Behavioural and weight status outcomes from an exploratory trial of the Healthy Lifestyles Programme (HeLP): a novel school-based obesity prevention programme

This is the final version of the article. Available from the publisher via the DOI in this record.OBJECTIVES: To assess the behavioural and weight status outcomes in English children in a feasibility study of a novel primary school-based obesity prevention programme. DESIGN: Exploratory cluster randomised controlled trial of the Healthy Lifestyles Programme. SETTING: Four city primary schools (two control and two intervention) in the South West of England. PARTICIPANTS: 202 children aged 9-10 years, of whom 193 and 188 were followed up at 18 and 24 months, respectively. No child was excluded from the study; however, to be eligible, schools were required to have at least one single Year 5 class. INTERVENTION: Four-phase multicomponent programme using a range of school-based activities including lessons, assemblies, parents' evenings, interactive drama workshops and goal setting to engage and support schools, children and their families in healthy lifestyle behaviours. It runs over the spring and summer term of Year 5 and the autumn term of Year 6. PRIMARY AND SECONDARY OUTCOMES: Weight status outcomes were body mass index, waist circumference and body fat standard deviation scores (SDS) at 18 and 24 months, and behavioural outcomes were physical activity, television (TV) viewing/screen time and food intake at 18 months. RESULTS: At 18 months of follow-up, intervention children consumed less energy-dense snacks and more healthy snacks; had less 'negative food markers', more 'positive food markers', lower mean TV/screen time and spent more time doing moderate-vigorous physical activity each day than those in the control schools. Intervention children had lower anthropometric measures at 18 and 24 months than control children, with larger differences at 24 months than at 18 months for nearly all measures. CONCLUSIONS: Results from this exploratory trial show consistent positive changes in favour of the intervention across all targeted behaviours, which, in turn, appear to affect weight status and body shape. A definitive trial is now justified.The Exploratory Trial was funded by the National Institute for Health Research (NIHR) Research for Patient Benefit Programme. JLL and KMW were partially supported by PenCLAHRC, the NIHR CLAHRC for the Southwest Peninsula. This paper presents independent research commissioned by the NIHR. The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health

The development, feasibility and acceptability of a school-based obesity prevention programme: results from three phases of piloting

addresses: Institute for Health Service Research, Peninsula College of Medicine and Dentistry, University of Exeter, Exeter, UK.notes: PMCID: PMC3191390types: Journal Article; Research Support, Non-U.S. Gov'tCopyright © 2011 by the BMJ Publishing Group Ltd. This articles was first published in: BMJ, 2011, Vol. 1, Issue 1, pp. e000026 -To develop a school-based obesity prevention programme and evaluate the feasibility and acceptability of the intervention and the planned definitive cluster randomised trial

Adapting to the digital age: a narrative approach

The article adopts a narrative inquiry approach to foreground informal learning and exposes a collection of stories from tutors about how they adapted comfortably to the digital age. We were concerned that despite substantial evidence that bringing about changes in pedagogic practices can be difficult, there is a gap in convincing approaches to help in this respect. In this context, this project takes a “bottom-up” approach and synthesises several life-stories into a single persuasive narrative to support the process of adapting to digital change. The project foregrounds the small, every-day motivating moments, cultural features and environmental factors in people's diverse lives which may have contributed to their positive dispositions towards change in relation to technology enhanced learning. We expect that such narrative approaches could serve to support colleagues in other institutions to warm up to ever-changing technological advances

Study protocol for a double blind, randomised, placebo-controlled trial of continuous subpectoral local anaesthetic infusion for pain and shoulder function following mastectomy: SUB-pectoral Local anaesthetic Infusion following MastEctomy (SUBLIME) study.

INTRODUCTION: Over 16 000 mastectomies are performed in England and Wales annually. Acute postoperative pain and nausea are common. The most frequently occurring long-term complications are chronic pain (up to 50%) and reduced shoulder function (reported at 35%). Regional techniques that improve acute postoperative pain relief may reduce the incidence of these complications. This study assesses the effectiveness of a 24-hour continuous local anaesthetic in the subpectoral plane in improving postoperative pain and quality of life in patients undergoing mastectomy. METHODS AND ANALYSIS: This is a randomised, double blind, placebo-controlled, two-centre, parallel group trial in women undergoing mastectomy with or without axillary involvement. One hundred and sixty participants will be randomised in a 1:1 ratio to receive either 0.25% levobupivacaine or 0.9% saline by subpectoral infusion postoperatively for 24 h. All participants will be provided with an intravenous morphine patient-controlled analgesia (PCA) system. Participants will be followed-up for 24 h in hospital and at approximately 14 days and 6 months postoperatively. Joint primary outcome measures are total morphine consumption and total pain score (captured via patient-recorded visual analogue scale (VAS) 4 hourly) during the first 24 h postoperatively. Primary statistical analysis of total pain is based on the area under the curve of pain versus time graph. Secondary outcomes include PCA attempts in first 24 h; VAS pain scores and shoulder function by goniometry at 24 h, 14 days (approximately) and 6 months; Verbal Rating Scale pain scores in first 24 h; Brief Pain Inventory and Oxford Shoulder Score at 6 months; duration of hospital stay; incidence of postoperative nausea and vomiting; cost-effectiveness. ETHICS AND DISSEMINATION: The study is approved by the South West England Research Ethics Committee (12/SW/0149). RESULTS: will be published in a peer-reviewed journal and presented at local, national and international scientific meetings. TRIAL REGISTRATION: ISRCTN46621916. EudraCT 2011-005775-16

Standing Practice In Rehabilitation Early after Stroke (SPIRES): a functional standing frame programme (prolonged standing and repeated sit to stand) to improve function and quality of life and reduce neuromuscular impairment in people with severe sub-acute stroke-a protocol for a feasibility randomised controlled trial.

Background: The most common physical deficit caused by a stroke is muscle weakness which limits a person's mobility. Mobility encompasses activities necessary for daily functioning: getting in and out bed, on/off toilet, sitting, standing and walking. These activities are significantly affected in people with severe stroke who typically spend most of their time in bed or a chair and are immobile. Immobility is primarily caused by neurological damage but exacerbated by secondary changes in musculoskeletal and cardiorespiratory systems. These secondary changes can theoretically be prevented or minimised by early mobilisation, in this case standing up early post-stroke.Standing up early post-stroke has been identified as an important priority for people who have suffered a severe stroke. However, trials of prolonged passive standing have not demonstrated any functional improvements. Conversely, task-specific training such as repeated sit-to-stand has demonstrated positive functional benefits. This feasibility trial combines prolonged standing and task-specific strength training with the aim of determining whether this novel combination of physiotherapy interventions is feasible for people with severe stroke as well as the overall feasibility of delivering the trial. Methods/design: This is a pragmatic multi-centre parallel single-blinded two-armed feasibility randomised controlled trial. Fifty people with a diagnosis of severe stroke will be randomly allocated to either the functional standing frame programme or usual physiotherapy. All patient participants will be assessed at baseline and followed up at 3 weeks, then 3, 6 and 12 months post-randomisation. Trial objectives are to determine the feasibility according to the following indicators:: (i) Process: recruitment and retention rate, ability to consent, eligibility criteria, willingness/ability of physiotherapists to recruit, willingness of patients to be randomised, and acceptability of the intervention; (ii) Resource: burden and potential costs; (iii) Management: treatment fidelity, participant adherence, acceptability and completeness of outcome measures, impact and management or orthostatic hypotension; and (iv) Safety: number and nature of adverse and serious adverse events. Discussion: The functional standing frame programme addresses a key concern for people who have suffered a severe stroke. However, several uncertainties exist which need to be understood prior to progressing to a full-scale trial, including acceptability and tolerance of the functional standing frame programme intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties. Trial registration: International Standard Randomised Controlled Trial Number ISRCTN15412695. Registration on 19 December 2016

Children’s Compliance With Wrist-Worn Accelerometry Within a Cluster-Randomized Controlled Trial: Findings From the Healthy Lifestyles Programme

This is the author accepted manuscript. The final version is available from Human Kinetics via the DOI in this recordPurpose: To assess children’s compliance with wrist worn accelerometry during a randomised control trial and to examine whether compliance differed by allocated condition or gender. Method: 886 children within the Healthy Lifestyles Programme (HeLP) trial were randomly allocated to wear a GENEActiv accelerometer at baseline and 18 month follow up. Compliance with minimum wear time criteria (≥10 hours for 3 week, 1 weekend day) was obtained for both time points. Chi- squared tests were used to determine associations between compliance, group allocation and gender. Results: At baseline, 851 children had useable data, 830 (97.5%) met the minimum wear time criteria, 631 (74.1%) had data for 7 days at 24 hours/day. At follow up, 789 children had useable data, 745 (94.4%) met the minimum wear time criteria, 528 (67%) children had complete data. Compliance did not differ by gender (baseline; X2 = 1.66, p = 0.2, follow up; X2 = 0.76, p = 0.4) or by group at follow up (X2 = 2.35, p = 0.13). Conclusion: The use of wrist worn accelerometers and robust trial procedures resulted in high compliance at two time points regardless of group allocation, demonstrating the feasibility of usingprecise physical activity monitors to measure intervention effectiveness.This research was supported by a grant PHR project 10/3010/01 from the National Institute for Health Research (NIHR) Public health research programme. In addition, this research was supported and funded by the NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula (PenCLAHRC)

Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children

This is the final version of the article. Available from the publisher via the DOI in this record.BACKGROUND: The Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9-10 year-old children. This article describes the detailed statistical analysis plan for the HeLP trial, including an amendment (and rationale for amendment) made to originally planned sensitivity analyses. METHODS AND DESIGN: The HeLP trial is a definitive, pragmatic, superiority, cluster randomised controlled trial with two parallel groups and blinded outcome assessment. This update article describes in detail (1) the primary and secondary outcomes, (2) the statistical analysis principles (including which children will be included in each analysis, how the clustered nature of the study design will be accounted for, which covariates will be included in each analysis, how the results will be presented), (3) planned sensitivity analyses, planned subgroup analyses and planned adherence-adjusted analyses for the primary outcome, (4) planned analyses for the secondary outcomes and (e) planned longitudinal analyses. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN15811706 . Registered on 1 May 2012.The definitive trial of HeLP is funded by the UK National Institute for Health Research (NIHR) Public Health Research Programme (10/3010/01) and a full report will be published on the NIHR website. KW and JL are partially supported by PenCLAHRC, the National Institute for Health Research (NIHR) CLAHRC for the Southwest Peninsul

Standing up in Multiple Sclerosis (SUMS): Protocol for a multi-centre randomised controlled trial evaluating the clinical and cost effectiveness of a home-based self-management standing frame programme in people with progressive multiple sclerosis.

This study is funded by the NIHR Health Technology Assessment Programme (14/176/12), United Kingdom.Background:  Impaired mobility is a cardinal feature of multiple sclerosis (MS) and is rated by people with MS as their highest priority. By the secondary progressive phase, balance, mobility and physical activity levels are significantly compromised; an estimated 70% of people with secondary progressive MS fall regularly. Our ongoing research has systematically developed ‘Balance Right in MS’ (BRiMS), an innovative, manualised 13-week guided self-management programme tailored to the needs of people with MS, designed to improve safe mobility and minimise falls. Our eventual aim is to assess the clinical and cost effectiveness of BRiMS in people with secondary progressive MS by undertaking an appropriately statistically powered, multi-centre, assessor-blinded definitive, randomised controlled trial. This feasibility study will assess the acceptability of the intervention and test the achievability of running such a definitive trial. Methods/design:  This is a pragmatic multi-centre feasibility randomised controlled trial with blinded outcome assessment. Sixty ambulant people with secondary progressive MS who self-report two or more falls in the previous 6 months will be randomly allocated (1:1) to either the BRiMS programme plus usual care or to usual care alone. All participants will be assessed at baseline and followed up at 15 weeks and 27 weeks post-randomisation. The outcomes of this feasibility trial include: • Feasibility outcomes, including trial recruitment, retention and completion • Assessment of the proposed outcome measures for the anticipated definitive trial (including measures of walking, quality of life, falls, balance and activity level) • Measures of adherence to the BRiMS programme • Data to inform the economic evaluation in a future trial • Process evaluation (assessment of treatment fidelity and qualitative evaluation of participant and treating therapist experience) Discussion:  The BRiMS intervention aims to address a key concern for MS service users and providers. However, there are several uncertainties which need to be addressed prior to progressing to a full-scale trial, including acceptability of the BRiMS intervention and practicality of the trial procedures. This feasibility trial will provide important insights to resolve these uncertainties and will enable a protocol to be finalised for use in the definitive trial.Publisher PDFPeer reviewe

Health trainer-led motivational intervention plus usual care for people under community supervision compared with usual care alone: a study protocol for a parallel-group pilot randomised controlled trial (STRENGTHEN).

INTRODUCTION: People with experience of the criminal justice system typically have worse physical and mental health, lower levels of mental well-being and have less healthy lifestyles than the general population. Health trainers have worked with offenders in the community to provide support for lifestyle change, enhance mental well-being and signpost to appropriate services. There has been no rigorous evaluation of the effectiveness and cost-effectiveness of providing such community support. This study aims to determine the feasibility and acceptability of conducting a randomised trial and delivering a health trainer intervention to people receiving community supervision in the UK. METHODS AND ANALYSIS: A multicentre, parallel, two-group randomised controlled trial recruiting 120 participants with 1:1 individual allocation to receive support from a health trainer and usual care or usual care alone, with mixed methods process evaluation. Participants receive community supervision from an offender manager in either a Community Rehabilitation Company or the National Probation Service. If they have served a custodial sentence, then they have to have been released for at least 2 months. The supervision period must have at least 7 months left at recruitment. Participants are interested in receiving support to change diet, physical activity, alcohol use and smoking and/or improve mental well-being. The primary outcome is mental well-being with secondary outcomes related to smoking, physical activity, alcohol consumption and diet. The primary outcome will inform sample size calculations for a definitive trial. ETHICS AND DISSEMINATION: The study has been approved by the Health and Care Research Wales Ethics Committee (REC reference 16/WA/0171). Dissemination will include publication of the intervention development process and findings for the stated outcomes, parallel process evaluation and economic evaluation in peer-reviewed journals. Results will also be disseminated to stakeholders and trial participants. TRIAL REGISTRATION NUMBERS: ISRCTN80475744; Pre-results

What is the longitudinal profile of impairments and can we predict difficulty caring for the profoundly-affected arm in the first year post-stroke?

OBJECTIVE: To establish the longitudinal profile of impairments of body functions and activity limitations of the arm, and evaluate potential predictors of difficulty caring for the profoundly-affected arm post-stroke. DESIGN: Prospective cohort study. SETTING: Three UK stroke services. PARTICIPANTS: People unlikely to regain functional use of the arm (N=155) were recruited at 2-4 weeks post-stroke, and followed up at 3, 6 and 12 months. Potential predictors at baseline were hypertonicity, pain, motor control, mood, sensation/perception, age and stroke severity. INTERVENTIONS: NA MAIN OUTCOME MEASURES: Difficulty caring for the arm (LASIS), pain, hypertonicity, range of movement, arm function and skin integrity. Multi-variable linear regression identified the best fitting model for predicting LASIS at 12 months. RESULTS: One hundred and ten participants (71%) were reviewed at one year. There was a large variation in the profile of arm functions and activity limitations. Inability or severe difficulty caring for the arm affected 29% of participants. Hypertonicity developed in 77%, with severe hypertonicity present in 25%. Pain was reported by 65%, 94% developed shoulder contracture and 6% had macerated skin. Difficulty caring for the arm increased with age, greater level of hypertonicity and stroke classification; collectively these factors accounted for 33% of the variance in LASIS. CONCLUSIONS: At one year post-stroke, there was a high incidence of impairments of body functions and activity limitations in people with a profoundly-affected arm. Individual profiles were very variable and although some pre-disposing factors have been identified, it remains difficult to predict who is at greatest risk