<p><strong>Background: </strong>Research in Children's Social Care in the United Kingdom operates in a framework that was initially designed to support medical research within healthcare settings. Although adaptations to this framework have been made for social care settings, our experience suggested that significant systemic and organisational challenges to conducting large-scale randomised controlled trials in fostering services in the United Kingdom still remain, which work against the likelihood of such studies being completed successfully. A further challenge we faced was that that many fostering services were relatively inexperienced with research and lacked the infrastructure to support it.</p><p><strong>Objective: </strong>To report on the opportunities, obstacles and challenges faced when conducting a trial evaluating foster care support in a children's social care setting and to describe how those working on this research project came together to adapt the existing systems and processes and overcome the challenges.</p><p><strong>Design: </strong>The Reflective Fostering Study was a randomised controlled trial evaluating an intervention to help foster carers care for the children they look after.</p><p><strong>Setting and participants: </strong>Local authority and independent fostering services in the United Kingdom. The main study recruited 524 foster carers and kinship carers. The main study was evaluating the Reflective Fostering Programme, a group intervention designed to improve reflective functioning in foster and kinship carers.</p><p><strong>Results: </strong>The main challenges identified in this study were lack of infrastructure, both within fostering organisations and outside, a lack of capacity, and on occasion, unnecessary bureaucracy. Working with fostering sites, the Clinical Research Network and across collaborating partners, we were able to make changes to existing processes so that the governance and oversight of the study were proportionate and the workload for our sites was minimised. Identifying likely departments to obtain key approvals, working with local Clinical Research Networks and providing templates made the site set-up process faster and supported recruitment.</p><p><strong>Limitations: </strong>The challenges reported were those encountered by a study that took place in fostering services in the United Kingdom. The challenges faced, and solutions identified, may not be mirrored in other sectors of children's social care, or other countries.</p><p><strong>Conclusions: </strong>Carrying out high-quality clinical trials within fostering services in the United Kingdom can face significant barriers. There has been a move to address these issues, but our study suggests that more could be done so that research in these settings increases. Ongoing review of the regulatory framework, which is designed to ensure best practice for research in children's social care, could ensure that research governance is proportiona
{"title":"Conducting a large-scale randomised controlled trial in children's social care: reflections on challenges, successes and lessons learned from the Reflective Fostering Study.","authors":"Karen Irvine, Beth Rider, Caroline Cresswell, Shayma Izzidien, Erika Sims, Caroline Smith, Rachael Stemp, Nick Midgley","doi":"10.3310/GJNM1603","DOIUrl":"https://doi.org/10.3310/GJNM1603","url":null,"abstract":"<p><strong>Background: </strong>Research in Children's Social Care in the United Kingdom operates in a framework that was initially designed to support medical research within healthcare settings. Although adaptations to this framework have been made for social care settings, our experience suggested that significant systemic and organisational challenges to conducting large-scale randomised controlled trials in fostering services in the United Kingdom still remain, which work against the likelihood of such studies being completed successfully. A further challenge we faced was that that many fostering services were relatively inexperienced with research and lacked the infrastructure to support it.</p><p><strong>Objective: </strong>To report on the opportunities, obstacles and challenges faced when conducting a trial evaluating foster care support in a children's social care setting and to describe how those working on this research project came together to adapt the existing systems and processes and overcome the challenges.</p><p><strong>Design: </strong>The Reflective Fostering Study was a randomised controlled trial evaluating an intervention to help foster carers care for the children they look after.</p><p><strong>Setting and participants: </strong>Local authority and independent fostering services in the United Kingdom. The main study recruited 524 foster carers and kinship carers. The main study was evaluating the Reflective Fostering Programme, a group intervention designed to improve reflective functioning in foster and kinship carers.</p><p><strong>Results: </strong>The main challenges identified in this study were lack of infrastructure, both within fostering organisations and outside, a lack of capacity, and on occasion, unnecessary bureaucracy. Working with fostering sites, the Clinical Research Network and across collaborating partners, we were able to make changes to existing processes so that the governance and oversight of the study were proportionate and the workload for our sites was minimised. Identifying likely departments to obtain key approvals, working with local Clinical Research Networks and providing templates made the site set-up process faster and supported recruitment.</p><p><strong>Limitations: </strong>The challenges reported were those encountered by a study that took place in fostering services in the United Kingdom. The challenges faced, and solutions identified, may not be mirrored in other sectors of children's social care, or other countries.</p><p><strong>Conclusions: </strong>Carrying out high-quality clinical trials within fostering services in the United Kingdom can face significant barriers. There has been a move to address these issues, but our study suggests that more could be done so that research in these settings increases. Ongoing review of the regulatory framework, which is designed to ensure best practice for research in children's social care, could ensure that research governance is proportiona","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":" ","pages":"1-16"},"PeriodicalIF":0.0,"publicationDate":"2026-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146108737","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Oliver Lloyd-Houldey, Neisha Sundaram, Semina Michalopoulou, Joanna Sturgess, Rosa Legood, Oliver Carlile, Elizabeth Allen, Stephen Scott, Dasha Nicholls, Steven Hope, Lee Hudson, Deborah Christie, Andrew Briggs, Russell Viner, Chris Bonell
<p><strong>Background: </strong>Young people's mental health worsened during and since the coronavirus disease discovered in 2019 pandemic. School environments play a key role in young people's mental health. Learning Together for Mental Health is a whole-school intervention aiming to promote mental health in secondary schools, adapted from the previous Learning Together intervention which was found effective in reducing bullying and promoting mental health.</p><p><strong>Objective: </strong>To adapt Learning Together to increase focus on mental health so producing the Learning Together for Mental Health intervention and evaluate the appropriateness of conducting a Phase III trial of the Learning Together for Mental Health intervention regarding pre-defined progression criteria relating to the intervention and trial methods, and assessing intervention feasibility, reach and acceptability, feasibility of trial measures and procedures, potential mechanisms and possible harms.</p><p><strong>Design and methods: </strong>We conducted a feasibility study with baseline and follow-up surveys, process evaluation and economic-evaluation feasibility-testing.</p><p><strong>Setting and participants: </strong>One school participated in intervention adaptation. Our feasibility study included four state, mixed-sex secondary schools in southern England (one of which dropped out after baselines and was replaced with another). We recruited 640 year-7 (age 11-12) students at baseline survey and 566 year-10 (age 14-15) students at 12-month follow-up. Baseline and follow-up participants were different groups, as the focus was assessing feasibility for the age groups to be surveyed at baseline and follow-up in a Phase III randomised controlled trial. Twenty staff, 27 year-8 (age 12-13) students and 22 year-10 students participated in qualitative research as did two trainers and one external facilitator.</p><p><strong>Interventions: </strong>As part of our feasibility study, all schools received the Learning Together for Mental Health intervention for one academic school year.</p><p><strong>Main outcome measures: </strong>Pre-defined criteria for progression to a Phase III trial.</p><p><strong>Results: </strong>The intervention was successfully adapted from the previous intervention using public involvement. The trial met all criteria for progression to Phase III. The all-staff and in-depth restorative practice training were implemented with fidelity in all schools and all schools had at least two staff trained in-depth in restorative practice. Curriculum training was delivered with fidelity in three of four schools. The response rate to the baseline (needs) survey across the three participating schools was 79%. Progression required at least two schools to have delivered the curriculum with at least 50% fidelity, which was achieved; one of the two schools which delivered the curriculum reported over 80% fidelity and the other school reported over 75% fidelity. All stude
{"title":"Learning together to promote mental health and well-being in English secondary schools: LTMH study refinement and feasibility evaluation, a comprehensive synopsis.","authors":"Oliver Lloyd-Houldey, Neisha Sundaram, Semina Michalopoulou, Joanna Sturgess, Rosa Legood, Oliver Carlile, Elizabeth Allen, Stephen Scott, Dasha Nicholls, Steven Hope, Lee Hudson, Deborah Christie, Andrew Briggs, Russell Viner, Chris Bonell","doi":"10.3310/PFHR4141","DOIUrl":"https://doi.org/10.3310/PFHR4141","url":null,"abstract":"<p><strong>Background: </strong>Young people's mental health worsened during and since the coronavirus disease discovered in 2019 pandemic. School environments play a key role in young people's mental health. Learning Together for Mental Health is a whole-school intervention aiming to promote mental health in secondary schools, adapted from the previous Learning Together intervention which was found effective in reducing bullying and promoting mental health.</p><p><strong>Objective: </strong>To adapt Learning Together to increase focus on mental health so producing the Learning Together for Mental Health intervention and evaluate the appropriateness of conducting a Phase III trial of the Learning Together for Mental Health intervention regarding pre-defined progression criteria relating to the intervention and trial methods, and assessing intervention feasibility, reach and acceptability, feasibility of trial measures and procedures, potential mechanisms and possible harms.</p><p><strong>Design and methods: </strong>We conducted a feasibility study with baseline and follow-up surveys, process evaluation and economic-evaluation feasibility-testing.</p><p><strong>Setting and participants: </strong>One school participated in intervention adaptation. Our feasibility study included four state, mixed-sex secondary schools in southern England (one of which dropped out after baselines and was replaced with another). We recruited 640 year-7 (age 11-12) students at baseline survey and 566 year-10 (age 14-15) students at 12-month follow-up. Baseline and follow-up participants were different groups, as the focus was assessing feasibility for the age groups to be surveyed at baseline and follow-up in a Phase III randomised controlled trial. Twenty staff, 27 year-8 (age 12-13) students and 22 year-10 students participated in qualitative research as did two trainers and one external facilitator.</p><p><strong>Interventions: </strong>As part of our feasibility study, all schools received the Learning Together for Mental Health intervention for one academic school year.</p><p><strong>Main outcome measures: </strong>Pre-defined criteria for progression to a Phase III trial.</p><p><strong>Results: </strong>The intervention was successfully adapted from the previous intervention using public involvement. The trial met all criteria for progression to Phase III. The all-staff and in-depth restorative practice training were implemented with fidelity in all schools and all schools had at least two staff trained in-depth in restorative practice. Curriculum training was delivered with fidelity in three of four schools. The response rate to the baseline (needs) survey across the three participating schools was 79%. Progression required at least two schools to have delivered the curriculum with at least 50% fidelity, which was achieved; one of the two schools which delivered the curriculum reported over 80% fidelity and the other school reported over 75% fidelity. All stude","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":"14 1","pages":"1-34"},"PeriodicalIF":0.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146013910","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Linda J Cobiac, Cherry Law, Richard Smith, Steven Cummins, Harry Rutter, Mike Rayner, Oliver Mytton, Adam D M Briggs, Henning Tarp Jensen, Marcus Keogh-Brown, Jean Adams, Martin White, Peter Scarborough
<p><strong>Background: </strong>The United Kingdom Soft Drinks Industry Levy was introduced in April 2018, resulting both in changes in sugar levels in drinks and purchases of drinks. Both mechanisms could impact on the incidence and prevalence of raised body weight, diabetes and diet-related diseases, and therefore, have implications for economic costs to the health sector.</p><p><strong>Objectives: </strong>To model future impacts of the Soft Drinks Industry Levy on population health and health sector costs and to estimate net monetary benefit to the health system.</p><p><strong>Design and methods: </strong>Proportional multistate lifetable modelling study - open and closed cohort analyses.</p><p><strong>Setting and population: </strong>All children and adults in the United Kingdom.</p><p><strong>Intervention: </strong>The Soft Drinks Industry Levy is a two-tier levy of £0.18/l on drinks with between 5 and 8 g of total sugars/100 ml and of £0.24/l on drinks with ≥ 8 g of total sugars/100 ml.</p><p><strong>Main outcome measures: </strong>We evaluated impact of the sugar reduction on: (1) prevalence of overweight and obesity, obesity-related diseases and dental health out to 2050 and (2) lifetime population health (measured in quality-adjusted life-years), change in costs to the health sector and the resulting net monetary benefit.</p><p><strong>Data sources: </strong>We estimated a per person reduction in sugar from a previously published interrupted time series analysis, which found an 8.0 g/household/week (95% confidence interval 2.4 to 13.6) reduction in sugar at 1 year after implementation. Our multistate lifetable model is parameterised using data from population health monitoring surveys, the Global Burden of Disease project, the Human Mortality Database and the Office for National Statistics. Health sector costs were obtained from Department of Health and Social Care budget allocations.</p><p><strong>Results: </strong>The model predicts that the Soft Drinks Industry Levy will reduce the prevalence of overweight and obesity in the United Kingdom by 0.18% points (95% uncertainty interval: 0.059 to 0.31) for males and by 0.20% points (0.064 to 0.34) for females. In the first 10 years of implementation, the reductions in sugar and overweight/obesity are predicted to prevent 270,000 (35,000-600,000) dental caries, 12,000 (3700-20,000) cases of type 2 diabetes, 3800 (1200-6700) cases of cardiovascular diseases and 350 (110-590) cases of obesity-related cancer. For the current United Kingdom population, it is estimated that the Soft Drinks Industry Levy will add 200,000 quality-adjusted life-years (63,500-342,000) over their lifetime and avert £174 million (£53.6-319) in their costs of health care (discounted at United Kingdom Treasury rates). At a United Kingdom Treasury value of £60,000 per quality-adjusted life-year, it is estimated that the Soft Drinks Industry Levy will produce a net monetary benefit of £12.2 billion (£3.88-20.8) for the he
{"title":"Population health and health sector cost impacts of the UK Soft Drinks Industry Levy: a modelling study.","authors":"Linda J Cobiac, Cherry Law, Richard Smith, Steven Cummins, Harry Rutter, Mike Rayner, Oliver Mytton, Adam D M Briggs, Henning Tarp Jensen, Marcus Keogh-Brown, Jean Adams, Martin White, Peter Scarborough","doi":"10.3310/GJMW1501","DOIUrl":"https://doi.org/10.3310/GJMW1501","url":null,"abstract":"<p><strong>Background: </strong>The United Kingdom Soft Drinks Industry Levy was introduced in April 2018, resulting both in changes in sugar levels in drinks and purchases of drinks. Both mechanisms could impact on the incidence and prevalence of raised body weight, diabetes and diet-related diseases, and therefore, have implications for economic costs to the health sector.</p><p><strong>Objectives: </strong>To model future impacts of the Soft Drinks Industry Levy on population health and health sector costs and to estimate net monetary benefit to the health system.</p><p><strong>Design and methods: </strong>Proportional multistate lifetable modelling study - open and closed cohort analyses.</p><p><strong>Setting and population: </strong>All children and adults in the United Kingdom.</p><p><strong>Intervention: </strong>The Soft Drinks Industry Levy is a two-tier levy of £0.18/l on drinks with between 5 and 8 g of total sugars/100 ml and of £0.24/l on drinks with ≥ 8 g of total sugars/100 ml.</p><p><strong>Main outcome measures: </strong>We evaluated impact of the sugar reduction on: (1) prevalence of overweight and obesity, obesity-related diseases and dental health out to 2050 and (2) lifetime population health (measured in quality-adjusted life-years), change in costs to the health sector and the resulting net monetary benefit.</p><p><strong>Data sources: </strong>We estimated a per person reduction in sugar from a previously published interrupted time series analysis, which found an 8.0 g/household/week (95% confidence interval 2.4 to 13.6) reduction in sugar at 1 year after implementation. Our multistate lifetable model is parameterised using data from population health monitoring surveys, the Global Burden of Disease project, the Human Mortality Database and the Office for National Statistics. Health sector costs were obtained from Department of Health and Social Care budget allocations.</p><p><strong>Results: </strong>The model predicts that the Soft Drinks Industry Levy will reduce the prevalence of overweight and obesity in the United Kingdom by 0.18% points (95% uncertainty interval: 0.059 to 0.31) for males and by 0.20% points (0.064 to 0.34) for females. In the first 10 years of implementation, the reductions in sugar and overweight/obesity are predicted to prevent 270,000 (35,000-600,000) dental caries, 12,000 (3700-20,000) cases of type 2 diabetes, 3800 (1200-6700) cases of cardiovascular diseases and 350 (110-590) cases of obesity-related cancer. For the current United Kingdom population, it is estimated that the Soft Drinks Industry Levy will add 200,000 quality-adjusted life-years (63,500-342,000) over their lifetime and avert £174 million (£53.6-319) in their costs of health care (discounted at United Kingdom Treasury rates). At a United Kingdom Treasury value of £60,000 per quality-adjusted life-year, it is estimated that the Soft Drinks Industry Levy will produce a net monetary benefit of £12.2 billion (£3.88-20.8) for the he","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":" ","pages":"1-17"},"PeriodicalIF":0.0,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145688832","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rabeea'h Waseem Aslam, Rhys Williams-Thomas, Julia Townson, Ruth Lewis, Jason Madan, G J Melendez-Torres, Fiona Lugg-Widger, Philip Pallmann, Rachel Brown, Chris Bonell, Gemma S Morgan, James White, Honor Young
<p><strong>Background: </strong>Adverse sexual health, dating and relationship violence, and sexual harassment are significant public health concerns, especially among young people. Sexually transmitted infection rates are at a 10-year high, and dating and relationship violence affects nearly half of young people. Further education provides a population-wide setting for delivering dating and relationship violence and sexual health interventions, but only a few interventions have been shown to be effective in further education.</p><p><strong>Objectives: </strong>To optimise intervention materials and identify refinements for the Sexual Health and Healthy Relationships for further education (SaFE) intervention, an intervention to improve sexual health and reduce dating and relationship violence and sexual harassment among young people attending further education. Optimised materials were used in a pilot cluster randomised controlled trial of SaFE. SaFE had three components: (1) onsite access to sexual health and relationship services in further education settings provided by sexual health nurses for 2 hours, 2 days per week; (2) publicity about onsite services and (3) further education staff training on how to promote sexual health and recognise and respond to dating and relationship violence and sexual harassment. This paper reports on the optimisation of the SaFE intervention materials.</p><p><strong>Design and methods: </strong>A multistage iterative process was used to optimise further education staff training and publicity materials. This involved a series of consultation and focus group feedback sessions.</p><p><strong>Setting and participants: </strong>In Stage 1, feedback was collected from the SaFE Trial Management Group. Stage 2 involved: (1) two focus groups; one with four further education staff and one with three further education students at one further education institution and (2) stakeholder consultation with seven experts. Stage 3 saw consultation with the Trial Steering Committee who had independent oversight of the study. The operational feasibility of the training was evaluated in Stage 4 through a trial run with further education safeguarding and well-being teams. Stage 5 comprised a final review of intervention material by the Trial Management Group. Stage 6 gained online feedback from a young people's advisory group. The study was conducted in England and Wales.</p><p><strong>Results: </strong>In Stage 1, Trial Management Group reviewers recommended improving clarity and factual accuracy, reducing the length of slide decks and adding content on sending explicit images. Stage 2 feedback from further education staff and students focused on training content addressing comprehensiveness, structure and visual design and training delivery addressing preferred training formats and opportunities for scenario-based learning. The Trial Steering Committee in Stage 3 advised on managing participant disclosures and reordering content. St
{"title":"Optimisation of a sexual health and healthy relationships intervention for Further Education in England and Wales (SaFE).","authors":"Rabeea'h Waseem Aslam, Rhys Williams-Thomas, Julia Townson, Ruth Lewis, Jason Madan, G J Melendez-Torres, Fiona Lugg-Widger, Philip Pallmann, Rachel Brown, Chris Bonell, Gemma S Morgan, James White, Honor Young","doi":"10.3310/AHDP8546","DOIUrl":"https://doi.org/10.3310/AHDP8546","url":null,"abstract":"<p><strong>Background: </strong>Adverse sexual health, dating and relationship violence, and sexual harassment are significant public health concerns, especially among young people. Sexually transmitted infection rates are at a 10-year high, and dating and relationship violence affects nearly half of young people. Further education provides a population-wide setting for delivering dating and relationship violence and sexual health interventions, but only a few interventions have been shown to be effective in further education.</p><p><strong>Objectives: </strong>To optimise intervention materials and identify refinements for the Sexual Health and Healthy Relationships for further education (SaFE) intervention, an intervention to improve sexual health and reduce dating and relationship violence and sexual harassment among young people attending further education. Optimised materials were used in a pilot cluster randomised controlled trial of SaFE. SaFE had three components: (1) onsite access to sexual health and relationship services in further education settings provided by sexual health nurses for 2 hours, 2 days per week; (2) publicity about onsite services and (3) further education staff training on how to promote sexual health and recognise and respond to dating and relationship violence and sexual harassment. This paper reports on the optimisation of the SaFE intervention materials.</p><p><strong>Design and methods: </strong>A multistage iterative process was used to optimise further education staff training and publicity materials. This involved a series of consultation and focus group feedback sessions.</p><p><strong>Setting and participants: </strong>In Stage 1, feedback was collected from the SaFE Trial Management Group. Stage 2 involved: (1) two focus groups; one with four further education staff and one with three further education students at one further education institution and (2) stakeholder consultation with seven experts. Stage 3 saw consultation with the Trial Steering Committee who had independent oversight of the study. The operational feasibility of the training was evaluated in Stage 4 through a trial run with further education safeguarding and well-being teams. Stage 5 comprised a final review of intervention material by the Trial Management Group. Stage 6 gained online feedback from a young people's advisory group. The study was conducted in England and Wales.</p><p><strong>Results: </strong>In Stage 1, Trial Management Group reviewers recommended improving clarity and factual accuracy, reducing the length of slide decks and adding content on sending explicit images. Stage 2 feedback from further education staff and students focused on training content addressing comprehensiveness, structure and visual design and training delivery addressing preferred training formats and opportunities for scenario-based learning. The Trial Steering Committee in Stage 3 advised on managing participant disclosures and reordering content. St","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":" ","pages":"1-20"},"PeriodicalIF":0.0,"publicationDate":"2025-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145703179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Katie Breheny, Francesca Spiga, Eve Tomlinson, Carolyn D Summerbell, Julian Pt Higgins
<p><strong>Background: </strong>Childhood obesity is a public health policy priority. Policy-makers need an understanding of the costs of interventions to prevent childhood obesity alongside their effectiveness when tested in randomised controlled trials. It is not known what cost data have been included in published randomised controlled trials of childhood obesity prevention interventions. This study aimed to summarise these costs and identify associated economic evaluations published separately.</p><p><strong>Methods: </strong>This review summarises data extracted from studies included in two Cochrane systematic reviews of interventions to prevent obesity in children aged 5-11 and 12-18 years old. Eligible interventions could be delivered in any setting and studies were randomised controlled trials reporting (standardised or unstandardised) body mass index outcome data at a minimum follow-up of 12 weeks post baseline. Databases searched included Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and PsycINFO. Searches were limited to between 1990 and 2023. Any cost data reported in the publications were extracted, in addition to citations of linked economic analyses. Data were tabulated and summarised using a narrative approach.</p><p><strong>Results: </strong>Of the 244 randomised controlled trials included in the Cochrane systematic reviews, 85 (35%) included costs related to the trial, intervention, school, health sector, out-of-pocket or productivity costs, or were linked to a full economic evaluation published separately. Of the studies reporting costs, five (6%) studies reported results of a full economic evaluation within the trial paper. The majority of research costs were incentives for participation, identified in 41 (48%) studies. Where these are not part of the intervention itself, these would not usually be included in economic evaluations. Thirty (35%) studies included intervention costs, although reporting was inconsistent. The payer of the intervention was unclear in most publications, making the attribution of costs to sectors difficult. Only one study reported healthcare resource use data, but some estimated the cost of obesity-related chronic conditions in linked decision models.</p><p><strong>Limitations and future work: </strong>The findings of this review are limited to randomised controlled trials only and interventions for children aged 5 years and over. Other study designs may provide important cost data. Future work could explore the cost data needs of public health policy-makers and the impact of including incentives on the effectiveness and cost-effectiveness in public health randomised controlled trials.</p><p><strong>Conclusions: </strong>This is a novel synthesis of costs reported in randomised controlled trials of interventions to prevent childhood obesity. Overall, the reporting of any type of costs was low (35% of studies). The most common type of reported costs were intervention costs (e.g. staff
背景：儿童肥胖是公共卫生政策的重点。决策者需要了解预防儿童肥胖的干预措施的成本，以及在随机对照试验中测试的有效性。目前尚不清楚在已发表的儿童肥胖预防干预的随机对照试验中包含了哪些成本数据。本研究旨在总结这些成本，并确定单独发表的相关经济评估。方法：本综述总结了两篇Cochrane系统综述中关于预防5-11岁和12-18岁儿童肥胖干预措施的研究数据。符合条件的干预措施可以在任何情况下实施，研究是随机对照试验，报告（标准化或非标准化）基线后至少12周的体重指数结果数据。检索的数据库包括Cochrane Central Register of Controlled Trials， MEDLINE， EMBASE和PsycINFO。研究仅限于1990年至2023年之间。除引用相关经济分析外，还摘录了出版物中报告的任何费用数据。用叙述的方法将数据制成表格并加以总结。结果：在Cochrane系统评价纳入的244项随机对照试验中，85项（35%）包括与试验、干预、学校、卫生部门、自费或生产力成本相关的成本，或与单独发表的完整经济评估相关的成本。在报告成本的研究中，有5项（6%）研究报告了试验论文中完整的经济评估结果。在41项（48%）研究中发现，大部分研究成本是参与奖励。如果这些不是干预本身的一部分，这些通常不会包括在经济评估中。30项（35%）研究包括干预费用，尽管报告不一致。在大多数出版物中，干预的付款人都不清楚，因此很难将成本归因于部门。只有一项研究报告了医疗资源使用数据，但一些研究在关联决策模型中估计了与肥胖相关的慢性疾病的成本。局限性和未来工作：本综述的发现仅限于随机对照试验和针对5岁及以上儿童的干预措施。其他研究设计可能提供重要的成本数据。未来的工作可以探索公共卫生政策制定者的成本数据需求，以及在公共卫生随机对照试验中纳入激励措施对有效性和成本效益的影响。结论：这是在预防儿童肥胖干预措施的随机对照试验中报告的一项新的综合成本。总体而言，任何类型的成本报告都很低（35%的研究）。最常见的报告费用类型是干预费用（例如人事费用、材料和培训）和参与者收集数据的奖励，尽管有五项研究包括全面的经济评价。本研究通过对有效性文献中包含的成本信息的普遍性、类型和质量提供新的见解，补充了该领域已发表的系统性经济评估综述。资助：本文介绍了由国家卫生与保健研究所（NIHR）公共卫生研究计划资助的独立研究，奖励号为NIHR131572。
{"title":"An evaluation of economic evidence included in published randomised controlled trials of interventions to prevent obesity in children.","authors":"Katie Breheny, Francesca Spiga, Eve Tomlinson, Carolyn D Summerbell, Julian Pt Higgins","doi":"10.3310/GJJH1321","DOIUrl":"https://doi.org/10.3310/GJJH1321","url":null,"abstract":"<p><strong>Background: </strong>Childhood obesity is a public health policy priority. Policy-makers need an understanding of the costs of interventions to prevent childhood obesity alongside their effectiveness when tested in randomised controlled trials. It is not known what cost data have been included in published randomised controlled trials of childhood obesity prevention interventions. This study aimed to summarise these costs and identify associated economic evaluations published separately.</p><p><strong>Methods: </strong>This review summarises data extracted from studies included in two Cochrane systematic reviews of interventions to prevent obesity in children aged 5-11 and 12-18 years old. Eligible interventions could be delivered in any setting and studies were randomised controlled trials reporting (standardised or unstandardised) body mass index outcome data at a minimum follow-up of 12 weeks post baseline. Databases searched included Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE and PsycINFO. Searches were limited to between 1990 and 2023. Any cost data reported in the publications were extracted, in addition to citations of linked economic analyses. Data were tabulated and summarised using a narrative approach.</p><p><strong>Results: </strong>Of the 244 randomised controlled trials included in the Cochrane systematic reviews, 85 (35%) included costs related to the trial, intervention, school, health sector, out-of-pocket or productivity costs, or were linked to a full economic evaluation published separately. Of the studies reporting costs, five (6%) studies reported results of a full economic evaluation within the trial paper. The majority of research costs were incentives for participation, identified in 41 (48%) studies. Where these are not part of the intervention itself, these would not usually be included in economic evaluations. Thirty (35%) studies included intervention costs, although reporting was inconsistent. The payer of the intervention was unclear in most publications, making the attribution of costs to sectors difficult. Only one study reported healthcare resource use data, but some estimated the cost of obesity-related chronic conditions in linked decision models.</p><p><strong>Limitations and future work: </strong>The findings of this review are limited to randomised controlled trials only and interventions for children aged 5 years and over. Other study designs may provide important cost data. Future work could explore the cost data needs of public health policy-makers and the impact of including incentives on the effectiveness and cost-effectiveness in public health randomised controlled trials.</p><p><strong>Conclusions: </strong>This is a novel synthesis of costs reported in randomised controlled trials of interventions to prevent childhood obesity. Overall, the reporting of any type of costs was low (35% of studies). The most common type of reported costs were intervention costs (e.g. staff","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":" ","pages":"1-28"},"PeriodicalIF":0.0,"publicationDate":"2025-11-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145574804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jinshuo Li, Qi Wu, Steve Parrott, Sharon Cox, Francesca Pesola, Kirstie Soar, Rachel Brown, Allison Ford, Peter Hajek, Caitlin Notley, Deborah Robson, Emma Ward, Anna Varley, Charlotte Mair, Lauren McMillan, Jessica Lennon, Janine Brierley, Amy Edwards, Bethany Gardner, Allan Tyler, Linda Bauld, Lynne Dawkins
<p><strong>Background: </strong>While smoking is common among those experiencing homelessness, the effectiveness of an e-cigarette intervention to reduce smoking in this population is unclear.</p><p><strong>Objective: </strong>To determine the cost-effectiveness of providing an e-cigarette for smoking cessation in homeless support centres compared to usual care.</p><p><strong>Design and methods: </strong>A multicentre two-arm cluster randomised controlled trial, with data collection time points at baseline, 4, 12 and 24 weeks post baseline.</p><p><strong>Setting and participants: </strong>Adults (aged 18+) who smoked daily and accessed 32 homeless support centres across six areas of Great Britain received either e-cigarette intervention (<i>n</i> = 239 in 16 centres) or usual care (<i>n</i> = 236 in 16 centres) by centre (cluster) randomisation.</p><p><strong>Intervention: </strong>The intervention was the provision of an e-cigarette starter kit plus 4 weeks' supply of e-liquids. The usual care comprised very brief advice for smoking cessation and signposting to local Stop Smoking Services.</p><p><strong>Main outcome measures: </strong>The total costs included costs of intervention/usual care, costs of smoking cessation outside of the trial and costs of general healthcare services use over 24 weeks. Quality-adjusted life-years were derived from EuroQol-5 Dimensions, five-level version administered at each data collection point. An incremental cost-effectiveness ratio was calculated for 24 weeks using the difference between groups in total costs and quality-adjusted life-years, with cost-effectiveness acceptability curve constructed based on bootstrap to examine uncertainty. A long-term model was employed to project a lifetime incremental cost-effectiveness ratio with probabilistic sensitivity analysis to examine uncertainty.</p><p><strong>Data sources: </strong>The analysis over 24 weeks was based on research team records and data collected via self-reported questionnaires. Unit costs for valuation were extracted from published secondary sources. The parameters of the long-term model were based on the 24-week results and published secondary sources.</p><p><strong>Results: </strong>Mean intervention costs were estimated at £92 [standard error (SE) £0] per participant and mean usual care costs at £50 (SE £0) per participant. Mean total costs per participant were estimated at £3859 (SE £441) in the e-cigarette group and £2716 (SE £386) in the usual care group. Mean quality-adjusted life-years were estimated at 0.303 (SE 0.008) in the e-cigarette group and 0.295 (SE 0.010) in the usual care group. Adjusting for baseline covariates and respective baseline values, e-cigarette group were £1267 (95% confidence interval £600 to £1938) more costly and yielded 0.007 (95% confidence interval -0.017 to 0.027) more quality-adjusted life-years than usual care. The incremental cost-effectiveness ratio was calculated at £181,000 per quality-adjusted life-year gai
{"title":"Cost-effectiveness of e-cigarettes for smoking cessation at homeless support centres: SCeTCH cRCT.","authors":"Jinshuo Li, Qi Wu, Steve Parrott, Sharon Cox, Francesca Pesola, Kirstie Soar, Rachel Brown, Allison Ford, Peter Hajek, Caitlin Notley, Deborah Robson, Emma Ward, Anna Varley, Charlotte Mair, Lauren McMillan, Jessica Lennon, Janine Brierley, Amy Edwards, Bethany Gardner, Allan Tyler, Linda Bauld, Lynne Dawkins","doi":"10.3310/GJLD2428","DOIUrl":"https://doi.org/10.3310/GJLD2428","url":null,"abstract":"<p><strong>Background: </strong>While smoking is common among those experiencing homelessness, the effectiveness of an e-cigarette intervention to reduce smoking in this population is unclear.</p><p><strong>Objective: </strong>To determine the cost-effectiveness of providing an e-cigarette for smoking cessation in homeless support centres compared to usual care.</p><p><strong>Design and methods: </strong>A multicentre two-arm cluster randomised controlled trial, with data collection time points at baseline, 4, 12 and 24 weeks post baseline.</p><p><strong>Setting and participants: </strong>Adults (aged 18+) who smoked daily and accessed 32 homeless support centres across six areas of Great Britain received either e-cigarette intervention (<i>n</i> = 239 in 16 centres) or usual care (<i>n</i> = 236 in 16 centres) by centre (cluster) randomisation.</p><p><strong>Intervention: </strong>The intervention was the provision of an e-cigarette starter kit plus 4 weeks' supply of e-liquids. The usual care comprised very brief advice for smoking cessation and signposting to local Stop Smoking Services.</p><p><strong>Main outcome measures: </strong>The total costs included costs of intervention/usual care, costs of smoking cessation outside of the trial and costs of general healthcare services use over 24 weeks. Quality-adjusted life-years were derived from EuroQol-5 Dimensions, five-level version administered at each data collection point. An incremental cost-effectiveness ratio was calculated for 24 weeks using the difference between groups in total costs and quality-adjusted life-years, with cost-effectiveness acceptability curve constructed based on bootstrap to examine uncertainty. A long-term model was employed to project a lifetime incremental cost-effectiveness ratio with probabilistic sensitivity analysis to examine uncertainty.</p><p><strong>Data sources: </strong>The analysis over 24 weeks was based on research team records and data collected via self-reported questionnaires. Unit costs for valuation were extracted from published secondary sources. The parameters of the long-term model were based on the 24-week results and published secondary sources.</p><p><strong>Results: </strong>Mean intervention costs were estimated at £92 [standard error (SE) £0] per participant and mean usual care costs at £50 (SE £0) per participant. Mean total costs per participant were estimated at £3859 (SE £441) in the e-cigarette group and £2716 (SE £386) in the usual care group. Mean quality-adjusted life-years were estimated at 0.303 (SE 0.008) in the e-cigarette group and 0.295 (SE 0.010) in the usual care group. Adjusting for baseline covariates and respective baseline values, e-cigarette group were £1267 (95% confidence interval £600 to £1938) more costly and yielded 0.007 (95% confidence interval -0.017 to 0.027) more quality-adjusted life-years than usual care. The incremental cost-effectiveness ratio was calculated at £181,000 per quality-adjusted life-year gai","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":" ","pages":"1-45"},"PeriodicalIF":0.0,"publicationDate":"2025-11-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145524783","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jacqui Rodgers, Nawaraj Bhattarai, Jane Goodwin, Isabel Gordon, Phil Heslop, Emma Nielsen, Rory Ciaran O'Connor, Emmanuel Ogundimu, Mirabel Pelton, Sheena Ramsay, Ellen Townsend, Luke Vale, Janelle Wagnild, Colin Wilson, Sarah Cassidy
<p><strong>Background: </strong>Suicide prevention is a national priority for United Kingdom government policy, and autistic people have recently been identified as a high-risk group in both the Department of Health and Social Care suicide prevention strategy and National Institute for Health and Care Excellence suicide prevention guidelines. No suicide prevention interventions have been developed specifically for autistic people. Safety plans are a simple, cost-effective, potentially life-saving intervention.</p><p><strong>Aims: </strong>To evaluate the feasibility and acceptability of the use of Autism Adapted Safety Plans for autistic adults and to undertake an external pilot to explore whether a larger future definitive trial is achievable.</p><p><strong>Methods: </strong>Stage 1 involved focus groups with autistic adults (<i>n</i> = 15), family members (<i>n</i> = 5) and service providers (<i>n</i> = 10) to inform adaptations to the Autism Adapted Safety Plans. Stage 2 was an interventional single-arm feasibility trial where autistic adults (<i>n</i> = 8) completed an Autism Adapted Safety Plans with a supporter (<i>n</i> = 8). Data on recruitment, completion of study measures and participant feedback informed final adaptations to the Autism Adapted Safety Plans and research methods prior to stage 3. Stage 3 was a pilot feasibility randomised controlled trial of Autism Adapted Safety Plans. Autistic adults were recruited via non-National Health Service organisations and self-referral. Participants were randomised without stratification to usual care ± Autism Adapted Safety Plans. The Autism Adapted Safety Plan was completed by the autistic adults with someone trained to support them. Research staff completing follow-up assessments were blind to participant allocation. Primary outcomes were feasibility and acceptability of the Autism Adapted Safety Plans to inform the parameters of a definitive randomised controlled trial. Participants were assessed at baseline, 1 and 6 months.</p><p><strong>Results: </strong>Stage 1 and 2 interviews highlighted the conditions needed to make the process of creating the Autism Adapted Safety Plans acceptable for autistic adults. Stage 2 also informed modifications to recruitment (to include self-referral) in stage 3. In stage 3, 53 participants consented, 49 were randomised to either Autism Adapted Safety Plans + usual care (<i>n</i> = 25) or usual care (<i>n</i> = 24). Sixty-eight per cent of participants were satisfied with the Autism Adapted Safety Plans and 41% rated it as usable. Feedback on the Autism Adapted Safety Plans and study processes employed in the trial were positive with suggested minor adaptations to some outcome measures. Retention of those randomised was 95% at 6-month follow-up. Completion rates for outcome measures were generally high (> 85%). Fidelity ratings for delivery of the Autism Adapted Safety Plans were 94% for therapeutic components and 91% for adherence to content.</p><p><stron
{"title":"Adapted Safety Plans to Address Self-Harm and Suicide Behaviours in Autistic Adults: single arm feasibility trial and external pilot RCT.","authors":"Jacqui Rodgers, Nawaraj Bhattarai, Jane Goodwin, Isabel Gordon, Phil Heslop, Emma Nielsen, Rory Ciaran O'Connor, Emmanuel Ogundimu, Mirabel Pelton, Sheena Ramsay, Ellen Townsend, Luke Vale, Janelle Wagnild, Colin Wilson, Sarah Cassidy","doi":"10.3310/CGDF8525","DOIUrl":"10.3310/CGDF8525","url":null,"abstract":"<p><strong>Background: </strong>Suicide prevention is a national priority for United Kingdom government policy, and autistic people have recently been identified as a high-risk group in both the Department of Health and Social Care suicide prevention strategy and National Institute for Health and Care Excellence suicide prevention guidelines. No suicide prevention interventions have been developed specifically for autistic people. Safety plans are a simple, cost-effective, potentially life-saving intervention.</p><p><strong>Aims: </strong>To evaluate the feasibility and acceptability of the use of Autism Adapted Safety Plans for autistic adults and to undertake an external pilot to explore whether a larger future definitive trial is achievable.</p><p><strong>Methods: </strong>Stage 1 involved focus groups with autistic adults (<i>n</i> = 15), family members (<i>n</i> = 5) and service providers (<i>n</i> = 10) to inform adaptations to the Autism Adapted Safety Plans. Stage 2 was an interventional single-arm feasibility trial where autistic adults (<i>n</i> = 8) completed an Autism Adapted Safety Plans with a supporter (<i>n</i> = 8). Data on recruitment, completion of study measures and participant feedback informed final adaptations to the Autism Adapted Safety Plans and research methods prior to stage 3. Stage 3 was a pilot feasibility randomised controlled trial of Autism Adapted Safety Plans. Autistic adults were recruited via non-National Health Service organisations and self-referral. Participants were randomised without stratification to usual care ± Autism Adapted Safety Plans. The Autism Adapted Safety Plan was completed by the autistic adults with someone trained to support them. Research staff completing follow-up assessments were blind to participant allocation. Primary outcomes were feasibility and acceptability of the Autism Adapted Safety Plans to inform the parameters of a definitive randomised controlled trial. Participants were assessed at baseline, 1 and 6 months.</p><p><strong>Results: </strong>Stage 1 and 2 interviews highlighted the conditions needed to make the process of creating the Autism Adapted Safety Plans acceptable for autistic adults. Stage 2 also informed modifications to recruitment (to include self-referral) in stage 3. In stage 3, 53 participants consented, 49 were randomised to either Autism Adapted Safety Plans + usual care (<i>n</i> = 25) or usual care (<i>n</i> = 24). Sixty-eight per cent of participants were satisfied with the Autism Adapted Safety Plans and 41% rated it as usable. Feedback on the Autism Adapted Safety Plans and study processes employed in the trial were positive with suggested minor adaptations to some outcome measures. Retention of those randomised was 95% at 6-month follow-up. Completion rates for outcome measures were generally high (> 85%). Fidelity ratings for delivery of the Autism Adapted Safety Plans were 94% for therapeutic components and 91% for adherence to content.</p><p><stron","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":"13 10","pages":"1-19"},"PeriodicalIF":0.0,"publicationDate":"2025-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145574740","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Francesca Spiga, Annabel L Davies, Jennifer C Palmer, Eve Tomlinson, Maddie Coleman, Elizabeth Sheldrick, Lucy Condon, Theresa Hm Moore, Deborah M Caldwell, Fiona B Gillison, Sharea Ijaz, James D Nobles, Jelena Savović, Rona Campbell, Carolyn Summerbell, Julian Pt Higgins
<p><strong>Background: </strong>Recent systematic reviews and meta-analyses on the effects of interventions to prevent obesity in children aged 5-18 years identified over 200 randomised trials. Interventions targeting diet, activity (including physical activity and sedentary behaviours) and both diet and activity appear to have small but beneficial effects on average. However, these effects varied between studies and might be explained by variation in characteristics of the interventions, for example, by the extent to which the children enjoyed the intervention or whether they aim to modify behaviour through education or physical changes to the environment. Here we develop a novel analytic framework to identify key intervention characteristics considered likely to explain differential effects.</p><p><strong>Objectives: </strong>To describe the development of the analytic framework, including the involvement of school-aged children, parents, teachers and other stakeholders, and to present the content of the finalised analytic framework and the results of the coding of the interventions.</p><p><strong>Design and methods: </strong>We first conducted a literature review to find out from the existing literature what different types of characteristics of interventions we should be thinking about and why. This information helped us to develop a comprehensive map (called a logic model) of these characteristics. We then used this logic model to develop a list of possible intervention characteristics. We held a series of workshops with children, parents, teachers and public health professionals to refine the list into a coding scheme. We then used this to code the characteristics of each intervention in all the trials which aimed to prevent obesity in children aged 5-18 years.</p><p><strong>Findings: </strong>Our finalised analytic framework included 25 questions across 12 characteristics. These addressed aspects such as the setting of the intervention (e.g. at school, at home or in the community), mode of delivery (e.g. to individuals or to groups of children), whether the intervention targeted diet and/or activity, complexity (e.g. focused on a single swap of juice for water or aimed to change all aspects of the diet), intensity, flexibility, choice, mechanism of action (e.g. through participation, education, change in the social environment, change in the physical environment), resonance (e.g. credibility of the person delivering the intervention), commercial involvement and the 'fun factor' (as perceived by children). We coded 255 interventions from 210 randomised trials.</p><p><strong>Conclusions: </strong>Our evidence-based analytic framework, refined by consulting with stakeholders, allowed us to code 255 interventions aiming to prevent obesity in children aged 5-18 years. Our confidence in the validity of the framework and coding results is increased by our rigorous methods and, especially, the involvement of children at multiple stages.</p><p><str
{"title":"Investigating differential effects of interventions to prevent obesity in children and young people: a novel analytic framework.","authors":"Francesca Spiga, Annabel L Davies, Jennifer C Palmer, Eve Tomlinson, Maddie Coleman, Elizabeth Sheldrick, Lucy Condon, Theresa Hm Moore, Deborah M Caldwell, Fiona B Gillison, Sharea Ijaz, James D Nobles, Jelena Savović, Rona Campbell, Carolyn Summerbell, Julian Pt Higgins","doi":"10.3310/QLPD8523","DOIUrl":"https://doi.org/10.3310/QLPD8523","url":null,"abstract":"<p><strong>Background: </strong>Recent systematic reviews and meta-analyses on the effects of interventions to prevent obesity in children aged 5-18 years identified over 200 randomised trials. Interventions targeting diet, activity (including physical activity and sedentary behaviours) and both diet and activity appear to have small but beneficial effects on average. However, these effects varied between studies and might be explained by variation in characteristics of the interventions, for example, by the extent to which the children enjoyed the intervention or whether they aim to modify behaviour through education or physical changes to the environment. Here we develop a novel analytic framework to identify key intervention characteristics considered likely to explain differential effects.</p><p><strong>Objectives: </strong>To describe the development of the analytic framework, including the involvement of school-aged children, parents, teachers and other stakeholders, and to present the content of the finalised analytic framework and the results of the coding of the interventions.</p><p><strong>Design and methods: </strong>We first conducted a literature review to find out from the existing literature what different types of characteristics of interventions we should be thinking about and why. This information helped us to develop a comprehensive map (called a logic model) of these characteristics. We then used this logic model to develop a list of possible intervention characteristics. We held a series of workshops with children, parents, teachers and public health professionals to refine the list into a coding scheme. We then used this to code the characteristics of each intervention in all the trials which aimed to prevent obesity in children aged 5-18 years.</p><p><strong>Findings: </strong>Our finalised analytic framework included 25 questions across 12 characteristics. These addressed aspects such as the setting of the intervention (e.g. at school, at home or in the community), mode of delivery (e.g. to individuals or to groups of children), whether the intervention targeted diet and/or activity, complexity (e.g. focused on a single swap of juice for water or aimed to change all aspects of the diet), intensity, flexibility, choice, mechanism of action (e.g. through participation, education, change in the social environment, change in the physical environment), resonance (e.g. credibility of the person delivering the intervention), commercial involvement and the 'fun factor' (as perceived by children). We coded 255 interventions from 210 randomised trials.</p><p><strong>Conclusions: </strong>Our evidence-based analytic framework, refined by consulting with stakeholders, allowed us to code 255 interventions aiming to prevent obesity in children aged 5-18 years. Our confidence in the validity of the framework and coding results is increased by our rigorous methods and, especially, the involvement of children at multiple stages.</p><p><str","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":" ","pages":"1-31"},"PeriodicalIF":0.0,"publicationDate":"2025-10-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145433091","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Nicole Stone, Cynthia Graham, Rowena Bedford, Lauren Towler, Louise Jackson, Stephen Bremner, Nuala McGrath, Katherine Brown, Katie Newby, Amanda Clarke, Leanne Morrison, Tom Nadarzynski, Ye To, Nicky Perry, Jake Bayley
<p><strong>Background: </strong>Sexually transmitted infections pose a significant public health challenge in the United Kingdom, prompting the Department of Health and Social Care to prioritise sexually transmitted infection rate reduction as a means of addressing sexual health inequalities. Correct and consistent condom use is the most effective method of reducing sexually transmitted infection transmission.</p><p><strong>Methods: </strong>A randomised controlled trial with three arms (two intervention arms and one control arm) was conducted to evaluate the effectiveness and cost-effectiveness of the home-based intervention strategy United Kingdom intervention in reducing chlamydia test positivity among 16- to 25-year-old men, and individuals with a penis, at risk of sexually transmitted infections. The home-based intervention strategy United Kingdom intervention, delivered either face to face by health promotion professionals or digitally through an interactive website, aimed to enhance condom use experiences and improve correct and consistent condom use. The control group received usual condom distribution care. Chlamydia screening was conducted at baseline and 6 months post randomisation, with follow-up through online questionnaires. Of the 2387 individuals assessed for eligibility, 1233 were eligible, and 725 participants completed all baseline assessments and were randomised (health promotion professionals: 241, interactive website: 243, control: 241). Five hundred and eighty men received the intervention arm as randomised (health promotion professionals: 51.9%, interactive website: 93.8%, control: 94.2%); 51.7% of participants engaged during follow-up, with 21.4% providing baseline and follow-up chlamydia screening results.</p><p><strong>Results: </strong>Findings showed the home-based intervention strategy United Kingdom to be well received, with participants valuing the condom kit and materials promoting pleasurable condom use. At the primary end point, home-based intervention strategy United Kingdom participants showed a 4.9 percentage point reduction in chlamydia test positivity compared to the control (7.9% vs. 12.8%). The odds of a positive test were 55% lower for home-based intervention strategy United Kingdom participants compared to the control. However, this reduction was not statistically significant due to the lower-than-planned participant recruitment (a consequence of COVID-19) affecting the trial's power. Home-based intervention strategy United Kingdom positively impacted recent condom use along with significant reductions in condom use errors and problems compared to the control. While no marked effect on consistent condom use emerged, attitudinal shifts were highly significant, with sustained positive condom attitudes, reduced perceived barriers and increased confidence in condom use among home-based intervention strategy United Kingdom participants.</p><p><strong>Conclusion: </strong>The home-based intervention strategy
{"title":"Home-based intervention strategy to reduce new chlamydia infection among young men: the HIS-UK RCT.","authors":"Nicole Stone, Cynthia Graham, Rowena Bedford, Lauren Towler, Louise Jackson, Stephen Bremner, Nuala McGrath, Katherine Brown, Katie Newby, Amanda Clarke, Leanne Morrison, Tom Nadarzynski, Ye To, Nicky Perry, Jake Bayley","doi":"10.3310/GJNS1528","DOIUrl":"10.3310/GJNS1528","url":null,"abstract":"<p><strong>Background: </strong>Sexually transmitted infections pose a significant public health challenge in the United Kingdom, prompting the Department of Health and Social Care to prioritise sexually transmitted infection rate reduction as a means of addressing sexual health inequalities. Correct and consistent condom use is the most effective method of reducing sexually transmitted infection transmission.</p><p><strong>Methods: </strong>A randomised controlled trial with three arms (two intervention arms and one control arm) was conducted to evaluate the effectiveness and cost-effectiveness of the home-based intervention strategy United Kingdom intervention in reducing chlamydia test positivity among 16- to 25-year-old men, and individuals with a penis, at risk of sexually transmitted infections. The home-based intervention strategy United Kingdom intervention, delivered either face to face by health promotion professionals or digitally through an interactive website, aimed to enhance condom use experiences and improve correct and consistent condom use. The control group received usual condom distribution care. Chlamydia screening was conducted at baseline and 6 months post randomisation, with follow-up through online questionnaires. Of the 2387 individuals assessed for eligibility, 1233 were eligible, and 725 participants completed all baseline assessments and were randomised (health promotion professionals: 241, interactive website: 243, control: 241). Five hundred and eighty men received the intervention arm as randomised (health promotion professionals: 51.9%, interactive website: 93.8%, control: 94.2%); 51.7% of participants engaged during follow-up, with 21.4% providing baseline and follow-up chlamydia screening results.</p><p><strong>Results: </strong>Findings showed the home-based intervention strategy United Kingdom to be well received, with participants valuing the condom kit and materials promoting pleasurable condom use. At the primary end point, home-based intervention strategy United Kingdom participants showed a 4.9 percentage point reduction in chlamydia test positivity compared to the control (7.9% vs. 12.8%). The odds of a positive test were 55% lower for home-based intervention strategy United Kingdom participants compared to the control. However, this reduction was not statistically significant due to the lower-than-planned participant recruitment (a consequence of COVID-19) affecting the trial's power. Home-based intervention strategy United Kingdom positively impacted recent condom use along with significant reductions in condom use errors and problems compared to the control. While no marked effect on consistent condom use emerged, attitudinal shifts were highly significant, with sustained positive condom attitudes, reduced perceived barriers and increased confidence in condom use among home-based intervention strategy United Kingdom participants.</p><p><strong>Conclusion: </strong>The home-based intervention strategy ","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":"13 8","pages":"1-47"},"PeriodicalIF":0.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145380127","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Russell Viner, Semina Michalopoulou, Lee Hudson, Steven Hope, Oliver Lloyd-Houldey, Neisha Sundaram, Stephen Scott, Dasha Nicholls, Chris Bonell
<p><strong>Background: </strong>The high prevalence of mental health disorders among adolescents point to the need for interventions that prevent or minimise harms from these. Schools are the ideal setting for such interventions, given almost all children can be reached. We adapted a whole-school health intervention to target mental health. As part of this research, we aimed to provide schools with a report on mental health needs among their students and a menu of evidence-based actions that schools could take to address these needs. Given the multiple existing systematic reviews in this area, the actions to be included in the menu were informed by a rapid systematic review of reviews.</p><p><strong>Aims: </strong>To identify effective school-level or simple interventions to address student needs across various domains of mental health in secondary schools or an equivalent phase, which have been identified in existing systematic reviews.</p><p><strong>Methods: </strong>We undertook a rapid systematic review of reviews. In January 2022, we searched three databases [PubMed, PsycInfo<sup>®</sup> (American Psychological Association, Washington, DC, USA) and Cochrane Library] for systematic reviews of mental health interventions in the domains of: antisocial behaviour, anxiety, body image, depressive symptoms, digital health, eating problems, emotional issues, general well-being, lesbian, gay, bisexual, trans, questioning and other (LGBTQ+) inclusion, mental health first aid, physical activity for mental health, positive mental health, self-harm, student voice and substance use. Eligible for inclusion were systematic reviews of randomised trials or quasi-experimental studies evaluating school-based interventions among secondary school- or equivalent-aged children. We retrieved 95 reviews, of which 41 were eligible for the present review. We defined effective intervention strategies as those identified as being effective in an eligible study in any review.</p><p><strong>Results: </strong>We identified a number of effective school-level or simple school interventions for addressing mental health in the above domains. Nine intervention focus areas were identified: (1) positive mental health and promotion of healthy development (five intervention strategies identified); (2) mental health literacy and awareness (six strategies); (3) LGBTQ+ mental health (two strategies); (4) mental health first aid (one strategy); (5) peer mentoring (two strategies); (6) support for transition from primary to secondary school (one strategy); (7) body image and body confidence (one strategy); (8) creative arts activities (one strategy); (9) physical activity (seven strategies) and (10) increasing access to nature (one strategy). Altogether, 27 strategies were identified.</p><p><strong>Conclusions and limitations: </strong>This rapid review identified 27 evidence-based school-level strategies that were used to inform the development of a menu of evidence-based whole-school a
{"title":"Learning Together for Mental Health: Rapid systematic review of reviews of school-level interventions to promote mental health and wellbeing.","authors":"Russell Viner, Semina Michalopoulou, Lee Hudson, Steven Hope, Oliver Lloyd-Houldey, Neisha Sundaram, Stephen Scott, Dasha Nicholls, Chris Bonell","doi":"10.3310/FFHR7745","DOIUrl":"10.3310/FFHR7745","url":null,"abstract":"<p><strong>Background: </strong>The high prevalence of mental health disorders among adolescents point to the need for interventions that prevent or minimise harms from these. Schools are the ideal setting for such interventions, given almost all children can be reached. We adapted a whole-school health intervention to target mental health. As part of this research, we aimed to provide schools with a report on mental health needs among their students and a menu of evidence-based actions that schools could take to address these needs. Given the multiple existing systematic reviews in this area, the actions to be included in the menu were informed by a rapid systematic review of reviews.</p><p><strong>Aims: </strong>To identify effective school-level or simple interventions to address student needs across various domains of mental health in secondary schools or an equivalent phase, which have been identified in existing systematic reviews.</p><p><strong>Methods: </strong>We undertook a rapid systematic review of reviews. In January 2022, we searched three databases [PubMed, PsycInfo<sup>®</sup> (American Psychological Association, Washington, DC, USA) and Cochrane Library] for systematic reviews of mental health interventions in the domains of: antisocial behaviour, anxiety, body image, depressive symptoms, digital health, eating problems, emotional issues, general well-being, lesbian, gay, bisexual, trans, questioning and other (LGBTQ+) inclusion, mental health first aid, physical activity for mental health, positive mental health, self-harm, student voice and substance use. Eligible for inclusion were systematic reviews of randomised trials or quasi-experimental studies evaluating school-based interventions among secondary school- or equivalent-aged children. We retrieved 95 reviews, of which 41 were eligible for the present review. We defined effective intervention strategies as those identified as being effective in an eligible study in any review.</p><p><strong>Results: </strong>We identified a number of effective school-level or simple school interventions for addressing mental health in the above domains. Nine intervention focus areas were identified: (1) positive mental health and promotion of healthy development (five intervention strategies identified); (2) mental health literacy and awareness (six strategies); (3) LGBTQ+ mental health (two strategies); (4) mental health first aid (one strategy); (5) peer mentoring (two strategies); (6) support for transition from primary to secondary school (one strategy); (7) body image and body confidence (one strategy); (8) creative arts activities (one strategy); (9) physical activity (seven strategies) and (10) increasing access to nature (one strategy). Altogether, 27 strategies were identified.</p><p><strong>Conclusions and limitations: </strong>This rapid review identified 27 evidence-based school-level strategies that were used to inform the development of a menu of evidence-based whole-school a","PeriodicalId":74615,"journal":{"name":"Public health research (Southampton, England)","volume":" ","pages":"1-34"},"PeriodicalIF":0.0,"publicationDate":"2025-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145314294","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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