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.

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.

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 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 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.

How does age affect the relationship between weight and health utility during the middle years of childhood?

PURPOSE: The limited literature examining weight status and preference-based health-related quality of life (HRQL) in young children is equivocal. This study aims to examine how the association between weight status and preference-based HRQL changes as children develop between the ages of 6 and 10 years old. METHODS: The Child Health Utility 9D (CHU-9D) was used to determine preference-based HRQL. Height and weight data were also collected and used to calculate z-BMI adjusted for age and gender. 1467 children were recruited from 54 schools across the West Midlands. Data were collected at four time points over 5 years. Impact of weight on dimensions of HRQL was assessed via the distribution of responses to CHU-9D dimensions by weight status. Multi-level regression analysis controlling for ethnicity, deprivation and other relevant co-variates was conducted to examine the relationship between weight and HRQL. RESULTS: There was no evidence to suggest that the weight status impacted upon the distribution of responses to CHU-9D dimensions. Correspondingly, the multi-level regression analysis found no statistically significant differences in CHU-9D scores between underweight, healthy weight, overweight and obese children. CONCLUSIONS: The evidence surrounding the link between preference-based HRQL and weight status in children is limited. This study found no association between weight status and HRQL as measured by the CHU-9D in children between the ages of 5 and 10 years in the UK. Given this, it is recommended that future studies aiming to prevent obesity in children in their middle years do not rely solely on preference-based measures for economic evaluation, and instead focus on capturing clinical or wellbeing outcomes.

Prevalence of adiposity and its association with sleep duration, quality, and timing among 9-12-year-old children in Guangzhou, China.

BACKGROUND: Short sleep duration has been reported to be associated with obesity in children, but findings are not consistent. Since few studies have examined the relationship between more complex sleep characteristics and obesity, we examined the association between adiposity and self-reported sleep duration, bedtime, and sleep quality in 9-12-year-old Chinese children using multilevel mixed models. METHODS: 5518 children aged 9-12 years were recruited from 29 randomly selected primary schools in Guangzhou, China in 2014. Standardized questionnaires were used to obtain data to estimate sleep duration on typical weekdays and weekends. Sleep quality data were collected using the Children's Sleep Habits Questionnaire (CSHQ). Trained researchers undertook measurements of weight, height, and waist circumference (WC) for all participating children. Body mass index (BMI) z-scores were derived using the World Health Organization (WHO) child growth reference, and children were classified as overweight or obese using +1 and +2 SD as cut-offs, respectively. Percentage body fat (BF%) was calculated using bioelectrical impedance. RESULTS: Longer sleep duration was inversely associated with BMI z-score (ß = -0.16, p < 0.05), WC (ß = -1.11, p < 0.05) and later bedtime was associated with higher BMI z-score (ß = 0.03, p < 0.05), WC (ß = 1.72, p < 0.001), and BF% (ß = 0.15, p < 0.05) in multivariable multilevel mixed models, after adjustment for age, gender, physical activity, parental education level, and average monthly income. No association was seen between sleep quality and adiposity. CONCLUSION: Shorter sleep duration and later bedtime are associated with higher adiposity indices in early adolescents from southern China.

Preventing vitamin D deficiency (VDD): a systematic review of economic evaluations.

Background: Vitamin D deficiency (VDD) is a public health concern worldwide. If untreated, it can lead to reduced quality of life and escalated costs brought about by ill-health. Preventive programmes to improve population vitamin D status exist but little is known about their cost-effectiveness. This information is vital so that decision-makers adopt efficient strategies and optimise use of public resources. Aims: Systematically review and critically appraise economic evaluations of population strategies to prevent VDD. Methods: The databases reviewed were MEDLINE, EMBASE, Econlit, NHS EED, CEA, and RepEc. All full economic evaluations of VDD prevention strategies were included. Interventions considered were food fortification, supplementation and public health campaigns. Data extracted included type of evaluation, population, setting, measure of benefit and main results. Results: Of the 2492 records screened, 14 studies were included. The majority of studies focused on supplementation within at-risk groups with the primary objective of either preventing fractures or falls in older adults. There was insufficient economic evidence to draw conclusions about the cost-effectiveness of population strategies. No study was identified that offered a direct comparison of the two main alternative population strategies: food fortification vs. supplementation. Conclusions: Whilst there is a growing body of evidence on the cost-effectiveness of micro nutrient programmes, there is a paucity of data on vitamin D fortification and how fortification programmes compare to population supplementation programmes. We highlight research gaps, and offer suggestions of what is required to undertake population-based cost-effectiveness analysis.

Relationship between weight status and health-related quality of life in Chinese primary school children in Guangzhou: a cross-sectional study.

BACKGROUND: To investigate the association between weight status and health-related quality of life (HRQOL) among pupils in Guangzhou, China. METHODS: The study comprised 5781 children aged 8-12 years from 29 schools. Height and weight were objectively measured using standardized methods, and BMI z-score derived using the age and sex specific WHO reference 2007 for 5-19 years. Weight status was classified as underweight (<-2SD), healthy weight (between -2SD and 1SD), overweight/obesity (>1SD). HRQOL was measured by the self-report version of the Pediatric Quality of Life Inventory 4.0. RESULTS: After controlling for gender, age, school type, parental education, and family income, HRQOL scores were significantly lower in overweight/obese compared with healthy weight children only in the social functioning domain (ß = -1.93, p = 0.001). Compared with healthy weight children, underweight children had significantly lower total (ß = -1.47, p = 0.05) and physical summary scores (ß = -2.18, p = 0.02). Subgroup analysis for gender indicated that compared to healthy weight, total (ß = -1.96, p = 0.02), psychosocial (ß = -2.40, p = 0.01), social functioning (ß = -3.36, p = 0.001), and school functioning (ß = -2.19, p = 0.03) scores were lower in overweight/obese girls, but not boys. On the other hand, being underweight was associated with lower physical functioning (ß = -2.27, p = 0.047) in girls, and lower social functioning (ß = -3.63, p = 0.01) in boys. The associations were mainly observed in children aged 10 and over, but were not significant in younger children. Children from private schools had generally lower HRQOL compared to those in public schools, but the associations with weight status were similar in both groups. CONCLUSIONS: The relationship between overweight/obesity and HRQOL in children in China is not as prominent as that seen in children in western or high-income countries. However, there appears to be gender and age differences, with more of an impact of overweight on HRQOL in girls and older children compared with boys and younger children. Underweight is also associated with lower HRQOL. Future intervention to prevent both obesity and undernutrition may have a positive impact on the HRQOL in children in China.

Socioeconomic determinants of childhood obesity among primary school children in Guangzhou, China.

BACKGROUND: Socioeconomic inequalities in childhood obesity prevalence differ according to a country's stage of nutrition transition. The aim of this study was to determine which socioeconomic factors influence inequalities in obesity prevalence in Chinese primary school children living in an urban setting. METHODS: We assessed obesity prevalence among 9917 children aged 5-12 years from a stratified random sample of 29 state-funded (residents) and private (migrants) schools in Guangzhou, China. Height and weight were objectively measured using standardised methods and overweight (+1 SD < BMI-for-age z-score ≤ +2 SD) and obesity (BMI-for-age z-score > +2 SD) were defined using the World Health Organisation reference 2007. Socioeconomic characteristics were ascertained through parental questionnaires. Generalised Linear Mixed Models with schools as a random effect were used to compare likelihood of overweight/obesity among children in private, with public schools, adjusting for child age and sex, maternal and paternal BMI and education level, and household per-capita income. RESULTS: The prevalence of overweight/obesity was 20.0 % (95 % CI 19.1 %-20.9 %) in resident compared with 14.3 % (95 % CI 13.0 %-15.4 %) in migrant children. In the adjusted model, the odds of overweight/obesity remained higher among resident children (OR 1.36; 1.16-1.59), was higher in boys compared with girls (OR 2.56; 2.24-2.93), and increased with increasing age (OR 2.78; 1.95-3.97 in 11-12 vs 5-6 year olds), per-capita household income (OR 1.27; 1.01-1.59 in highest vs lowest quartile) and maternal education (OR 1.51; 1.16-1.97 in highest vs lowest). Socioeconomic differences were most marked in older boys, and were only statistically significant in resident children. CONCLUSIONS: The socioeconomic gradient for childhood obesity in China is the reverse of the patterns seen in countries at more advanced stages of the obesity epidemic. This presents an opportunity to intervene and prevent the onset of social inequalities that are likely to ensue with further economic development. The marked gender inequality in obesity needs further exploration.

Parent and child perceptions of school-based obesity prevention in England: a qualitative study.

BACKGROUND: Schools are key settings for childhood obesity prevention, and the location for many intervention studies. This qualitative study aims to explore parent and child experiences of the WAVES study obesity prevention intervention, in order to gain understanding of the mechanisms by which the intervention results in behaviour change, and provide context to support interpretation of the main trial results. METHODS: Focus groups were held with 30 parents and 62 children (aged 6-7 years) from primary schools in the West Midlands, UK. Data analysis (conducted using NVivo 10) was guided by the Framework Approach. RESULTS: Three over-arching themes were identified: 'Impact', 'Sustainability' and 'Responsibilities', under which sub-themes were determined. Participants were supportive of the school-based intervention. Parental involvement and the influential role of the teacher were seen as key ingredients for success in promoting consistent messages and empowering some parents to make positive behavioural changes at home. Parents recognised that whilst they held the primary responsibility for obesity prevention in their children, they faced a number of barriers to healthier lifestyles, and agreed that schools have an important role to play. CONCLUSIONS: This study enabled us to better understand aspects of the WAVES study intervention programme that have the potential to initiate positive behaviour changes in families, and indicated that a combination of pathways influenced such changes. Pathways included: increasing capability through improving knowledge and skills of children and parents; increasing motivation through parental empowerment and role modelling; and the direct provision of opportunities to lead healthier lifestyles. Strategies to sustain behaviour changes, and the school role in supporting these, are important considerations.

A cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6-7 year old children: the WAVES study protocol.

BACKGROUND: There is some evidence that school-based interventions are effective in preventing childhood obesity. However, longer term outcomes, equity of effects and cost-effectiveness of interventions have not been assessed. The aim of this trial is to assess the clinical and cost-effectiveness of a multi-component intervention programme targeting the school and family environment through primary schools, in preventing obesity in 6-7 year old children, compared to usual practice. METHODS: This cluster randomised controlled trial is set in 54 primary schools within the West Midlands, UK, including a multi-ethnic, socioeconomically diverse population of children aged 6-7 years. The 12-month intervention consists of healthy diet and physical activity promotion. These include: activities to increase time spent doing physical activity within the school day, participation in the 'Villa Vitality' programme (a programme that is delivered by an iconic sporting institution (Aston Villa Football Club), which provides interactive learning opportunities for physical activity and healthy eating), healthy cooking skills workshops in school time for parents and children, and provision of information to families signposting local leisure opportunities. The primary (clinical) outcome is the difference in body mass index (BMI) z-scores between arms at 3 and 18 months post-intervention completion. Cost per Quality Adjusted Life Year (QALY) will also be assessed. The sample size estimate (1000 children split across 50 schools at follow-up) is based on 90% power to detect differences in BMI z-score of 0.25 (estimated ICC ≤ 0.04), assuming a correlation between baseline and follow-up BMI z-score of 0.9. Treatment effects will be examined using mixed model ANCOVA. Primary analysis will adjust for baseline BMI z-score, and secondary analysis will adjust for pre-specified baseline school and child level covariates. DISCUSSION: The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study is the first trial that will examine the cost-effectiveness and long term outcomes of a childhood obesity prevention programme in a multi-ethnic population, with a sufficient sample size to detect clinically important differences in adiposity. The intervention was developed using the Medical Research Council framework for complex interventions, and outcomes are measured objectively, together with a comprehensive process evaluation. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586 (registered May 2010).

Is utility-based quality of life associated with overweight in children? Evidence from the UK WAVES randomised controlled study.

BACKGROUND: Quality-Adjusted Life Years (QALYs) are often used to make judgements about the relative cost-effectiveness of competing interventions and require an understanding of the relationship between health and health-related quality of life (HRQOL) when measured in utility terms. There is a dearth of information in the literature concerning how childhood overweight is associated with quality of life when this is measured using utilities. This study explores how weight is associated with utility-based HRQOL in 5-6 year olds and examines the psychometric properties of a newly developed pediatric utility measure - the CHU9D instrument. METHODS: Weight and HRQOL were examined using data collected from 1334 children recruited within a UK randomised controlled trial (WAVES) (ISRCTN97000586). Utility-based HRQOL was measured using the CHU9D, and general HRQOL measured using the PedsQL instrument. The association between weight and HRQOL was examined through a series of descriptive and multivariate analysis. The construct validity of the CHU9D was further assessed in relation to weight status, in direct comparison to the PedsQL instrument. RESULTS: The HRQOL of children who were either overweight or obese was not statistically different from children who were healthy or underweight. This result was the same for when HRQOL was measured in utility terms using the CHU9D instrument, and in general terms using the PedsQL instrument. Furthermore, the results support the construct validity of the newly developed CHU9D as the PedsQL total HRQOL scores corresponded well with the individual CHU9D dimensions. CONCLUSION: At age 5-6 years, the inverse association between overweight and HRQOL is not being captured by either the utility-based CHU9D instrument nor the PedsQL instrument. This result has implications for how the cost-effectiveness of childhood obesity interventions is measured in children aged 5-6 years. TRIAL REGISTRATION: ISRCTN Registry: ISRCTN97000586 19(th) May 2010.

Process evaluation design in a cluster randomised controlled childhood obesity prevention trial: the WAVES study.

BACKGROUND: The implementation of a complex intervention is heavily influenced by individual context. Variation in implementation and tailoring of the intervention to the particular context will occur, even in a trial setting. It is recognised that in trials, evaluating the process of implementation of a complex intervention is important, yet process evaluation methods are rarely reported. The WAVES study is a cluster randomised controlled trial to evaluate the effectiveness of an obesity prevention intervention programme targeting children aged 6-7 years, delivered by teachers in primary schools across the West Midlands, UK. The intervention promoted activities encouraging physical activity and healthy eating. This paper presents the methods used to assess implementation of the intervention. METHODS: Previous literature was used to identify the dimensions of intervention process and implementation to be assessed, including adherence, exposure, quality of delivery, participant responsiveness, context, and programme differentiation. RESULTS: Multiple methods and tools were developed to capture information on all these dimensions. These included observations, logbooks, qualitative evaluation, questionnaires and research team reflection. DISCUSSION: Data collection posed several challenges, predominantly when relying on teachers to complete paperwork, which they saw as burdensome on top of their teaching responsibilities. However, the use of multiple methods helped to ensure data on each dimension, where possible, was collected using more than one method. This also allowed for triangulation of the findings when several data sources on any one dimension were available. CONCLUSIONS: We have reported a comprehensive approach to the assessment of the implementation and processes of a complex childhood obesity prevention intervention within a cluster randomised controlled trial. These approaches can be transferred and adapted for use in other complex intervention trials. TRIAL REGISTRATION NUMBER: ISRCTN97000586.

Cost-effectiveness of a community-based physical activity programme for adults (Be Active) in the UK: an economic analysis within a natural experiment.

OBJECTIVE: To determine the cost-effectiveness of a physical activity programme (Be Active) aimed at city-dwelling adults living in Birmingham, UK. METHODS: Very little is known about the cost-effectiveness of public health programmes to improve city-wide physical activity rates. This paper presents a cost-effectiveness analysis that compares a physical activity intervention (Be Active) with no intervention (usual care) using an economic model to quantify the reduction in disease risk over a lifetime. Metabolic equivalent minutes achieved per week, quality-adjusted life years (QALYs) gained and healthcare costs were all included as the main outcome measures in the model. A cost-benefit analysis was also conducted using 'willingness-to-pay' as a measure of value. RESULTS: Under base-case assumptions-that is, assuming that the benefits of increased physical activity are sustained over 5 years, participation in the Be Active programme increased quality-adjusted life expectancy by 0.06 years, at an expected discounted cost of £3552, and thus the cost-effectiveness of Be Active is £400 per QALY. When the start-up costs of the programme are removed from the economic model, the cost-effectiveness is further improved to £16 per QALY. The societal value placed on the Be Active programme was greater than the operation cost therefore the Be Active physical activity intervention results in a net benefit to society. CONCLUSIONS: Participation in Be Active appeared to be cost-effective and cost-beneficial. These results support the use of Be Active as part of a public health programme to improve physical activity levels within the Birmingham-wide population.

Tracking changes in weight status in primary school children in Birmingham: an analysis of the National Child Measurement Programme - a retrospective cohort study.

One-in-four 4-5 years and more than one-in-three 10-11 years have excess weight in England. AIM: To identify characteristics associated with (1) having overweight, obesity and severe obesity at 11 years and (2) rapid weight gain (defined as increasing weight status by one or more body mass index (BMI) categories) between the ages of 4-5 and 10-11 years. METHOD: Using National Child Measurement Programme data, BMI at reception (4-5 years) and year 6 (10-11 years) were linked for 15 390 children. Weight categories were identified at both time points using BMI centile classifications.For each child, the number of BMI categories they crossed between reception and year 6 was identified. Logistic regression models were fitted to explore associations with sociodemographic characteristics of children with excess weight at age 10-11 years and with children experiencing rapid weight gain between reception and year 6. RESULTS: Overall, 61.9% of children remained in their original weight category; 30% whose weight increased by ≥1 weight categories and 11.7% by ≥2 weight categories. Only 7.8% had decreased ≥1 weight categories and 0.9% had decreased ≥2 weight categories.Adjusting for other sociodemographic characteristics, girls were less likely than boys to increase ≥2 weight categories between reception and year 6 (OR 0.64; 95% CI 0.58 to 0.71; p<0.001). Compared to white children, Asian and mixed-ethnicity children had higher odds of rapid weight gain. Children with the highest deprivation were over 6 times more likely to increase ≥2 weight categories between reception and year 6 compared with children with the lowest deprivation (OR 6.1; 95% CI 1.92 to 19.10; p<0.01). CONCLUSION: Male children, children of Asian and mixed ethnicity and children with high deprivation are at higher risk of rapid weight gain and should be targeted for intervention.

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.

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.

Development of a childhood obesity prevention programme with a focus on UK South Asian communities.

OBJECTIVE: We report the development of a childhood obesity prevention intervention for UK South Asian primary school-aged children, guided by the UK Medical Research Council (MRC) framework for complex intervention development and evaluation. METHODS: We combined information gained from a literature review, stakeholder focus groups, an expert group, review of local resources and mapping to the Analysis Grid for Environments Linked to Obesity (ANGELO framework) in an intervention development process. The study took place in 2007 in Birmingham, UK. RESULTS: Contextual information from the stakeholder focus groups was essential for informing intervention development. The expert group defined guiding principles for the intervention. Informing intervention design by assessing existing local resources addressed intervention sustainability. The use of the ANGELO framework ensured a comprehensive environmental approach to intervention development. The intervention consisted of two broad processes; increasing children's physical activity levels through school, and increasing skills of families through activity-based learning. The developed intervention is being evaluated in a major study. CONCLUSIONS: The intervention development process has resulted in a tailored intervention programme to prevent childhood obesity in UK South Asian communities, but also intervention processes that could be applied to other communities and tailored to local context.

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.