlled trials investigating the effects of exercise on upper body muscle strength (UBMS) and lower body muscle strength (LBMS), lower body muscle function (LBMF) and aerobic fitness in adult patients with cancer.ResultsExercise significantly improved UBMS (β=0.20, 95% Confidence Interval (CI) 0.14 to 0.26), LBMS (β=0.29, 95% CI 0.23 to 0.35), LBMF (β=0.16, 95% CI 0.08 to 0.24) and aerobic fitness (β=0.28, 95% CI 0.23 to 0.34), with larger effects for supervised interventions. Exercise effects on UBMS were larger during treatment, when supervised interventions included ≥3 sessions per week, when resistance exercises were included and when session duration was >60 min. Exercise effects on LBMS were larger for patients who were living alone, for supervised interventions including resistance exercise and when session duration was >60 min. Exercise effects on aerobic fitness were larger for younger patients and when supervised interventions included aerobic exercise.ConclusionExercise interventions during and following cancer treatment had small effects on UBMS, LBMS, LBMF and aerobic fitness. Demographic, intervention-related and exercise-related characteristics including age, marital status, intervention timing, delivery mode and frequency and type and time of exercise sessions moderated the exercise effect on UBMS, LBMS and aerobic fitness.

Objectives Regular physical exercise may preserve β cell function in newly diagnosed adults with type 1 diabetes (T1D). However, clinical trials to test this theory require the recruitment and retention of adults with new-onset T1D, which can be challenging. We sought to determine the overall experiences of newly diagnosed adults with T1D in an exercise study, to understand issues that influence the retention of trial participants in such studies. Design Qualitative methodology using individual face-to-face (n=6) and telephone interviews (n=14). Interview transcripts were thematically analysed using the framework method. Setting The study took place at five participating UK hospitals. Participants Twenty participants, aged 19–55 years, in the Exercise for Type 1 Diabetes study were interviewed to explore their study experiences and identify motivators and deterrents towards the study. Participants in control and intervention arms were interviewed, as were people with T1D who had completed (n=16) and withdrawn (n=4). Results Participants revealed barriers and facilitators to retention; the majority were generalisable to clinical trials of people with newly diagnosed T1D. Coming to terms with a diagnosis of T1D, lack of time, work pressures, level of health professional support, volume, clarity and consistency of information and feedback and a desire for knowledge about their condition were all cited as influencing factors to trial retention. Conclusions To our knowledge, this is the first qualitative study to examine the experience of being involved in an exercise trial by people with T1D. Findings suggest appointments could be shorter, available outside of working hours and planned longer in advance; study information should be clear, consistent and in electronic and paper formats; questionnaires need minimising; healthcare support and feedback needs providing regularly; thought is required around how to support non-exercising arm participants. These considerations may improve participant retention rates in new-onset T1D studies.

OBJECTIVE: To assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity.DESIGN: Cluster randomised controlled trial.SETTING: UK primary schools from the West Midlands.PARTICIPANTS: 200 schools were randomly selected from all state run primary schools within 35 miles of the study centre (n=980), oversampling those with high minority ethnic populations. These schools were randomly ordered and sequentially invited to participate. 144 eligible schools were approached to achieve the target recruitment of 54 schools. After baseline measurements 1467 year 1 pupils aged 5 and 6 years (control: 28 schools, 778 pupils) were randomised, using a blocked balancing algorithm. 53 schools remained in the trial and data on 1287 (87.7%) and 1169 (79.7%) pupils were available at first follow-up (15 month) and second follow-up (30 month), respectively.INTERVENTIONS: The 12 month intervention encouraged healthy eating and physical activity, including a daily additional 30 minute school time physical activity opportunity, a six week interactive skill based programme in conjunction with Aston Villa football club, signposting of local family physical activity opportunities through mail-outs every six months, and termly school led family workshops on healthy cooking skills.MAIN OUTCOME MEASURES: The protocol defined primary outcomes, assessed blind to allocation, were between arm difference in body mass index (BMI) z score at 15 and 30 months. Secondary outcomes were further anthropometric, dietary, physical activity, and psychological measurements, and difference in BMI z score at 39 months in a subset.RESULTS: Data for primary outcome analyses were: baseline, 54 schools: 1392 pupils (732 controls); first follow-up (15 months post-baseline), 53 schools: 1249 pupils (675 controls); second follow-up (30 months post-baseline), 53 schools: 1145 pupils (621 controls). The mean BMI z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference -0.075 (95% confidence interval -0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was -0.027 (-0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm).CONCLUSIONS: The primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments.TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586.

BackgroundSystematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes.ObjectiveTo assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children.DesignA cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible.SettingPrimary schools, West Midlands, UK.ParticipantsSchools within a 35-mile radius of the study centre and all year 1 pupils (aged 5–6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses.InterventionsThe 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting ‘Villa Vitality’ (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities.Main outcome measuresThe primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools.ResultsTwo groups of schools were randomised: 27 in 2011 (n = 650 pupils) [group 1 (G1)] and another 27 in 2012 (n = 817 pupils) [group 2 (G2)]. Primary outcome data were available at first follow-up (n = 1249 pupils) and second follow-up (n = 1145 pupils) from 53 schools. The mean difference (MD) in BMI-z between the control and intervention arms was –0.075 [95% confidence interval (CI) –0.183 to 0.033] and –0.027 (95% CI –0.137 to 0.083) at 3 and 18 months post intervention, respectively. The main analyses showed no evidence of between-arm differences for any secondary outcomes. Third follow-up included data on 467 pupils from 27 G1 schools, and showed a statistically significant difference in BMI-z (MD –0.20, 95% CI –0.40 to –0.01). The mean cost of the intervention was £266.35 per consented child (£155.53 per child receiving the intervention). The incremental cost-effectiveness ratio associated with the base case was £46,083 per QALY (best case £26,804 per QALY), suggesting that the intervention was not cost-effective.LimitationsThe presence of baseline primary outcome imbalance between the arms, and interschool variation in fidelity of intervention delivery.ConclusionsThe primary analyses show no evidence of clinical effectiveness or cost-effectiveness of the WAVES study intervention. A post hoc analysis, driven by findings at third follow-up, suggests a possible intervention effect, which could have been attenuated by baseline imbalances. There was no evidence of an intervention effect on measures of diet or PA and no evidence of harm.Future workA realist evidence synthesis could provide insights into contextual factors and strategies for future interventions. School-based interventions need to be integrated within a wider societal framework and supported by upstream interventions.Trial registrationCurrent Controlled Trials ISRCTN97000586.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 22, No. 8. See the NIHR Journals Library website for further project information.

BackgroundSmoking during pregnancy is the main preventable cause of poor birth outcomes. Improved methods are needed to help women to stop smoking during pregnancy. Pregnancy provides a compelling rationale for physical activity (PA) interventions as cessation medication is contraindicated or ineffective, and an effective PA intervention could be highly cost-effective.ObjectiveTo examine the effectiveness and cost-effectiveness of a PA intervention plus standard behavioural support for smoking cessation relative to behavioural support alone for achieving smoking cessation at the end of pregnancy.DesignMulticentre, two-group, pragmatic randomised controlled trial and economic evaluation with follow-up at the end of pregnancy and 6 months postnatally. Randomisation was stratified by centre and a computer-generated sequence was used to allocate participants using a 1 : 1 ratio.Setting13 hospitals offering antenatal care in the UK.ParticipantsWomen between 10 and 24 weeks’ gestation smoking five or more cigarettes a day before pregnancy and one or more during pregnancy.InterventionsParticipants were randomised to behavioural support for smoking cessation (control) or behavioural support plus a PA intervention consisting of supervised treadmill exercise plus PA consultations. Neither participants nor researchers were blinded to treatment allocation.Main outcome measuresThe primary outcome was self-reported, continuous smoking abstinence between a quit date and end of pregnancy, validated by expired carbon monoxide and/or salivary cotinine. Secondary outcomes were maternal weight, depression, birth outcomes, withdrawal symptoms and urges to smoke. The economic evaluation investigated the costs of the PA intervention compared with the control intervention.ResultsIn total, 789 women were randomised (n = 394 PA,n = 395 control). Four were excluded post randomisation (two had been enrolled twice in sequential pregnancies and two were ineligible and randomised erroneously). The intention-to-treat analysis comprised 785 participants (n = 392 PA,n = 393 control). There was no significant difference in the rate of abstinence at the end of pregnancy between the PA group (7.7%) and the control group (6.4%) [odds ratio for PA group abstinence 1.21, 95% confidence interval (CI) 0.70 to 2.10]. For the PA group compared with the control group, there was a 33% (95% CI 14% to 56%), 28% (95% CI 7% to 52%) and 36% (95% CI 12% to 65%) significantly greater increase in self-reported minutes of moderate- and vigorous-intensity PA from baseline to 1 week, 4 weeks and 6 weeks respectively. Accelerometer data showed that there was no significant difference in PA levels between the groups. There were no significant differences between the groups for change in maternal weight, depression, withdrawal symptoms or urges to smoke. Adverse events and birth outcomes were similar between the groups except for there being significantly more caesarean births in the control group than in the PA group (28.7% vs. 21.3%;p ConclusionsDuring pregnancy, offering an intervention combining supervised exercise and PA counselling does not add to the effectiveness of behavioural support for smoking cessation. Only 10% of participants had PA levels accessed by accelerometer and it is, therefore, unclear whether or not the lack of an effect on the primary outcome is the result of insufficient increases in PA. Research is needed to identify the smoking populations most suitable for PA interventions and methods for increasing PA adherence.Trial registrationCurrent Controlled Trials ISRCTN48600346.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 84. See the NIHR Journals Library website for further project information.

To investigate the efficacy of water preloading before meals as a weight loss strategy for adults with obesity.A two-group randomized controlled trial was conducted in Birmingham, England. Eighty-four adults with obesity were recruited from general practices. All participants were given a face-to-face weight management consultation at baseline (30 min) and a follow-up telephone consultation at 2 weeks (10 min). At baseline, participants were randomized to either drinking 500 ml of water 30 min before their main meals or an attention control group where participants were asked to imagine their stomach was full before meals. The primary outcome was weight change at 12-week follow-up. Several measures of adherence were also used, including 24 h total urine collections.41 participants were randomized to the intervention group and 43 to the comparator group. The water preloading group lost -1.3 kg (95% CI -2.4 to -0.1, P = 0.028) more than comparators at follow up. Adjusting for ethnicity, deprivation, age, and gender resulted in the intervention group losing -1.2 kg (95% CI -2.4 to 0.07, P = 0.063) more than the comparator.There is preliminary evidence that water preloading before main meals leads to a moderate weight loss at follow up. ISRCTN33238158.

BACKGROUND/OBJECTIVES: Maintaining a healthy weight is important for the prevention of many chronic diseases. Little is known about the strategies used by young women to manage their weight, or the effectiveness of these in preventing weight gain. We aimed to identify clusters of weight control strategies used by women and determine the average annual weight change among women in each cluster from 2000 to 2009. METHODS: Latent cluster analysis of weight control strategies reported by 8125 participants in the Australian Longitudinal Study of Women's Health. Analyses were performed in March-November 2014. RESULTS: Weight control strategies were used by 79% of the women, and four unique clusters were found. The largest cluster group (39.7%) was named dieters as 90% had been on a diet in the past year, and half of these women had lost 5 kg on purpose. Women cut down on size of meals, fats and sugars and took part in vigorous physical activity. Additionally 20% had used a commercial programme. The next largest cluster (30.2%) was the healthy living group who followed the public health messages of 'eat less and move more'. The do nothing group (20%) did not actively control their weight whereas the perpetual dieters group (10.7%) used all strategies, including unhealthy behaviours. On average women gained 700 g per year (over nine years), however the perpetual dieters group gained significantly more weight (210 g) than the do nothing group (P