Manual Study No. 6

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Supplementary table 1 summarises all changes between trial registration and trial protocol. In particular, at the early planning stages for the trial and before the start of baseline measurements the investigator team modified the primary outcomes from those specified at trial registration. To increase power to detect change and for consistency and comparability with previous trials, we changed the primary outcome for clinical effectiveness from the binary variable specified in the registry of difference in proportion of children categorised as overweight or obese between arms to the continuous outcome specified in the protocol of difference in BMI z scores between arms.

Concurrently this binary variable and the additional anthropometric measurements included as primary outcomes at trial registration were specified as secondary outcomes. The reporting of the trial is in keeping with the published protocol, 8 which was submitted before the start of data analysis, but any differences between what is reported and the trial registration information are specified in both the text and the tables.

Public involvement was a key feature of the early phases of trial development and feasibility testing before this main trial. Intervention development was informed by detailed consultation with parents, teachers, and other school staff. The intervention was further refined and the process for measuring outcomes tested and adapted by asking the children, parents, and teachers about their experiences during the feasibility study. Measures of wellbeing and body dissatisfaction were included as outcomes based on their perceived importance among school staff.

Our research team includes an education advisor at the Health Education Service, who has regular contact with schools and advised on school and participant recruitment. No patients were involved in this trial. Figure 1 shows the flow of schools and pupils during the trial. Among eligible pupils from 54 participating schools at baseline, parental consent for baseline measurements was obtained from Recruitment took place between April and May group 1 schools and pupils and from January to May group 2 schools and pupils.

Table 3 summarises the baseline characteristics. Although school characteristics were balanced between the two groups, there was baseline imbalance at the pupil level, with children in the control arm compared with intervention arm more likely to be male The primary outcomes are also reported in the trial protocol table 4. At 15 months the mean BMI z score was non-significantly lower in the intervention arm compared with control arm: Adjusted differences for body mass index BMI z score between control and intervention groups at first, second, and third follow-up.

The secondary outcomes are as reported in the trial protocol and trial registration information, unless stated otherwise table 5. Adjusted differences for secondary outcomes anthropometric, diet, physical activity, and psychosocial between control and intervention arm at first and second follow-up. The mean difference in sum of skinfolds, waist circumference z score, and body fat percentage were all non-significant, but slightly favoured the control group. Diet, physical activity, and blood pressure —the mean differences in total daily energy intake, physical activity energy expenditure, and systolic and diastolic blood pressures between groups were inconsistent in direction and statistically non-significant at both follow-ups.

We were not aware of any contextual or intervention delivery aspects that differed between the groups. To investigate why the intervention appeared more effective at this later time point, we undertook post hoc analysis to consider whether schools recruited in group 1 differed from those in group 2, both in characteristics see appendix, table A1 and in outcomes at earlier time points see appendix, table A2.

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This showed a noticeable imbalance in baseline adiposity between arms in group 2 schools and baseline differences in ethnicity, deprivation, and adiposity between group 1 and group 2 schools. Analysis of outcomes by school group showed a statistically significantly lower BMI z score in the intervention arm compared with control arm at first follow-up in group 1 schools mean difference —0. In contrast there was no significant difference between arms at any time point in group 2 schools see appendix, table A2. Harms —quality of life, as total score or subdomains, social acceptance, or dissatisfaction with body image did not differ significantly between arms at any time.

Thus we found no evidence of harm from the intervention. Subgroup and sensitivity analyses —all subgroup analyses by ethnicity, sex, socioeconomic or weight status, and fidelity of implementation and sensitivity analyses were consistent with the main analyses and did not change any conclusions results not shown. Process evaluation —detailed results from the process evaluation are reported separately. However, despite some challenges to implementation, the interviews and focus groups indicated that the programme was often well received both by teachers 19 and by parents and children see box.

I teached my mum how to cook it when we cooked in Aston Villa. And I chop a bit at home because I learned how to chop at Aston Villa child. We found no overall evidence of improvement in the primary outcomes of reduction in body mass index BMI z scores at 15 and 30 months after a childhood obesity prevention programme delivered through schools and targeting 6 and 7 year olds. However, confidence intervals did not exclude between arm differences in BMI z score of 0. The intervention did not have any effects on secondary anthropometric, behavioural, or clinical outcomes, and there were no differential effects in prespecified subgroups.

A clinically significant difference in BMI z score in favour of the intervention was seen in the first cohort of schools recruited that had data available at 39 months. Subsequent post hoc analysis suggests this may have been a cohort effect, with evidence of effectiveness in group 1 schools at all time points but no effect seen in group 2 schools at any time point. The outcomes used to assess harm did not differ between the groups. The WAVES study is a large childhood obesity prevention trial within a socioeconomically and ethnically diverse population, with sufficient sample size to assess the primary outcome.

Phased development of the 12 month multicomponent intervention was guided by the Medical Research Council framework for complex interventions, 9 21 including a successful feasibility trial. A prespecified analysis plan took account of clustering, and the findings were robust to a range of sensitivity analyses.

This was also one of few trials that undertook longer term follow-up 39 months to assess sustainability of intervention effects. Comprehensive process evaluation described in more detail elsewhere 16 helped to contextualise the findings and to interpret the results. Nevertheless, there were also several limitations. The balancing algorithm to allocate schools was based on whole school cluster level data.

However, within clusters, only children from one year group were included, and just over half of those consented to study measurements. There was notable baseline imbalance between arms in the group 2 cohort with the intervention arm having greater adiposity than the control arm , which, despite the use of adjustment methods, may have attenuated the main results. Statistical adjustment assumes a common linear relation between covariates and outcome in all clusters, and misspecification of the model may lead to both under-adjustment and over-adjustment.

Baseline imbalance is a known limitation of cluster trials and can best be overcome with recruitment of larger numbers of clusters. Although follow-up to 30 months was in all groups, longer term follow-up to 39 months was limited to a subset of participating schools. However, estimates of dietary intake may not reflect habitual intake, there was a risk of misreporting, 26 and there may have been seasonal variation 27 between data collection periods.

These are similar to the rates achieved in other such studies. Our results build on the findings of previous reviews and address limitations in previous childhood obesity prevention trials. Two systematic reviews suggested that there was moderate 6 to strong 5 evidence of effectiveness of school based interventions in preventing childhood obesity, although heterogeneity of interventions, variable design quality, and lack of longer term follow-up limit interpretation.

Since the publication of the reviews, findings from another UK cluster randomised controlled trial, the Active for Life Year 5 AFLY5 including more than children from 60 schools are available. The intervention was curriculum based, focusing on educational approaches rather than the more experiential skills based intervention in the WAVES study.

In contrast with our trial, the target population was children at the end of the primary school years, when rates of obesity have already increased substantially, and included few children from minority ethnic groups and more deprived areas. Nevertheless, similar to our findings, there was no evidence of an intervention effect on behavioural or weight outcomes at 12 months. The balance of components, intensity, and behaviour change strategies used to deliver the intervention may have contributed to the absence of evidence of effect on the primary outcomes in WAVES and other trials.

Although fidelity of implementation for the WAVES study intervention programme was reasonably high overall, no school delivered all components completely per protocol, and a few schools failed to deliver some or all of the components. This may have attenuated any effect. This suggests that delivery of a more intensive teacher led intervention in a school setting would not be feasible without additional resources. Educational and experiential interventions of longer duration that are embedded within a whole school setting are likely to be prohibitively costly and complex to evaluate using clinical trial methods.

The intervention was developed on the basis of promising strategies in trials published before the feasibility study about 10 years before the definitive trial. As a result, strategies such as those based on behavioural economics aimed at altering the social and physical environment were not included as part of the intervention. Although the findings from the feasibility study suggested the WAVES intervention was promising, intervention delivery for the trial and subsequent follow-up measurements took place some years later, during which time wider environmental changes might have diluted any effects.

Researcher contact with schools during the feasibility study was also much greater, but this was not replicable in the definitive trial with a larger number of schools and would not be implementable outside of a trial setting. Methodological limitations with baseline imbalance may have also contributed to the observed findings with heterogeneity of effect between schools. However, even the cohort effect observed in group 1 schools was small, suggesting that childhood obesity prevention is unlikely to be achieved by schools alone.

The qualitative data from teachers 19 and parents, 20 collected as part of our process evaluation, support the possibility that these wider influences have a greater effect than any school based intervention. A metasynthesis of qualitative studies exploring the role of primary schools in preventing childhood obesity highlighted the need for schools, parents, and government to work together to promote healthy lifestyles in children and to support activities in the school setting.

The multicomponent WAVES study intervention, which was feasible to deliver and for which there was no evidence of harm, did not result in a statistically significant difference in BMI z score overall, and there was no evidence of effect on measured diet or physical activity levels in children. Although wider implementation of this intervention cannot be recommended for obesity prevention, the lower cost components could be considered by schools to fulfil their mandated responsibilities for education on health and wellbeing. Within the context of the wider evidence, it is likely that any effect of school based educational, motivational, and skill centred interventions on obesity prevention is small.

Several community based interventions targeting wider environments have also been evaluated recently, using non-randomised experimental designs. Although a few of these have shown evidence of small effects and lower weight gain in children from intervention communities, 31 32 the findings are not consistent 33 and need further evaluation. Interventions based on behavioural economics such as nudge theory 34 also merit further investigation. Even marginal effects may be important within a wider systems approach to obesity prevention, which incorporates multiple agencies and widespread policy change to support healthy behaviours.

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Comprehensive systematic reviews have suggested that school based interventions could be effective in preventing childhood obesity in high income countries. Furthermore, inconsistent findings in relation to differential effects on subgroups, and impact on inequalities, limited data on potential harms, process measures, and long term effects, as well as lack of data on cost effectiveness, restrict interpretation and wider applicability.

It did not result in any meaningful effect on adiposity, dietary intake, or physical activity after 15 or 30 months. Although such interventions can fulfil the responsibility of schools for wider education, without upstream support they are unlikely to halt the childhood obesity epidemic. The remaining authors TB to SP are listed alphabetically. We thank the children, school staff, and parents who participated in the trial; the children, teachers, and parents who took part in interviews and focus groups as part of the process evaluation; the support of staff at Aston Villa football club in delivering the Villa Vitality programme; the study team, including Behnoush Mohammadpoor Ahranjani and Emma Popo who helped in overseeing the study measurements and data collection; the administrative team who facilitated the running of the project; the research staff who undertook the study measurements; and Robert Lancashire who developed the trial database and oversaw data management.

The trial steering committee met annually and included: Kelvin Jordan, Keele University; subject expert: Louise Longworth, Brunel University; public representative: Owing to the timelines of recruitment and outcome assessments, there was no opportunity for interim analyses, and the trial steering committee undertook the role of assessment of data quality and completion. PA wrote the first draft of the paper and all authors contributed to critical revisions.

ERL coordinated all aspects of the trial, oversaw data collection, collation, and cleaning, and contributed to data analysis. She also contributed to the first draft of the manuscript. EF contributed to the design of the trial and analysis plan, and AC advised on study instruments and undertook some of the analysis.

JJD and KaH contributed to sampling, sample size estimation, and the statistical analysis plan. UE advised on physical activity measurements and related methods and oversaw the preparation of the physical activity data. KiH led data collection and analysis of dietary data. JLD advised on some of the psychosocial assessment methods.

RB and PG advised on aspects related to ethnicity. AD advised on the physical activity intervention component. SP advised on school recruitment and approaches to keeping schools engaged. EM advised on the dietary intervention components.

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JP advised on process evaluation, and TG designed the detailed methods for this. TG and JLC contributed to data collection and undertook analysis and interpretation of the process evaluation. The final manuscript was read and approved by all authors. The funder had no role in study design, data collection, data analysis, data interpretation, or writing of the report. The corresponding author had full access to all the data in the study and had final responsibility for the decision to submit for publication. The University of Birmingham holds the relevant insurance policy for this study and acted as the main sponsor.

The funders have played no role in the design, collection, analysis, and interpretation of data, nor in the writing of the manuscript and in the decision to submit the manuscript for publication. Requests for access to data from the WAVES study should be addressed to the corresponding author at p.

All the individual participant data collected during the trial including the data dictionary will be available, after deidentification, immediately after publication with no end date.

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The study protocol has been published. All proposals requesting data access will need to specify how it is planned to use the data, and all proposals will need approval of the trial co-investigator team before data release. The guarantors PA, ERL, and MP affirm that the manuscript is an honest, accurate, and transparent account of the study bring reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned and, if relevant, registered have been explained. Skip to main content. We use cookies to improve our service and to tailor our content and advertising to you.

More info Close You can manage your cookie settings via your browser at any time. To learn more about how we use cookies, please see our cookies policy Close. Research Effectiveness of a Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: Research Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: Article Related content Metrics Responses Peer review.

This article has a correction. Abstract 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.

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Introduction Excess weight in childhood is a global problem, affecting around 41 million children under the age of 5 years. Interventions and intervention development Irrespective of whether children participated in measurements, intervention delivery was at school class level to all eligible children and their families. View popup View inline. WAVES study intervention and its delivery The intervention components, delivered over 12 months, targeted the home and school environment.

The intervention programme summarised in table 1 comprised four overlapping components: Class teachers selected two preferred resources out of four offered and were taken through each selected resource and its detailed delivery materials by a researcher 2 Termly cooking workshops during school time, which parents were invited to attend to participate in with their child and that were preceded by short classroom sessions for the children. To minimise teacher preparation time and ensure delivery of consistent nutritional messages, the presentation and interactive activity materials, together with take home information sheets and suggested lesson and workshop plans were provided, but timing of sessions and how parents were involved was left to the discretion of teachers 3 A six week programme Villa Vitality developed to encourage healthy eating and increase physical activity and delivered by staff from an iconic sporting institution.

The teacher customised the elements undertaken in school supported by a school visit from a member of staff from Villa Vitality 4 Information sheets signposting children and their families on ways to be active over the summer identical for all schools and physical activity opportunities in their local area school specific sheets produced by the study team and checked before distribution by the school. Comparator intervention Schools allocated to the comparator arm continued with ongoing year 2 health related activities.

Outcomes The primary outcome for clinical effectiveness specified in our analysis plan and trial protocol was the difference in BMI z scores between arms at 15 and 30 months.

Implementation The trial statistician KH undertook sampling and subsequent randomisation, and the trial coordinator ERL recruited schools. Participant assessment and data collection procedures Baseline assessment took place when children were at the end of year 1 aged 5 or 6 years.

Randomisation A blocked balancing algorithm was used to randomise participating schools to intervention or comparator arms. Statistical analysis Analyses of all outcomes were by intention to treat and are reported at 15, 30, and 39 months after baseline 3, 18, and 27 months after the end of the intervention.

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Process evaluation We used a variety of methods for assessment of intervention delivery and process, including interviews with teachers; parent and child focus groups; head teacher, class teacher, and parental questionnaires; teacher logbooks; and direct observation of sessions by researchers. Changes to methods from trial registration stage The trial registration was submitted before the practical planning for the trial had started.

Patient and public involvement Public involvement was a key feature of the early phases of trial development and feasibility testing before this main trial. Results Figure 1 shows the flow of schools and pupils during the trial. Fig 1 Flow of school recruitment and trial arm allocation.

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To ensure even action of the fingers playing the figure in semiquavers he recommends to start practicing in a non legato where the fingers do not lose contact with the key. For the final legato the weight of the hand should bear slightly on each semiquaver to produce a kind of portamento with a timbre that will not merge into the upper melodic line. From Wikipedia, the free encyclopedia. Schlesinger , June Max Hesses Verlag, , p. Profiles of the Man and the Musician. The Man and His Music. Charles Scribner's Sons, , p. Edizioni Curci, , p.