Supporting healthcare professionals to address child weight with parents: a qualitative study.

BACKGROUND: Primary care and community healthcare professionals (HCPs) are well placed to discuss child excess weight with parents and support them to make changes. However, HCPs have concerns about addressing this issue. There is a need to understand the factors that influence HCPs in initiating these conversations to inform strategies to support them. AIM: To explore with HCPs, working in primary care and community settings, their experiences of having conversations about child weight with parents, and the factors that create barriers or facilitate them to have these conversations. DESIGN AND SETTING: A qualitative study with GPs, primary care nurses (PNs), and school nurses (SNs) in England. METHOD: GPs and PNs were recruited to participate in semi-structured interviews. SNs from a community healthcare NHS trust were recruited to participate in focus groups. Vignettes were used to stimulate discussion. Data were analysed guided by the Framework approach. RESULTS: Thirteen GPs, seven PNs, and 20 SNs participated. The following three themes were identified regarding barriers to HCPs having conversations about child excess weight: structural and organisational; HCP related; and parent or family related. The themes identified for the factors that facilitate these conversations were: structural changes (for example, dedicated appointments, access to weight assessment data, joined-up working across agencies); HCP approaches (for example, providing appropriate dietary and physical activity advice); and HCP knowledge and skills (for example, enhancing HCPs' general and weight management-related skills and knowledge of child weight management services). CONCLUSION: A range of barriers exist to HCPs addressing child excess weight with parents in primary care and community settings. Actions to effect structural changes and support HCPs in developing relevant knowledge and skills are required to overcome these barriers.

Safeguarding in adolescent mental health research: navigating dilemmas and developing procedures.

Mental disorders are prevalent during adolescence. Self-harm and suicide are more common in adolescents with a probable mental disorder, with one in four reporting to have attempted self-harm. Research involving adolescents is, therefore, likely to include participants experiencing mental ill health, even if mental health is not the primary focus. Researchers should adopt procedures and principles that safeguard adolescent mental health in their research practice. Yet there are gaps between theory and practice of research with adolescents in relation to their mental health, and limited guidance is available.We discuss emerging safeguarding dilemmas and procedures in adolescent mental health research. Our experiences of safeguarding adolescent mental health are grounded in the UK National Institute for Health and Care Research-funded SMART Schools Study. Drawing from this secondary school-based study, we focus on how our research team encountered and addressed a high prevalence of participants (aged 12-13 and 14-15 years) reporting thoughts and behaviours related to self-harm or suicide (24% of participants). This included reviewing our existing risk mitigation processes and consulting with several committees including young people with lived experiences of mental health.We present the SMART Schools study safeguarding approach for adolescent mental health. This encompasses key safeguarding principles, study procedures and relevant justifications. We address school and university roles and responsibilities, pupil understanding, and efficient, effective and secure communication pathways. We embed guidance throughout this article for researchers working with adolescents in the context of mental health. Lastly, we present five key recommendations to safeguard the mental health of adolescents participating in research, including (1) appointing a safeguarding lead within the research team; (2) codesigning a bespoke study safeguarding approach; (3) adopting a responsive approach to mental health safeguarding; (4) being transparent about the study mental health safeguarding approach and (5) report the implementation and outcomes of safeguarding approaches.Trial registration number ISRCTN77948572.

Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial.

BACKGROUND: One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3-4-year-olds. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA with high acceptability in the UK. The study aims to evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve nutritional intake. METHODS: Multi-centre cluster RCT with process and economic evaluation. Participants are children aged 2 years or over, attending UK early years settings (nurseries) for ≥ 12 h/week or ≥ 15 h/week during term time and their parents, and staff at participating nurseries. The 12-month intervention involves nursery managers working with a Partner (public health practitioner) to self-assess policies and practices relating to physical activity and nutrition; nursery staff attending one physical activity and one nutrition training workshop and setting goals to be achieved within 6 months. The Partner provides support and reviews progress. Nursery staff receive a further workshop and new goals are set, with Partner support for a further 6 months. The comparator is usual practice. Up to 56 nurseries will be stratified by area and randomly allocated to intervention or comparator arm with minimisation of differences in level of deprivation. PRIMARY OUTCOMES: accelerometer-assessed mean total activity time on nursery days and average total energy (kcal) intake per eating occasion of lunch and morning/afternoon snacks consumed within nurseries. SECONDARY OUTCOMES: accelerometer-assessed mean daily minutes of moderate-to-vigorous physical activity and sedentary time per nursery day, total physical activity on nursery days compared to non-nursery days, average serving size of lunch and morning/afternoon snacks in nursery per day, average percentage of core and non-core food in lunch and morning/afternoon snacks, zBMI, proportion of children who are overweight/obese and child quality-of-life. A process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will compare costs and consequences from the perspective of the local government, nursery and parents. TRIAL REGISTRATION: ISRCTN33134697, 31/10/2019.

Extended brief interventions for weight management and obesity prevention in children: A rapid evidence review.

Uptake of child weight management (CWM) support is typically low, and services are not available in all areas. Extended brief interventions (EBIs) have been proposed as an affordable way to provide enhanced support, at a level between one-off brief advice and intensive CWM programs. This rapid systematic review sought to synthesize evidence on the efficacy of EBIs for weight management and obesity prevention in children (2-18 years). Embase and Web of Science were searched from January 2012 to January 2022. Nineteen studies, reporting on 17 separate EBIs, were included. The quality of studies was variable, and the EBIs were heterogeneous. The majority of EBIs (n = 14) were based on motivational interviewing. Five of the included studies reported significant improvements in parent or child determinants of health behavior change. However, robust measures of behavioral determinants were rarely used. No studies reported significant positive effects on child weight. No clear patterns in outcomes were identified. There is currently insufficient evidence for EBIs to be adopted as part of CWM services. To improve the evidence base, EBIs that are currently being implemented by local health services, should be evaluated to establish the most effective content, how it should be delivered, and by whom.

Smartphones, social Media and Adolescent mental well-being: the impact of school policies Restricting dayTime use-protocol for a natural experimental observational study using mixed methods at secondary schools in England (SMART Schools Study).

INTRODUCTION: Smartphone and social media use is prevalent during adolescence, with high levels of use associated with lower levels of mental well-being. Secondary schools in the UK have introduced policies that restrict daytime use of smartphones and social media, but there is no evaluation on the impact of these policies on adolescent mental well-being. The SMART Schools Study aims to determine the impact of daytime restrictions of smartphone and social media use on indicators of adolescent mental well-being, anxiety, depression, physical activity, sleep, classroom behaviour, attainment and addictive social media use. METHODS AND ANALYSIS: This is a natural experimental observational study using mixed methods. Secondary schools within a 100 mile radius of the recruiting centre in the West Midlands (UK) have been categorised into two groups: Schools that restrict (intervention) and permit (comparator) daytime use of smartphones. We aim to recruit 30 schools (20 restrictive, 10 permissive) and 1170 pupils aged 12-13 and 14-15 years. We will collect data on mental well-being, anxiety and depressive symptoms, phone and social media use, sleep and physical activity from pupil surveys, and accelerometers. Policy implementation measures and data on individual pupil factors will be collected through school staff surveys, and website/policy analysis. Six case study schools will explore individual, school and family/home factors that influence relationships between school smartphone policies, smartphone/social media use, and mental well-being. Economic evaluation will be completed through a cost-consequence analysis from an education sector perspective. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Birmingham's Research Ethics Committee (ERN_22-0723). Parents/carers of pupil participants can complete a form to opt their child out of the study. Pupil, school staff and parent/carer participants are asked to complete online/written consent (or assent). Findings will be disseminated through policy briefings, resources for schools, social media, reports, and open access publications. TRIAL REGISTRATION NUMBER: ISRCTN77948572.

Protocol to evaluate the effectiveness and cost-effectiveness of an environmental nutrition and physical activity intervention in nurseries (Nutrition and Physical Activity Self Assessment for Child Care - NAP SACC UK): a multicentre cluster randomised controlled trial.

Background One in seven UK children have obesity when starting school, with higher prevalence associated with deprivation. Most pre-school children do not meet UK recommendations for physical activity and nutrition. Formal childcare settings provide opportunities to deliver interventions to improve nutritional quality and physical activity to the majority of 3-4-year-olds. The nutrition and physical activity self-assessment for childcare (NAP SACC) intervention has demonstrated effectiveness in the USA with high acceptability in the UK. The study aims to evaluate the effectiveness and cost-effectiveness of the NAP SACC UK intervention to increase physical activity, reduce sedentary time and improve nutritional intake. Methods Multi-centre cluster RCT with process and economic evaluation. Participants are children aged 2 years or over, attending UK early years settings (nurseries) for ≥ 12 hours/week or ≥ 15 hours/week during term time and their parents, and staff at participating nurseries. The 12-month intervention involves nursery managers working with a Partner (public health practitioner) to self-assess policies and practices relating to physical activity and nutrition; nursery staff attending one physical activity and one nutrition training workshop and setting goals to be achieved within six months. The Partner provides support and reviews progress. Nursery staff receive a further workshop and new goals are set, with Partner support for a further six months. The comparator is usual practice. Up to 56 nurseries will be stratified by area and randomly allocated to intervention or comparator arm with minimisation of differences in level of deprivation. PRIMARY OUTCOMES: accelerometer-assessed mean total activity time on nursery days and average total energy (kcal) intake per eating occasion of lunch and morning/afternoon snacks consumed within nurseries. SECONDARY OUTCOMES: accelerometer-assessed mean daily minutes of moderate-to-vigorous physical activity and sedentary time per nursery day, total physical activity on nursery days compared to non-nursery days, average serving size of lunch and morning/afternoon snacks in nursery per day, average percentage of core and non-core food in lunch and morning/afternoon snacks, zBMI, proportion of children who are overweight/obese and child quality-of-life. A process evaluation will examine fidelity, acceptability, sustainability and context. An economic evaluation will compare costs and consequences from the perspective of the local government, nursery and parents. TRIAL REGISTRATION: ISRCTN33134697.

Relationship Between Weight Status and Health-Related Quality of Life in School-age Children in China.

Background: Some studies from high-income countries suggest that overweight and/or obesity in children are negatively associated with health-related quality of life (HRQOL). However, the relationship between weight status and HRQOL is not well established in China, where obesity trends follow a different pattern compared with high-income countries. The risk of obesity is greater in children from higher socioeconomic backgrounds and higher in boys compared with girls. Objective: The aim of this study was to examine the relationship between weight status and HRQOL in children between 6 and 7 years old in this unique country context. Methods: Baseline HRQOL and demographic data were collected from children recruited to the CHIRPY DRAGON obesity prevention trial in China. HRQOL was measured using the Chinese version of the Child Health Utility-9D (CHU-9D-CHN) and the Pediatric Quality of Life Inventory™ (PedsQL™) instruments. CHU-9D-CHN utility scores were generated using 2 scoring algorithms (UK and Chinese tariffs). Height and weight measures were taken at school by trained researchers using standardized methods, and BMI z scores were calculated using the World Health Organization 2007 growth charts. The relationship between HRQOL and weight status was examined using multivariable analyses, adjusting for age, gender, and socioeconomic status. Results: Full data were available for 1539 children (mean age, 6 years). In both unadjusted and adjusted analyses, HRQOL, using both the CHU-9D-CHN and the PedsQL™, was marginally higher in children who were overweight or living with obesity compared with children with healthy weight, although this difference did not reach statistical significance. Separate analyses and models by gender showed that the relationship between weight status and HRQOL scores was similar in boys and girls. Conclusions: Our results suggest no statistically significant difference in HRQOL between children with overweight/obesity compared with those with healthy weight. These results have implications for the methods of economic evaluation for obesity treatment and prevention interventions within this population cohort and country setting, as there appears to be no discernible consequences on children's HRQOL from living with overweight and obesity.

Cost-Effectiveness of a School-and Family-Based Childhood Obesity Prevention Programme in China: The "CHIRPY DRAGON" Cluster-Randomised Controlled Trial.

Objectives: Rapid socioeconomic and nutrition transitions in Chinese populations have contributed to the growth in childhood obesity. This study presents a cost-effectiveness analysis of a school- and family-based childhood obesity prevention programme in China. Methods: A trial-based economic evaluation assessed cost-effectiveness at 12 months. Forty schools with 1,641 children were randomised to either receive the multi-component (diet and physical activity) intervention or to continue with usual activities. Both public sector and societal perspectives were adopted. Costs and benefits in the form of quality-adjusted life years (QALYs) were compared and uncertainty was assessed using established UK and US thresholds. Results: The intervention cost was 35.53 Yuan (£7.04/US$10.01) per child from a public sector perspective and 536.95 Yuan (£106/US$151) from a societal perspective. The incremental cost-effectiveness ratio (ICER) was 272.7 Yuan (£54/US$77)/BMI z-score change. The ICER was 8,888 Yuan (£1,760/US$2,502) and 73,831 Yuan (£14,620/US$20,796) per QALY from a public sector and societal perspective, respectively and was cost-effective using UK (£20,000) and US (US$50,000) per QALY thresholds. Conclusion: A multi-component school-based prevention programme is a cost-effective means of preventing childhood obesity in China.

Effectiveness of school-based interventions to prevent obesity among children aged 4 to 12 years old in middle-income countries: A systematic review and meta-analysis.

Economic and accompanying nutrition transition in middle-income countries is resulting in rapidly increasing childhood obesity prevalence, exceeding acceleration rates in the West. Previous school-based obesity prevention reviews have mainly included studies from high-income countries. This review aimed to summarize the evidence from randomized controlled trials evaluating the effectiveness of school-based interventions in preventing childhood obesity in middle-income countries. Six electronic databases were searched: MEDLINE, EMBASE, CINAHL Plus, LILACS, IBECS and WPRIM. Eligibility criteria included middle-income country setting, randomized/cluster-randomized controlled trials, children aged 4-12 years and school-based interventions targeting dietary intake and/or physical activity. Twenty-one cluster-randomized controlled trials, conducted in Asia (n = 10), South America (n = 4), North America (n = 4) and the Middle East (n = 3), were included. Fifteen studies reported a significant intervention effect on at least one adiposity-related outcome. Characteristics of effective interventions included combined diet and PA interventions, school teacher-delivery, duration of >8 months, parental involvement, education sessions and school food modifications. The risk of bias in these trials was mixed. The pooled estimate of the odds ratio for obesity in intervention versus control schools (nine studies) was 0.77; 95% CI, 0.63 to 0.94; p = 0.009. In conclusion, there is some evidence to support school-based interventions in preventing childhood obesity in middle-income countries.

Relationship between primary school healthy eating and physical activity promoting environments and children's dietary intake, physical activity and weight status: a longitudinal study in the West Midlands, UK.

OBJECTIVE: We aimed to examine the association between food and physical activity environments in primary schools and child anthropometric, healthy eating and physical activity measures. DESIGN: Observational longitudinal study using data from a childhood obesity prevention trial. SETTING: State primary schools in the West Midlands region, UK. PARTICIPANTS: 1392 pupils who participated in the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) childhood obesity prevention trial (2011-2015). PRIMARY AND SECONDARY OUTCOME MEASURES: School environment (exposure) was categorised according to questionnaire responses indicating their support for healthy eating and/or physical activity. Child outcome measures, undertaken at three time points (ages 5-6, 7-8 and 8-9 years), included body mass index z-scores, dietary intake (using a 24-hour food ticklist) and physical activity (using an Actiheart monitor over 5 days). Associations between school food and physical activity environment categories and outcomes were explored through multilevel models. RESULTS: Data were available for 1304 children (94% of the study sample). At age 8-9 years, children in 10 schools with healthy eating and physical activity-supportive environments had a higher physical activity energy expenditure than those in 22 schools with less supportive healthy eating/physical activity environments (mean difference=5.3 kJ/kg body weight/24 hours; p=0.05). Children in schools with supportive physical activity environments (n=8) had a lower body mass index z-score than those in schools with less supportive healthy eating/physical activity environments (n=22; mean difference=-0.17, p=0.02). School food and physical activity promoting environments were not significantly associated with dietary outcomes. CONCLUSIONS: School environments that support healthy food and physical activity behaviours may positively influence physical activity and childhood obesity. TRIAL REGISTRATION NUMBER: ISRCTN97000586.

Childhood obesity and dental caries: an ecological investigation of the shape and moderators of the association.

BACKGROUND: Despite sharing a common risk factor in dietary sugars, the association between obesity and dental caries remains unclear. We investigated the association between obesity and dental caries in young children in England in an ecological study. METHODS: We analysed data from 326 lower tier English local authorities. Data on obesity and dental caries were retrieved from 2014/15 to 2016/17 National Child Measurement Programme and 2016/17 National Dental Epidemiology Programme. We used fractional polynomial models to explore the shape of the association between obesity and dental caries. We also examined the modifying effect of deprivation, lone parenthood, ethnicity, and fluoridation. RESULTS: Best fitting second order fractional polynomial models did not provide better fit than the linear models for the association between obesity and prevalence and severity of dental caries; therefore, the linear model was found suitable. Despite significant association, after adjusting for the effect of deprivation, obesity was neither associated with prevalence (coefficient = 0.2, 95% CI - 0.71, 0.75), nor with severity (coefficient = 0.001, 95% CI - 0.03, 0.03) of dental caries. In fully adjusted models, the proportion of white ethnicity and being in fluoridated areas were associated with a decrease in dental caries. The association between obesity and dental caries was moderated by the effect of deprivation, white ethnicity, and lone parenthood. CONCLUSIONS: The association between obesity and dental caries was linear and moderated by some demographic factors. Consequently, interventions that reduce obesity and dental caries may have a greater impact on specific groups of the population.

The Food provision, cUlture and Environment in secondary schooLs (FUEL) study: protocol of a mixed methods evaluation of national School Food Standards implementation in secondary schools and their impact on pupils' dietary intake and dental health.

INTRODUCTION: Excess free sugar intake is associated with obesity and poor dental health. Adolescents consume substantially more free sugar than is recommended. National (UK) School Food Standards (SFS) are in place but are not mandatory in all schools, and their impact on the diets of secondary school pupils is unknown. We aim to evaluate how SFS and wider healthy eating recommendations (from the national School Food Plan (SFP)) are implemented in secondary schools and how they influence pupils' diets and dental health. METHODS AND ANALYSIS: Secondary-level academies/free schools in the West Midlands, UK were divided into two groups: SFS mandated and SFS non-mandated. Using propensity scores to guide sampling, we aim to recruit 22 schools in each group. We will compare data on school food provision and sales, school food culture and environment, and the food curriculum from each group, collected through: school staff, governor, pupil, parent surveys; school documents; and observation. We will explore the implementation level for the SFS requirements and SFP recommendations and develop a school food typology. We aim to recruit 1980 pupils aged 11-15 years across the 44 schools and collect dietary intake (24-hour recall) and dental health data through self-completion surveys. We will compare free sugar/other dietary intake and dental health across the two SFS groups and across the identified school types. School type will be further characterised in 4-8 case study schools through school staff interviews and pupil focus groups. Evaluation of economic impact will be through a cost-consequence analysis and an exploratory cost-utility analysis. ETHICS AND DISSEMINATION: Ethical approval was obtained from the University of Birmingham Ethical Review Committee (ERN_18-1738). Findings will be disseminated to key national and local agencies, schools and the public through reports, presentations, the media and open access publications. TRIAL REGISTRATION NUMBER: ISRCTN 68757496 (registered 17 October 2019).

Micronutrient deficiencies and health-related quality of life: the case of children with vitamin D deficiency.

OBJECTIVE: To explore the extent to which micronutrient deficiencies (MND) affect children's health-related quality of life (HRQoL), using vitamin D deficiency (VDD) as a case study. DESIGN: Proxy valuation study to estimate the impact of VDD on the HRQoL of younger (0-4 years) and older (>4 years) children. We used the Child Health Utility 9 Dimension (CHU9D) questionnaire to estimate HRQoL for children within six VDD-related health states: 'hypocalcaemic cardiomyopathy', 'hypocalcaemic seizures', 'active rickets', 'bone deformities', 'pain and muscle weakness' and 'subclinical VDD'. SETTING: Sampling was not restricted to any particular setting and worldwide experts were recruited. PARTICIPANTS: Respondents were paediatric bone experts recruited through network sampling. RESULTS: Thirty-eight experts completed the survey. The health state with the largest detrimental impact (mean score (se)) on children's HRQoL was hypocalcaemic cardiomyopathy (0·47 (0·02)), followed by hypocalcaemic seizures (0·50 (0·02)) and active rickets (0·62 (0·02) in young children; 0·57 (0·02) in older children). Asymptomatic VDD had a modest but noticeable negative impact on HRQoL, attributed mostly to tiredness in both age groups and pain in the older paediatric population. CONCLUSIONS: Elicitation of HRQoL from clinical experts suggests a negative impact of VDD on HRQoL, even if there is no recognizable clinical manifestation. HRQoL data from populations of patients with MND will inform public health policy decisions. In some settings, routine collection of HRQoL data alongside national nutrition surveys may help capture the full burden of MND and prioritize resources towards effective prevention.

Healthy Dads, Healthy Kids UK, a weight management programme for fathers: feasibility RCT.

OBJECTIVE: To assess (1) the feasibility of delivering a culturally adapted weight management programme, Healthy Dads, Healthy Kids United Kingdom (HDHK-UK), for fathers with overweight or obesity and their primary school-aged children, and (2) the feasibility of conducting a definitive randomised controlled trial (RCT). DESIGN: A two-arm, randomised feasibility trial with a mixed-methods process evaluation. SETTING: Socioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK. PARTICIPANTS: Fathers with overweight or obesity and their children aged 4-11 years. INTERVENTION: Participants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions. OUTCOMES: Feasibility of the intervention and RCT was assessed according to prespecified progression criteria: study recruitment, consent and follow-up, ability to deliver intervention, intervention fidelity, adherence and acceptability, weight loss, using questionnaires and measurements at baseline, 3 and 6 months, and through qualitative interviews. RESULTS: The study recruited 43 men, 48% of the target sample size; the mean body mass index was 30.2 kg/m2 (SD 5.1); 61% were from a minority ethnic group; and 54% were from communities in the most disadvantaged quintile for socioeconomic deprivation. Recruitment was challenging. Retention at follow-up of 3 and 6 months was 63%. Identifying delivery sites and appropriately skilled and trained programme facilitators proved difficult. Four programmes were delivered in leisure centres and community venues. Of the 29 intervention participants, 20 (69%) attended the intervention at least once, of whom 75% attended ≥5 sessions. Sessions were delivered with high fidelity. Participants rated sessions as 'good/very good' and reported lifestyle behavioural change. Weight loss at 6 months in the intervention group (n=17) was 2.9 kg (95% CI -5.1 to -0.6). CONCLUSIONS: The intervention was well received, but there were significant challenges in recruitment, programme delivery and follow-up. The HDHK-UK study was not considered feasible for progression to a full RCT based on prespecified stop-go criteria. TRIAL REGISTRATION NUMBER: ISRCTN16724454.

The CHIRPY DRAGON intervention in preventing obesity in Chinese primary-school--aged children: A cluster-randomised controlled trial.

BACKGROUND: In countries undergoing rapid economic transition such as China, rates of increase in childhood obesity exceed that in the West. However, prevention trials in these countries are inadequate in both quantity and methodological quality. In high-income countries, recent reviews have demonstrated that school-based prevention interventions are moderately effective but have some methodological limitations. To address these issues, this study evaluated clinical- and cost- effectiveness of the Chinese Primary School Children Physical Activity and Dietary Behaviour Changes Intervention (CHIRPY DRAGON) developed using the United Kingdom Medical Research Council complex intervention framework to prevent obesity in Chinese primary-school-aged children. METHODS AND FINDINGS: In this cluster-randomised controlled trial, we recruited 40 state-funded primary schools from urban districts of Guangzhou, China. A total of 1,641 year-one children with parent/guardian consent took part in baseline assessments prior to stratified randomisation of schools (intervention arm, 20 schools, n = 832, mean age = 6.15 years, 55.6% boys; control arm n = 809, mean age = 6.14 years, 53.3% boys). The 12-month intervention programme included 4 school- and family-based components delivered by 5 dedicated project staff. We promoted physical activity and healthy eating behaviours through educational and practical workshops, family activities, and supporting the school to improve physical activity and food provision. The primary outcome, assessed blind to allocation, was between-arm difference in body mass index (BMI) z score at completion of the intervention. A range of prespecified, secondary anthropometric, behavioural, and psychosocial outcomes were also measured. We estimated cost effectiveness based on quality-adjusted life years (QALYs), taking a public sector perspective. Attrition was low with 55 children lost to follow up (3.4%) and no school dropout. Implementation adherence was high. Using intention to treat analysis, the mean difference (MD) in BMI z scores (intervention - control) was -0.13 (-0.26 to 0.00, p = 0.048), with the effect being greater in girls (MD = -0.18, -0.32 to -0.05, p = 0.007, p for interaction = 0.015) and in children with overweight or obesity at baseline (MD = -0.49, -0.73 to -0.25, p < 0.001, p for interaction < 0.001). Significant beneficial intervention effects were also observed on consumption of fruit and vegetables, sugar-sweetened beverages and unhealthy snacks, screen-based sedentary behaviour, and physical activity in the intervention group. Cost effectiveness was estimated at £1,760 per QALY, with the probability of the intervention being cost effective compared with usual care being at least 95% at a willingness to pay threshold of £20,000 to 30,000 per QALY. There was no evidence of adverse effects or harms. The main limitations of this study were the use of dietary assessment tools not yet validated for Chinese children and the use of the UK value set to estimate QALYS. CONCLUSIONS: This school- and family-based obesity prevention programme was effective and highly cost effective in reducing BMI z scores in primary-school-aged children in China. Future research should identify strategies to enhance beneficial effects among boys and investigate the transferability of the intervention to other provinces in China and countries that share the same language and cultures. TRIAL REGISTRATION: ISRCTN Identifier ISRCTN11867516.

Cultural adaptation of an existing children's weight management programme: the CHANGE intervention and feasibility RCT.

BACKGROUND: Excess weight in children is a continuing health issue. Community-based children's weight management programmes have had some effect in promoting weight loss. Families from minority ethnic communities are less likely to complete these programmes but, to date, no programmes have been culturally adapted to address this. OBJECTIVES: We aimed to (1) culturally adapt an existing weight management programme for children aged 4-11 years and their families to make it more suited to Pakistani and Bangladeshi communities but inclusive of all families and (2) evaluate the adapted programme to assess its feasibility and acceptability, as well as the feasibility of methods, for a future full-scale trial. DESIGN: In phase I, a cultural adaptation of a programme that was informed by formative research and guided by two theoretical frameworks was undertaken and in phase II this adapted programme was delivered in a cluster-randomised feasibility study (for which the clusters were the standard and adapted children's weight management programmes). SETTING: Birmingham: a large, ethnically diverse UK city. PARTICIPANTS: In phase I, Pakistani and Bangladeshi parents of children with excess weight, and, in phase II, children aged 4-11 years who have excess weight and their families. INTERVENTIONS: A culturally adapted children's weight management programme, comprising six sessions, which was delivered to children and parents, targeting diet and physical activity and incorporating behaviour change techniques, was developed in phase I and delivered in the intervention arm to 16 groups in phase II. The eight groups in the comparator arm received the standard (unadapted) children's weight management programme. MAIN OUTCOME MEASURES: The primary outcome was the proportion of Pakistani and Bangladeshi families completing (attending ≥ 60% of) the adapted programme. Secondary outcomes included the proportion of all families completing the adapted programme, the feasibility of delivery of the programme, the programme's acceptability to participants, the feasibility of trial processes and the feasibility of collection of outcome and cost data. RESULTS: The proportion of Pakistani and Bangladeshi families and all families completing the adapted programme was 78.8% [95% confidence interval (CI) 64.8% to 88.2%] and 76.3% (95% CI 67.0% to 83.6%), respectively. The programme was feasible to deliver with some refinements and was well received. Ninety-two families participated in outcome data collection. Data collection was mostly feasible, but participant burden was high. Data collection on the cost of programme delivery was feasible, but costs to families were more challenging to capture. There was high attrition over the 6-month follow-up period (35%) and differential attrition in the two study arms (29% and 52% in the intervention and comparator arms, respectively). LIMITATIONS: The study was not designed to address the issue of low participant uptake of children's weight management programmes. The design of a future trial may include individual randomisation and a 'minimal intervention' arm, the acceptability of which has not been evaluated in this study. CONCLUSIONS: The theoretically informed, culturally adapted children's weight management programme was highly acceptable to children and families of all ethnicities. Consideration should be given to a future trial to evaluate clinical effectiveness and cost-effectiveness of the adapted programme, but the design of a future trial would need to address the logistics of data collection, participant burden and study attrition. TRIAL REGISTRATION: Current Controlled Trials ISRCTN81798055. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 33. See the NIHR Journals Library website for further project information. Kate Jolly is part-funded by the Collaboration for Leadership in Applied Health Research and Care West Midlands.

Many programmes have been designed for children with excess weight and their families to help them try and lose weight. Often families start going to these programmes but do not complete them. This has been noted to be an issue in families from ethnic minority communities. We aimed to adapt an existing programme for families of primary school children with excess weight to make it more suitable for Pakistani and Bangladeshi families. We asked parents from these communities who had experience of the existing programme what they thought about it and what they would like to change. We used this information to help us adapt the existing programme. We also aimed to make the programme acceptable to families of all ethnicities. We then aimed to (1) test delivery of the adapted programme, (2) see whether or not it was acceptable to Pakistani and Bangladeshi families and families of other ethnicities and (3) test methods to be used in a future research study to determine whether or not the adapted programme helps children to lose weight and provides value for money. We asked parents and children who attended and the staff delivering the new programme for their views. A panel of Pakistani and Bangladeshi parents helped us to plan our study methods. The programme was successfully delivered and the parents, children and staff all enjoyed it. Overall, 76% of families from all ethnic backgrounds who started attending the programme completed it. This was substantially higher than the 58% of families who completed the standard (unadapted) programme. We identified several issues that we would need to take into account when designing a future study. These include making sure that the families taking part are not overburdened and that we take steps to make sure that as many families as possible are followed up until the end of the study.

Economic evaluation of a childhood obesity prevention programme for children: Results from the WAVES cluster randomised controlled trial conducted in schools.

BACKGROUND: Childhood obesity is a serious public health challenge and schools have been identified as an ideal place to implement prevention interventions. The aim of this study was to measure the cost-effectiveness of a multi-faceted school-based obesity prevention intervention targeting children aged 6-7 years when compared to 'usual activities'. METHODS: A cluster randomised controlled trial in 54 schools across the West Midlands (UK) was conducted. The 12-month intervention aimed to increase physical activity by 30 minutes per day and encourage healthy eating. Costs were captured from a public sector perspective and utility-based health related outcomes measured using the CHU-9D. Multiple imputation using chained equations was used to address missing data. The cost effectiveness was measured at 30 months from baseline using a hierarchical net-benefit regression framework, that controlled for clustering and prespecified covariates. Any uncertainty in the results was characterised using cost-effectiveness acceptability curves. RESULTS: At 30 months, the total adjusted incremental mean cost of the intervention was £155 (95% confidence interval [CI]: £139, £171), and the incremental mean QALYs gained was 0.006 (95% CI: -0.024, 0.036), per child. The incremental cost-effectiveness at 30 months was £26,815 per QALY and using a standard willingness to pay threshold of £30,000 per QALY, there was a 52% chance that the intervention was cost-effective. CONCLUSIONS: The cost-effectiveness of the school-based WAVES intervention was subject to substantial uncertainty. We therefore recommend more research to explore obesity prevention within schools as part of a wider systems approach to obesity prevention. TRIAL REGISTRATION: This paper uses data collected by the WAVES trial: Controlled trials ISRCTN97000586 (registered May 2010).

Cultural adaptation of a children's weight management programme: Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study.

BACKGROUND: Childhood obesity prevalence continues to be at high levels in the United Kingdom (UK). South Asian children (mainly Pakistani and Bangladeshi origin) with excess adiposity are at particular risk from the cardiovascular consequences of obesity. Many community-based children's weight management programmes have been delivered in the UK, but none have been adapted for diverse cultural communities. The aim of the Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study, was to culturally adapt an existing children's weight management programme for children aged 4-11 years so that the programme was more able to meet the needs of families from South Asian communities. METHODS: The adaptation process was applied to First Steps, an evidence informed programme being delivered in Birmingham (a large, ethnically diverse city). A qualitative study was undertaken to obtain the views of South Asian parents of children with excess weight, who had fully or partially attended, or who had initially agreed but then declined to attend the First Steps programme. The resulting data were integrated with current research evidence and local programme information as part of a cultural adaptation process that was guided by two theoretical frameworks. RESULTS: Interviews or focus groups with 31 parents in their preferred languages were undertaken. Themes arising from the data included the need for convenient timing of a programme in a close familiar location, support for those who do not speak English, the need to focus on health rather than weight, nutritional content that focuses on traditional and Western diets, more physical activity content, and support with parenting skills. The data were mapped to the Behaviour Change Wheel framework and Typology of Cultural Adaptation to develop an intervention programme outline. The research evidence and local programme information was then used in the detailed planning of the programme sessions. CONCLUSIONS: The process of cultural adaptation of an existing children's weight management programme resulted in a theoretically underpinned programme that is culturally adapted at both the surface and deep structural levels. TRIAL REGISTRATION: ISRCTN81798055 , registered: 13/05/2014.

Effectiveness of a brief behavioural intervention to prevent weight gain over the Christmas holiday period: randomised controlled trial.

OBJECTIVE: To test the effectiveness of a brief behavioural intervention to prevent weight gain over the Christmas holiday period. DESIGN: Two group, double blinded randomised controlled trial. SETTING: Recruitment from workplaces, social media platforms, and schools pre-Christmas 2016 and 2017 in Birmingham, UK. PARTICIPANTS: 272 adults aged 18 years or more with a body mass index of 20 or more: 136 were randomised to a brief behavioural intervention and 136 to a leaflet on healthy living (comparator). Baseline assessments were conducted in November and December with follow-up assessments in January and February (4-8 weeks after baseline). INTERVENTIONS: The intervention aimed to increase restraint of eating and drinking through regular self weighing and recording of weight and reflection on weight trajectory; providing information on good weight management strategies over the Christmas period; and pictorial information on the physical activity calorie equivalent (PACE) of regularly consumed festive foods and drinks. The goal was to gain no more than 0.5 kg of baseline weight. The comparator group received a leaflet on healthy living. MAIN OUTCOME MEASURES: The primary outcome was weight at follow-up. The primary analysis compared weight at follow-up between the intervention and comparator arms, adjusting for baseline weight and the stratification variable of attendance at a commercial weight loss programme. Secondary outcomes (recorded at follow-up) were: weight gain of 0.5 kg or less, self reported frequency of self weighing (at least twice weekly versus less than twice weekly), percentage body fat, and cognitive restraint of eating, emotional eating, and uncontrolled eating. RESULTS: Mean weight change was -0.13 kg (95% confidence interval -0.4 to 0.15) in the intervention group and 0.37 kg (0.12 to 0.62) in the comparator group. The adjusted mean difference in weight (intervention-comparator) was -0.49 kg (95% confidence interval -0.85 to -0.13, P=0.008). The odds ratio for gaining no more than 0.5 kg was non-significant (1.22, 95% confidence interval 0.74 to 2.00, P=0.44). CONCLUSION: A brief behavioural intervention involving regular self weighing, weight management advice, and information about the amount of physical activity required to expend the calories in festive foods and drinks prevented weight gain over the Christmas holiday period. TRIAL REGISTRATION: ISRCTN Registry ISRCTN15071781.