Understanding for whom, under what conditions and how smoking cessation services for pregnant women in the United Kingdom work-a rapid realist review.

BACKGROUND: Maternal smoking in pregnancy is associated with several adverse maternal and infant health outcomes including increased risk of miscarriage, stillbirth, low birth weight, preterm birth, and asthma. Progress to reduce rates of smoking at time of delivery in England have been slow and over the last decade, less than half of pregnant women who accessed services went onto report having quit. This realist review was undertaken to improve the understanding of how smoking cessation services in pregnancy work and to understand the heterogeneity of outcomes observed. METHODS: The initial programme theory was developed using the National Centre for Smoking Cession and Training Standard Treatment Programme for Pregnant Women and the National Institute for Health and Care Excellence guidance on treating tobacco dependency. A search strategy and inclusion criteria were developed. Four databases were searched to identify published papers and four websites were hand searched to identify any unpublished literature that could contribute to theory building. Realist logic was applied to the analysis of papers to identify the contexts in which the intended behaviour change mechanism(s) were triggered, or not, and towards what outcomes to develop context mechanism outcome configurations. RESULTS: The review included 33 papers. The analysis produced 19 context mechanism outcome configurations structured under five closely interconnected domains (i) articulating harm, (ii) promoting support, (iii) managing cravings, (iv) maintaining commitment and (v) building self-efficacy. This review identifies two key processes involved in how services achieve their effects: how material resources are implemented and relationships. Of the two key processes identified, more existing literature was available evidencing how material resources are implemented. However, the review provides some evidence that non-judgemental and supportive relationships with healthcare workers where regular contact is provided can play an important role in interrupting the social cues and social practice of smoking, even where those around women continue to smoke. CONCLUSIONS: This review clarifies the range of interconnected and bi-directional relationships between services and the personal and social factors in women's lives. It underscores the importance of aligning efforts across the models five domains to strengthen services' ability to achieve smoking cessation.

A Qualitative Exploration of Patient and Staff Experiences of the Receipt and Delivery of Specialist Weight Management Services in the UK.

BACKGROUND: Addressing the increasing prevalence of obesity is a global public health priority. Severe obesity (body mass index > 40) reduces life expectancy, due to its association with people developing complications (e.g. diabetes, cancer, cardiovascular disease), and greatly impairs quality of life. The National Health Service (NHS) in the UK provides specialist weight management services (SWMS) for people with severe obesity, but key uncertainties remain around patient access to and engagement with weight management services, as well as pathways beyond the service. METHODS: In this multiple methods study, using online forum data and semi-structured interviews, stakeholders' experiences of delivering and receiving SWMS were explored. Using the web search engine Google with keywords and web address (URL) identifiers, relevant public online platforms were sourced with snowball sampling and search strings used to identify threads related to people's experiences of accessing SWMS (n = 57). Interviews were conducted with 24 participants (nine patients, 15 staff), and data from all sources were analysed thematically using the framework approach. RESULTS: Six themes related to access to and engagement with SWMS emerged during data analysis: (1) making the first move, (2) uncertainty and confusion, (3) resource issues, (4) respect and understanding, (5) mode of delivery, and (6) desire for ongoing support. CONCLUSION: There is a mixed and varied picture of SWMS provision across the UK. The service offered is based on local clinical decision making and available resources, resulting in a range of patient experiences and perspectives. Whilst service capacity issues and patient anxiety were seen as barriers to accessing care, peer support and positive clinical and group interactions (connectedness between individuals) were considered to increase engagement.

Healthy Parent Carers: Acceptability and practicability of online delivery and learning through implementation by delivery partner organisations.

BACKGROUND: Parent carers of disabled children are at increased risk of physical and mental health problems. The Healthy Parent Carers (HPC) programme is a manualised peer-led group-based programme that aims to promote parent carer health and wellbeing. Previously, the programme had been delivered in person, with recruitment and delivery managed in a research context. This study explored implementation by two delivery partner organisations in the United Kingdom. Facilitator Training and Delivery Manuals were modified for online delivery using Zoom due to COVID-19. METHODS: The study methodology utilised the Replicating Effective Programs framework. A series of stakeholder workshops informed the development of the Implementation Logic Model and an Implementation Package. After delivering the programme, delivery partner organisations and facilitators participated in a workshop to discuss experiences of implementing the programme. A wider group of stakeholders, including commissioners, Parent Carer Forums and charity organisations representatives and researchers subsequently met to consider the sustainability and potential barriers to delivering the programme outside the research context. RESULTS: This study explored implementation by two delivery partner organisations in the United Kingdom that were able to recruit facilitators, who we trained, and they recruited participants and delivered the programme to parent carers in different localities using Zoom. The co-created Implementation Logic Model and Implementation Package were subsequently refined to enable the further roll-out of the programme with other delivery partner organisations. CONCLUSIONS: This study provides insight and understanding of how the HPC programme can be implemented sustainably outside of the research context. Further research will evaluate the effectiveness of the programme and refine the implementation processes. PATIENT AND PUBLIC CONTRIBUTION: Parent carers, delivery partner organisation staff and service commissioners were consulted on the design, delivery and reporting of the research.

A group-based behavioural intervention for weight management (PROGROUP) versus usual care in adults with severe obesity: a feasibility randomised controlled trial protocol.

BACKGROUND: Approximately 15 million people in the UK live with obesity, around 5 million of whom have severe obesity (body mass index (BMI) ≥35kg/m2). Having severe obesity markedly compromises health, well-being and quality of life, and substantially reduces life expectancy. These adverse outcomes are prevented or ameliorated by weight loss, for which sustained behavioural change is the cornerstone of treatment. Although NHS specialist 'Tier 3' Weight Management Services (T3WMS) support people with severe obesity, using individual and group-based treatment, the current evidence on optimal intervention design and outcomes is limited. Due to heterogeneity of severe obesity, there is a need to tailor treatment to address individual needs. Despite this heterogeneity, there are good reasons to suspect that a structured group-based behavioural intervention may be more effective and cost-effective for the treatment of severe obesity compared to usual care. The aims of this study are to test the feasibility of establishing and delivering a multi-centre randomised controlled clinical trial to compare a group-based behavioural intervention versus usual care in people with severe obesity. METHODS: This feasibility randomised controlled study is a partially clustered multi-centre trial of PROGROUP (a novel group-based behavioural intervention) versus usual care. Adults ≥18 years of age who have been newly referred to and accepted by NHS T3WMS will be eligible if they have a BMI ≥40, or ≥35 kg/m2 with comorbidity, are suitable for group-based care and are willing to be randomised. Exclusion criteria are participation in another weight management study, planned bariatric surgery during the trial, and unwillingness or inability to attend group sessions. Outcome assessors will be blinded to treatment allocation and success of blinding will be evaluated. Clinical measures will be collected at baseline, 6 and 12 months post-randomisation. Secondary outcome measures will be self-reported and collected remotely. Process and economic evaluations will be conducted. DISCUSSION: This randomised feasibility study has been designed to test all the required research procedures and additionally explore three key issues; the feasibility of implementing a complex trial at participating NHS T3WMS, training the multidisciplinary healthcare teams in a standard intervention, and the acceptability of a group intervention for these particularly complex patients. TRIAL REGISTRATION: ISRCTN number 22088800.

How can we optimise learning from trials in child and adolescent mental health?

Improving child and adolescent mental health requires the careful development and rigorous testing of interventions and delivery methods. This includes universal school-based mindfulness training, evaluated in the My Resilience in Adolescence (MYRIAD) trial reported in this special edition. While discovering effective interventions through randomised controlled trials is our ultimate aim, null or negative results can and should play an important role in progressing our understanding of what works. Unfortunately, alongside publication bias there can be a tendency to ignore, spin or unfairly undermine disappointing findings. This creates research waste that can increase risk and reduce benefits for future service users. We advocate several practices to help optimise learning from all trials, whatever the results: stronger intervention design reduces the likelihood of foreseeable null or negative results; an evidence-informed conceptual map of the subject area assists with understanding how results contribute to the knowledge base; mixed methods trial designs aid explanation of outcome results; various open science practices support the dispassionate analysis of data and transparent reporting of trial findings; and preparation for null or negative results helps to temper stakeholder expectations and increase understanding of why we conduct trials in the first place. To embed these practices, research funders must be willing to pay for pilot studies and 'thicker' trials, and publishers should judge trials according to their conduct and not their outcome. MYRIAD is an exemplar of how to design, conduct and report a trial to optimise learning, with important implications for practice.

Promoting Learning from Null or Negative Results in Prevention Science Trials.

There can be a tendency for investigators to disregard or explain away null or negative results in prevention science trials. Examples include not publicizing findings, conducting spurious subgroup analyses, or attributing the outcome post hoc to real or perceived weaknesses in trial design or intervention implementation. This is unhelpful for several reasons, not least that it skews the evidence base, contributes to research "waste", undermines respect for science, and stifles creativity in intervention development. In this paper, we identify possible policy and practice responses when interventions have null (ineffective) or negative (harmful) results, and argue that these are influenced by: the intervention itself (e.g., stage of gestation, perceived importance); trial design, conduct, and results (e.g., pattern of null/negative effects, internal and external validity); context (e.g., wider evidence base, state of policy); and individual perspectives and interests (e.g., stake in the intervention). We advance several strategies to promote more informative null or negative effect trials and enable learning from such results, focusing on changes to culture, process, intervention design, trial design, and environment.

Enablers and barriers English secondary schools face in promoting healthy diet and physical activity behaviours.

This study sought to understand the current challenges mainstream secondary schools in England face in creating a health promoting school culture for diet and physical activity behaviours. An in-depth qualitative case study of two purposely selected state-funded schools, including interviews with teachers, observations of school activities including meal breaks and a qualitative survey with parents was done. Inductive thematic analysis was used to explore emerging themes. Additional interviews with the leadership team from four further schools were used to develop and refine emerging themes. Four main themes emerged from the data: competing pressures, school environment, personnel and policy. Results demonstrate that schools recognize they have role to play in promoting healthy lifestyle behaviours to pupils; however, several significant barriers were identified such as lack of government support and regulation, school structures and organization, focus on core subjects, business-run canteens and lack of family and community engagement. Given the importance of maintaining a healthy weight throughout the life course, schools have an important role to play in creating healthy environments in which students can easily make a healthy choice. Future school promotion initiatives need to consider addressing the barriers that schools face by working with them and the communities in which they are embedded.

There has been little research done in secondary schools to understand how to promote healthy lifestyle behaviours to adolescents (secondary schools provide secondary education for students aged 11­18 years). COVID-19 has brought the importance of maintaining a healthy weight back into sharp focus and schools are an ideal setting to educate and support young people in making healthy diet and activity choices. This research sought to understand how important school staff thought creating a health-promoting culture in schools was, how they could create such a culture and what support they had or needed to do so. From interviews with school staff, observing school activities and a questionnaire to parents, we found that schools and parents believe that schools have a role to play in supporting healthy diet and physical activity behaviours although they identified many pressures that prevent making health promotion a priority; these include time and resources as well as a lack of government policy. The importance of having a head teacher with a belief in the benefits of a healthy lifestyle was recognized. The way secondary schools are structured in England makes a joined-up approach difficult and requires central planning and coordination. More support, including resources and policy commitments, are needed to support secondary schools to create a healthy school environment.

Healthy Parent Carers programme: mixed methods process evaluation and refinement of a health promotion intervention.

OBJECTIVES: Parent carers of children with special educational needs or disability are at risk of poorer mental and physical health. In response to these needs, we codeveloped the 'Healthy Parent Carers' (HPC) programme. This study examined the views and experiences of participants in the HPC feasibility trial to inform programme refinement. INTERVENTION, SETTING AND PARTICIPANTS: HPC is a peer-led group-based intervention (supported by online materials) for primary carers of disabled children, encouraging behaviours linked with health and well-being. It was delivered by two lead and six assistant peer facilitators in six community sites (one lead and one assistant per group) in South West England over six or 12 sessions. Control participants had online materials only. The trial involved 47 intervention and 45 control parent carers (97% female and 97% white) and eight facilitators (one male). DESIGN: A preplanned mixed methods process evaluation using questionnaires and checklists (during and after the intervention), qualitative interviews with participants after intervention (n=18) and a focus group with facilitators after trial. RESULTS: HPC was highly acceptable to participants and facilitators and experiences were very positive. Participants reported that the programme increased awareness of what parent carers could and could not change and their self-efficacy to engage in health-promoting behaviours. The intended mechanisms of action (social identification and peer support) matched participants' expectations and experiences. Control participants found the online-only programme flexible but isolating, as there were no opportunities to share ideas and problem solve with peers, the key function of the programme. Areas for improvement were identified for programme content, facilitator training and delivery. CONCLUSION: HPC was acceptable, well received and offers considerable potential to improve the health of parent carers. Under the pandemic, the challenge going forward is how best to maintain reach and fidelity to function while delivering a more virtual programme. TRIAL REGISTRATION NUMBER: ISRCTN151144652.

Healthy Parent Carers: feasibility randomised controlled trial of a peer-led group-based health promotion intervention for parent carers of disabled children.

BACKGROUND: Parent carers of children with special educational needs or disability are at higher risk of poor mental and physical health. The need for a tailored, peer-led group programme was raised by parent carers, who co-developed the Healthy Parent Carers programme with researchers. This study aimed to test the feasibility of programme delivery in community settings, and the feasibility and acceptability of a randomised controlled trial design. METHODS: Participants were individually randomised with concealed allocation to a structured group programme and access to online resources (intervention), or access to the online resources only (control). Measures of wellbeing and secondary and economic outcomes were collected before randomisation, immediately post-intervention, and 6 months post-intervention. Descriptive statistics on recruitment and attrition, demographics, attendance, and fidelity of intervention delivery were analysed with feedback on the acceptability of the trial design. RESULTS: One hundred and ninety-three parent carers expressed an interest in taking part. Ninety-two participants recruited from across six sites were randomised (47 intervention, 45 control). Lead and assistant facilitators were trained and delivered the group sessions. Sixteen (34%) participants in the intervention arm did not attend any sessions, and attendance varied across sites and sessions. One participant withdrew post-randomisation, and 83 (90%) participants completed outcome measures at the six-month follow-up. CONCLUSIONS: The study demonstrated that it was feasible to deliver the programme in community settings. The number of parent carers who expressed interest signifies the need for such a programme and the feasibility of recruiting to a definitive trial. Loss to follow-up was low. Further research is needed to explore ways to reduce barriers to participation in person and assess the feasibility and acceptability of programme content and delivery for more ethnically diverse groups, and potentially using interpreters. Given the Covid-19 pandemic and delivery format feedback, there is also a need to investigate remote or blended delivery strategies. Although the results indicate that a definitive trial is feasible, programme impact would be strengthened through exploration of these uncertainties. TRIAL REGISTRATION: ISRCTN, ISRCTN15144652 , registered on 25 October 2018, ClinicalTrials.gov , NCT03705221 , registered on 15 October 2018.

Implementing a set of health promoting processes in English secondary schools: A comparative case study.

Objective: To understand the enablers and barriers to implementing a set of adaptive processes aimed at supporting secondary schools to reflect on and subsequently address how they could adjust school practices, culture and the environment to create a whole school approach to promoting healthy lifestyles. Study design: A qualitative, comparative case study. Methods: Two in depth case studies were created of two purposefully selected schools in low socio-economic areas of South West England. Data were collected via meetings, observations, field notes, interviews and audit. Interviews were transcribed verbatim. Individual thematic analyses were conducted for each school and a comparative analysis approach was used to understand the barriers and enablers across both cases. Results: Schools were supported to use a health-promoting lens and identify feasible improvements through an adaptive and context specific process. The school environment and ethos were identified as the areas where schools could conceive the most adjustments to enhance the promotion of healthy lifestyle choices. With the lack of government policy for health promotion in schools (HPS), the Head teacher's approach to health was key to making meaningful changes. Conclusions: Health promoting school approaches need to be adaptive to local context, actively involve community partners and link to local initiatives where possible, with support from Head teachers and business managers. Starting with what teachers, pupils and parents see as the barriers to health can create a whole school ethos for broad reaching and sustainable HPS programmes.

Healthy Parent Carers peer-led group-based health promotion intervention for parent carers of disabled children: protocol for a feasibility study using a parallel group randomised controlled trial design.

BACKGROUND: Parent carers of disabled children are at increased risk of mental and physical health problems. They often experience challenges to maintaining good health which have implications for their well-being and their ability to care for their children. In response to these needs, researchers and parent carers developed the Healthy Parent Carers (HPC) programme. It is a peer-led, group-based intervention that promotes behaviours associated with health and well-being. The aims of this trial are to assess the acceptability of the HPC programme and the feasibility of its delivery in the community and to assess the feasibility and acceptability of the design of the definitive trial to evaluate the programme's effectiveness and cost-effectiveness. METHODS: We will establish six research sites and train facilitators to deliver the manualised intervention. Parent carers of children with special educational needs and disabilities will be individually randomised, stratified by group delivery site, to either take part in a group programme and online resources (intervention) or to receive access to the online resources only (control). Measures of mental health; well-being; health-related quality of life; health behaviours; patient activation; protective factors such as resilience, social connections, and practical support; and use of health care, social care, and wider societal resources will be collected before randomisation (baseline), immediately post-intervention, and 6 months later. Recruitment of participants, adherence to the programme, and the dose received will be assessed. Group sessions will be audio-recorded to evaluate the fidelity of delivery and participant engagement. Participants' and facilitators' feedback on the programme content and delivery, their experience, and the acceptability of the outcome measures and trial design will be collected through feedback forms, interviews, and focus groups. DISCUSSION: This trial will assess whether the programme delivery and evaluative trial design are feasible, to inform whether to progress to a definitive randomised controlled trial to test the effectiveness and cost-effectiveness of the Healthy Parent Carers programme. TRIAL REGISTRATION: ISRCTN, ISRCTN151144652, registered on 25 October 2018; ClinicalTrials.gov, NCT03705221, registered on 15 October 2018.

Response and interventions into harmful sexual behaviour in schools.

Internationally young people report experiencing sexual abuse and violence within schools. Developments within the field of adolescent sexual harm are increasingly recognising the need for ecological approaches to harm. Yet, to date, interventions with young people displaying harmful sexual behaviours have prioritised individual behaviours and characteristics over place-based interventions. This article presents empirical evidence from a mixed-methods study aimed at understanding the enablers and barriers to preventing and responding to harmful sexual behaviour in schools. Research was carried out in seven schools and four multi-agency partnerships in England, UK. Using evidence from focus groups, observations, case reviews and policy analysis the article outlines nine components that enable, or are barriers to, effective responses and interventions into harmful sexual behaviour in schools. The paper concludes that responses and interventions into harmful sexual behaviour must move beyond responding to individual behaviours to intervening within factors within schools themselves.

Are We Overestimating Physical Activity Prevalence in Children?

BACKGROUND: Physical activity guidelines state that children should achieve at least 60 minutes of moderate to vigorous physical activity (MVPA) on each day of the week. Accurate assessment of adherence to these guidelines should, ideally, include measurement over 7 days. When less than 7 days of data are available, researchers often report the average minutes of MVPA per day as a proxy for 7-day measurement. The aim of this study was to compare prevalence estimates generated by average MVPA per day versus MVPA assessed over 7 days. METHODS: Data were collected as part of the Healthy Lifestyles Programme. One class from each school was randomized to wear a GENEActiv accelerometer for 8 days. The percentages of children achieving an average of ≥60 minutes of MVPA per day and those achieving ≥60 minutes of MVPA on each of 7 days were calculated. RESULTS: A total of 807 children provided 7 days of data. When the average MVPA per day was calculated, 30.6% (n = 247) of children accumulated ≥60 minutes of MVPA per day. Only 3.2% (n = 26) accumulated ≥60 minutes of MVPA on every day of the week. CONCLUSION: Previous studies utilizing average MVPA per day are likely to have overestimated the percentage of children meeting recommendations.

Children's Compliance With Wrist-Worn Accelerometry Within a Cluster-Randomized Controlled Trial: Findings From the Healthy Lifestyles Programme.

PURPOSE: The purpose of this study was to assess children's compliance with wrist-worn accelerometry during a randomized controlled trial and to examine whether compliance differed by allocated condition or gender. METHODS: A total of 886 children within the Healthy Lifestyles Programme trial were randomly allocated to wear a GENEActiv accelerometer at baseline and 18-month follow-up. Compliance with minimum wear-time criteria (≥10 h for 3 weekdays and 1 weekend day) was obtained for both time points. Chi-square tests were used to determine associations between compliance, group allocation, and gender. RESULTS: At baseline, 851 children had usable data, 830 (97.5%) met the minimum wear-time criteria, and 631 (74.1%) had data for 7 days at 24 hours per day. At follow-up, 789 children had usable data, 745 (94.4%) met the minimum wear-time criteria, and 528 (67%) had complete data. Compliance did not differ by gender (baseline: χ2 = 1.66, P = .2; follow-up: χ2 = 0.76, P = .4) or by group at follow-up (χ2 = 2.35, P = .13). CONCLUSION: The use of wrist-worn accelerometers and robust trial procedures resulted in high compliance at 2 time points regardless of group allocation, demonstrating the feasibility of using precise physical activity monitors to measure intervention effectiveness.

Effectiveness of the Healthy Lifestyles Programme (HeLP) to prevent obesity in UK primary-school children: a cluster randomised controlled trial.

Background: Although childhood overweight and obesity prevalence has increased substantially worldwide in the past three decades, scarce evidence exists for effective preventive strategies. We aimed to establish whether a school-based intervention for children aged 9-10 years would prevent excessive weight gain after 24 months. Methods: This pragmatic cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a school-based obesity prevention intervention, was done in 32 schools in southwest England. All state-run primary and junior schools in Devon and Plymouth (UK) with enough pupils for at least one year-5 class were eligible. Schools were assigned (1:1) using a computer-generated sequence to either intervention or control, stratified by the number of year-5 classes (one vs more than one) and the proportion of children eligible for free school meals (<19% [the national average] vs ≥19%). HeLP was delivered to year-5 children (ages 9-10 years) over 1 year, and included dynamic and interactive activities such as physical activity workshops, education sessions delivered by teachers with short homework tasks, drama sessions, and setting goals to modify behaviour (with parental support and one-to-one discussions with HeLP coordinators). The primary outcome was change in body-mass index (BMI) standard deviation score (SDS) between baseline and 24 months, analysed in children with BMI data available for both timepoints. This study is registered with the International Standard Randomised Controlled Trial register, number ISRCTN15811706, and the trial status is complete. Findings: Between March 21, 2012, and Sept 30, 2013, 32 eligible schools with 1324 children were recruited, of which 16 schools (676 children) were randomly assigned to the HeLP intervention and 16 schools (648 children) to control. All schools that began the trial completed the intervention, and 1244 children (628 in intervention group and 616 in control group) had BMI data at both baseline and 24 months for the primary outcome analysis. Mean BMI SDS was 0·32 (SD 1·16) at baseline and 0·35 (1·25) at 24 months in the intervention group, and 0·18 (1·14) at baseline and 0·22 (1·22) at 24 months in the control group. With adjustment for school-level clustering, baseline BMI scores, sex, cohort, and number of year-5 classes and socioeconomic status of each school, the mean difference in BMI SDS score (intervention-control) at 24 months was -0·02 (95% CI -0·09 to 0·05), p=0·57. One parent reported an adverse event related to their child's eating and activity behaviours, but agreed for the child to continue trial participation after discussion with the chief investigator. Interpretation: Despite a theoretically informed and extensively piloted intervention that achieved high levels of engagement, follow-up, and fidelity of delivery, we found no effect of the intervention on preventing overweight or obesity. Although schools are an ideal setting in which to deliver population-based interventions, school-based interventions might not be sufficiently intense to affect both the school and the family environment, and hence the weight status of children. Future research should focus on more upstream determinants of obesity and use whole-systems approaches. Funding: UK National Institute for Health Research, Public Health Research Programme.

Intervention fidelity in the definitive cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP) trial: findings from the process evaluation.

BACKGROUND: The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. METHODS: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. RESULTS: All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. CONCLUSION: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. TRIAL REGISTRATION: ISRCTN15811706.

Trial baseline characteristics of a cluster randomised controlled trial of a school-located obesity prevention programme; the Healthy Lifestyles Programme (HeLP) trial.

BACKGROUND: We have developed a healthy lifestyles programme (HeLP) for primary school aged children (9-10 years), currently being evaluated in a definitive cluster randomised controlled trial. This paper descriptively presents the baseline characteristics of trial children (BMI, waist circumference, % body fat, diet and physical activity) by gender, cluster level socio-economic status, school size and time of recruitment into the trial. METHODS: Schools were recruited from across the South West of England and allocated 1:1 to either intervention (HeLP) or control (usual practice) stratified by the proportion of children eligible for free school meals (FSM, <19%, ≥19%) and school size (one Year 5 class, >1 Year 5 class). The primary outcome is change in body mass index standard deviation score (BMI sds) at 24 months post-randomisation. Secondary outcomes are BMI sds at 18 months, waist circumference and percentage body fat sds at 18 and 24 months, proportion of children classified as underweight, overweight and obese at 18 and 24 months, physical activity (for a sub-sample) and food intake at 18 months. RESULTS: At baseline 11.4% and 13.6% of children were categorised as overweight or obese respectively. A higher percentage of girls than boys (25.3% vs 24.8%) and children from schools in FSM category 2 (28.2% vs 23.2%) were overweight or obese. Children were consuming a mean (range) of 4.15 (0-13) energy dense snacks (EDS) and 3.23 (0-9) healthy snacks (HS) per day with children from schools in FSM category 2 consuming more EDS and negative food markers and less HS and positive food markers. Children spent an average 53.6 min per day (11.9 to 124.8) in MVPA and thirteen hours (779.3 min) per day (11 h to 15 h) doing less than 'light' intensity activity. Less than 5% of children achieved the Departments of Health's recommendation of 60 min of MVPA every day. CONCLUSION: We have excellent completeness of baseline data for all measures and have achieved compliance to accelerometry not seen before in other large scale studies. Our anthropometric baseline data is representative of local and national data for children this age and reflects the gender and socio-economic variations expected of children this age in relation to physical activity and weight status. TRIAL REGISTRATION: ISRCTN15811706 (1/05/2012).

Detailed statistical analysis plan for a cluster randomised controlled trial of the Healthy Lifestyles Programme (HeLP), a novel school-based intervention to prevent obesity in school children.

BACKGROUND: The Healthy Lifestyles Programme (HeLP) trial is being conducted to determine whether a novel school-based intervention is effective and cost-effective in preventing obesity in 9-10 year-old children. This article describes the detailed statistical analysis plan for the HeLP trial, including an amendment (and rationale for amendment) made to originally planned sensitivity analyses. METHODS AND DESIGN: The HeLP trial is a definitive, pragmatic, superiority, cluster randomised controlled trial with two parallel groups and blinded outcome assessment. This update article describes in detail (1) the primary and secondary outcomes, (2) the statistical analysis principles (including which children will be included in each analysis, how the clustered nature of the study design will be accounted for, which covariates will be included in each analysis, how the results will be presented), (3) planned sensitivity analyses, planned subgroup analyses and planned adherence-adjusted analyses for the primary outcome, (4) planned analyses for the secondary outcomes and (e) planned longitudinal analyses. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) register: ISRCTN15811706 . Registered on 1 May 2012.

The Healthy Lifestyles Programme (HeLP)--an overview of and recommendations arising from the conceptualisation and development of an innovative approach to promoting healthy lifestyles for children and their families.

Despite the rise in childhood obesity, there remains a paucity of evidence for effective interventions that engage children and parents sufficiently to make and sustain lifestyle behaviour change. The Healthy Lifestyles Programme (HeLP) is a school-located obesity prevention programme, which has been developed with teachers, families and healthcare professionals. The underpinning assumption in the development of HeLP was to take a relational approach to changing behaviour, building relationships with the schools, children and their families to create supportive environments for healthy lifestyle choices. Thus, HeLP was conceptualised as a complex intervention within a complex system and developed as a dynamic, evolving set of processes to support and motivate children towards healthy behaviours. The delivery methods used are highly interactive and encourage identification with and ownership of the healthy lifestyle messages so that the children are motivated to take them home to their parents and effect change within the family. We have good evidence that HeLP engages schools and children such that they want to participate in the Programme. Results from an exploratory trial showed that the Programme is feasible and acceptable and has the potential to change behaviours and affect weight status. This paper presents an overview of and recommendations arising from the conceptualization; development and evaluation of the Healthy Lifestyles Programme as part of a special issue focusing on novel approaches to the global problem of childhood obesity.

Qualitative findings from an exploratory trial of the Healthy Lifestyles Programme (HeLP) and their implications for the process evaluation in the definitive trial.

BACKGROUND: Approximately one third of 10-11 year olds in England are now overweight or obese suggesting that population approaches are urgently required. However, despite the increasing number of school-based interventions to prevent obesity, results continue to be inconsistent and it is still unclear what the necessary conditions are that lead to the sustained behaviour change required to affect weight status. The Healthy Lifestyles Programme is a theoretically informed four phase multi-component intervention which seeks to create supportive school and home environments for healthy behaviours. METHODS: A process evaluation has run alongside the exploratory trial of the Healthy Lifestyles Programme to ascertain the feasibility and acceptability of; the trial design (including the trial outcomes) and the HeLP Programme and whether it is able to engage schools, children and their families. Data was collected using interviews with teachers (n = 12) and parents (n = 17) and six focus groups with children (n = 47) and a questionnaire for parents of children in the intervention schools. Interview and focus group data relating to the intervention was analysed using framework analysis. RESULTS: Four schools and 201 children participated in the exploratory trial. The data showed that the trial design was feasible and acceptable for schools and children. Three themes emerged for the data in relation to the acceptability and feasibility of the HeLP Programme (value, compatibility with the curriculum and enjoyment) and two themes emerged in relation to engagement ('knowledge and awareness' and 'taking messages on board'). The latter could be broken down into 4 subthemes ('initiating discussion with family and friends', 'acceptance of family rules', 'increased responsibility' and 'the importance of the mode and agent of delivery'). The use of highly inclusive and interactive delivery methods where the children were encouraged to identify with and take ownership of the healthy lifestyle messages were identified as important factors in motivating the children to take the messages home, seek parental support and initiate family lifestyle behaviour change. CONCLUSION: The process evaluation of the exploratory trial has not only provided evidence of the feasibility and acceptability of the Programme, it has also allowed an understanding of how HeLP engages schools, children and their families. These findings have informed the process evaluation for the definitive trial.