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Effectiveness and cost-effectiveness of The Daily Mile on childhood weight outcomes and wellbeing: a cluster randomised controlled trial.
Breheny, K, Passmore, S, Adab, P, Martin, J, Hemming, K, Lancashire, ER, Frew, E
International journal of obesity (2005). 2020;(4):812-822
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Abstract
BACKGROUND The Daily Mile is designed to increase physical activity levels with children running or walking around school grounds for 15-min daily. It has been adopted by schools worldwide and endorsed as a solution to tackle obesity, despite no robust evidence of its benefits. We conducted a cluster randomised controlled trial to determine its clinical and cost-effectiveness. METHODS Forty schools were randomly assigned (1:1) to either the Daily Mile intervention or control group in which only the usual school health and wellbeing activities were implemented. The primary outcome was BMI z-score (BMIz) at 12 months follow-up from baseline, with planned subgroup analysis to examine differential effects. Primary economic analysis outcome was incremental cost per Quality-Adjusted-Life-Year (QALY) gained. RESULTS Using a constrained randomisation approach, balanced on school size, baseline BMIz and proportion of pupils eligible for free school meals, 20 schools were allocated to intervention (n = 1,153 participants) and 20 to control (n = 1,127); 3 schools withdrew (2 intervention, 1 control). At 12 months, BMIz data were available for 18 intervention schools (n = 850) and 19 control schools (n = 820 participants). Using intention-to-treat analysis the adjusted mean difference (MD) in BMIz (intervention - control) was -0.036 (95% CI: -0.085 to 0.013, p = 0.146). Pre-specified subgroup analysis showed a significant interaction with sex (p = 0.001) suggesting a moderate size benefit of The Daily Mile in girls (MD -0.097, 95% CI -0.156 to -0.037). This was consistent with the exploratory economic results that showed The Daily Mile to be highly cost-effective in girls (£2,492 per QALY), but not in boys, and overall to have a 76% chance of cost-effectiveness for the whole sample, at the commonly applied UK threshold of £20,000 per QALY. CONCLUSIONS Overall the Daily Mile had a small but non-significant effect on BMIz, however, it had a greater effect in girls suggesting that it might be considered as a cost-effective component of a system-wide approach to childhood obesity prevention.
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Effectiveness of a childhood obesity prevention programme delivered through schools, targeting 6 and 7 year olds: cluster randomised controlled trial (WAVES study).
Adab, P, Pallan, MJ, Lancashire, ER, Hemming, K, Frew, E, Barrett, T, Bhopal, R, Cade, JE, Canaway, A, Clarke, JL, et al
BMJ (Clinical research ed.). 2018;360:k211
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Plain language summary
Excess weight in childhood is a global problem affecting around 41 million children under the age of 5 years. In addition to physical and psychosocial health consequences in these early years, childhood excess weight is an important predictor of obesity in adulthood. The aim of the study is to assess the effectiveness of a school and family based healthy lifestyle programme (WAVES intervention) compared with usual practice, in preventing childhood obesity. The primary outcome for clinical effectiveness was the difference in BMI z scores between arms at 15 and 30 months. The study was a school based, cluster randomised, controlled trial where 200 schools were randomly selected from all state run primary schools within 35miles of the study centre (n=980). 144 eligible schools were approached to achieve the target recruitment of 54 schools. The intervention components were delivered over a period of 12 months and targeted the home and school environment. The results show that there was 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 was delivered through schools and targeting 6 and 7-year olds. The intervention did not have any effects on secondary anthropometric, behavioural, or clinical outcomes. A clinically significant difference in BMI z score in favour of the intervention was seen in the first cohort of schools recruited. However, post hoc analysis suggested that this outcome may have been a cohort effect as no effect was seen in group 2 schools at any time point. Authors conclude that the study intervention 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. However, the lower cost components of the intervention could be considered by schools to fulfil their mandated responsibilities for education on health and wellbeing.
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. 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.
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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.
Adab, P, Barrett, T, Bhopal, R, Cade, JE, Canaway, A, Cheng, KK, Clarke, J, Daley, A, Deeks, J, Duda, J, et al
Health technology assessment (Winchester, England). 2018;(8):1-608
Abstract
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.
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Process evaluation results of a cluster randomised controlled childhood obesity prevention trial: the WAVES study.
Griffin, TL, Clarke, JL, Lancashire, ER, Pallan, MJ, Adab, P, ,
BMC public health. 2017;(1):681
Abstract
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.
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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.
Adab, P, Pallan, MJ, Lancashire, ER, Hemming, K, Frew, E, Griffin, T, Barrett, T, Bhopal, R, Cade, JE, Daley, A, et al
BMC public health. 2015;:488
Abstract
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).
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Parent and child perceptions of school-based obesity prevention in England: a qualitative study.
Clarke, JL, Griffin, TL, Lancashire, ER, Adab, P, Parry, JM, Pallan, MJ, ,
BMC public health. 2015;:1224
Abstract
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.
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Process evaluation design in a cluster randomised controlled childhood obesity prevention trial: the WAVES study.
Griffin, TL, Pallan, MJ, Clarke, JL, Lancashire, ER, Lyon, A, Parry, JM, Adab, P, ,
The international journal of behavioral nutrition and physical activity. 2014;:112
Abstract
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.