Abstract
BackgroundThe 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.MethodsForty 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.ResultsUsing 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.ConclusionsOverall 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.
Highlights
These authors contributed : Katie Breheny, Sandra Passmore
A Cochrane review of previous school based physical activity interventions has shown that whilst overall such programmes increase physical activity levels during the school period and reduce the time children are sedentary, their impact on overall physical activity levels is relatively small, and there was no evidence that the programmes reduce levels of obesity [8]. In this cluster randomised controlled trial (RCT), we aimed to evaluate the clinical- and cost-effectiveness of The Daily Mile for obesity prevention in children, when compared with usual health and wellbeing activities in schools
Baseline characteristics and outcome measures were well balanced between the intervention and control arms (Table 1), children in the control arm were slightly less likely to live in deprived areas (IMD quintiles 3–5) and fewer were in the White ethnic group
Summary
In this cluster randomised controlled trial (RCT), we aimed to evaluate the clinical- and cost-effectiveness of The Daily Mile for obesity prevention in children, when compared with usual health and wellbeing activities in schools
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