scholarly journals Protocol for an effectiveness- implementation hybrid trial to assess the effectiveness and cost-effectiveness of an m-health intervention to decrease the consumption of discretionary foods packed in school lunchboxes: the ‘SWAP IT’ trial

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Rachel Sutherland ◽  
Alison Brown ◽  
Nicole Nathan ◽  
Lisa Janssen ◽  
Renee Reynolds ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Energy Intake ◽  
Primary Schools ◽  
Controlled Trial ◽  
Population Level ◽  
Health Intervention ◽  
Trial Registration ◽  
School Based ◽  
Randomised Controlled

Abstract Background At a population level, small reductions in energy intake have the potential to contribute to a reduction in the prevalence of childhood obesity. In many school systems, there is the potential to achieve a reduction in energy intake through modest improvements in foods packed in children’s school lunchboxes. This study will assess the effectiveness and cost-effectiveness of a multi-component intervention that uses an existing school-based communication application to reduce the kilojoule content from discretionary foods and drinks consumed by children from school lunchboxes whilst at school. Methods A Type I hybrid effectiveness-implementation cluster randomised controlled trial will be conducted in up to 36 primary schools in the Hunter New England, Central Coast and Mid North Coast regions of New South Wales, Australia. Designed using the Behaviour Change Wheel, schools will be randomly allocated to receive either a 5-month (1.5 school terms) multi-component intervention that includes: 1) school lunchbox nutrition guidelines; 2) curriculum lessons; 3) information pushed to parents via an existing school-based communication application and 4) additional parent resources to address common barriers to packing healthy lunchboxes or a control arm (standard school practices). The study will assess both child level dietary outcomes and school-level implementation outcomes. The primary trial outcome, mean energy (kJ) content of discretionary lunchbox foods packed in children’s lunchboxes, will be assessed at baseline and immediately post intervention (5 months or 1.5 school terms). Analyses will be performed using intention to treat principles, assessing differences between groups via hierarchical linear regression models. Discussion This study will be the first fully powered randomised controlled trial internationally to examine the impact of an m-health intervention to reduce the mean energy from discretionary food and drinks packed in the school lunchbox. The intervention has been designed with scalability in mind and will address an important evidence gap which, if shown to be effective, has the potential to be applied at a population level. Trial registration Australian Clinical Trials Registry ACTRN:12618001731280 registered on 17/10/2018. Protocol Version 1.

scholarly journals A cluster-randomised controlled trial comparing school and community-based deworming for soil transmitted helminth control in school-age children: the CoDe-STH trial protocol

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Naomi E. Clarke ◽  
Dinh Ng-Nguyen ◽  
Rebecca J. Traub ◽  
Archie C. A. Clements ◽  
Kate Halton ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Schools ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Trial Registration ◽  
School Age Children ◽  
School Age ◽  
School Based ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background Current guidelines and targets for soil-transmitted helminth (STH) control focus on school-based deworming for school-age children, given the high risk of associated morbidity in this age group. However, expanding deworming to all age groups may achieve improved STH control among both the community in general and school-age children, by reducing their risk of reinfection. This trial aims to compare school-based targeted deworming with community-wide mass deworming in terms of impact on STH infections among school-age children. Methods The CoDe-STH (Community Deworming against STH) trial is a cluster-randomised controlled trial (RCT) in 64 primary schools in Dak Lak province, Vietnam. The control arm will receive one round of school-based targeted deworming with albendazole, while in the intervention arm, community-wide mass deworming with albendazole will be implemented alongside school-based deworming. Prevalence of STH infections will be measured in school-age children at baseline and 12 months following deworming. The primary outcome is hookworm prevalence in school-age children at 12 months, by quantitative PCR. Analysis will be intention-to-treat, with outcomes compared between study arms using generalised linear and non-linear mixed models. Additionally, cost-effectiveness of mass and targeted deworming will be calculated and compared, and focus group discussions and interviews will be used to assess acceptability and feasibility of deworming approaches. Individual based stochastic models will be used to predict the impact of mass and targeted deworming strategies beyond the RCT timeframe to assess the likelihood of parasite population ‘bounce-back’ if deworming is ceased due to low STH prevalence. Discussion The first large-scale trial comparing mass and targeted deworming for STH control in South East Asia will provide key information for policy makers regarding the optimal design of STH control programs. Trial registration ACTRN12619000309189.

scholarly journals Group antenatal care (Pregnancy Circles) for diverse and disadvantaged women: study protocol for a randomised controlled trial with integral process and economic evaluations

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Meg Wiggins ◽  
Mary Sawtell ◽  
Octavia Wiseman ◽  
Christine McCourt ◽  
Sandra Eldridge ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Antenatal Care ◽  
Standard Care ◽  
Controlled Trial ◽  
Trial Registration ◽  
Secondary Outcome ◽  
The World ◽  
Randomised Controlled

Abstract Background Group antenatal care has been successfully implemented around the world with suggestions of improved outcomes, including for disadvantaged groups, but it has not been formally tested in the UK in the context of the NHS. To address this the REACH Pregnancy Circles intervention was developed and a randomised controlled trial (RCT), based on a pilot study, is in progress. Methods The RCT is a pragmatic, two-arm, individually randomised, parallel group RCT designed to test clinical and cost-effectiveness of REACH Pregnancy Circles compared with standard care. Recruitment will be through NHS services. The sample size is 1732 (866 randomised to the intervention and 866 to standard care). The primary outcome measure is a ‘healthy baby’ composite measured at 1 month postnatal using routine maternity data. Secondary outcome measures will be assessed using participant questionnaires completed at recruitment (baseline), 35 weeks gestation (follow-up 1) and 3 months postnatal (follow-up 2). An integrated process evaluation, to include exploration of fidelity, will be conducted using mixed methods. Analyses will be on an intention to treat as allocated basis. The primary analysis will compare the number of babies born “healthy” in the control and intervention arms and provide an odds ratio. A cost-effectiveness analysis will compare the incremental cost per Quality Adjusted Life Years and per additional ‘healthy and positive birth’ of the intervention with standard care. Qualitative data will be analysed thematically. Discussion This multi-site randomised trial in England is planned to be the largest trial of group antenatal care in the world to date; as well as the first rigorous test within the NHS of this maternity service change. It has a recruitment focus on ethnically, culturally and linguistically diverse and disadvantaged participants, including non-English speakers. Trial registration Trial registration; ISRCTN, ISRCTN91977441. Registered 11 February 2019 - retrospectively registered. The current protocol is Version 4; 28/01/2020.

scholarly journals Promoting mental health and wellbeing in schools: examining Mindfulness, Relaxation and Strategies for Safety and Wellbeing in English primary and secondary schools: study protocol for a multi-school, cluster randomised controlled trial (INSPIRE)

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Daniel Hayes ◽  
Anna Moore ◽  
Emily Stapley ◽  
Neil Humphrey ◽  
Rosie Mansfield ◽  
...  
Keyword(s):  
Mental Health ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Secondary Schools ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Implementation Evaluation ◽  
School Based ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Background There are increasing rates of internalising difficulties, particularly anxiety and depression, being reported in children and young people in England. School-based, universal prevention programmes are thought to be one way of helping tackle such difficulties. This protocol describes a four-arm cluster randomised controlled trial, investigating the effectiveness of three different interventions when compared to usual provision, in English primary and secondary pupils. The primary outcome for Mindfulness and Relaxation interventions is a measure of internalising difficulties, while Strategies for Safety and Wellbeing will be examined in relation to intended help-seeking. In addition to the effectiveness analysis, a process and implementation evaluation and a cost-effectiveness evaluation will be undertaken. Methods and analysis Overall, 160 primary schools and 64 secondary schools will be recruited across England. This corresponds to 17,600 participants. Measures will be collected online at baseline, 3–6 months later, and 9–12 months after the commencement of the intervention. An economic evaluation will assess the cost-effectiveness of the interventions. Moreover, a process and implementation evaluation (including a qualitative research component) will explore several aspects of implementation (fidelity, quality, dosage, reach, participant responsiveness, adaptations), social validity (acceptability, appropriateness and feasibility), and their moderating effects on the outcomes of interest, and perceived impact. Discussion This trial aims to address important questions about whether schools’ practices around the promotion of mental wellbeing and the prevention of mental health problems can: (1) be formalised into feasible and effective models of school-based support and (2) whether these practices and their effects can be sustained over time. Given the focus of these interventions on mirroring popular practice in schools and on prioritising approaches that present low-burden, high-acceptability to schools, if proved effective, and cost-effective, the findings will indicate models that are not only empirically tested but also offer high potential for widespread use and, therefore, potentially widespread benefits beyond the life of the trial. Trial registration ISRCTN16386254. Registered on 30 August 2018.

scholarly journals A trial protocol for the effectiveness of digital interventions for preventing depression in adolescents: The Future Proofing Study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Aliza Werner-Seidler ◽  
Kit Huckvale ◽  
Mark E. Larsen ◽  
Alison L. Calear ◽  
Kate Maston ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Trial Registration ◽  
Control Group ◽  
School Students ◽  
School Based ◽  
Randomised Controlled ◽  
To Receive

Abstract Background Depression frequently first emerges during adolescence, and one in five young people will experience an episode of depression by the age of 18 years. Despite advances in treatment, there has been limited progress in addressing the burden at a population level. Accordingly, there has been growing interest in prevention approaches as an additional pathway to address depression. Depression can be prevented using evidence-based psychological programmes. However, barriers to implementing and accessing these programmes remain, typically reflecting a requirement for delivery by clinical experts and high associated delivery costs. Digital technologies, specifically smartphones, are now considered a key strategy to overcome the barriers inhibiting access to mental health programmes. The Future Proofing Study is a large-scale school-based trial investigating whether cognitive behaviour therapies (CBT) delivered by smartphone application can prevent depression. Methods A randomised controlled trial targeting up to 10,000 Year 8 Australian secondary school students will be conducted. In Stage I, schools will be randomised at the cluster level either to receive the CBT intervention app (SPARX) or to a non-active control group comparator. The primary outcome will be symptoms of depression, and secondary outcomes include psychological distress, anxiety and insomnia. At the 12-month follow-up, participants in the intervention arm with elevated depressive symptoms will participate in an individual-level randomised controlled trial (Stage II) and be randomised to receive a second CBT app which targets sleep difficulties (Sleep Ninja) or a control condition. Assessments will occur post intervention (both trial stages) and at 6, 12, 24, 36, 48 and 60 months post baseline. Primary analyses will use an intention-to-treat approach and compare changes in symptoms from baseline to follow-up relative to the control group using mixed-effect models. Discussion This is the first trial testing the effectiveness of smartphone apps delivered to school students to prevent depression at scale. Results from this trial will provide much-needed insight into the feasibility of this approach. They stand to inform policy and commission decisions concerning if and how such programmes should be deployed in school-based settings in Australia and beyond. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12619000855123. Registered on 31 May 2019. Clinical Trial Notification Scheme (CTN), CT-2019-CTN-02110-1-v1. Registered on 30 June 2019.

39-LB: Individualised Screening for Diabetic Retinopathy: The ISDR Study—A Randomised Controlled Trial of Safety, Efficacy, and Cost-Effectiveness

Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 39-LB
Author(s):  
DEBORAH MARY BROADBENT ◽  
AMU WANG ◽  
CHRISTOPHER P. CHEYNE ◽  
JAMES G. LATHE ◽  
IRENE M. STRATTON ◽  
...  
Keyword(s):  
Diabetic Retinopathy ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Randomised Controlled
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