A cluster randomised controlled trial and evaluation and cost-effectiveness analysis of the Roots of Empathy schools-based programme for improving social and emotional well-being outcomes among 8- to 9-year-olds in Northern Ireland

Background There is growing consensus regarding the importance of attending to children’s social and emotional well-being. There is now a substantial evidence base demonstrating the links between a child’s early social and emotional development and a range of key longer-term education, social and health outcomes. Universal school-based interventions provide a significant opportunity for early intervention in this area and yet the existing evidence base, particularly in relation to their long-term effects, is limited. Objectives and main outcomes To determine the effectiveness and cost-effectiveness of Roots of Empathy (ROE), a universal school-based programme that, through attempting to enhance children’s empathy, seeks to achieve the following two main outcomes: improvement in prosocial behaviour and reduction in difficult behaviour. Design A cluster randomised controlled trial and an economic evaluation. A total of 74 primary schools were randomly assigned to deliver ROE or to join a waiting list control group. Seven schools withdrew post randomisation and a further two withdrew before the immediate post-test time point. Children (n = 1278) were measured pre test and immediately post test, and then for 3 years following the end of the programme. Data were also collected from teachers and parents. Setting and participants The intervention schools delivered ROE to their Year 5 children (aged 8–9 years) as a whole class. Intervention ROE is delivered on a whole-class basis for one academic year (October–June). It consists of 27 lessons based around the monthly visit from a baby and parent who are usually recruited from the local community. Children learn about the baby’s growth and development and are encouraged to generalise from this to develop empathy towards others. Results Although it was developed in Canada, the programme was very well received by schools, parents and children, and it was delivered effectively with high fidelity. ROE was also found to be effective in achieving small improvements in children’s prosocial behaviour (Hedges’ g = 0.20; p = 0.045) and reductions in their difficult behaviour (Hedges’ g = –0.16; p = 0.060) immediately post test. Although the gains in prosocial behaviour were not sustained after the immediately post-test time point, there was some tentative evidence that the effects associated with reductions in difficult behaviour may have remained up to 36 months from the end of the programme. These positive effects of ROE on children’s behaviour were not found to be associated with improvements in empathy or other social and emotional skills (such as emotional recognition and emotional regulation), on which the trial found no evidence of ROE having an effect. The study also found that ROE was likely to be cost-effective in line with national guidelines. Conclusions These findings are consistent with those of other evaluations of ROE and suggest that it is an effective and cost-effective programme that can be delivered appropriately and effectively in regions such as Northern Ireland. A number of issues for further consideration are raised regarding opportunities to enhance the role of parents; how a time-limited programme such as ROE can form part of a wider and progressive curriculum in schools to build on and sustain children’s social and emotional development; and the need to develop a better theory of change for how ROE works. Trial registration Current Controlled Trials ISRCTN07540423. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 6, No. 4. See the NIHR Journals Library website for further project information.

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Sit–stand desks to reduce sedentary behaviour in 9- to 10-year-olds: the Stand Out in Class pilot cluster RCT

Public Health Research ◽

10.3310/phr08080 ◽

2020 ◽

Vol 8 (8) ◽

pp. 1-126

Author(s):

Stacy A Clemes ◽

Daniel D Bingham ◽

Natalie Pearson ◽

Yu-Ling Chen ◽

Charlotte Edwardson ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Outcome Measures ◽

Health Research ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Public Health Research ◽

Sitting Time ◽

Definitive Trial ◽

Cluster Randomised ◽

Randomised Controlled

Background Sedentary behaviour (sitting) is a highly prevalent negative health behaviour, with individuals of all ages exposed to environments that promote prolonged sitting. The school classroom represents an ideal setting for environmental change through the provision of sit–stand desks. Objectives The aim of this study was to undertake a pilot cluster randomised controlled trial of the introduction of sit–stand desks in primary school classrooms, to inform a definitive trial. Objectives included providing information on school and participant recruitment and retention, acceptability of the intervention, and outcome measures. A preliminary estimate of the intervention’s effectiveness on the proposed primary outcome (change in weekday sitting time) for inclusion in a definitive trial was calculated, along with a preliminary assessment of potential cost-effectiveness. A full process evaluation was also undertaken. Design A two-armed pilot cluster randomised controlled trial with economic and qualitative evaluations. Schools were randomised on a 1 : 1 basis to the intervention (n = 4) or control (n = 4) trial arms. Setting Primary schools in Bradford, West Yorkshire, UK. Participants Children in Year 5 (i.e. aged 9–10 years). Intervention Six sit–stand desks replaced three standard desks (sitting six children) in the intervention classrooms for 4.5 months. Teachers were encouraged to ensure that all pupils were exposed to the sit–stand desks for at least 1 hour per day, on average, using a rotation system. Schools assigned to the control arm continued with their usual practice. Main outcome measures Trial feasibility outcomes included school and participant recruitment and attrition, acceptability of the intervention, and acceptability of and compliance with the proposed outcome measures [including weekday sitting measured using activPAL™ (PAL Technologies Ltd, Glasgow, UK) accelerometers, physical activity, adiposity, blood pressure, cognitive function, musculoskeletal comfort, academic progress, engagement and behaviour]. Results Thirty-three per cent of schools approached and 75% (n = 176) of eligible children took part. At the 7-month follow-up, retention rates were 100% for schools and 97% for children. Outcome measure completion rates ranged from 63% to 97%. A preliminary estimate of intervention effectiveness, from a weighted linear regression model (adjusting for baseline sitting time and wear time) revealed a mean difference in change in sitting of –30.6 minutes per day (95% confidence interval –56.42 to –4.84 minutes per day) between the intervention and control trial arms. The process evaluation revealed that the intervention, recruitment and evaluation procedures were acceptable to teachers and children, with the exception of minor issues around activPAL attachment. A preliminary within-trial economic analysis revealed no difference between intervention and control trial arms in health and education resource use or outcomes. Long-term modelling estimated an unadjusted incremental cost-effectiveness ratio of Stand Out in Class of £78,986 per quality-adjusted life-year gained. Conclusion This study has provided evidence of the acceptability and feasibility of the Stand Out in Class intervention and evaluation methods. Preliminary evidence suggests that the intervention may have a positive direction of effect on weekday sitting time, which warrants testing in a full cluster randomised controlled trial. Lessons learnt from this trial will inform the planning of a definitive trial. Trial registration Current Controlled Trials ISRCTN12915848. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 8. See the NIHR Journals Library website for further project information.

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Cluster randomised controlled trial and economic and process evaluation to determine the effectiveness and cost-effectiveness of a novel intervention [Healthy Lifestyles Programme (HeLP)] to prevent obesity in school children

Public Health Research ◽

10.3310/phr06010 ◽

2018 ◽

Vol 6 (1) ◽

pp. 1-204 ◽

Cited By ~ 2

Author(s):

Katrina Wyatt ◽

Jenny Lloyd ◽

Siobhan Creanor ◽

Colin Green ◽

Sarah G Dean ◽

...

Keyword(s):

Cost Effectiveness ◽

Process Evaluation ◽

Health Research ◽

Controlled Trial ◽

Cost Effective ◽

Cluster Randomised Controlled Trial ◽

Public Health Research ◽

Healthy Lifestyles ◽

Percentage Body Fat

BackgroundApproximately one-third of children in England leave primary school overweight or obese. There is little evidence of effective obesity prevention programmes for children in this age group.ObjectiveTo determine the effectiveness and cost-effectiveness of a school-based healthy lifestyles programme in preventing obesity in children aged 9–10 years.DesignA cluster randomised controlled trial with an economic and process evaluation.SettingThirty-two primary schools in south-west England.ParticipantsChildren in Year 5 (aged 9–10 years) at recruitment and in Year 7 (aged 11–12 years) at 24 months’ post-baseline follow-up.InterventionThe Healthy Lifestyles Programme (HeLP) ran during the spring and summer terms of Year 5 into the autumn term of Year 6 and included four phases: (1) building a receptive environment, (2) a drama-based healthy lifestyles week, (3) one-to-one goal setting and (4) reinforcement activities.Main outcome measuresThe primary outcome measure was body mass index (BMI) standard deviation score (SDS) at 24 months post baseline measures (12 months post intervention). The secondary outcomes comprised waist circumference SDS, percentage body fat SDS, proportion of children overweight and obese at 18 and 24 months, accelerometer-assessed physical activity and food intake at 18 months, and cost-effectiveness.ResultsWe recruited 32 schools and 1324 children. We had a rate of 94% follow-up for the primary outcome. No difference in BMI SDS was found at 24 months [mean difference –0.02, 95% confidence interval (CI) –0.09 to 0.05] or at 18 months (mean difference –0.02, 95% CI –0.08 to 0.05) between children in the intervention schools and children in the control schools. No difference was found between the intervention and control groups in waist circumference SDS, percentage body fat SDS or physical activity levels. Self-reported dietary behaviours showed that, at 18 months, children in the intervention schools consumed fewer energy-dense snacks and had fewer negative food markers than children in the control schools. The intervention effect on negative food markers was fully mediated by ‘knowledge’ and three composite variables: ‘confidence and motivation’, ‘family approval/behaviours and child attitudes’ and ‘behaviours and strategies’. The intervention effect on energy-dense snacks was partially mediated by ‘knowledge’ and the same composite variables apart from ‘behaviours and strategies’. The cost of implementing the intervention was approximately £210 per child. The intervention was not cost-effective compared with control. The programme was delivered with high fidelity, and it engaged children, schools and families across the socioeconomic spectrum.LimitationsThe rate of response to the parent questionnaire in the process evaluation was low. Although the schools in the HeLP study included a range of levels of socioeconomic deprivation, class sizes and rural and urban settings, the number of children for whom English was an additional language was considerably lower than the national average.ConclusionsHeLP is not effective or cost-effective in preventing overweight or obesity in children aged 9–10 years.Future workOur very high levels of follow-up and fidelity of intervention delivery lead us to conclude that it is unlikely that school-based programmes targeting a single age group can ever be sufficiently intense to affect weight status. New approaches are needed that affect the school, the family and the wider environment to prevent childhood obesity.Trial registrationCurrent Controlled Trials ISRCTN15811706.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 6, No. 1. See the NIHR Journals Library website for further project information.

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The PATHS curriculum for promoting social and emotional well-being among children aged 7–9 years: a cluster RCT

Public Health Research ◽

10.3310/phr06100 ◽

2018 ◽

Vol 6 (10) ◽

pp. 1-116 ◽

Cited By ~ 4

Author(s):

Neil Humphrey ◽

Alexandra Hennessey ◽

Ann Lendrum ◽

Michael Wigelsworth ◽

Alexander Turner ◽

...

Keyword(s):

Public Health ◽

Social Skills ◽

Health Research ◽

Primary Schools ◽

Well Being ◽

Public Health Research ◽

Psychological Well Being ◽

Social And Emotional ◽

The Social ◽

Children's Social Skills

BackgroundUniversal social and emotional learning interventions can produce significant practical improvements in children’s social skills and other outcomes. However, the UK evidence base remains limited.ObjectivesTo investigate the implementation, impact and cost-effectiveness of the Promoting Alternative THinking Strategies (PATHS) curriculum.DesignCluster randomised controlled trial. Primary schools (n = 45) were randomly assigned to implement PATHS or to continue with their usual provision for 2 years.SettingPrimary schools in seven local authorities in Greater Manchester.ParticipantsChildren (n = 5218) in Years 3–5 (aged 7–9 years) attending participating schools.InterventionPATHS aims to promote children’s social skills via a taught curriculum, which is delivered by the class teacher, generalisation activities and techniques, and supplementary materials for parents. Schools in the usual provision group delivered the Social and Emotional Aspects of Learning programme and related interventions.Main outcome measuresChildren’s social skills (primary outcome, assessed by the Social Skills Improvement System); pro-social behaviour and mental health difficulties (Strengths and Difficulties Questionnaire); psychological well-being, perceptions of peer and social support, and school environment (Kidscreen-27); exclusions, attendance and attainment (National Pupil Database records); and quality-adjusted life-years (QALYs) (Child Health Utility 9 Dimensions). A comprehensive implementation and process evaluation was undertaken, involving usual provision surveys, structured observations of PATHS lessons, interviews with school staff and parents, and focus groups with children.ResultsThere was tentative evidence (at ap-value of < 0.10) that PATHS led to very small improvements in children’s social skills, perceptions of peer and social support, and reductions in exclusions immediately following implementation. A very small but statistically significant improvement in children’s psychological well-being [d = 0.12, 95% confidence interval (CI) –0.02 to 0.25;p < 0.05) was also found. No lasting improvements in any outcomes were observed at 12- or 24-month post-intervention follow-up. PATHS was implemented well, but not at the recommended frequency; our qualitative analysis revealed that this was primarily due to competing priorities and pressure to focus on the core academic curriculum. Higher levels of implementation quality and participant responsiveness were associated with significant improvements in psychological well-being. Finally, the mean incremental cost of PATHS compared with usual provision was determined to be £29.93 per child. Mean incremental QALYs were positive and statistically significant (adjusted mean 0.0019, 95% CI 0.0009 to 0.0029;p < 0.05), and the incremental net benefit of introducing PATHS was determined to be £7.64. The probability of cost-effectiveness in our base-case scenario was 88%.LimitationsModerate attrition through the course of the main trial, and significant attrition thereafter (although this was mitigated by the use of multiple imputation of missing data); suboptimal frequency of delivery of PATHS lessons.ConclusionsThe impact of PATHS was modest and limited, although that which was observed may still represent value for money. Future work should examine the possibility of further modifications to the intervention to improve goodness of fit with the English school context without compromising its efficacy, and identify whether or not particular subgroups benefit differentially from PATHS.Trial registrationCurrent Controlled Trials ISRCTN85087674 (the study protocol can be found at:www.journalslibrary.nihr.ac.uk/programmes/phr/10300601/#/).FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol 6, No. 10. See the NIHR Journals Library website for further project information.

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Steps Towards Alcohol Misuse Prevention Programme (STAMPP): a school- and community-based cluster randomised controlled trial

Public Health Research ◽

10.3310/phr05020 ◽

2017 ◽

Vol 5 (2) ◽

pp. 1-154 ◽

Cited By ~ 10

Author(s):

Harry Sumnall ◽

Ashley Agus ◽

Jon Cole ◽

Paul Doherty ◽

David Foxcroft ◽

...

Keyword(s):

Public Health ◽

Health Research ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Public Health Research ◽

Study Condition ◽

School Year ◽

Intervention Costs ◽

Randomised Controlled ◽

Mean Cost

BackgroundAlcohol use in young people remains a public health concern, with adverse impacts on outcomes such as health, well-being, education and relationships.ObjectivesTo assess the effectiveness and cost-effectiveness of a combined classroom curriculum and parental intervention on self-reported alcohol use [heavy episodic drinking (HED)] and alcohol-related harms (indicators such as getting into fights after drinking, poorer school performance and trouble with friends and family).DesignA two-arm, cluster randomised controlled trial with schools as the unit of randomisation.SettingA total of 105 post-primary schools in Northern Ireland (NI) and Glasgow/Inverclyde Educational Authority areas.ParticipantsA total of 12,738 male and female secondary school students (intervention delivered when students were in school year 9 in NI or S2 in Scotland in the academic year 2012–13 and aged 12–13 years) were randomised. Randomisation and baseline (T0) surveys took place when children were in school year 8 or S1. Schools were randomised (1 : 1) by an independent statistician to the Steps Towards Alcohol Misuse Prevention Programme (STAMPP) or to education as normal (EAN). All schools were stratified by free school meal provision. Schools in NI were also stratified by school type (male/female/coeducational).InterventionsSTAMPP combined a school-based alcohol harm reduction curriculum [an adapted version of the School Health and Alcohol Harm Reduction Project (SHAHRP)] and a brief parental intervention designed to support parents in setting family rules around drinking. The classroom component comprised two phases delivered over 2 years, and the parental component comprised a standardised presentation delivered by a trained facilitator at specially arranged parent evenings on school premises. This was followed up a few weeks later by an information leaflet mailed to all intervention pupils’ parents highlighting the main points of the evening.Main outcome measures(1) Self-reported HED (defined as self-reported consumption of ≥ 6 units in a single episode in the previous 30 days for male students and ≥ 4.5 units for female students) assessed at 33 months from baseline (T3); and (2) the number of self-reported harms (harms caused by own drinking) assessed at T3.Data sourcesSelf-completed pupil questionnaires.ResultsAt final follow-up (T3), data were available for 5160 intervention and 5073 control pupils for the HED outcome, and for 5234 intervention and 5146 control pupils for the self-reported harms outcome. The intervention reduced self-reported HED compared with EAN (p < 0.001), but did not reduce self-reported harms associated with own drinking. The odds ratio for the intervention effect on HED was 0.596 (standard error 0.0596, 95% confidence interval 0.490 to 0.725). The mean cost of delivery per school was £818 and the mean cost per individual was £15. There were no clear cost savings in terms of service utilisation associated with the intervention. The process evaluation showed that the classroom component engaged and was enjoyed by pupils, and was valued by teachers. Schools, students, intervention trainers and delivery staff (teachers) were not blind to study condition. Data collection was undertaken by a team of researchers that included the trial manager and research assistants, some of whom were not blinded to study condition. Data analysis of primary and secondary outcomes was undertaken by the trial statistician, who was blinded to the study condition.LimitationsAlthough the classroom component was largely delivered as intended, there was very low attendance at the parent/carer event; however, all intervention pupils’ parents/carers received an intervention leaflet.ConclusionsThe results of this trial provide some support for the effectiveness and cost-effectiveness of STAMPP in reducing heavy episodic (binge) drinking, but not in reducing self-reported alcohol-related harms, in young people over a 33-month follow-up period. As there was low uptake of the parental component, it is uncertain whether or not the intervention effect was accounted for by the classroom component alone.Trial registrationCurrent Controlled Trials ISRCTN47028486.FundingThis project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full inPublic Health Research; Vol. 5, No. 2. See the NIHR Journals Library website for further project information. The Public Health Agency of NI and Education Boards of Glasgow/Inverclyde provided some intervention costs. Diageo provided funds to print some workbooks. The remaining intervention costs were internally funded.

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Child-care self-assessment to improve physical activity, oral health and nutrition for 2- to 4-year-olds: a feasibility cluster RCT

Public Health Research ◽

10.3310/phr07130 ◽

2019 ◽

Vol 7 (13) ◽

pp. 1-164 ◽

Cited By ~ 1

Author(s):

Ruth Kipping ◽

Rebecca Langford ◽

Rowan Brockman ◽

Sian Wells ◽

Chris Metcalfe ◽

...

Keyword(s):

Public Health ◽

Physical Activity ◽

Health Research ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Public Health Research ◽

Post Intervention ◽

Randomised Controlled ◽

The Uk ◽

Food Photography

Background The Nutrition And Physical Activity Self Assessment for Child Care (NAP SACC) intervention has shown evidence of effectiveness in the USA but not been adapted or assessed for effectiveness in the UK. Objectives To evaluate the feasibility and acceptability of implementing NAP SACC in the UK. Design Adaptation and development of NAP SACC and feasibility cluster randomised controlled trial (RCT) including process and economic evaluations. Substudies assessed mediator questionnaire test–retest reliability and feasibility of food photography methods. Setting Nurseries, staff and parents in North Somerset, Cardiff, Gloucestershire and Bristol. Participants Development – 15 early years/public health staff and health visitors, 12 nursery managers and 31 parents. RCT – 12 nurseries and 31 staff, four partners and 168 children/parents. Mediator substudy – 82 parents and 69 nursery staff. Food photography substudy – four nurseries, 18 staff and 51 children. Intervention NAP SACC UK partners supported nurseries to review policies and practices and set goals to improve nutrition, oral health and physical activity (PA) over 5 months. Two workshops were delivered to nursery staff by local experts. A home component [website, short message service (SMS) and e-mails] supported parents. The control arm continued with usual practice. Main outcome measures Feasibility and acceptability of the intervention and methods according to prespecified criteria. Data sources Qualitative data to adapt the intervention. Measurements with children, parents and staff at baseline and post intervention (8–10 months after baseline). Interviews with nursery managers, staff, parents and NAP SACC UK partners; observations of training, workshops and meetings. Nursery environment observation, nursery Review and Reflect score, and resource log. Child height and weight, accelerometer-determined PA and sedentary time, screen time and dietary outcomes using the Child and Diet Evaluation Tool. Staff and parent questionnaires of knowledge, motivation and self-efficacy. Child quality of life and nursery, family and health-care costs. Food photography of everything consumed by individual children and staff questionnaire to assess acceptability. Results Thirty-two per cent (12/38) of nurseries and 35.3% (168/476) of children were recruited; no nurseries withdrew. The intervention was delivered in five out of six nurseries, with high levels of fidelity and acceptability. Partners found it feasible but had concerns about workload. The child loss to follow-up rate was 14.2%. There was suggestion of promise in intervention compared with control nurseries post intervention for snacks, screen time, proportion overweight or obese and accelerometer-measured total PA and moderate to vigorous PA. Many parental and nursery knowledge and motivation mediators improved. The average cost of delivering the intervention was £1184 per nursery excluding partner training, and the average cost per child was £27. Fourteen per cent of parents used the home component and the mediator questionnaire had good internal consistency and test–retest reliability. Photography of food was acceptable and feasible. Limitations Following nursery leavers was difficult. Accelerometer data, diet data and environmental assessment would have been more reliable with 2 days of data. Conclusions The NAP SACC UK intervention and methods were found to be feasible and acceptable to participants, except for the home component. There was sufficient suggestion of promise to justify a definitive trial. Future work A multicentre cluster randomised controlled trial to evaluate the effectiveness and cost-effectiveness of NAP SACC UK has been funded by NIHR and will start in July 2019 (PHR NIHR 127551). Trial registration Current Controlled Trials ISRCTN16287377. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 13. See the NIHR Journals Library website for further project information. Funding was also provided by the North Somerset and Gloucestershire Councils, Development and Evaluation of Complex Interventions for Public Health Improvement (DECIPHer) (MR/KO232331/1), and the Elizabeth Blackwell Institute.

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Study design, rationale and methods of the Revitalising Informal Settlements and their Environments (RISE) study: a cluster randomised controlled trial to evaluate environmental and human health impacts of a water-sensitive intervention in informal settlements in Indonesia and Fiji

BMJ Open ◽

10.1136/bmjopen-2020-042850 ◽

2021 ◽

Vol 11 (1) ◽

pp. e042850

Author(s):

Karin Leder ◽

John J Openshaw ◽

Pascale Allotey ◽

Ansariadi Ansariadi ◽

S Fiona Barker ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Human Health ◽

Controlled Trial ◽

Informal Settlements ◽

Cluster Randomised Controlled Trial ◽

Well Being ◽

Cluster Randomised ◽

Abundance And Diversity ◽

Randomised Controlled ◽

Health And Well Being

IntroductionIncreasing urban populations have led to the growth of informal settlements, with contaminated environments linked to poor human health through a range of interlinked pathways. Here, we describe the design and methods for the Revitalising Informal Settlements and their Environments (RISE) study, a transdisciplinary randomised trial evaluating impacts of an intervention to upgrade urban informal settlements in two Asia-Pacific countries.Methods and analysisRISE is a cluster randomised controlled trial among 12 settlements in Makassar, Indonesia, and 12 in Suva, Fiji. Six settlements in each country have been randomised to receive the intervention at the outset; the remainder will serve as controls and be offered intervention delivery after trial completion. The intervention involves a water-sensitive approach, delivering site-specific, modular, decentralised infrastructure primarily aimed at improving health by decreasing exposure to environmental faecal contamination. Consenting households within each informal settlement site have been enrolled, with longitudinal assessment to involve health and well-being surveys, and human and environmental sampling. Primary outcomes will be evaluated in children under 5 years of age and include prevalence and diversity of gastrointestinal pathogens, abundance and diversity of antimicrobial resistance (AMR) genes in gastrointestinal microorganisms and markers of gastrointestinal inflammation. Diverse secondary outcomes include changes in microbial contamination; abundance and diversity of pathogens and AMR genes in environmental samples; impacts on ecological biodiversity and microclimates; mosquito vector abundance; anthropometric assessments, nutrition markers and systemic inflammation in children; caregiver-reported and self-reported health symptoms and healthcare utilisation; and measures of individual and community psychological, emotional and economic well-being. The study aims to provide proof-of-concept evidence to inform policies on upgrading of informal settlements to improve environments and human health and well-being.EthicsStudy protocols have been approved by ethics boards at Monash University, Fiji National University and Hasanuddin University.Trial registration numberACTRN12618000633280; Pre-results.

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Therapeutic Affordances of Social Media and Associated Quality of Life Outcomes in Young Adults

Social Science Computer Review ◽

10.1177/08944393211032940 ◽

2021 ◽

pp. 089443932110329

Author(s):

Paul Dodemaide ◽

Mark Merolli ◽

Nicole Hill ◽

Lynette Joubert

Keyword(s):

Quality Of Life ◽

Social Media ◽

Young Adults ◽

Well Being ◽

Evidence Base ◽

Social And Emotional ◽

Perceived Quality Of Life ◽

Use Of Social Media ◽

The Relationship

There is a growing body of literature exploring the general population’s use of social media for assistance in dealing with stigmatized health issues. This study presents novel research examining the relationship between social media use and young adults. It utilizes a therapeutic affordance (TA) framework. Quantitative results from this study are complemented by qualitative data. The relationships between distinct social media and their TA (a–b) are presented to highlight their potential to impact positively on social and emotional well-being outcomes. Evidence includes broad support for “connection,” “narration,” and “collaboration” TAs in this context and the relationship between the use of distinct social media and perceived quality of life (QOL) outcomes (a–c). TA provides an appropriate and valuable theoretical framework which is useful for the development of an evidence-base from the analysis of young adult’s social media usage. An analysis of the association between social media and their QOL outcomes is presented according to the TA relationship pathway (a–c–b). The adoption of a TA framework enables a nuanced analysis of significant associations between specific social media, TA, and improved QOL outcomes. This study demonstrates the significant association between social media and perceived QOL outcomes in young adults.

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Individual health trainers to support health and well-being for people under community supervision in the criminal justice system: the STRENGTHEN pilot RCT

Public Health Research ◽

10.3310/phr07200 ◽

2019 ◽

Vol 7 (20) ◽

pp. 1-136

Author(s):

Lynne Callaghan ◽

Tom P Thompson ◽

Siobhan Creanor ◽

Cath Quinn ◽

Jane Senior ◽

...

Keyword(s):

Cost Effectiveness ◽

Usual Care ◽

Health Research ◽

Pilot Trial ◽

Well Being ◽

Public Health Research ◽

Scale Scores ◽

Mental Well Being ◽

Health And Well Being ◽

Full Trial

Background Little is known about the effectiveness or cost-effectiveness of interventions, such as health trainer support, to improve the health and well-being of people recently released from prison or serving a community sentence, because of the challenges in recruiting participants and following them up. Objectives This pilot trial aimed to assess the acceptability and feasibility of the trial methods and intervention (and associated costs) for a randomised trial to assess the effectiveness and cost-effectiveness of health trainer support versus usual care. Design This trial involved a pilot 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 a mixed-methods process evaluation, in 2017–18. Setting Participants were identified, screened and recruited in Community Rehabilitation Companies in Plymouth and Manchester or the National Probation Service in Plymouth. The intervention was delivered in the community. Participants Those who had been out of prison for at least 2 months (to allow community stabilisation), with at least 7 months of a community sentence remaining, were invited to participate; those who may have posed an unacceptable risk to the researchers and health trainers and those who were not interested in the trial or intervention support were excluded. Interventions The intervention group received, in addition to usual care, our person-centred health trainer support in one-to-one sessions for up to 14 weeks, either in person or via telephone. Health trainers aimed to empower participants to make healthy lifestyle changes (particularly in alcohol use, smoking, diet and physical activity) and take on the Five Ways to Well-being [Foresight Projects. Mental Capital and Wellbeing: Final Project Report. 2008. URL: www.gov.uk/government/publications/mental-capital-and-wellbeing-making-the-most-of-ourselves-in-the-21st-century (accessed 24 January 2019).], and also signposted to other options for support. The control group received treatment as usual, defined by available community and public service options for improving health and well-being. Main outcome measures The main outcomes included the Warwick–Edinburgh Mental Well-being Scale scores, alcohol use, smoking behaviour, dietary behaviour, physical activity, substance use, resource use, quality of life, intervention costs, intervention engagement and feasibility and acceptability of trial methods and the intervention. Results A great deal about recruitment was learned and the target of 120 participants was achieved. The minimum trial retention target at 6 months (60%) was met. Among those offered health trainer support, 62% had at least two sessions. The mixed-methods process evaluation generally supported the trial methods and intervention acceptability and feasibility. The proposed primary outcome, the Warwick–Edinburgh Mental Well-being Scale scores, provided us with valuable data to estimate the sample size for a full trial in which to test the effectiveness and cost-effectiveness of the intervention. Conclusions Based on the findings from this pilot trial, a full trial (with some modifications) seems justified, with a sample size of around 900 participants to detect between-group differences in the Warwick-Edinburgh Mental Well-being Scale scores at a 6-month follow-up. Future work A number of recruitment, trial retention, intervention engagement and blinding issues were identified in this pilot and recommendations are made in preparation of and within a full trial. Trial registration Current Controlled Trials ISRCTN80475744. Funding This project was funded by the National Institute for Health Research Public Health Research programme and will be published in full in Public Health Research; Vol. 7, No. 20. See the National Institute for Health Research Journals Library website for further project information.

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An assets-based intervention before and after birth to improve breastfeeding initiation and continuation: the ABA feasibility RCT

Public Health Research ◽

10.3310/phr08070 ◽

2020 ◽

Vol 8 (7) ◽

pp. 1-156

Author(s):

Joanne L Clarke ◽

Jenny Ingram ◽

Debbie Johnson ◽

Gill Thomson ◽

Heather Trickey ◽

...

Keyword(s):

Public Health ◽

Randomised Controlled Trial ◽

Infant Feeding ◽

Health Research ◽

Controlled Trial ◽

Intervention Group ◽

Public Health Research ◽

Breastfeeding Initiation ◽

Before And After ◽

Randomised Controlled

Background The UK has low levels of breastfeeding initiation and continuation, with evident socioeconomic disparities. To be inclusive, peer-support interventions should be woman-centred rather than breastfeeding-centred. Assets-based approaches to public health focus on the positive capabilities of individuals and communities, rather than their deficits and problems. The Assets-based feeding help Before and After birth (ABA) intervention offers an assets-based approach based on behaviour change theory. Objective To investigate the feasibility of delivering the ABA infant feeding intervention in a randomised controlled trial. Design This was an individually randomised controlled feasibility trial; women were randomised in a 1 : 1 ratio to either the intervention group or the comparator (usual care) group. Setting Two separate English sites were selected because they had an existing breastfeeding peer support service, relatively high levels of socioeconomic disadvantage and low rates of breastfeeding. Participants Women aged ≥ 16 years who were pregnant with their first child, irrespective of feeding intention (n = 103), were recruited by researchers in antenatal clinics. Interventions Proactive, woman-centred support, using an assets-based approach and including behaviour change techniques, was provided by an infant-feeding helper (a breastfeeding peer supporter trained in the ABA intervention) and delivered through face-to-face contact, telephone conversations and text messages. The intervention commenced at around 30 weeks’ gestation and could continue until 5 months postnatally. Main outcome measures The main outcome measures were feasibility of intervention delivery with the requisite intensity and duration; acceptability to women, infant-feeding helpers and maternity services; and feasibility of a future randomised controlled trial. Outcomes included recruitment rates and follow-up rates at 3 days, 8 weeks and 6 months postnatally, and outcomes for a future full trial were collected via participant questionnaires. A mixed-methods process evaluation included qualitative interviews with women, infant-feeding helpers and maternity services; infant-feeding helper logs; and audio-recordings of antenatal contacts to check intervention fidelity. Results Of the 135 eligible women approached, 103 (76.3%) agreed to participate. The study was successful in recruiting teenagers (8.7%) and women living in areas of socioeconomic disadvantage (37.3% resided in the most deprived 40% of small areas in England). Postnatal follow-up rates were 68.0%, 85.4% and 80.6% at 3 days, 8 weeks and 6 months, respectively. Feeding status at 8 weeks was obtained for 95.1% of participants. Recruitment took place from February 2017 until August 2017. It was possible to recruit and train existing peer supporters to the infant-feeding helper role. The intervention was delivered to most women with relatively high fidelity. Among the 50 women in the intervention group, 39 received antenatal visits and 40 received postnatal support. Qualitative data showed that the intervention was acceptable. There was no evidence of intervention-related harms. Limitations Birth notification delays resulted in delays in the collection of postnatal feeding status data and in the offer of postnatal support. In addition, the intervention needs to better consider all infant-feeding types and did not adequately accommodate women who delivered prematurely. Conclusion It is feasible to deliver the intervention and trial. Future work The intervention should be tested in a fully powered randomised controlled trial. Trial registration Current Controlled Trials ISRCTN14760978. Funding This project was funded by the National Institute for Health Research (NIHR) Public Health Research programme and will be published in full in Public Health Research; Vol. 8, No. 7. See the NIHR Journals Library website for further project information.

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Preschoolers in the Playground: a pilot cluster randomised controlled trial of a physical activity intervention for children aged 18 months to 4 years

Public Health Research ◽

10.3310/phr03050 ◽

2015 ◽

Vol 3 (5) ◽

pp. 1-210 ◽

Cited By ~ 3

Author(s):

Sally E Barber ◽

Shaheen Akhtar ◽

Cath Jackson ◽

Daniel D Bingham ◽

Catherine Hewitt ◽

...

Keyword(s):

Physical Activity ◽

Physical Activity Intervention ◽

Controlled Trial ◽

Cluster Randomised Controlled Trial ◽

Public Health Research ◽

Early Years ◽

Cluster Rct ◽

Initiation Phase ◽

Randomised Controlled ◽

Full Trial

BackgroundThe preschool years are considered critical for establishing healthy lifestyle behaviours such as physical activity. Levels of physical activity track through childhood into adulthood and establishing habitual physical activity early in life is therefore vital. Time spent outdoors is associated with greater physical activity and playground interventions have been shown to increase physical activity in school-aged children. There are few preschool, playground-based interventions and these have given inconclusive results. A report published by the UK’s Chief Medical Officer (CMO) highlighted the need for new interventions to promote movement in the early years (0–5 years).ObjectivesThis study aimed to undertake a pilot cluster randomised controlled trial (RCT) of an outdoor playground-based physical activity intervention for parents and their children aged from 18 months to 4 years (Preschoolers in the Playground or PiP) and to assess the feasibility of conducting a full-scale cluster RCT.DesignThe study was a two-armed pilot cluster RCT with economic and qualitative evaluations. Participants were randomised on a 1 : 1 basis to the PiP intervention (n = 83) or usual practice (control;n = 81).SettingBradford, West Yorkshire, UK.ParticipantsChildren aged from 18 months to 4 years.InterventionThe PiP intervention is grounded in behavioural theory (social cognitive theory) and is in accordance with CMO guidance for physical activity in the early years. It is informed by existing literature and data collected from focus groups with parents. The intervention was delivered in primary school playgrounds. Six 30-minute PiP sessions per week were available for 30 weeks; families were encouraged to come to three a week. The 10-week initiation phase was facilitated by a member of school staff and the maintenance phase was unsupervised.Main outcome measuresRecruitment and retention of schools and families to the trial were the main outcome measures. The acceptability of trial procedures and the intervention, the feasibility of collecting health outcome data and the fidelity of the implementation of the intervention were also evaluated. A preliminary assessment of cost-effectiveness and a sample size calculation for a full trial were conducted.ResultsIn total, 37% of schools and 48% of parents approached agreed to take part. Levels of retention were good at 10 and 52 weeks’ follow-up (82.3% and 83.5% respectively). Both the trial procedures and the intervention were acceptable. However, attendance was low during the autumn and winter/spring initiation phases but somewhat better in the summer initiation phase. Attendance was poor throughout all maintenance phases. The accelerometry protocol for measuring physical activity requires modification. The fidelity of intervention implementation was good (81% adherence). The intervention was borderline cost-effective. A sample size of 600 children from 38 schools is required for a full trial.ConclusionA full RCT of the PiP intervention is feasible. The PiP intervention requires some modification, for example running the intervention during the summer term only, but was found to be acceptable to schools and families.Trial registrationCurrent Controlled Trials ISRCTN54165860.FundingThis project was funded by the NIHR Public Health Research programme and will be published in full inPublic Health Research; Vol. 3, No. 5. See the NIHR Journals Library website for further project information.

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