Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity:The baby milk intervention and trial

Introduction. We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods. We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets; hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine them. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions. In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders. This trial is registered with ISRTCN: 20814693 Baby Milk Trial

Implementation of a nurse-led behaviour change intervention to support medication taking in type 2 diabetes: beyond hypothesised active ingredients (SAMS Consultation Study).

BACKGROUND: Implementation of trial interventions is rarely assessed, despite its effects on findings. We assessed the implementation of a nurse-led intervention to facilitate medication adherence in type 2 diabetes (SAMS) in a trial against standard care in general practice. The intervention increased adherence, but not through the hypothesised psychological mechanism. This study aimed to develop a reliable coding frame for tape-recorded consultations, assessing both a priori hypothesised and potential active ingredients observed during implementation, and to describe the delivery and receipt of intervention and standard care components to understand how the intervention might have worked. METHODS: 211 patients were randomised to intervention or comparison groups and 194/211 consultations were tape-recorded. Practice nurses delivered standard care to all patients and motivational and action planning (implementation intention) techniques to intervention patients only. The coding frame was developed and piloted iteratively on selected tape recordings until a priori reliability thresholds were achieved. All tape-recorded consultations were coded and a random subsample double-coded. RESULTS: Nurse communication, nurse-patient relationship and patient responses were identified as potential active ingredients over and above the a priori hypothesised techniques. The coding frame proved reliable. Intervention and standard care were clearly differentiated. Nurse protocol adherence was good (M (SD) = 3.95 (0.91)) and competence of intervention delivery moderate (M (SD) = 3.15 (1.01)). Nurses frequently reinforced positive beliefs about taking medication (e.g., 65% for advantages) but rarely prompted problem solving of negative beliefs (e.g., 21% for barriers). Patients' action plans were virtually identical to current routines. Nurses showed significantly less patient-centred communication with the intervention than comparison group. CONCLUSIONS: It is feasible to reliably assess the implementation of behaviour change interventions in clinical practice. The main study results could not be explained by poor delivery of motivational and action planning components, definition of new action plans, improved problem solving or patient-centred communication. Possible mechanisms of increased medication adherence include spending more time discussing it and mental rehearsal of successful performance of current routines, combined with action planning. Delivery of a new behaviour change intervention may lead to less patient-centred communication and possible reduction in overall trial effects. TRIAL REGISTRATION: ISRCTN30522359

Development and feasibility study of very brief interventions for physical activity in primary care

Abstract Background There is increasing interest in brief and very brief behaviour change interventions for physical activity as they are potentially scalable to the population level. However, few very brief interventions (VBIs) have been published, and evidence is lacking about their feasibility, acceptability and which ‘active ingredients’ (behaviour change techniques) would maximise their effectiveness. The aim of this research was to identify and develop promising VBIs for physical activity and test their feasibility and acceptability in the context of preventive health checks in primary care. Methods The process included two stages, guided by four criteria: effectiveness, feasibility, acceptability, and cost. In Stage 1, we used an iterative approach informed by systematic reviews, a scoping review of BCTs, team discussion, stakeholder consultation, a qualitative study, and cost estimation to guide the development of promising VBIs. In Stage 2, a feasibility study assessed the feasibility and acceptability of the short-listed VBIs, using tape-recordings and interviews with practitioners (n = 4) and patients (n = 68), to decide which VBIs merited further evaluation in a pilot trial. Results Four VBIs were short-listed: Motivational intervention; Action Planning intervention; Pedometer intervention; and Physical Activity Diary intervention. All were deliverable in around five minutes and were feasible and acceptable to participants and practitioners. Based on the results of interviews with practitioners and patients, techniques from the VBIs were combined into three new VBIs for further evaluation in a pilot trial. Conclusions Using a two-stage approach, in which we considered the practicability of VBIs (acceptability, feasibility and cost) alongside potential efficacy from the outset, we developed a short-list of four promising VBIs for physical activity and demonstrated that they were acceptable and feasible as part of a preventive health check in primary care. Trial registration Current Controlled Trials ISRCTN02863077 . Registered 5 October 2012

The effects of social distancing and self-isolation during the COVID-19 pandemic on adults diagnosed with asthma: A qualitative study

This study aimed to explore how social distancing and self-isolation measures, aimed at protecting vulnerable groups from COVID-19, affected the wellbeing and physical activity levels among adults diagnosed with asthma. Twenty-seven participants took part across four online focus groups. Transcripts were analysed using thematic analysis. Participants reported becoming more health conscious due to being labelled as vulnerable. Their relationship with the severity of their asthma was altered and they reported making positive changes to increase their physical activity levels. Findings suggest there is a window of opportunity to engage with people diagnosed with asthma to promote beneficial lifestyle changes and self-management

A systematic review of just-in-time adaptive interventions (JITAIs) to promote physical activity.

BACKGROUND: Progress in mobile health (mHealth) technology has enabled the design of just-in-time adaptive interventions (JITAIs). We define JITAIs as having three features: behavioural support that directly corresponds to a need in real-time; content or timing of support is adapted or tailored according to input collected by the system since support was initiated; support is system-triggered. We conducted a systematic review of JITAIs for physical activity to identify their features, feasibility, acceptability and effectiveness. METHODS: We searched Scopus, Medline, Embase, PsycINFO, Web of Science, DBLP, ACM Digital Library, Cochrane Central Register of Controlled Trials, ClinicalTrials.gov and the ISRCTN register using terms related to physical activity, mHealth interventions and JITAIs. We included primary studies of any design reporting data about JITAIs, irrespective of population, age and setting. Outcomes included physical activity, engagement, uptake, feasibility and acceptability. Paper screening and data extraction were independently validated. Synthesis was narrative. We used the mHealth Evidence Reporting and Assessment checklist to assess quality of intervention descriptions. RESULTS: We screened 2200 titles, 840 abstracts, 169 full-text papers, and included 19 papers reporting 14 unique JITAIs, including six randomised studies. Five JITAIs targeted both physical activity and sedentary behaviour, five sedentary behaviour only, and four physical activity only. JITAIs prompted breaks following sedentary periods and/or suggested physical activities during opportunistic moments, typically over three to four weeks. Feasibility challenges related to the technology, sensor reliability and timeliness of just-in-time messages. Overall, participants found JITAIs acceptable. We found mixed evidence for intervention effects on behaviour, but no study was sufficiently powered to detect any effects. Common behaviour change techniques were goal setting (behaviour), prompts/cues, feedback on behaviour and action planning. Five studies reported a theory-base. We found lack of evidence about cost-effectiveness, uptake, reach, impact on health inequalities, and sustained engagement. CONCLUSIONS: Research into JITAIs to increase physical activity and reduce sedentary behaviour is in its early stages. Consistent use and a shared definition of the term 'JITAI' will aid evidence synthesis. We recommend robust evaluation of theory and evidence-based JITAIs in representative populations. Decision makers and health professionals need to be cautious in signposting patients to JITAIs until such evidence is available, although they are unlikely to cause health-related harm. REFERENCE: PROSPERO 2017 CRD42017070849.The work was undertaken by the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research Centre of Excellence. Funding from the British Heart Foundation, Cancer Research UK, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration (MR/K023187/), is gratefully acknowledged

Development and feasibility study of very brief interventions for physical activity in primary care

Abstract Background There is increasing interest in brief and very brief behaviour change interventions for physical activity as they are potentially scalable to the population level. However, few very brief interventions (VBIs) have been published, and evidence is lacking about their feasibility, acceptability and which ‘active ingredients’ (behaviour change techniques) would maximise their effectiveness. The aim of this research was to identify and develop promising VBIs for physical activity and test their feasibility and acceptability in the context of preventive health checks in primary care. Methods The process included two stages, guided by four criteria: effectiveness, feasibility, acceptability, and cost. In Stage 1, we used an iterative approach informed by systematic reviews, a scoping review of BCTs, team discussion, stakeholder consultation, a qualitative study, and cost estimation to guide the development of promising VBIs. In Stage 2, a feasibility study assessed the feasibility and acceptability of the short-listed VBIs, using tape-recordings and interviews with practitioners (n = 4) and patients (n = 68), to decide which VBIs merited further evaluation in a pilot trial. Results Four VBIs were short-listed: Motivational intervention; Action Planning intervention; Pedometer intervention; and Physical Activity Diary intervention. All were deliverable in around five minutes and were feasible and acceptable to participants and practitioners. Based on the results of interviews with practitioners and patients, techniques from the VBIs were combined into three new VBIs for further evaluation in a pilot trial. Conclusions Using a two-stage approach, in which we considered the practicability of VBIs (acceptability, feasibility and cost) alongside potential efficacy from the outset, we developed a short-list of four promising VBIs for physical activity and demonstrated that they were acceptable and feasible as part of a preventive health check in primary care. Trial registration Current Controlled Trials ISRCTN02863077 . Registered 5 October 2012

Erratum to: Development and feasibility study of very brief interventions for physical activity in primary care.

Upon publication of this article [1] it has been noted that due to a technical error the publisher missed to include the Open Access Licence statement in the copyright line. The correct copyright line should have read: © 2015 Pears et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://​creativecommons.​org/​licenses/​by/​4.​0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://​creativecommons.​org/​publicdomain/​zero/​1.​0/​) applies to the data made available in this article, unless otherwise stated

Systematic review of techniques to monitor remission of acute Charcot-neuroarthropathy in people with diabetes

Aim: The management of acute Charcot neuroarthropathy relies on off-loading which is costly and time-consuming. Published studies have used monitoring techniques with unknown diagnostic precision to detect remission. We performed a systematic review of techniques for monitoring response to offloading in acute Charcot neuroarthropathy. Materials and Methods: We included studies of off-loading which evaluated or described monitoring techniques in acute Charcot neuroarthropathy. PubMed, EMBASE, CINAHL and Cochrane databases were searched (January1993-July 2018). We extracted data from papers including study design, setting, population, monitoring techniques and treatment outcomes. We also extracted information on the cost, clinical applicability, sensitivity and specificity, safety and participant acceptability of the monitoring techniques. Results: We screened 1205 titles, 140 abstracts and 45 full-texts, and included 29 studies. All studies were of low quality and at high risk of bias. In seven studies, the primary aim was to evaluate monitoring techniques: three evaluated magnetic resonance imaging, two thermography monitoring, one three-phase bone scanning and one Doppler spectrum analysis. The remaining 22 observational studies reported treatment outcomes and described the monitoring techniques used to assess the Charcot neuroarthropathy. Heterogeneity prevented the pooling of data. Very few studies included data on cost, clinical applicability, sensitivity and specificity, safety and patient acceptability of the monitoring techniques used. Conclusion: Multiple techniques have been used to evaluate remission in acute Charcot neuroathropathy but uncertainty remains about their effectiveness. We recommend further research into the influences of different monitoring techniques on treatment outcomes

Using the Medical Research Council framework for the development and evaluation of complex interventions in a theory-based infant feeding intervention to prevent childhood obesity: The Baby Milk intervention and trial’

Introduction - We describe our experience of using the Medical Research Council framework on complex interventions to guide the development and evaluation of an intervention to prevent obesity by modifying infant feeding behaviours. Methods - We reviewed the epidemiological evidence on early life risk factors for obesity and interventions to prevent obesity in this age group. The review suggested prevention of excess weight gain in bottle-fed babies and appropriate weaning as intervention targets, hence we undertook systematic reviews to further our understanding of these behaviours. We chose theory and behaviour change techniques that demonstrated evidence of effectiveness in altering dietary behaviours. We subsequently developed intervention materials and evaluation tools and conducted qualitative studies with mothers (intervention recipients) and healthcare professionals (intervention deliverers) to refine these. We developed a questionnaire to assess maternal attitudes and feeding practices to understand the mechanism of any intervention effects. Conclusions - In addition to informing development of our specific intervention and evaluation materials, use of the Medical Research Council framework has helped to build a generalisable evidence base for early life nutritional interventions. However, the process is resource intensive and prolonged, and this should be taken into account by public health research funders.This work was supported by the Centre for Diet and Activity Research (CEDAR), a UKCRC Public Health Research Centre of Excellence. Funding from the British Heart Foundation, Economic and Social Research Council, Medical Research Council, the National Institute for Health Research, and the Wellcome Trust, under the auspices of the UK Clinical Research Collaboration, is gratefully acknowledged. The Baby Milk Trial is funded by the National Prevention Research Initiative (http://www.npri.org.uk Grant number MR/J000361/1). The Funding Partners relevant to this award are (in alphabetical order): Alzheimer's Research Trust; Alzheimer's Society; Biotechnology and Biological Sciences Research Council; British Heart Foundation; Cancer Research UK; Chief Scientist Office, Scottish Government Health Directorate; Department of Health; Diabetes UK; Economic and Social Research Council; Health and Social Care Research and Development Division of the Public Health Agency (HSC R&D Division); Medical Research Council; The Stroke Association; Wellcome Trust; Welsh Assembly Government; and World Cancer Research Fund. RL was funded by a MRC Population Health Fellowship (Grant number G070165).This is the final published version. It is also available from Hindawi at http://www.hindawi.com/journals/jobe/2014/646504/