Development of a core outcome set for behavioural weight management programmes for adults with overweight and obesity:protocol for obtaining expert consensus using Delphi methodology

Introduction: Weight management interventions in research studies and in clinical practice differ in length, advice, frequency of meetings, staff and cost. Very few real-world programmes have published patient-related outcomes, and those that have published used different ways of reporting the information, making it impossible to compare interventions and further develop the evidence base. Developing a core outcome set for behavioural weight management programmes (BWMPs) for adults with overweight and obesity will allow different BWMPs to be compared and reveal which interventions work best for which members of the population. Methods and analysis: An expert group, comprised of 40 people who work in, refer to, or attend BWMPs for adults with overweight and obesity, will be asked to decide which outcomes services should report. An online Delphi process will be employed to help the group reach consensus as to which outcomes should be measured and reported, and which definitions/instruments should be used in order to do so. The first stage of the Delphi process (three rounds of questionnaires) will focus on outcomes while the second stage (three additional rounds of questionnaires) will focus on definition/instrument selection. Ethics and dissemination: Ethical approval for this study has been received from the University of Glasgow College of Medical, Veterinary and Life Sciences Ethics Committee. With regard to disseminating results, a report will be submitted to our funding body, the Chief Scientist Office of the Scottish Government Health Department. In addition, early findings will be shared with Public Health England and Health Scotland, and results communicated via conference presentations, peer review publication and our institutions’ social media platforms

Challenges of a community based pragmatic, randomised controlled trial of weight loss maintenance

Background Randomised controlled trials (RCTs) have a reputation for being inherently difficult to deliver as planned and often face unforeseen challenges and delays, particularly in relation to organisational and governance difficulties, participant interest, constraints due to allocation of costs, local investigator interest and lengthy bureaucracy. Recruitment is often difficult and the challenges faced often impact on the cost and delivery of a successful trial within the funded period. This paper reflects upon the challenges faced in delivering a pragmatic RCT of weight loss maintenance in a community setting and suggests some potential solutions. Methods The weight loss maintenance in adults trial aimed to evaluate the impact of a 12 month, individually tailored weight maintenance intervention on BMI 3 years from randomisation. Participants were recruited primarily from participant identification centres (PICs)—GP surgeries, exercise on referral schemes and slimming world. The intervention was delivered in community settings. A recruitment strategy implementation plan was drafted to address and monitor poor recruitment. Results Delays in opening and recruitment were experienced early on. Some were beyond the control of the study team such as; disagreement over allocation of national health service costs and PIC classification as well as difficulties in securing support from research networks. That the intervention was delivered in community settings was often at the root of these issues. Key items to address at the design stage of future trials include feasibility of eligibility criteria. The most effective element of the recruitment implementation plan was to refocus sources of recruitment and target only those who could fulfil the eligibility criteria immediately. Conclusions Learnings from this trial should be kept in mind by those designing similar studies in the future. Considering potential governance, cost and research network support implications at the design stage of pragmatic trials of any community-based complex intervention is paramount. The appropriateness and viability of inclusion criteria also require careful consideration as does use of a targeted advertising strategy

A qualitative study of parental strategies to enable pre-school children’s outdoor and nature experiences during COVID-19 restrictions

Outdoor and nature experiences including play have been shown to be beneficial for children's physical, cognitive, social and emotional development. Parents/carers play an important role in encouraging or impeding their child's access to the outdoor environment and participation in outdoor play. The COVID-19 pandemic and associated restrictions on free movement and social interactions placed an unprecedented pressure on families to manage the drastic change in their daily routines. This paper reports findings from two combined data sets generated in 2020 during the COVID-19 pandemic and provides a deeper understanding of the interconnected nature of how contextual factors influence parenting processes and outcomes relating to young children's outdoor and nature experiences and subsequent child health. Findings have the potential to inform the messaging of existing outdoor play policies and the content of new interventions aiming to promote the exposure of children to the natural outdoor environment

Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update.

BACKGROUND: The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. METHODS: There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. RESULTS: Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six 'core elements' that should guide all phases of complex intervention research: consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. LIMITATIONS: The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. CONCLUSIONS: This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as 'events in systems' that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers. FUTURE WORK: We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. FUNDING: This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514)

An app-, web- and social support-based weight loss intervention for adults with obesity: the HelpMeDoIt! feasibility RCT

Background: Finding solutions to rising levels of obesity continues to be a major public health focus. Social support has an important role in successful weight loss, and digital interventions can reach a large proportion of the population at low cost. Objective: To develop and assess the feasibility and acceptability of an application (app), web- and social support-based intervention in supporting adults with obesity to achieve weight loss goals. Design: Stage 1 – intervention development phase involved three focus groups (n = 10) with users, and think-aloud interviews and field testing with another group (n = 28). Stage 2 – the intervention and evaluation methods were explored in a feasibility randomised controlled trial with economic and process evaluation. Setting: Greater Glasgow and Clyde, UK. Participants: Adults with a body mass index of ≥ 30kg/m2 who owned a smartphone and were interested in losing weight were randomised 2 : 1 (intervention : control) and followed up at 12 months. Recruitment took place in April–October 2016. Interventions: The intervention group had access to HelpMeDoIt! for 12 months. This encouraged them to (1) set goals, (2) monitor progress and (3) harness social support by inviting ‘helpers’ from their existing social network. The control group received a healthy lifestyle leaflet. Main outcome measures: Data from stage 1 informed the intervention design. Key measures in stage 2 assessed the feasibility and acceptability of the intervention and trial methods against prespecified progression criteria. Three primary outcomes were explored: body mass index, diet and physical activity. Secondary outcomes included weight, waist and hip circumference, social support, self-efficacy, motivation, mental health, health-related quality of life, NHS resource use, participant-borne costs and intervention costs. Qualitative interviews with participants (n = 26) and helpers (n = 9) explored the feasibility and acceptability of the trial methods and intervention. Results: Stage 1 produced (1) a website that provided evidence-based information for lifestyle change and harnessing social support, and (2) an app that facilitated goal-setting, self-monitoring and supportive interaction between participants and their helper(s). Progression criteria were met, demonstrating that the intervention and trial methods were feasible and acceptable. A total of 109 participants (intervention, n = 73; control, n = 36) were recruited, with 84 participants (77%: intervention, 71%; control, 89%) followed up at 12 months. Data were successfully collected for most outcome measures (≥ 82% completion). Participants and helpers were generally positive, although helper engagement with the app was low. Of the 54 (74%) participants who downloaded the app, 48 (89%) used it twice or more, 28 helpers enrolled via the app, and 19 (36%) participants interacted with their helper(s) via the app. Interview data indicated that HelpMeDoIt! prompted support from helpers that often occurred without the helpers using the app. Limitations: Early technical problems meant that some participants and helpers had difficulty accessing the app. Ethical constraints meant that we were unable to contact helpers directly for interview. Conclusions: The HelpMeDoIt! study demonstrated that a weight loss intervention delivered via an app and a website is feasible and acceptable. Progression criteria were met, supporting further evaluation of the intervention. Future work: To further explore (1) the motivation and engagement of helpers, (2) the programme theory and (3) the effectiveness and cost-effectiveness of the intervention. Trial registration: Current Controlled Trials ISRCTN85615983. Funding: This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 3. See the NIHR Journals Library website for further project information

Introducing the revised framework for developing and evaluating complex interventions : A challenge and a resource for nursing research

This invited discussion paper highlights key updates in the MRC/NIHR's revised framework for the development and evaluation of complex nursing interventions and reflects on the implications for nursing research

SAFETEL randomised controlled feasibility trial of a safety planning intervention with follow-up telephone contact to reduce suicidal behaviour: study protocol

Introduction: There are no evidence-based interventions that can be administered in hospital settings following a general hospital admission after a suicide attempt. Aim: To determine whether a safety planning intervention (SPI) with follow-up telephone support (SAFETEL) is feasible and acceptable to patients admitted to UK hospitals following a suicide attempt. Methods and Analysis: Three-phase development and feasibility study with embedded process evaluation. Phase I comprises tailoring an SPI with telephone follow-up originally designed for veterans in the USA, for use in the UK. Phase II involves piloting the intervention with patients (n=30) who have been hospitalised following a suicide attempt. Phase III is a feasibility randomised controlled trial of 120 patients who have been hospitalised following a suicide attempt with a 6-month follow-up. Phase III participants will be recruited from across four National Health Service hospitals in Scotland and randomised to receive either the SPI with telephone follow-up and treatment as usual (n=80) or treatment as usual only (n=40). The primary outcomes are feasibility outcomes and include the acceptability of the intervention to participants and intervention staff, the feasibility of delivery in this setting, recruitment, retention and intervention adherence as well as the feasibility of collecting the self-harm readmission to hospital outcome data. Statistical analyses will include description of recruitment rates, intervention adherence/use, response rates and estimates of the primary outcome event rates, and intervention effect size (Phase III). Thematic analyses will be conducted on interview and focus group data. Ethics and Dissemination: The East of Scotland Research Ethics Service (EoSRES) approved this study in March 2017 (GN17MH101 Ref: 17/ES/0036). The study results will be disseminated via peer-reviewed publication and conference presentations. A participant summary paper will also be disseminated to patients, service providers and policy makers alongside the main publication. Trial Registration Number: ISRCTN62181241

Environmental and practice factors associated with children's device-measured physical activity and sedentary time in early childhood education and care centres: a systematic review

Background Early childhood education and care (ECEC) settings offer a potentially cost-effective and sustainable solution for ensuring children have opportunities to meet physical activity (PA) and sedentary time (ST) guidelines. This paper systematically reviewed the association between childcare environment and practice and children’s PA and ST. Methods Three electronic databases were searched, and citation tracking of eligible studies performed between June–July 2020 (updated March 2022). Studies were eligible when (i) participants attended ECEC settings, (ii) they reported the association between use of outdoor space, including factors of time, availability, play, size and equipment, and children’s device-measured PA and ST, and (iii) where applicable, they compared the exposure to use of indoor space. Risk of bias was assessed using the Critical Appraisal Skills Program (CASP) tools. A synthesis was performed using effect direct plots and charts to visualise effect sizes. Results Of 1617 reports screened, 29 studies met the inclusion criteria. Studies provided data on outdoor versus indoor time (n = 9; 960 children), outdoor versus indoor play (n = 3; 1104 children), outdoor play space (n = 19; 9596 children), outdoor space use external to ECEC (n = 2; 1148 children), and portable (n = 7; 2408 children) and fixed (n = 7; 2451 children) outdoor equipment. Time spent outdoors versus indoors was associated with increased moderate-to-vigorous PA (MVPA), light PA (LPA) and total PA, while the association with ST was inconclusive. The mean (standard deviation) levels of outdoor MVPA (4.0 ± 3.2 to 18.6 ± 5.6 min/h) and LPA (9.9 ± 2.6 to 30.8 ± 11.8 min/h) were low, and ST high (30.0 ± 6.5 to 46.1 ± 4.3 min/h). MVPA levels doubled when children played outdoors versus indoors. Outdoor play space, and outdoor portable equipment, were associated with increased MVPA. A dose-response relationship for outdoor play area size was observed, demonstrating increased MVPA with areas ≥505m2 (5436 ft2), but no further increases when areas were > 900m2 (9688 ft2). No studies reported on injuries in outdoor settings. Conclusions ECEC policies and practices should promote not only outdoor time but also the availability of resources such as portable play equipment and sufficient size of outdoor play areas that enable children to be physically active for sustained periods while outdoors