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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. [ABSTRACT FROM AUTHOR]

Background: Technological progress has enabled the provision of personalised feedback across multiple dimensions of physical activity that are important for health. Whether this multidimensional approach supports physical activity behaviour change has not yet been examined. Our objective was to examine the effectiveness of a novel digital system and app that provided multidimensional physical activity feedback combined with health trainer support in primary care patients identified as at risk of chronic disease. Methods: MIPACT was a parallel-group, randomised controlled trial that recruited patients at medium (≥10 and < 20%) or high (≥20%) risk of cardiovascular disease and/or type II diabetes from six primary care practices in the United Kingdom. Intervention group participants (n = 120) received personal multidimensional physical activity feedback using a customised digital system and web-app for 3 months plus five health trainer-led sessions. All participants received standardised information regarding physical activity. Control group participants (n = 84) received no further intervention. The primary outcome was device-based assessment of physical activity at 12 months. Results: Mean intervention effects were: moderate-vigorous physical activity: -1.1 (95% CI, − 17.9 to 15.7) min/day; moderate-vigorous physical activity in ≥10-min bouts: 0.2 (− 14.2 to 14.6) min/day; Physical Activity Level (PAL): 0.00 (− 0.036 to 0.054); vigorous physical activity: 1.8 (− 0.8 to 4.2) min/day; and sedentary time: 10 (− 19.3 to 39.3) min/day. For all of these outcomes, the results showed that the groups were practically equivalent and statistically ruled out meaningful positive or negative effects (>minimum clinically important difference, MCID). However, there was profound physical activity multidimensionality, and only a small proportion (5%) of patients had consistently low physical activity across all dimensions. Conclusion: In patients at risk of cardiovascular disease and/or type II diabetes, MIPACT did not increase mean physical activity. Using a sophisticated multidimensional digital approach revealed enormous heterogeneity in baseline physical activity in primary care patients, and practitioners may need to screen for low physical activity across dimensions rather than rely on disease-risk algorithms that are heavily influenced by age. Trial registration: This trial is registered with the ISRCTN registry (ISRCTN18008011; registration date 31 July 2013). [ABSTRACT FROM AUTHOR]

Background. Extracurricular programmes could provide a mechanism to increase the physical activity (PA) of primary-school-aged children. The aim of this feasibility study was to examine whether the Action 3:30 intervention, which is delivered by teaching assistants, holds promise as a means of increasing the PA of Year 5 and 6 children. Methods. A cluster randomised feasibility trial was conducted in 20 primary schools. Ten schools received the Action 3:30 intervention and 10 schools were allocated to the control arm. The intervention was 40 one-hour sessions, delivered twice a week by teaching assistants. The proportion of participants recruited per school was calculated. Session delivery and session attendance was calculated for intervention schools. Weekday and after-school (3.30 to 8.30 pm) moderate to vigorous intensity physical (MVPA) was assessed by accelerometer at baseline (T0), during the last few weeks of the intervention (T1) and four months after the intervention had ended (T2). The costs of delivering the intervention were estimated. Results. Five intervention schools ran all 40 of the intended sessions. Of the remaining five, three ran 39, one ran 38 and one ran 29 sessions. Mean attendance was 53%. The adjusted difference in weekday MVPA at T1 was 4.3 minutes (95% CI −2.6 to 11.3). Sex-stratified analyses indicated that boys obtained 8.6 more minutes of weekday MVPA than the control group (95% CI 2.8 to 14.5) at T1 with no effect for girls (0.15 minutes, 95% CI −9.7 to 10.0). There was no evidence that participation in the programme increased MVPA once the club sessions ceased (T2). The indicative average cost of this intervention was £2,425 per school or £81 per participating child during its first year and £1,461 per school or £49 per participating child thereafter. Conclusions. The effect of the Action 3:30 interventions was comparable to previous physical activity interventions but further analysis indicated that there was a marked sex difference with a positive impact on boys and no evidence of an effect on girls. The Action 3:30 intervention holds considerable promise but more work is needed to enhance the effectiveness of the intervention, particularly for girls. [ABSTRACT FROM AUTHOR]

Background Detailed assessment of physical activity (PA) in older adults is required to comprehensively describe habitual PA-levels in this growing population segment. Current evidence of population PA-levels is predominantly based on self-report. Methods We examined PA and sedentary behaviour in a nationally representative sample of British people aged 60-64, using individually-calibrated combined heart-rate and movement sensing and a validated questionnaire (EPAQ2), and the socio-demographic and behavioural factors that may explain between-individual variation in PA. Results Between 2006-2010, 2224 participants completed EPAQ2 capturing the past year's activity in four domains (leisure, work, transportation and domestic life) and 1787 participants provided 2-5 days of combined-sensing data. According to objective estimates, median(IQR) physical activity energy expenditure (PAEE) was 33.5 (25.3-42.2) and 35.5 (26.6- 47.3) kJ/kg/day for women and men, respectively. Median (IQR) time spent in moderate-to-vigorous PA (MVPA; >3MET), light-intensity PA (1.5-3MET) and sedentary (<1.5MET) was 26.0 (12.3-48.1) min/day, 5.4 (4.2-6.7) h/day and 18.0 (16.6-19.4) h/day, respectively, in women; and 41.0 (18.8-73.0) min/day, 5.2 (4.0-6.5) h/day and 17.9 (16.3-19.4) h/day in men. PAEE and time spent in MVPA were lower and sedentary time was greater in obese individuals, those with poor health, and those with lower educational attainment (women only). Questionnaire-derived PAEE and MVPA tended to have similar patterns of variation across socio-demographic strata. In the whole sample, domestic PA had the greatest relative contribution to total questionnaire-derived PAEE (58%), whereas occupational PA was the main driver among employed participants (54%). Only 2.2% of participants achieved an average of >30 min MVPA per day combined with >60 min strength-training per week. Conclusions The use of both self-report and objective monitoring to assess PA in early old age provides important information on the domains of PA, PAEE and time spent at different intensity levels. Our findings suggest PA levels are generally low and observed patterns of variation indicate specific subgroups who might benefit from targeted interventions to increase PA. [ABSTRACT FROM AUTHOR]