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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.

ObjectiveTo 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).DesignA two-arm, randomised feasibility trial with a mixed-methods process evaluation.SettingSocioeconomically disadvantaged, ethnically diverse localities in West Midlands, UK.ParticipantsFathers with overweight or obesity and their children aged 4–11 years.InterventionParticipants were randomised in a 1:2 ratio to control (family voucher for a leisure centre) or intervention comprising 9 weekly healthy lifestyle group sessions.OutcomesFeasibility 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.ResultsThe 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).ConclusionsThe 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.

Background Community-based programmes for children with excess weight are widely available, but few have been developed to meet the needs of culturally diverse populations. We adapted an existing children’s weight management programme, focusing on Pakistani and Bangladeshi communities. We report the evaluation of this programme to assess feasibility of programme delivery, acceptability of the programme to participants from diverse communities, and feasibility of methods to inform a future trial. Methods A cluster-randomised feasibility trial was undertaken in a large UK city. Children’s weight management programmes ( n  = 24) were randomised to be delivered as the adapted or the standard programme (2:1 ratio). Routine data on participant attendance ( n  = 243) at the sessions were used to estimate the proportion of families completing the adapted and standard programmes (to indicate programme acceptability). Families planning to attend the programmes were recruited to participate in the feasibility study ( n  = 92). Outcome data were collected from children and parents at baseline, end of programme, and 6 months post-programme. A subsample ( n  = 24) of those attending the adapted programme participated in interviews to gain their views of the content and delivery and assess programme acceptability. Feasibility of programme delivery was assessed through observation and consultation with facilitators, and data on costs were collected. Results The proportion of Pakistani and Bangladeshi families and families of all ethnicities completing the adapted programme was similar: 78.8% (95% CI 64.8–88.2%) and 76.3% (95% CI 67.0–83.6%) respectively. OR for completion of adapted vs. standard programme was 2.40 (95% CI 1.32–4.34, p  = 0.004). The programme was feasible to deliver with some refinements, and participant interview data showed that the programme was well received. Study participant recruitment was successful, but attrition was high (35% at 6 months). Data collection was mostly feasible, but participant burden was high. Data collection on cost of programme delivery was feasible, but costs to families were more challenging to capture. Conclusions This culturally adapted programme was feasible to deliver and highly acceptable to participants, with increased completion rates compared with the standard programme. Consideration should be given to a future trial to evaluate its clinical and cost-effectiveness. Trial registration ISRCTN81798055 , registered: 13/05/2014

BackgroundThere is limited evidence that nutritional labelling on food/drinks is changing eating behaviours. Physical activity calorie equivalent (PACE) food labelling aims to provide the public with information about the amount of physical activity required to expend the number of kilocalories in food/drinks (eg, calories in this pizza requires 45 min of running to burn), to encourage healthier food choices and reduce disease.ObjectiveWe aimed to systematically search for randomised controlled trials and experimental studies of the effects of PACE food labelling on the selection, purchase or consumption of food/drinks.MethodsPACE food labelling was compared with any other type of food labelling or no labelling (comparator). Reports were identified by searching electronic databases, websites and social media platforms. Inverse variance meta-analysis was used to summarise evidence. Weighted mean differences (WMD) and 95% CIs were used to describe between-group differences using a random effects model.Results15 studies were eligible for inclusion. When PACE labelling was displayed on food/drinks and menus, significantly fewer calories were selected, relative to comparator labelling (WMD=−64.9 kcal, 95% CI −103.2 to −26.6, p=0.009, n=4606). Presenting participants with PACE food labelling results in the consumption of significantly fewer calories (WMD=−80.4 kcal, 95% CI−136.7 to −24.2, p=0.005, n=486) relative to comparator food labelling.ConclusionBased on current evidence PACE food labelling may reduce the number of kilocalories selected from menus and decrease the number of kilocalories/grams of food consumed by the public, compared with other types of food labelling/no labelling.Trial registration numberCRD42018088567.

AbstractObjectiveTo assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity.DesignCluster randomised controlled trial.SettingUK primary schools from the West Midlands.Participants200 schools were randomly selected from all state run primary schools within 35 miles of the study centre (n=980), oversampling those with high minority ethnic populations. These schools were randomly ordered and sequentially invited to participate. 144 eligible schools were approached to achieve the target recruitment of 54 schools. After baseline measurements 1467 year 1 pupils aged 5 and 6 years (control: 28 schools, 778 pupils) were randomised, using a blocked balancing algorithm. 53 schools remained in the trial and data on 1287 (87.7%) and 1169 (79.7%) pupils were available at first follow-up (15 month) and second follow-up (30 month), respectively.InterventionsThe 12 month intervention encouraged healthy eating and physical activity, including a daily additional 30 minute school time physical activity opportunity, a six week interactive skill based programme in conjunction with Aston Villa football club, signposting of local family physical activity opportunities through mail-outs every six months, and termly school led family workshops on healthy cooking skills.Main outcome measuresThe protocol defined primary outcomes, assessed blind to allocation, were between arm difference in body mass index (BMI) z score at 15 and 30 months. Secondary outcomes were further anthropometric, dietary, physical activity, and psychological measurements, and difference in BMI z score at 39 months in a subset.ResultsData for primary outcome analyses were: baseline, 54 schools: 1392 pupils (732 controls); first follow-up (15 months post-baseline), 53 schools: 1249 pupils (675 controls); second follow-up (30 months post-baseline), 53 schools: 1145 pupils (621 controls). The mean BMI z score was non-significantly lower in the intervention arm compared with the control arm at 15 months (mean difference −0.075 (95% confidence interval −0.183 to 0.033, P=0.18) in the baseline adjusted models. At 30 months the mean difference was −0.027 (−0.137 to 0.083, P=0.63). There was no statistically significant difference between groups for other anthropometric, dietary, physical activity, or psychological measurements (including assessment of harm).ConclusionsThe primary analyses suggest that this experiential focused intervention had no statistically significant effect on BMI z score or on preventing childhood obesity. Schools are unlikely to impact on the childhood obesity epidemic by incorporating such interventions without wider support across multiple sectors and environments.Trial registrationCurrent Controlled Trials ISRCTN97000586.

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'. 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. 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. 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. This paper uses data collected by the WAVES trial: Controlled trials ISRCTN97000586 (registered May 2010).

Background In response to a resurgence of symptomatic cases of vitamin D deficiency in a high-risk predominantly ethnic minority population, a programme of universal rather than targeted vitamin D supplementation was begun with a public awareness campaign about the importance of vitamin D. Objective To evaluate the effectiveness of this programme in reducing case numbers. Methods Cases of symptomatic vitamin D deficiency in children under 5 years resident in a primary care trust catchment area presenting at local hospitals were identified through laboratory records of low vitamin D levels which were cross-checked against medical records to confirm the diagnosis. Comparisons were made of the case incidence rate, level of public knowledge and vitamin supplement uptake rate at the onset of the programme in 2005 and 4 years later. Results The number of cases of symptomatic vitamin D deficiency in those under 5 years fell by 59% (case incidence rate falling from 120/100 000 to 49/100 000) despite the supplement uptake rate rising only to 17%. Public awareness of vitamin D deficiency rose to near universal levels. Conclusions A programme of universal rather than targeted Healthy Start vitamin D supplementation for pregnant and lactating women and young children has led to a substantial decrease in cases of symptomatic vitamin D deficiency in a high-risk population. Supplementation was also started at a younger age than in the national programme. This approach has implications for the delivery of vitamin D supplementation programmes in similar populations.

Background Increasing prevalence of childhood obesity and its related consequences emphasises the importance of developing and evaluating interventions aimed at prevention. The importance of process evaluation in health intervention research is increasingly recognised, assessing implementation and participant response, and how these may relate to intervention success or failure. A comprehensive process evaluation was designed and undertaken for the West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study that tested the effectiveness of an obesity prevention programme for children aged 6-7 years, delivered in 24 UK schools. The four intervention components were: additional daily school-time physical activity (PA); cooking workshops for children and parents; Villa Vitality (VV), a 6-week healthy lifestyle promotion programme run by a local football club; and signposting to local PA opportunities. Methods Data relating to six dimensions (Fidelity, Reach, Recruitment, Quality, Participant Responsiveness, Context) were collected via questionnaires, logbooks, direct observations, focus groups and interviews. Multiple data collection methods allowed for data triangulation and validation of methods, comparing research observations with teacher records. The 6-stage WAVES study model ((i) Data collection, (ii) Collation, (iii) Tabulation, (iv) Score allocation and discussion, (v) Consultation, (vi) Final score allocation) was developed to guide the collection, assimilation and analysis of process evaluation data. Two researchers independently allocated school scores on a 5-point Likert scale for each process evaluation dimension. Researchers then discussed school score allocations and reached a consensus. Schools were ranked by total score, and grouped to reflect low, medium or high intervention implementation. Results The intervention was predominantly well-implemented and well-received by teachers, parents and children. The PA component was identified as the most challenging, VV the least. Median implementation score across schools was 56/75 (IQR, 51.0 - 60.8). Agreement between teacher logbooks and researcher observations was generally high, the main discrepancies occurred in session duration reporting where in some cases teachers’ estimations tended to be higher than researchers’. Conclusions The WAVES study model provides a rigorous and replicable approach to undertaking and analysing a multi-component process evaluation. Challenges to implementing school-based obesity prevention interventions have been identified which can be used to inform future trials. Trial registration ISRCTN97000586 . 19 May 2010.

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).

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