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.

Life in lockdown: a qualitative study exploring the experience of living through the initial COVID-19 lockdown in the UK and its impact on diet, physical activity and mental health.

BACKGROUND: In response to the COVID-19 pandemic, the UK imposed a national lockdown prompting change to daily routines. Among behaviours impacted by the lockdown, diet and physical activity may be particularly important due to their association with mental health and physical health. The aim of this study was to explore people's experiences of how lockdown impacted their physical activity, dietary behaviours and mental health, with a view to informing public health promotion. METHODS: This phenomenological qualitative study used semi-structured telephone interviews. Interviews were audio-recorded and transcribed verbatim. Thematic analysis was conducted, guided by the Framework Approach. RESULTS: Forty participants (28 female) completed an interview (mean duration: 36 min) between May and July 2020. The overarching themes identified were (i) Disruption (loss of routines, social interaction and cues to physical activity) and (ii) Adaptation (structuring the day, accessing the outdoor environment, finding new ways for social support). The disruption to daily routines altered people's cues for physical activity and eating; some participants spoke of comfort eating and increased alcohol intake in the early days of lockdown, and how they consciously tried to change these when restrictions lasted longer than first anticipated. Others spoke of adapting to the restrictions using food preparation and meals to provide both routine and social time for families. Disruptions from the closure of workplaces resulted in flexible working times for some, allowing for physical activity to be built into the day. In later stages of restrictions, physical activity became an opportunity for social interaction and several participants reported intending to continue to replace sedentary means of socialising (e.g., meeting in cafes) with more active, outdoor activities (e.g., walking) once restrictions were lifted. Staying active and building activity into the day was seen as important to support physical and mental health during the challenging times of the pandemic. CONCLUSIONS: Whilst many participants found the UK lockdown challenging, adaptations to cope with the restrictions presented some positive changes related to physical activity and diet behaviours. Helping people sustain their new healthier activities since restrictions have lifted is a challenge but presents an opportunity for public health promotion.

Life in lockdown: a longitudinal study investigating the impact of the UK COVID-19 lockdown measures on lifestyle behaviours and mental health.

BACKGROUND: The COVID-19 pandemic led to the UK government enforcing lockdown restrictions to control virus transmission. Such restrictions present opportunities and barriers for physical activity and healthy eating. Emerging research suggests that in the early stages of the pandemic, physical activity levels decreased, consumption of unhealthy foods increased, while levels of mental distress increased. Our aims were to understand patterns of diet, physical activity, and mental health during the first lockdown, how these had changed twelve-months later, and the factors associated with change. METHODS: An online survey was conducted with UK adults (N = 636; 78% female) during the first national lockdown (May-June 2020). The survey collected information on demographics, physical activity, diet, mental health, and how participants perceived lifestyle behaviours had changed from before the pandemic. Participants who provided contact details were invited to complete a twelve-month follow-up survey (May-June 2021), 160 adults completed the survey at both time-points. Descriptive statistics, T-tests and McNemar Chi Square statistics were used to assess patterns of diet, physical activity, and mental health at baseline and change in behaviours between baseline and follow-up. Linear regression models were conducted to explore prospective associations between demographic and psycho-social variables at baseline with change in healthy eating habit, anxiety, and wellbeing respectively. RESULTS: Between baseline and follow-up, healthy eating habit strength, and the importance of and confidence in eating healthily reduced. Self-rated health (positively) and confidence in eating healthily (negatively) were associated with change in healthy eating habit. There were no differences between baseline and follow-up for depression or physical activity. Mean anxiety score reduced, and wellbeing increased, from baseline to follow-up. Living with children aged 12-17 (compared to living alone) was associated with an increase in anxiety, while perceiving mental health to have worsened during the first lockdown (compared to staying the same) was associated with reduced anxiety and an increase in mental wellbeing. CONCLUSIONS: While healthy eating habits worsened in the 12 months since the onset of the pandemic, anxiety and mental wellbeing improved. However, anxiety may have increased for parents of secondary school aged children.

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.

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).

Parents' Perceptions and Responses to the UK Soft Drinks Industry Levy.

OBJECTIVE: To record parents' awareness of the UK soft drinks industry levy (SDIL) and explore associations between negative psychological reactance to the levy and motivation and intentions to change consumption and purchasing. METHODS: A cross-sectional online survey with UK-based parents of children aged 5-11 years (n = 237). Regression analyses were used to test associations between psychosocial responses to the levy and behavioral intentions to change family consumption and purchasing. RESULTS: A total of 92% of responding parents were aware of the SDIL. Of the responding parents, 57% supported its aims, but 29% felt it threatened their freedom of choice. A total of 41% expressed intention to change shopping habits or restrict their child's intake as a result. Reactance and motivation were poorer in low-income families, and intentions to change were positively predicted by motivation. CONCLUSIONS AND IMPLICATIONS: This snapshot suggests that the UK SDIL is largely supported by parents and associated with intentions to change their children's intake.

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.

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.

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.

A cluster-randomised feasibility trial of a children's weight management programme: the Child weigHt mANaGement for Ethnically diverse communities (CHANGE) study.

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.

Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: cluster randomised controlled trial (WAVES study).

OBJECTIVE: To assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity. DESIGN: Cluster randomised controlled trial. SETTING: UK primary schools from the West Midlands. PARTICIPANTS: 200 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. INTERVENTIONS: The 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 MEASURES: The 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. RESULTS: Data 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). CONCLUSIONS: The 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 REGISTRATION: Current Controlled Trials ISRCTN97000586.

The West Midlands ActiVe lifestyle and healthy Eating in School children (WAVES) study: a cluster randomised controlled trial testing the clinical effectiveness and cost-effectiveness of a multifaceted obesity prevention intervention programme targeted at children aged 6-7 years.

BACKGROUND: Systematic reviews suggest that school-based interventions can be effective in preventing childhood obesity, but better-designed trials are needed that consider costs, process, equity, potential harms and longer-term outcomes. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of the WAVES (West Midlands ActiVe lifestyle and healthy Eating in School children) study intervention, compared with usual practice, in preventing obesity among primary school children. DESIGN: A cluster randomised controlled trial, split across two groups, which were randomised using a blocked balancing algorithm. Schools/participants could not be blinded to trial arm. Measurement staff were blind to allocation arm as far as possible. SETTING: Primary schools, West Midlands, UK. PARTICIPANTS: Schools within a 35-mile radius of the study centre and all year 1 pupils (aged 5-6 years) were eligible. Schools with a higher proportion of pupils from minority ethnic populations were oversampled to enable subgroup analyses. INTERVENTIONS: The 12-month intervention encouraged healthy eating/physical activity (PA) by (1) helping teachers to provide 30 minutes of additional daily PA, (2) promoting 'Villa Vitality' (interactive healthy lifestyles learning, in an inspirational setting), (3) running school-based healthy cooking skills/education workshops for parents and children and (4) highlighting information to families with regard to local PA opportunities. MAIN OUTCOME MEASURES: The primary outcomes were the difference in body mass index z-scores (BMI-zs) between arms (adjusted for baseline body mass index) at 3 and 18 months post intervention (clinical outcome), and cost per quality-adjusted life-year (QALY) (cost-effectiveness outcome). The secondary outcomes were further anthropometric, dietary, PA and psychological measurements, and the difference in BMI-z between arms at 27 months post intervention in a subset of schools. RESULTS: Two groups of schools were randomised: 27 in 2011 (n = 650 pupils) [group 1 (G1)] and another 27 in 2012 (n = 817 pupils) [group 2 (G2)]. Primary outcome data were available at first follow-up (n = 1249 pupils) and second follow-up (n = 1145 pupils) from 53 schools. The mean difference (MD) in BMI-z between the control and intervention arms was -0.075 [95% confidence interval (CI) -0.183 to 0.033] and -0.027 (95% CI -0.137 to 0.083) at 3 and 18 months post intervention, respectively. The main analyses showed no evidence of between-arm differences for any secondary outcomes. Third follow-up included data on 467 pupils from 27 G1 schools, and showed a statistically significant difference in BMI-z (MD -0.20, 95% CI -0.40 to -0.01). The mean cost of the intervention was £266.35 per consented child (£155.53 per child receiving the intervention). The incremental cost-effectiveness ratio associated with the base case was £46,083 per QALY (best case £26,804 per QALY), suggesting that the intervention was not cost-effective. LIMITATIONS: The presence of baseline primary outcome imbalance between the arms, and interschool variation in fidelity of intervention delivery. CONCLUSIONS: The primary analyses show no evidence of clinical effectiveness or cost-effectiveness of the WAVES study intervention. A post hoc analysis, driven by findings at third follow-up, suggests a possible intervention effect, which could have been attenuated by baseline imbalances. There was no evidence of an intervention effect on measures of diet or PA and no evidence of harm. FUTURE WORK: A realist evidence synthesis could provide insights into contextual factors and strategies for future interventions. School-based interventions need to be integrated within a wider societal framework and supported by upstream interventions. TRIAL REGISTRATION: Current Controlled Trials ISRCTN97000586. 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. 22, No. 8. See the NIHR Journals Library website for further project information.

Cultural adaptation of a children's weight management programme for Bangladeshi and Pakistani families in the UK: a cluster-randomised feasibility study protocol.

BACKGROUND: Group-based children's weight management programmes are widely available in the UK and evidence shows that these are effective in the short-term. No programmes have been specifically developed to meet the cultural requirements of UK minority ethnic communities. South Asian children are a high-risk group for obesity and its consequences; therefore, the study aim is to adapt an existing weight management programme for children aged 4-11 years and their families to ensure cultural relevance to Pakistani and Bangladeshi communities, and undertake a feasibility study of the adapted programme. METHODS/DESIGN: Pakistani and Bangladeshi families of overweight children who have been offered the existing children's weight management programme in Birmingham, UK, will be invited to interviews and focus groups to explore their experiences and views of the programme. These data, together with existing literature and service provider information, will inform adaptation of the programme to be more culturally relevant to these families. The feasibility study will employ a cluster-randomised design, and will assess success of programme adaptation and feasibility of programme delivery. Planned programmes will be randomised to be delivered as the adapted programme (intervention) or the standard programme (comparator) with a 2:1 ratio. The primary outcome will be the proportion of Pakistani and Bangladeshi families completing the adapted programme. To assess recruitment, retention and data collection methods to inform a future trial, we aim to recruit 80 participants. A range of assessments will be undertaken with participants pre-, post- and 6-months post-intervention. DISCUSSION: This study addresses the identified need to provide children's weight management programmes that are suitable for minority ethnic communities. Whilst the focus of the intervention adaptation is on Pakistani and Bangladeshi communities, the programme will be developed to be flexibly delivered to meet the cultural needs of communities of all ethnic compositions. The feasibility study will directly compare the adapted and existing weight management programmes, and will enable a comprehensive evaluation of the success of the adaptation. Essential information will also be gathered to inform the design and sample size calculation of a future trial to evaluate intervention effectiveness. TRIAL REGISTRATION: ISRCTN81798055, registered: 13/05/2014.

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 Brief Educational Intervention Increases Knowledge of the Sugar Content of Foods and Drinks but Does Not Decrease Intakes in Scottish Children Aged 10-12 Years.

OBJECTIVE: To assess the effectiveness of an educational intervention to improve children's knowledge of the sugar content of food and beverages. METHODS: Cluster-randomized, controlled trial with 268 children (aged 10-12 years) from 14 primary schools in Aberdeen, Scotland. The intervention group received 2 interactive classroom sessions about sugar. A questionnaire to assess knowledge was completed at baseline and 4, 10, and 34 weeks postintervention. Dietary intake was assessed by food frequency questionnaire at baseline and on weeks 10 and 34. RESULTS: After the intervention, the intervention group demonstrated greater knowledge of sugar than did the control group (P < .001), which was sustained at week 34 (P < .001). Dietary intakes of sugar did not change postintervention. Pre-intervention children underestimated the sugar content of fruit-based beverages. CONCLUSIONS AND IMPLICATIONS: Children's knowledge of sugar in food and beverages is limited but can be improved through a simple educational intervention. Further intervention would be needed to encourage a change in dietary intake.

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).

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.