The effectiveness of a knowledge translation intervention on the implementation of NEWS2 in nursing homes, a pragmatic cluster RCT.

BACKGROUND: Improving the uptake of relevant and reliable research is an important priority in long-term care to achieve sustainable and high-quality services for the increasingly older population. AIM: The purpose was to assess the effectiveness of a tailored, adaptive and a multifaceted KT capacity program, relative to usual practice, on the implementation of National Early Warning Score 2 (NEWS2). METHODS: This study was carried out as a pragmatic cluster-randomized controlled trial. The capacity program consisted of an educational part to address implementation capacity gaps and a facilitation-upon-implementation part to address a relevant knowledge gap in nursing homes. A collective decision was made to address the challenge of early detection of clinical deterioration among nursing home residents, by implementing the (NEWS2) as clinical innovation. Public nursing homes in a Norwegian municipality (n = 21) with a total of 1 466 beds were eligible for inclusion. The study-period spanned over a 22-month period, including a 12-month follow-up. Data was extracted from the Electronic Patient Journal system and analyzed using multilevel growth model analysis. RESULTS: The intervention had a large effect on the use of NEWS2 among care staff in intervention nursing homes, compared to the control group (standardized mean difference, d = 2.42). During the final month of the implementation period, residents in the intervention group was assessed with NEWS2 1.44 times (95% CI: 1.23, 1.64) per month, which is almost four times more often than in the control group (mean = 0.38, 95% CI: 0.19, 0.57). During the follow-up period, the effect of the intervention was not only sustained in the intervention group but there was a substantial increase in the use of NEWS2 in both the intervention (mean = 1.75, 95% CI: 1.55, 1.96) and control groups (mean = 1.45, 95% CI: 1.27, 1.65). CONCLUSIONS: This tailored implementation strategy had a large effect on the use of NEWS2 among care staff, demonstrating that integrated knowledge translation strategies can be a promising strategy to achieve evidence-based care in the nursing home sector. TRIAL REGISTRATION: ISRCTN12437773 . Registered 19/3 2020, retrospectively.

Effectiveness and cost-effectiveness of a community intervention in enhancing access to care and improving clinical outcomes for depression: a protocol for a cluster randomised controlled trial in India.

BACKGROUND: Although depression is the leading cause of disability worldwide, treatment coverage for the condition is inadequate. Supply-side barriers (e.g. shortage of specialist mental health professionals) and demand-side barriers (e.g. lack of awareness about depression) lead to limited availability of evidence-based interventions, poor demand for care, and low levels of adherence to care. The aim of our study is to examine if the addition of a community intervention delivered by community volunteers enhances the population-level impact of an evidence based psychosocial intervention (Healthy Activity Program [HAP]) in routine primary care by increasing demand for HAP and improving HAP adherence and effectiveness. METHODS: A hybrid type 2 effectiveness implementation cluster randomised controlled trial will be implemented in the state of Goa, India. Twenty-eight clusters of villages and their associated public sector health centres will be randomly allocated through restricted randomisation. Clusters will be randomly allocated to the 'Community Model' or 'Facility Model' arms. All clusters will offer the HAP and clusters in the 'Community Model' arm will additionally receive activities delivered by community volunteers ("Sangathis") to increase awareness about depression and support demand for and adherence to HAP. The primary outcomes are Contact Coverage (Patient Health Questionnaire [PHQ-9] score > 4 as a proportion of those screened) and Effectiveness Coverage (mean PHQ-9 score amongst those who score ≥ 15 at baseline, i.e. those who have moderately severe to severe depression) at 3 months post-recruitment. Additional outcomes at 3 and 6 months will assess sustained effectiveness, remission, response to treatment, depression awareness, social support, treatment completion, and activation levels. Economic and disability outcomes will be assessed to estimate incremental cost-effectiveness ratios. Implementation will be evaluated through process data and qualitative data informed by the RE-AIM framework. A minimum of 79488 primary care attenders will be screened for the Contact Coverage outcome, and 588 individuals with PHQ-9 ≥ 15 will be recruited for the Effectiveness Coverage outcome. DISCUSSION: If effective, our community intervention will have relevance to India's Ayushman Bharat universal healthcare programme which is scaling up care for depression in primary care, and also to other low- and middle- income countries. TRIAL REGISTRATION: Registered on ClincalTrials.gov ( NCT05890222 .) on 12/05/2023.

The Gestational Obesity Weight Management: Implementation of National Guidelines (GLOWING) study: a pilot cluster randomised controlled trial.

BACKGROUND: Pregnancy weight management interventions can improve maternal diet, physical activity, gestational weight gain, and postnatal weight retention. UK guidelines were published in 2010 but health professionals report multiple complex barriers to practice. GLOWING used social cognitive theory to address evidence-based barriers to midwives' implementation of weight management guidelines into routine practice. This paper reports the pilot trial outcomes relating to feasibility and acceptability of intervention delivery and trial procedures. METHODS: GLOWING was a multi-centre parallel-group pilot cluster RCT comparing the delivery of a behaviour change intervention for midwives (delivered as training workshops) with usual practice. The clusters were four NHS Trusts in Northeast England, randomised to intervention or control arms. Blinding of allocation was not possible due to the nature of the intervention. We aimed to deliver the intervention to all eligible midwives in the intervention arm, in groups of 6 midwives per workshop, and to pilot questionnaire data collection for a future definitive trial. Intervention arm midwives' acceptability of GLOWING content and delivery was assessed using a mixed methods questionnaire, and pregnant women's acceptability of trial procedures by interviews. Quantitative data were analysed descriptively and qualitative data thematically. RESULTS: In intervention arm Trusts, 100% of eligible midwives (n = 67) were recruited to, and received, the intervention; however, not all workshops had the planned number of attendees (range 3-8). The consent rate amongst midwives randomised (n = 100) to complete questionnaires was 74% (n = 74) (95% CI 65%, 83%), and overall completion rate 89% (n = 66) (95% CI 82%, 96%). Follow-up response rate was 66% (n = 49) (95% CI 55%, 77%), with a marked difference between intervention (39%, n = 15) and control (94%, n = 34) groups potentially due to the volume of research activities. Overall, 64% (n = 47) (95% CI 53%, 75%) completed both baseline and follow-up questionnaires. Midwives viewed the intervention as acceptable and directly relevant to routine practice. The least popular components related to scripted role-plays. Pregnant women viewed the recruitment and trial processes to be acceptable. CONCLUSIONS: This rigorously conducted pilot study demonstrated feasibility intervention delivery and a high level of acceptability amongst participants. It has provided information required to refine the intervention and trial protocol, enhancing confidence that a definitive trial could be carried out. TRIAL REGISTRATION: ISRCTN46869894; retrospectively registered 25th May 2016, www.isrctn.com/ISRCTN46869894 .

Effect of a multimodal prevention strategy on dialysis-associated infection events in outpatients receiving haemodialysis: The DIPS stepped wedge, cluster-randomized trial.

OBJECTIVES: Patients with haemodialysis catheters are susceptible to dialysis-associated infections, particularly bloodstream infections. There have been few systematic attempts to reduce this burden. Our study aimed to investigate the effect of a multimodal prevention strategy on dialysis-associated infection events (DAIE) among haemodialysis outpatients. METHODS: A multicentre, stepped wedge, cluster-randomized controlled trial was done from October 2019 to September 2021. Outpatient dialysis facilities entered into the intervention phase in three randomly assigned clusters, at three predefined time points. The multimodal prevention strategy consisted of infection surveillance and hand hygiene (HH) compliance observation with active feedback and teaching aseptic procedures, and a patient flyer. The primary outcome was incidence rates of different DAIE, such as bloodstream infections, intravenous antimicrobial starts, and local access-site infections per 1000 dialysis. As secondary outcome, we analysed the HH compliance change. RESULTS: A total of 43 haemodialysis outpatient facilities with 11 251 patients and 1 413 457 proceeded haemodialysis were included in the DIPS-trial. Incidence rates were 0.71 DAIE per 1000 dialysis (95% CI, 0.65-0.78) in the control and 0.31 (95% CI, 0.27-0.36) in the intervention group. The univariable analysis yielded an incidence rate ratio (IRR) of 0.44 (95% CI, 0.33-0.59) for DAIE. Especially in patients with a central venous catheter, we saw a significant decrease in DAIE in the intervention group (IRR 0.4; 95% CI, 0.28-0.58). The HH observation combined with feedback and intensified training, resulted in an increase of HH compliance from 58-65%. DISCUSSION: A multimodal prevention strategy showed a significant preventive effect on DAIE among haemodialysis outpatients. This reduction also applied to bloodstream infections, especially in patients with a central venous catheter.

Efficacy of a Neuromuscular Warm-up Program in Reducing the Risk of School Sports Injury among Chinese Children: A Cluster Randomized Controlled Trial.

Background: Children who participate in sports have reduced cardiovascular risk, obesity, and type 2 diabetes. However, sports participation also comes with an inherent risk of sports-related injuries. Purpose: To examine the efficacy of a school-based neuromuscular warm-up program (NWP) in reducing the risk of school sports injury (SSI) in children and the impact of different levels of compliance on the effectiveness of the program. Study Design: Randomized controlled trial; Level of evidence, 1. Methods: A total of 421 students from grades 4 to 6 at a single school (age range, 9-14 years) were randomized by grade to an intervention group and a control group. The intervention group participated in a 13-week simplified (8-minute) NWP designed to reduce SSI risk. The control group participated in a standard warm-up of the same length and duration. Exposure, compliance, and injury data were collected via a weekly form. The primary injury outcome was all SSIs. Secondary outcomes included injuries from physical education (PE) and non-PE class, upper and lower extremity injuries, other location injuries, and time-loss injuries. A Poisson regression model using an intent-to-treat analysis was performed to estimate the incidence rate ratio (IRR) for all injuries in the intervention group compared with the control group. To examine the influence of level of compliance, we divided the intervention group into low compliance (participation 1-2 times/wk) and high compliance (participation >2 times/wk) then compared the difference on injury rates (IRs) between these groups and the control group. Results: There were significant differences between the intervention and control groups regarding all SSIs (IRR, 0.47; 95% CI, 0.23-0.96; P = .038), PE class injuries (IRR, 0.37; 95% CI, 0.14-0.99; P = .048), and other location injuries (IRR, 0.20; 95% CI, 0.05-0.82; P = .025). The compliance analysis revealed that although the low-compliance group was able to reduce the risk of SSIs (IR, 4.43; 95% CI, 2.49-6.37) compared with the control group (IR, 7.60; 95% CI, 5.61-9.59), the high-compliance group produced a better effect in reducing the SSI risk (IR, 1.80; 95% CI, 0.04-3.56). Conclusion: The simplified NWP used in this study was efficacious in the reduction of SSIs in children. Registration: ChiCTR2100043875 (Chinese Clinical Trial Registry; http://www.chictr.org.cn).

A participatory ergonomics intervention to re-design work and improve the musculoskeletal health of paramedics: protocol for a cluster randomised controlled trial.

BACKGROUND: In this paper, we present the protocol for a cluster randomised controlled trial to evaluate the effectiveness and implementation of a participative risk management intervention to address work-related musculoskeletal disorders (WMSDs). The aims of the study include to evaluate the implementation process and the impact of the intervention on work related musculoskeletal pain and discomfort and exposure to physical and psychosocial hazards in paramedics over a 12-month period. METHODS: The intervention in this study is to implement A Participative Hazard Identification and Risk Management (APHIRM) toolkit in an ambulance service. Eighteen work groups containing eligible participants (registered paramedics) will be randomised into the intervention or wait-list control arm in one of three rolling recruitment periods. The APHIRM toolkit survey will be offered at baseline and 12 months later, to all current eligible participants in each work group allocated to the trial. The intervention work groups will receive the remainder of the APHIRM toolkit procedures. Identifying data about individual participants will not be collected in the survey, to protect participant privacy and encourage participation. Changes in primary (musculoskeletal pain and discomfort) and secondary (exposure to physical and psychosocial hazards at work) outcomes measured in the survey will be analysed comparing the baseline and follow up response of the cluster. A process evaluation is included to analyse the implementation and associated barriers or facilitators. DISCUSSION: This study is important in providing a comprehensive approach which focusses on both physical and psychosocial hazards using worker participation, to address WMSDs, a well-known and significant problem for ambulance services. The effectiveness of the intervention in work groups will be rigorously evaluated. If significant positive results are observed, the intervention may be adopted in ambulance services, both nationally and internationally. TRIAL REGISTRATION: ISRCTN77150219. Registered 21 November 2021.

Bayesian design and analysis of two-arm cluster randomized trials using assurance.

We consider the design of a two-arm superiority cluster randomized controlled trial (RCT) with a continuous outcome. We detail Bayesian inference for the analysis of the trial using a linear mixed-effects model. The treatment is compared to control using the posterior distribution for the treatment effect. We develop the form of the assurance to choose the sample size based on this analysis, and its evaluation using a two loop Monte Carlo sampling scheme. We assess the proposed approach, considering the effect of different forms of prior distribution, and the number of Monte Carlo samples needed in both loops for accurate determination of the assurance and sample size. Based on this assessment, we provide general advice on each of these choices. We apply the approach to the choice of sample size for a cluster RCT into poststroke incontinence, and compare the resulting sample size to that from assurance based on a Wald test for the treatment effect. The Bayesian approach to design and analysis developed in this article can offer advantages in terms of an increase in the robustness of the chosen sample size to parameter mis-specification and reduced sample sizes if prior information indicates the treatment effect is likely to be larger than the minimal clinically important difference.

The effectiveness and health-economic evaluation of "Partner in Balance," a blended self-management program for early-stage dementia caregivers: study protocol for a cluster-randomized controlled trial.

BACKGROUND: Informal caregivers of people with dementia are crucial in dementia care. However, they are insufficiently supported and report caregiver burdens, which urges the need for cost-effective interventions aimed at supporting caregivers. This paper presents the design of a study evaluating the effectiveness, cost-effectiveness, and cost-utility of a blended self-management program for early-stage dementia caregivers. METHODS/DESIGN: A pragmatic, cluster randomized controlled trial with a shared control group will be conducted. Participants will be informal caregivers of people with early-stage dementia and will be recruited by local care professionals. Randomization will be carried out at the level of the care professional level in a ratio of 35% to 65% (control arm vs. intervention arm). Participants in the control arm will receive care as usual and the intervention arm will receive the blended care self-management program "Partner in Balance" within a usual care setting in the Netherlands. Data will be collected at baseline and at 3-, 6-, 12-, and 24-month follow-ups. The primary outcome for effectiveness (part 1) is care management self-efficacy. For the health-economic evaluation (part 2) total care costs and the quality of life for individuals with dementia (cost-effectiveness) and quality-adjusted life years (cost-utility) will be the base case analysis. Secondary outcomes (parts 1 and 2) will include depression, anxiety, perceived informal caregiving stress, service-use self-efficacy, quality of life, caregivers' gain, and perseverance time. A process evaluation (part 3) will investigate the internal and external validity of the intervention. DISCUSSION: In this trial, we plan to evaluate the effectiveness, cost-effectiveness, and cost-utility of "Partner in Balance" among informal caregivers of people with dementia. We expect to find a significant increase in care management self-efficacy, and the program to be cost-effective, and provide valuable insights to stakeholders of "Partner in Balance." TRIAL REGISTRATION: ClinicalTrials.gov, NCT05450146. Registered on 4 November 2022.

Compliance with national snakebite treatment guidelines in rural Sri Lankan hospitals: a cluster randomized controlled trial of a brief educational intervention.

BACKGROUND: Snakebite is a global health problem that predominantly occurs in rural areas. In Sri Lanka, the majority of snakebite patients first present to smaller rural primary hospitals. Improving care delivered at rural hospitals has the potential to reduce morbidity and mortality from snakebites. OBJECTIVE: In this study, we evaluated whether an educational intervention would increase compliance with national snakebite treatment guidelines in primary hospitals. METHODS: The hospitals were randomized into educational intervention (n = 24) and control groups (n = 20). The intervention hospitals received a brief educational intervention based on Sri Lankan Medical Association (SLMA) guidelines on the management of snakebites. Control hospitals had free access to the guidelines but no additional promotion. Four outcomes were assessed: pre- and post-test knowledge at the completion of a one-day workshop of educational intervention (intervention group only); improvement in the quality of the patient's medical records; appropriateness of transfers to higher hospitals; and quality of overall management graded by a blinded expert. The data was collected over a period of 12 months. RESULTS: All case notes of snakebite hospital admissions were reviewed. There were 1021 cases in the intervention group hospitals and 1165 cases in the control hospitals. Four hospitals in the intervention group and three hospitals in the control group did not have snakebite admissions and were excluded from the cluster analysis. The absolute quality of care was high in both groups. Post-test knowledge was improved (p < 0.0001) following the intervention group's educational workshop. There was no statistical difference between the two groups in terms of clinical data documentation in hospital notes (scores, p = 0.58) or transfer appropriateness (p = 0.68)-both of which were significantly different from the guidelines. CONCLUSION: Education of primary hospital staff improved the immediate knowledge gained but did not improve record-keeping or the appropriateness of inter-hospital patient transfer. TRIAL REGISTRATION: The study was registered with Sri Lanka Medical Associations' clinical trial registry. Reg. No SLCTR -2013-023. Registered: 30/07/2013.

Hockey Fans in Training (Hockey FIT): Rationale, design, and baseline characteristics from a cluster randomized controlled trial in men with overweight or obesity.

BACKGROUND: Previous research highlights the need for effective lifestyle interventions for men. Hockey Fans in Training (Hockey FIT) was developed as a pragmatic healthy lifestyle program tailored to men with overweight or obesity. This paper overviews the rationale, program details, and design of a recently completed cluster randomized controlled trial (RCT) of Hockey FIT. Participant engagement and baseline characteristics are also described. METHODS: The RCT evaluated the effectiveness, cost-effectiveness, and implementation of Hockey FIT. Forty-two sites in Canada and the United States were randomized to either the Hockey FIT intervention group or wait-list control group. Participants were men, aged 35-65 years, with a body mass index (BMI) ≥27 kg/m2. Hockey FIT is a group-based, off-ice, in-person healthy lifestyle program, including both a 3-month active phase and a 9-month minimally-supported phase. Outcomes were assessed at baseline, 3, and 12 months. The primary outcome was weight loss at 12 months. RESULTS: The design of the cluster RCT incorporates evaluations of participant health outcomes, program implementation, and broader healthcare system impact. In the RCT, 1397 participants were assessed for eligibility and 997 were enrolled. Most participants heard about the program through social media or hockey team emails. Participants averaged 49 years of age, had BMI values of 35.3 kg/m2, were predominately white, and had varying levels of education. CONCLUSION: The intended audience for Hockey FIT was recruited successfully, however, targeted recruitment to better engage diverse populations is warranted. This paper affords a useful outline for evaluating future lifestyle interventions tailored to men. This trial was registered on August 17, 2018 with ClinicalTrials.gov (identifier: NCT03636282).

Effect of an educational intervention on diet and physical activity among school-aged adolescents in Delhi -The i-PROMISe (PROMoting health literacy in Schools) Plus Study.

Purpose: Emerging lifestyle changes due to rapid urbanization have led to an epidemiological transition and the rising prevalence of obesity is responsible for major non-communicable diseases (NCDs) which have further aggravated due to the COVID-19 pandemic. This study aims to assess the effectiveness of a comprehensive school-based intervention on diet and physical activity-related behavior of adolescents. Methods: In 2019, a cluster-randomized controlled trial was conducted in randomly selected (n = 8) private schools. A 2-year intervention program was implemented over consecutive academic years (2019-2020 and 2020-2021) with students who were in the 6th and 7th grades when the study began. Four schools were randomly assigned to the intervention (n = 794) and four schools to the control group (n = 774). Results: The difference in changes in diet and physical-activity-related behaviors of the students between the intervention and control schools were not significant in the intention to treat analysis probably due to the large drop-out due to COVID-19 measures: 304 students were available for follow-up in the intervention group and 122 in the control group (391 cases were excluded to make data comparable with baseline survey). The intake of vegetables (once a day) [ß = 0.35, OR = 1.42, 95% CI (1.03, 1.95)] in the per-protocol analysis has increased among adolescents in the intervention group as compared to the control group. Conclusion: The findings of this study indicated a positive effect of the intervention on diet and physical-activity-related changes in the expected direction and highlights the importance of addressing such behavior to prevent obesity among adolescents and thus NCDs in the later stage of life.

Video-based e-learning program for schoolteachers to support children of parents with mental illness: a cluster randomized trial.

BACKGROUND: Some children of parents with mental illness need support. This study aimed to develop and test the effectiveness of an e-learning program for training elementary schoolteachers to support children of parents with mental illness. METHODS: The program, which included a 30-min video-based e-learning program, aimed to help schoolteachers gain basic knowledge about mental illness and children of parents with mental illness, recognize children in need of support, and gain confidence in supporting them. A school-based cluster randomized controlled trial was conducted, and the schools were randomly divided into intervention and control groups. The teachers at these schools signed up for the program and participated individually. The outcome measures for the schoolteachers were evaluated at three time points: baseline (T1), post (T2), and one month later (T3). Along with the Sense of Coping Difficulty subscale (primary outcome measure), the following self-developed outcome measures were used: actual behaviors and attitude toward supporting children, knowledge, and self-assessment of program goals achievement. The Sense of Coping Difficulty subscale results at T3 were compared between the groups. Effectiveness over time was assessed for all the outcome measures. The interaction between baseline and intervention effects on the Sense of Coping Difficulty subscale was analyzed. As a part of the process evaluation, open-ended text responses were analyzed qualitatively. RESULTS: Baseline responses were collected from 87 participants in the intervention group and 84 in the control group. The total score of the Sense of Coping Difficulty subscale at T3 was significantly lower in the intervention group than in the control group (p = 0.007). Over time, a significant effect was observed on the Sense of Coping Difficulty subscale, actual behavior, knowledge of onset timing and probability of onset, and achievement of all program goals. Exploratory analysis was particularly effective for those who encountered a high level of difficulty in supporting children. The participants' text responses indicated that they planned to look carefully at children's backgrounds and stay close to them in the future. CONCLUSIONS: The program was effective for schoolteachers in supporting children of parents with mental illness. TRIAL REGISTRATION: UMIN000045483; 14/09/2021.

Community participatory learning and action cycle groups to reduce type 2 diabetes in Bangladesh (D:Clare): an updated study protocol for a parallel arm cluster randomised controlled trial.

The "Diabetes: Community-led Awareness, Response and Evaluation" (D:Clare) trial aims to scale up and replicate an evidence-based participatory learning and action cycle intervention in Bangladesh, to inform policy on population-level T2DM prevention and control.The trial was originally designed as a stepped-wedge cluster randomised controlled trial, with the interventions running from March 2020 to September 2022. Twelve clusters were randomly allocated (1:1) to implement the intervention at months 1 or 12 in two steps, and evaluated through three cross-sectional surveys at months 1, 12 and 24. However, due to the COVID-19 pandemic, we suspended project activities on the 20th of March 2020. As a result of the changed risk landscape and the delays introduced by the COVID-19 pandemic, we changed from the stepped-wedge design to a wait-list parallel arm cluster RCT (cRCT) with baseline data. We had four key reasons for eventually agreeing to change designs: equipoise, temporal bias in exposure and outcomes, loss of power and time and funding considerations.Trial registration ISRCTN42219712 . Registered on 31 October 2019.

Evaluation of a workplace suicide prevention program in the Australian manufacturing industry: protocol for a cluster-randomised trial of MATES in manufacturing.

Males are at higher risk of death by suicide than females in Australia, and among men, blue-collar males are at higher risk compared to other working males. In response, MATES in Construction developed a workplace suicide prevention program for the construction sector in 2007 that has been widely implemented in Australia. In the current project, this program is being adapted and trialled in the manufacturing sector. The common aims of MATES programs are to improve suicide prevention literacy, help-seeking intentions, and helping behaviours. The program will be evaluated using a cluster randomised-controlled trial design with waitlist controls across up to 12 manufacturing worksites in Australia. We hypothesise that after 8 months of the MATES in Manufacturing program, there will be significantly greater improvements in help-seeking intentions (primary outcome) compared to waitlist controls. The project is led by Deakin University in collaboration with the University of Melbourne, and in partnership with MATES in Construction and a joint labour-management Steering Group.Trial registration: The trial was registered retrospectively with the Australian New Zealand Clinical Trials Registry on 25 January 2022 (ACTRN12622000122752).Protocol version: 2.0, November 2022.

The Impact of Antenatal Balanced Plate Nutrition Education for Pregnant Women on Birth Weight: A Cluster Randomised Controlled Trial in Rural Bangladesh.

Low birth weight (LBW) is a global public health problem with the highest prevalence in South Asia. It is strongly associated with maternal undernutrition. In South Asia, intra-household food distribution is inequitable, with lower dietary adequacy in women. Evidence that nutrition education improves diet during pregnancy and reduces LBW is weak. We assessed the impact of nutrition education for pregnant women on birth weight in rural Bangladesh. We conducted a parallel, two-arm, cluster-randomised controlled trial, with 36 clusters allocated equally to intervention (n = 445) or standard care (n = 448). From their first trimester until delivery, intervention participants received education about eating balanced meals to meet daily dietary requirements with diverse food groups. The primary outcome of mean birth weight was 127.5 g higher in the intervention compared to control women, and the intervention reduced the risk of LBW by 57%. Post hoc analyses showed a significantly higher birth weight and a greater reduction in LBW amongst adolescent mothers. The mean number of food groups consumed was significantly higher in the intervention from the third month of pregnancy than in the control. A community-based balanced plate nutrition education intervention effectively increased mean birth weight and reduced LBW, and improved dietary diversity in rural Bangladeshi women.

Evaluation of the PhunkyFoods intervention on food literacy and cooking skills of children aged 7-9 years: a cluster randomised controlled trial in Yorkshire Primary Schools UK.

BACKGROUND: Childhood obesity rates more than double during primary school in England. Acquiring competent cooking skills is a key part of children's education that can lead to improved knowledge of a healthy lifestyle and dietary behaviours. Evaluation of the impact of 'PhunkyFoods', a school-based food and nutrition education programme, will assess food literacy, cooking skills and dietary behaviour in primary-school children. METHODS: A cluster randomised controlled trial will be undertaken in 28 primary schools in North Yorkshire, UK, including a total population of children aged 7-9 years (n = 420). The trial has two arms: (a) the intervention group receiving PhunkyFoods programme (n = 210) and (b) the wait-list control group receiving the usual school curriculum (n = 210). The intervention 'PhunkyFoods' will be delivered by Purely Nutrition Ltd. The participating school staff are supported with training, policy development and access to resources to improve the delivery of nutrition education. Children participate through whole school assemblies, classroom activities, and after-school clubs about food preparation, cooking healthy meals and healthy living. Schools, parents and children have access to healthy meal recipes through the PhunkyFoods website. The primary outcomes are differences in food literacy and cooking skills scores between control and intervention arms after 12 months of the intervention and adjusted for baseline values. The secondary outcome is differences in fruit and vegetable intake between the arms after 12 months (adjusted for baseline). Treatment effects will be examined using mixed ANOVA and regression analysis. Primary analyses will adjust for baseline food literacy and cooking skills scores and secondary analysis will adjust for pre-specified baseline school and child level covariates. DISCUSSION: The PhunkyFoods programme is a flexible menu of options for schools to choose from, making this a highly complex intervention. Following Medical Research Council guidance, research perspectives will focus on effectiveness and theory-based approaches: to what extent the intervention produces the intended outcomes in real-world settings and what works in which circumstances. TRIAL REGISTRATION: ISRCTN ISRCTN68114155 . Prospectively registered on 22 October 2021.

The short-term effect of a modified comprehensive geriatric assessment and regularly case conferencing on neuropsychiatric symptoms in nursing homes: a cluster randomized trial.

AIMS: To investigate the short-term effect of implementing a modified comprehensive geriatric assessment and regularly case conferencing in nursing homes on neuropsychiatric symptoms. BACKGROUND: Neuropsychiatric symptoms are common and may persist over time in nursing home residents. Evidence of effective interventions is scarce. DESIGN: A parallel cluster-randomised controlled trial. METHODS: The intervention was monthly standardised case conferencing in combination with a modified comprehensive geriatric assessment. The control group received care as usual. MAIN OUTCOME MEASURE: The total score on the short version of the Neuropsychiatric Inventory (NPI-Q, 12-items). RESULTS: A total of 309 residents at 34 long-term care wards in 17 nursing homes (unit of randomisation) were included. The intervention care units conducted on average two case conference-meetings (range 1-3), discussing a mean of 4.8 (range 1-8) residents. After 3 months, there were no difference of NPI-Q total score between the intervention (-0.4) and the control group (0.5) (estimated mean difference = -1.0, 95% CI -2.4 to 0.5, p = 0.19). There was a difference in favour of the intervention group on one of the secondary outcome measures, the apathy symptoms (-0.5 95% CI: -0.9 to -0.1, p = 0.03). CONCLUSION: In this study there were no short-term effect of case conferencing and modified comprehensive geriatric assessments after three months on the total score on neuropsychiatric symptoms. The intervention group had less apathy at 3 months follow-up compared to those receiving care as usual. The findings suggest that a more comprehensive intervention is needed to improve the total Neuropsychiatric symptoms burden and complex symptoms. TRIAL REGISTRATION: Due to delays in the organisation, the study was registered after study start, i.e. retrospectively in Clinicaltrials.gov # NCT02790372 at  https://clinicaltrials.gov/ ; Date of clinical trial registration: 03/06/2016.

Statistical power and sample size requirements to detect an intervention by time interaction in four-level longitudinal cluster randomized trials.

Cluster/group randomized controlled trials (CRTs) have a long history in the study of health sciences. CRT is a special type of intervention trial in which a complete group is randomly assigned to a study condition (or intervention). It is typically performed when individual randomization is difficult/impossible without substantial risk of contamination across study arms or prohibitive from the cost or group dynamics point of view. In this article, the aim is to design and analyze four-level longitudinal cluster randomized trials. The main interest here is to study the difference between treatment groups over time for such a four-level hierarchical data structure. This work is motivated by a real-life study for education based HIV prevention. Such trials are not only popular for administrative convenience, ethical considerations, subject compliance, but also help to reduce contamination bias. A random intercept mixed effects linear regression including a time by intervention interaction is used for modeling. Closed form expression of the power function to detect the interaction effect is determined. Sample size equations depend on correlation among schools but not on correlations among classes or students while, the power function depends on the product of number of units at different levels. Optimal allocation of units under a fixed cost by minimizing the expected standardized variance is also determined and are shown to be independent of correlations among units in any level. Results of detailed simulation studies find the theoretical power estimates based on the derived formulae close to the empirical estimates.

Efficacy of the Virtual Reality Intervention VR FestLab on Alcohol Refusal Self-Efficacy: A Cluster-Randomized Controlled Trial.

It is currently unknown whether a virtual social environment can support young people in building their skills to overcome peer pressure when offered alcohol. This study evaluated the efficacy of the newly developed virtual reality simulation game VR FestLab on the refusal self-efficacy regarding social pressures to drink of Danish male and female students aged 15-18. VR FestLab features a party setting where adolescents can "steer" their own party experience. Eleven schools were included in a cluster-randomized controlled trial and allocated to either the intervention (n = 181) or the active control group (n = 191). Students in intervention schools played VR FestLab, while those in the control group played the VR game Oculus Quest-First Steps. The primary outcome measure was the social pressure subscale of the drinking refusal self-efficacy scale (DRSEQ-RA). The intervention effects were measured immediately after the intervention/control session (T1) and after a 6-week follow-up (T2). Data were examined using linear mixed regression models. Our study did not demonstrate a significant effect of drinking refusal self-efficacy at T1. For all secondary outcomes, we observed no substantial differences between the intervention and control groups. This study provides new insights into the feasibility and effectiveness of an innovative virtual reality alcohol prevention tool. VR FestLab can be an innovative and promising contribution to complement existing school-based alcohol prevention, but more research is needed to improve its effectiveness.

Internet-based treatment for depressive symptoms in hemodialysis patients: A cluster randomized controlled trial.

OBJECTIVE: To investigate the effectiveness of a guided internet-based self-help intervention for hemodialysis patients with depressive symptoms. METHOD: Chronic hemodialysis patients from nine Dutch hospitals with a depression score on the Beck Depression Inventory - second edition (BDI-II) of ≥10, were cluster-randomized into a five modules guided internet-based self-help problem solving therapy intervention or a parallel care-as-usual control group. Clusters were based on hemodialysis shift. The primary outcome depression was measured with the BDI-II. Analysis was performed with linear mixed models. RESULTS: A total of 190 hemodialysis patients were cluster-randomized to the intervention (n = 89) or control group (n = 101). Post-intervention measurement was completed by 127 patients (67%) and more than half of the patients (54%) completed the intervention. No significant differences were found on the BDI-II score between the groups (mean difference - 0.1, 95%CI -3.0; 2.7, p = 0.94). Per protocol sensitivity analysis showed comparable results. No significant differences in secondary outcomes were observed between groups. CONCLUSIONS: Guided internet-based self-help problem solving therapy for hemodialysis patients with depressive symptoms does not seem to be effective in reducing these symptoms as compared to usual care. Future research should examine how to best design content and accessibility of an intervention for depressive symptoms in hemodialysis patients. TRIAL REGISTRATION: Dutch Trial Register: Trial NL6648 (NTR6834) (prospectively registered 13th November 2017).