scholarly journals Strategies to enhance routine physical activity in care home residents: the REACH research programme including a cluster feasibility RCT

2021 ◽  
Vol 9 (9) ◽  
pp. 1-314
Author(s):  
Anne Forster ◽  
Mary Godfrey ◽  
John Green ◽  
Nicola McMaster ◽  
Jennifer Airlie ◽  
...  
Keyword(s):  
Physical Activity ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Care Home ◽  
Intervention Mapping ◽  
Research Programme ◽  
Care Homes ◽  
Feasibility Trial ◽  
Daily Routines ◽  
Cluster Randomised

Background Care home residents are mainly inactive, leading to increased dependency and low mood. Although exercise classes may increase activity, a more sustainable model is to engage staff and residents in increasing routine activity. Objectives The objectives were to develop and preliminarily test strategies to enhance the routine physical activity of care home residents to improve their physical, psychological and social well-being through five overlapping workstreams. Design This trial had a mixed-methods research design to develop and test the feasibility of undertaking an evaluative study consisting of gaining an understanding of the opportunities for and barriers to enhancing physical activity in care homes (workstream 1); testing physical activity assessment instruments (workstream 2); developing an intervention through a process of intervention mapping (workstream 3); refining the provisional intervention in the care home setting and clarifying outcome measurement (workstream 4); and undertaking a cluster randomised feasibility trial of the intervention [introduced via three facilitated workshops at baseline (with physiotherapist input), 2 weeks (with artist input) and 2 months], with embedded process and health economic evaluations (workstream 5). Setting The trial was set in 12 residential care homes differing in size, location, ownership and provision in Yorkshire, UK. Participants The participants were elderly residents, carers, managers and staff of care homes. Intervention The intervention was MoveMore, designed for the whole home, to encourage and support the movement of residents in their daily routines. Main outcome measures The main outcome measures related to the feasibility and acceptability of implementing a full-scale trial in terms of recruitment and retention of care homes and residents, intervention delivery, completion and reporting of baseline data and outcomes (including hours of accelerometer wear, hours of sedentary behaviour and hours and type of physical activity), and safety and cost data (workstream 5). Results Workstream 1 – through a detailed understanding of life in a care home, a needs assessment was produced, and barriers to and facilitators of activity were identified. Key factors included ethos of care; organisation, management and delivery of care; use of space; and the residents’ daily routines. Workstream 2 – 22 (73.3%) out of 30 residents who wore a hip accelerometer had valid data (≥ 8 hours on ≥ 4 days of the week). Workstream 3 – practical mechanisms for increasing physical activity were developed, informed by an advisory group of stakeholders and outputs from workstreams 1 and 2, framed by the process of intervention mapping. Workstream 4 – action groups were convened in four care homes to refine the intervention, leading to further development of implementation strategies. The intervention, MoveMore, is a whole-home intervention involving engagement with a stakeholder group to implement a cyclical process of change to encourage and support the movement of residents in their daily routines. Workstream 5 – 12 care homes and 153 residents were recruited to the cluster randomised feasibility trial. Recruitment in the care homes varied (40–89%). Five care homes were randomised to the intervention and seven were randomised to usual care. Predetermined progression criteria were recruitment of care homes and residents (green); intervention delivery (amber); and data collection and follow-up – 52% of residents provided usable accelerometer data at 9 months (red), > 75% of residents had reported outcomes at 9 months (green, but self-reported resident outcomes were red), 26% loss of residents to follow-up at 9 months [just missing green criterion (no greater than 25%)] and safety concerns (green). Limitations Observations of residents’ movements were not conducted in private spaces. Working with care home residents to identify appropriate outcome measures was challenging. Take-up of the intervention was suboptimal in some sites. It was not possible to make a reliably informed decision on the most appropriate physical activity end point(s) for future use in a definitive trial. Conclusions A whole-home intervention was developed that was owned and delivered by staff and was informed by residents and staff. The feasibility of conducting a cluster randomised controlled trial was successfully tested: the target numbers of care homes and residents were recruited, demonstrating that it is possible to recruit care home residents to a cluster randomised trial, although this process was time-consuming and resource heavy. A large data set was collected, which provided a comprehensive picture of the environment, residents and staff in care homes. Extensive quantitative and qualitative work comprehensively explored a neglected area of health and social care research. Completion of ethnographic work in a range of settings enabled the production of an in-depth picture of life in care homes that will be helpful for other researchers considering organisational change in this setting. Future work The content and delivery of the intervention requires optimisation and the outcome measurement requires further refinement prior to undertaking a full trial evaluation. Consideration could be given to a recommended, simplified, core outcome set, which would facilitate data collection in this population. Trial registration Current Controlled Trials ISRCTN16076575. Funding This project was funded by the National Institute for Health Research (NIHR) Programme Grant for Applied Research programme and will be published in full in Programme Grant for Applied Research; Vol. 9, No. 9. See the NIHR Journals Library website for further project information.

scholarly journals Action 3:30R: Results of a Cluster Randomised Feasibility Study of a Revised Teaching Assistant-Led Extracurricular Physical Activity Intervention for 8 to 10 Year Olds

2019 ◽  
Vol 16 (1) ◽  
pp. 131 ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Emily Sanderson ◽  
Emma L. Bird ◽  
Alice Porter ◽  
...  
Keyword(s):  
Physical Activity ◽  
Primary Schools ◽  
Physical Activity Intervention ◽  
Vigorous Physical Activity ◽  
Feasibility Trial ◽  
After School ◽  
Cluster Randomised ◽  
The Difference ◽  
And Control ◽  
Programme Delivery

Many children are not sufficiently physically active. We conducted a cluster-randomised feasibility trial of a revised after-school physical activity (PA) programme delivered by trained teaching assistants (TAs) to assess the potential evidence of promise for increasing moderate-to-vigorous physical activity (MVPA). Participants (n = 335) aged 8–10 years were recruited from 12 primary schools in South West England. Six schools were randomised to receive the intervention and six acted as non-intervention controls. In intervention schools, TAs were trained to deliver an after-school programme for 15 weeks. The difference in mean accelerometer-assessed MVPA between intervention and control schools was assessed at follow-up (T1). The cost of programme delivery was estimated. Two schools did not deliver the intervention, meaning four intervention and six control schools were analysed at T1. There was no evidence for a difference in MVPA at T1 between intervention and control groups. Programme delivery cost was estimated at £2.06 per pupil per session. Existing provision in the 12 schools cost £5.91 per pupil per session. Action 3:30 was feasible to deliver and considerably cheaper than existing after-school provision. No difference in weekday MVPA was observed at T1 between the two groups, thus progression to a full trial is not warranted.

scholarly journals A classroom intervention targeting working memory, attention and language skills: a cluster randomised feasibility trial

2020 ◽  
Author(s):  
Anita Rowe ◽  
Jill Titterington ◽  
Joni Holmes ◽  
Lucy Henry ◽  
Laurence Taggart
Keyword(s):  
Working Memory ◽  
Outcome Measures ◽  
Health Professionals ◽  
Language Skills ◽  
Language Disorders ◽  
Feasibility Trial ◽  
Classroom Interventions ◽  
Definitive Trial ◽  
Cluster Randomised ◽  
Intervention Protocol

Abstract Background: International debate around the best models of speech and language therapy provision for children with language disorders has highlighted the need for research into classroom-based approaches and intervention dosage. Working memory (WM) is a cognitive skill that underpins attention and language. ‘Recall to Enhance Children’s Attention, Language and Learning’ (RECALL) is a novel, six-week, classroom-based intervention targeting WM to enhance attention and language skills in 4-5 year olds.Methods : A cluster randomised feasibility trial was conducted to address uncertainties around: the feasibility of a definitive trial to evaluate RECALL; the acceptability of RECALL to the health professionals and teachers who would deliver it; and the factors that may impact on the fidelity of its delivery in the classroom. Six classes of 4-5 year olds participated: 2 received RECALL; 2 received an existing intervention targeting attention skills (not underpinned by WM theory); and 2 received education as usual (no intervention). Ten children in each class ( n= 60) were sampled to assess the appropriateness of the outcome measures that may be used in a definitive trial. A process evaluation included: observations of the fidelity of the intervention delivery and semi-structured interviews with the health professionals (HPs) and teachers who delivered RECALL.Results: The recruitment targets were achieved and all six schools completed the trial. For the experimental RECALL intervention, 95% of sessions were delivered but fidelity to the intervention protocol varied between the two schools (76% versus 45%). The interview data revealed mixed findings regarding the acceptability of the intervention tasks and the outcome measures. A greater understanding of the theory underpinning RECALL would have enhanced the teachers’ fidelity to its delivery. Conclusions: The trial processes (e.g., recruitment and consent procedures) could be easily scaled-up into a future definitive trial but the RECALL intervention requires modification to enhance its acceptability. Large class sizes, child and facilitator factors impacted on the dose (number of practice items) accessed by individual children, particularly those most at risk. This study highlights the need for thorough training for teachers and HPs engaged in the delivery of classroom interventions for children with language disorders. Trial registration: ISRCTN13633886 . Registered 7 Sept 2018 . Keywords: working memory, classroom interventions, dosage, working memory, attention, language, feasibility

scholarly journals Evidence-based intervention to reduce avoidable hospital admissions in care home residents (the Better Health in Residents in Care Homes (BHiRCH) study): protocol for a pilot cluster randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e026510 ◽  
Author(s):  
Elizabeth L Sampson ◽  
Alexandra Feast ◽  
Alan Blighe ◽  
Katherine Froggatt ◽  
Rachael Hunter ◽  
...  
Keyword(s):  
Hospital Admission ◽  
Hospital Admissions ◽  
Care Home ◽  
Care Homes ◽  
System Level ◽  
Link Type ◽  
Cluster Randomised ◽  
Level Data ◽  
Tract Infections ◽  
Practice Development

IntroductionAcute hospital admission is distressing for care home residents. Ambulatory care sensitive conditions, such as respiratory and urinary tract infections, are conditions that can cause unplanned hospital admission but may have been avoidable with timely detection and intervention in the community. The Better Health in Residents in Care Homes (BHiRCH) programme has feasibility tested and will pilot a multicomponent intervention to reduce these avoidable hospital admissions. The BHiRCH intervention comprises an early warning tool for noting changes in resident health, a care pathway (clinical guidance and decision support system) and a structured method for communicating with primary care, adapted for use in the care home. We use practice development champions to support implementation and embed changes in care.Methods and analysisCluster randomised pilot trial to test study procedures and indicate whether a further definitive trial is warranted. Fourteen care homes with nursing (nursing homes) will be randomly allocated to intervention (delivered at nursing home level) or control groups. Two nurses from each home become Practice Development Champions trained to implement the intervention, supported by a practice development support group. Data will be collected for 3 months preintervention, monthly during the 12-month intervention and 1 month after. Individual-level data includes resident, care partner and staff demographics, resident functional status, service use and quality of life (for health economic analysis) and the extent to which staff perceive the organisation supports person centred care. System-level data includes primary and secondary health services contacts (ie, general practitioner and hospital admissions). Process evaluation assesses intervention acceptability, feasibility, fidelity, ease of implementation in practice and study procedures (ie, consent and recruitment rates).Ethics and disseminationApproved by Research Ethics Committee and the UK Health Research Authority. Findings will be disseminated via academic and policy conferences, peer-reviewed publications and social media (eg, Twitter).Trial registration numberISRCTN74109734; Pre-results.

A posture and mobility (skilful care) training package for care home staff: results of a cluster randomised controlled feasibility trial

Physiotherapy ◽  
2020 ◽  
Vol 107 ◽  
pp. e32
Author(s):  
A. Forster ◽  
B. Cundill ◽  
A. Ellwood ◽  
J. Fisher ◽  
M. Goodwin ◽  
...  
Keyword(s):  
Care Home ◽  
Feasibility Trial ◽  
Care Home Staff ◽  
Training Package ◽  
Cluster Randomised ◽  
Care Training ◽  
Randomised Controlled

scholarly journals National trends and local delivery in old age mental health services: towards an evidence base. A mixed-methodology study of the balance of care approach, community mental health teams and specialist mental health outreach to care homes

2014 ◽  
Vol 2 (4) ◽  
pp. 1-480 ◽  
Author(s):  
David Challis ◽  
Sue Tucker ◽  
Mark Wilberforce ◽  
Christian Brand ◽  
Michele Abendstern ◽  
...  
Keyword(s):  
Mental Health ◽  
Community Mental Health ◽  
Older People ◽  
Mental Health Problems ◽  
Care Home ◽  
Research Programme ◽  
Community Services ◽  
Care Homes ◽  
Care Home Staff ◽  
Mental Health Outreach

BackgroundThe rising number of older people with mental health problems makes the effective use of mental health resources imperative. Little is known about the clinical effectiveness and/or cost-effectiveness of different service models.AimsThe programme aimed to (1) refine and apply an existing planning tool [‘balance of care’ (BoC)] to this client group; (2) identify whether, how and at what cost the mix of institutional and community services could be improved; (3) enable decision-makers to apply the BoC framework independently; (4) identify variation in the structure, organisation and processes of community mental health teams for older people (CMHTsOP); (5) examine whether or not different community mental health teams (CMHTs) models are associated with different costs/outcomes; (6) identify variation in mental health outreach services for older care home residents; (7) scope the evidence on the association between different outreach models and resident outcomes; and (8) disseminate the research findings to multiple stakeholder groups.MethodsThe programme employed a mixed-methods approach including three systematic literature reviews; a BoC study, which used a systematic framework for choosing between alternative patterns of support by identifying people whose needs could be met in more than one setting and comparing their costs/outcomes; a national survey of CMHTs’ organisation, structure and processes; a multiple case study of CMHTs exhibiting different levels of integration encompassing staff interviews, an observational study of user outcomes and a staff survey; national surveys of CMHTs’ outreach activities and care homes. A planned randomised trial of depression management in care homes was removed at the review stage by the National Institute for Health Research (NIHR) prior to funding award.ResultsBoC: Past studies exhibited several methodological limitations, and just two related to older people with mental health problems. The current study suggested that if enhanced community services were available, a substantial proportion of care home and inpatient admissions could be diverted, although only the latter would release significant monies. CMHTsOP: 60% of teams were considered multidisciplinary. Most were colocated, had a single point of access (SPA) and standardised assessment documentation. Evidence of the impact of particular CMHT features was limited. Although staff spoke positively about integration, no evidence was found that more integrated teams produced better user outcomes. Working in high-integration teams was associated with poor job outcomes, but other factors negated the statistical significance of this. Care home outreach: Typical services in the literature undertook some combination of screening (less common), assessment, medication review, behaviour management and training, and evidence suggested intervention can benefit depressed residents. Care home staff were perceived to lack necessary skills, but relatively few CMHTs provided formal training.LimitationsLimitations include a necessary reliance on observational rather than experimental methods, which were not feasible given the nature of the services explored.ConclusionsBoC: Shifting care towards the community would require the growth of support services; clarification of extra care housing’s (ECH) role; timely responses to people at risk of psychiatric admission; and improved hospital discharge planning. However, the promotion of care at home will not necessarily reduce public expenditure. CMHTsOP: Although practitioners favoured integration, its goals need clarification. Occupational therapists (OTs) and social workers faced difficulties identifying optimal roles, and support workers’ career structures needed delineating. Care home outreach: Further CMHT input to build care home staff skills and screen for depression may be beneficial. Priority areas for further study include the costs and benefits for older people of age inclusive mental health services and the relative cost-effectiveness of different models of mental health outreach for older care home residents.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

“Care … about physical activity” in care homes in Scotland

2014 ◽  
Vol 18 (3) ◽  
pp. 120-127 ◽  
Author(s):  
Edith A. Macintosh ◽  
Bob Laventure
Keyword(s):  
Physical Activity ◽  
Care Home ◽  
Care Homes ◽  
Activity Increase ◽  
Content Type ◽  
Starting Point ◽  
Significant Difference ◽  
Improvement Process ◽  
Activity Choices

Purpose – The purpose of this paper is to outline an approach being taken, to improve opportunities and increase levels of physical activity amongst residents in care homes in Scotland, which has the potential to make a significant difference to the quality of lives. The approach is designed to raise awareness about the importance of physical activity, increase skills, knowledge and capacity amongst the workforce. Design/methodology/approach – The paper describes the reasons for promoting physical activity in care homes. It describes the challenge to this, associated issues and introduces you to a resource pack which offers solutions to care homes through a self-improvement process. It provides a case study which exemplifies how the ideas can be applied on a day-to-day basis. Findings – The paper provides insights into the challenges in the care home sector to promoting physical activity and offers some ways round these. It describes two strategies within the new resource pack to support care home residents to make person centred physical activity choices. Practical implications – This paper suggests that to promote physical activity in a care home the choices and needs of an individual must be the starting point. It requires partnership working and good leadership where staff have the permission to work in a new way. It suggests that risk enablement is key and the benefits of physical activity outweigh the risks even with frail older people. Originality/value – This paper promotes a new resource pack for care homes in Scotland for promoting an active life based on a self-improvement process.

scholarly journals BEAM study (Breathing, Education, Awareness, Movement): a randomised controlled feasibility trial of tai chi exercise in patients with COPD

2020 ◽  
Vol 7 (1) ◽  
pp. e000697
Author(s):  
Gloria Y. Yeh ◽  
Daniel Litrownik ◽  
Peter M. Wayne ◽  
Douglas Beach ◽  
Elizabeth S. Klings ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Self Efficacy ◽  
Tai Chi ◽  
Emotional Health ◽  
Outcome Measurement ◽  
Feasibility Trial ◽  
Medical Setting ◽  
Patient Reported

BackgroundDespite therapeutic advances, the management of chronic obstructive pulmonary disease (COPD) remains complex. There is growing interest in multidimensional, mind-body exercises to improve both physical and psychosocial aspects of COPD burden. Few US data are available in this population on tai chi (TC) a mind-body exercise incorporating physical activity, breathing and mindful awareness. We explored feasibility and preliminary efficacy of TC in COPD in an US academic medical setting.MethodsPatients with COPD Global Obstructive Lung Disease (GOLD) stages 2–4 were randomised to a 12-week TC programme or education control. At 12 weeks, those in TC were randomised again to continue in maintenance classes or not to further explore optimal duration. All groups were followed to 24 weeks. Feasibility/safety parameters were analysed descriptively. Preliminary between-group differences were estimated in symptoms (dyspnoea, fatigue), health-related quality-of-life (Chronic Respiratory Questionnaire CRQ), cognitive-emotional measures (mood, COPD self-efficacy) and functional status (6 min walk test, lower body strength, flexibility, physical activity).ResultsNinety-two subjects were randomised (N=61 TC, N=31 education). Mean age was 68±8 years, 66% male, mean forced expiratory volume in 1 s % predicted 57±13, 28% were GOLD stage 3–4. Overall retention was 85%. Nineteen adverse events occurred, most being study-unrelated COPD exacerbations. From baseline to 12 weeks, there were between-group improvements favouring TC, in CRQ-total (Cohen’s d effect size (ES)=0.46; adj mean diff (AMD)=0.31), CRQ-emotion (ES=0.54; AMD=0.49), Centre for Epidemiologic Studies Depression (ES=−0.37; AMD=2.39) and Patient-Reported Outcome Measurement Information System (PROMIS)-fatigue (ES=−0.34; AMD=−0.17). From baseline to 24 weeks, there was an improvement favouring TC in CRQ-dyspnoea (ES=0.41; AMD=0.46). Among TC participants, there was a positive effect of maintenance classes on self-efficacy (ES=−0.69; AMD=−0.40), 6 min walk (ES=0.56; AMD=49.26 feet), PROMIS-fatigue (ES=−0.41; AMD=−0.28) and chair stand (0.43; AMD=0.56).ConclusionTC in patients with COPD is feasible and safe. Preliminary analyses support a potential modest role in improving quality-of-life, cognitive-emotional health and function that should be further studied.Trial registration numberNCT01551953.IRB referenceBIDMC 2010P-000412; VA 2540.

scholarly journals Care home resident and staff perceptions of the acceptability of nutrition intervention trial procedures: a qualitative study embedded within a cluster randomised feasibility trial

BMJ Open ◽  
2018 ◽  
Vol 8 (7) ◽  
pp. e022307
Author(s):  
Ruth Elizabeth Stow ◽  
Christina H Smith ◽  
Alison B Rushton
Keyword(s):  
Focus Groups ◽  
Care Home ◽  
Nutrition Intervention ◽  
Nutrition Support ◽  
Feasibility Trial ◽  
Trial Participation ◽  
Staff Perceptions ◽  
Nutritional Interventions ◽  
Cluster Randomised ◽  
Care Home Resident

ObjectivesTo examine care home resident and staff perceptions of the acceptability of participating in a feasibility trial evaluating nutritional interventions in the treatment of malnutrition.DesignExploratory qualitative methodology was used to gather descriptions of resident and staff perceptions of trial procedures, using semi-structured interviews with residents and focus groups with staff. The interviews were used to explore individual perceptions of the acceptability of the assigned intervention and the outcomes measured. Focus groups were used to explore staff experiences of trial participation and perspectives of nutritional support interventions.SettingThe study was embedded within a cluster randomised feasibility trial, which randomised six care homes to provide standard care (SC), food-based (FB) intervention or oral nutritional supplement (ONS) intervention to residents with, or at risk of, malnutrition.ParticipantsResidents in the trial with capacity to consent (n=7) formed the sampling frame for inclusion. Four agreed to be approached by the researcher and to take part in the individual interviews. All were women, representing two arms of the trial (ONS and SC). Twelve staff participated in six focus groups, one at each care home. All participants were women, representing all three arms of the trial.ResultsMajor themes that emerged from both interviews and focus groups included the perceived acceptability of trial involvement, the value of residents completing participant-reported outcome measures and the challenges associated with outcomes measurement in this setting. Themes that emerged from the focus groups alone, included the importance of individualising an intervention, and the perceived value of FB and ONS interventions and dietetic input.ConclusionsResidents and staff perceived involvement in a trial evaluating nutritional interventions to be acceptable, although the challenges associated with research in this setting were acknowledged. Resident preferences were highlighted by staff as an important consideration when implementing a nutrition support plan.Trial registration numberISRCTN38047922

scholarly journals A Cluster-Randomised Crossover Pilot Feasibility Study of a Multicomponent Intervention to Reduce Occupational Sedentary Behaviour in Professional Male Employees

2021 ◽  
Vol 18 (17) ◽  
pp. 9292
Author(s):  
Gail Helena Nicolson ◽  
Catherine B. Hayes ◽  
Catherine D. Darker
Keyword(s):  
Physical Activity ◽  
Sedentary Behaviour ◽  
Ecological Model ◽  
Smartphone Application ◽  
Retention Rates ◽  
Feasibility Trial ◽  
Multicomponent Intervention ◽  
Cluster Randomised ◽  
Manual Recording ◽  
Set Up

Professional male office employees have been identified as those most at risk of prolonged sedentary time, which is associated with many long-term adverse health conditions. The aim of the study was to assess the acceptability and feasibility of a gender-sensitive multicomponent intervention, guided by the socio-ecological model, to reduce occupational sedentary behaviour by increasing physical activity in professional men. The main elements of the intervention comprised: a Garmin watch with associated web-based platform/smartphone application, an under-desk pedal machine, and management participation and support. A cluster-randomised crossover pilot feasibility trial recruiting professional males was conducted in two workplaces. Mixed methods were used to assess the primary outcomes of recruitment, retention, and acceptability and feasibility of the intervention. Secondary outcomes included objectively measured sedentary behaviour, standing and physical activity. Focus groups were used to explore the acceptability of the intervention in a real-world setting. Twenty-two participants were recruited (mean age 42.9 years (SD 11.0)). Recruitment and retention rates were 73.3% and 95%, respectively. Overall, participants found the intervention acceptable and feasible, and expressed enjoyment of the intervention, however desk set-up issues with the pedal devices were noted. The manual recording of the pedalling bouts was overly burdensome. Preliminary data indicate that the intervention may reduce occupational sedentary behaviour and increase physical activity. This intervention should be further tested in a definitive trial following consideration of the findings of this pilot feasibility trial.

scholarly journals A cluster randomised feasibility trial evaluating nutritional interventions in the treatment of malnutrition in care home adult residents

Trials ◽  
2015 ◽  
Vol 16 (1) ◽  
Author(s):  
Ruth Stow ◽  
Natalie Ives ◽  
Christina Smith ◽  
Caroline Rick ◽  
Alison Rushton
Keyword(s):  
Care Home ◽  
Feasibility Trial ◽  
Nutritional Interventions ◽  
Cluster Randomised
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