Long-term effects of the Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial

Objective: To investigate the long-term effectiveness of a school-based intervention to improve physical activity and diet in children. Design: Cluster-randomised controlled trial. Setting: 60 primary schools in the southwest of England. Participants: Primary school children who were aged 8-9 years at recruitment, 9-10 years during the intervention and 10-11 years at the long-term follow-up assessment. Intervention: Teacher training, provision of lesson and child-parent interactive homework plans and teaching materials. Main Outcome Measures: Primary outcomes were accelerometer-assessed minutes of moderate to vigorous physical activity (MVPA) per day, accelerometer-assessed minutes of sedentary behaviour per day and reported daily consumption of servings of fruit and vegetables. Results: 60 schools with 2221 eligible children were recruited. As in the previously published assessment immediately after the end of the intervention, none of the three primary outcomes differed between children in schools allocated to the intervention, compared with those in control schools at the end of the long-term follow-up (1 year after the end of the intervention). Differences in secondary outcomes were consistent with those at the immediate follow-up, with no evidence that these had diminished over time. Comparing intervention with control schools, the difference in mean child-reported screen viewing at the weekend was -16.03 min (95% CI -32.82 to 0.73), for servings of snacks per day, the difference was -0.11 (95% CI -0.39 to 0.06), in servings of high-energy drinks per day -0.20 (95% CI -0.39 to -0.01) and in servings of high-fat foods per day -0.12 (95% CI -0.39 to 0.00). None of these reached our predefined level of statistical significance, especially after accounting for multiple testing. Conclusions: School-based curriculum interventions alone are unlikely to have a major public health impact on children's diet and physical activity.Emma L Anderson, Laura D Howe, Ruth R Kipping, Rona Campbell, Russell Jago, Sian M Noble, Sian Wells, Catherine Chittleborough, Tim J Peters, Debbie A Lawlo

Further considerations for placebo controls in surgical trials

© 2023. The Author(s).Peer reviewedPublisher PD

Salivary free light chains as a new biomarker to measure psychological stress: the impact of a university exam period on salivary immunoglobulins, cortisol, DHEA and symptoms of infection:the impact of a university exam period on salivary immunoglobulins, cortisol, DHEA and symptoms of infection

Introduction: Measurement of immunoglobulin free light chains (FLCs) in saliva can serve as a non-invasive biomarker in health and behavioural research. FLCs have been explored in relation to physiological stress but FLC responses to psychological stress and their relationship with infections remain unknown. This study aimed to investigate the impact of exam period stress on salivary FLCs alongside other established biomarkers of stress and whether FLCs relate to symptoms of infection. Methods: 58 healthy adults studying at university completed saliva samples and questionnaires in a period without exams (baseline), and again prior to the start of an exam period. Saliva samples were assessed for FLCs, IgA, cortisol and dehydroepiandrosterone (DHEA). Measures of life events stress, perceived stress, anxiety and depression were completed. Students also reported incidence and severity of symptoms of infection and rated general well-being at baseline, prior to, during and after the exam period. Exercise, sleep and alcohol consumption were also assessed at both timepoints. Results: FLCs secretion rates were significantly lower at the exam period compared to baseline (p &lt;.01), with reductions of 26% and 25% for κ FLC and λ FLC, respectively. In agreement, salivary IgA secretion rate was lower at exams (non-significant trend, p =.07). Cortisol concentration significantly increased at exams (p &lt;.05) while DHEA did not change, leading to an increase in the cortisol:DHEA ratio (p =.06). Depression (p &lt;.05) and anxiety increased from baseline to exams and life stress reported in the build up to the exam period was higher compared with baseline (p &lt;.001). Well-being significantly decreased from baseline to exams (p &lt;.01). The proportion of participants reporting infection symptoms (70%) was unchanged between baseline and prior to exams. No significant relationships were found between FLCs or other saliva parameters and infection symptoms, well-being or stress/psychological measures. Changes in saliva parameters between timepoints were independent of health behaviours. Conclusions: Salivary FLCs are responsive to life events stress and corroborate with IgA. This preliminary study highlights the potential utility of FLCs as a new salivary biomarker in stress research.</p

Effect of intervention aimed at increasing physical activity, reducing sedentary behaviour, and increasing fruit and vegetable consumption in children: Active for Life Year 5 (AFLY5) school based cluster randomised controlled trial

Objective To investigate the effectiveness of a school based intervention to increase physical activity, reduce sedentary behaviour, and increase fruit and vegetable consumption in children. Design Cluster randomised controlled trial. Setting 60 primary schools in the south west of England. Participants Primary school children who were in school year 4 (age 8-9 years) at recruitment and baseline assessment, in year 5 during the intervention, and at the end of year 5 (age 9-10) at follow-up assessment. Intervention The Active for Life Year 5 (AFLY5) intervention consisted of teacher training, provision of lesson and child-parent interactive homework plans, all materials required for lessons and homework, and written materials for school newsletters and parents. The intervention was delivered when children were in school year 5 (age 9-10 years). Schools allocated to control received standard teaching. Main outcome measures The pre-specified primary outcomes were accelerometer assessed minutes of moderate to vigorous physical activity per day, accelerometer assessed minutes of sedentary behaviour per day, and reported daily consumption of servings of fruit and vegetables. Results 60 schools with more than 2221 children were recruited; valid data were available for fruit and vegetable consumption for 2121 children, for accelerometer assessed physical activity and sedentary behaviour for 1252 children, and for secondary outcomes for between 1825 and 2212 children for the main analyses. None of the three primary outcomes differed between children in schools allocated to the AFLY5 intervention and those allocated to the control group. The difference in means comparing the intervention group with the control group was -1.35 (95% confidence interval -5.29 to 2.59) minutes per day for moderate to vigorous physical activity, -0.11 (-9.71 to 9.49) minutes per day for sedentary behaviour, and 0.08 (-0.12 to 0.28) servings per day for fruit and vegetable consumption. The intervention was effective for three out of nine of the secondary outcomes after multiple testing was taken into account: self reported time spent in screen viewing at the weekend (-21 (-37 to -4) minutes per day), self reported servings of snacks per day (-0.22 (-0.38 to -0.05)), and servings of high energy drinks per day (-0.26 (-0.43 to -0.10)) were all reduced. Results from a series of sensitivity analyses testing different assumptions about missing data and from per protocol analyses produced similar results. Conclusion The findings suggest that the AFLY5 school based intervention is not effective at increasing levels of physical activity, decreasing sedentary behaviour, and increasing fruit and vegetable consumption in primary school children. Change in these activities may require more intensive behavioural interventions with children or upstream interventions at the family and societal level, as well as at the school environment level. These findings have relevance for researchers, policy makers, public health practitioners, and doctors who are involved in health promotion, policy making, and commissioning services

How do pilot and feasibility studies inform randomised placebo-controlled trials in surgery? : A systematic review

© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.Peer reviewedPublisher PD

Patient information leaflets for placebo-controlled surgical trials : a review of current practice and recommendations for developers

Contributions Sian Cousin: methodology; formal analysis; writing—original draft; writing—review and editing; visualisation. Marc Huttman: data collection, review and editing. Natalie Blencowe: conceptualisation; methodology; formal analysis; writing—original draft; writing—review and editing; visualisation. Carmen Tsang: data collection, review and editing. Daisy Elliott: formal analysis, review and editing. Jane Blazeby: review and editing. David Beard: conceptualisation, review and editing. Marion Campbell: conceptualisation, review and editing. Katie Gillies: conceptualisation; methodology; formal analysis; writing—original draft; writing—review and editing; visualisation.Peer reviewe

Intervention fidelity in a school-based diet and physical activity intervention in the UK:Active for Life Year 5

Active for Life Year 5 (AFLY5) is an educational programme for Year 5 children (aged 9-10) designed to increase children's physical activity, decrease sedentary behaviour and increase fruit and vegetable intake. This paper reports findings from a process evaluation embedded within a randomised controlled trial evaluating the programme's effectiveness. It considers the fidelity of implementation of AFLY5 with a focus on three research questions: 1. To what extent was the intervention delivered as planned? 2. In what ways, if any, did the teachers amend the programme? and 3. What were the reasons for any amendments?Mixed methods were used including data collection via observation of the intervention delivery, questionnaire, teacher's intervention delivery log and semi-structured interviews with teachers and parents. Qualitative data were analysed thematically and quantitative data were summarised using descriptive statistics.Following training, 42 of the 43 intervention school teachers/teaching staff (98%) were confident they could deliver the nutrition and physical activity lessons according to plan. The mean number of lessons taught was 12.3 (s.d. 3.7), equating to 77% of the intervention. Reach was high with 95% of children in intervention schools receiving lessons. A mean of 6.2 (s.d. 2.6) out of 10 homeworks were delivered. Median lesson preparation time was 10 min (IQR 10-20) and 28% of lessons were reported as having been amended. Qualitative findings revealed that those who amended the lessons did so to differentiate for student ability, update them for use with new technologies and to enhance teacher and student engagement. Teachers endorsed the aims of the intervention, but some were frustrated with having to adapt the lesson materials. Teachers also a reported tendency to delegate the physical activity lessons to other staff not trained in the intervention.Fidelity of intervention implementation was good but teachers' enthusiasm for the AFLY5 programme was mixed despite them believing that the messages behind the lessons were important. This may have meant that the intervention messages were not delivered as anticipated and explain why the intervention was found not to be effective.ISRCTN50133740.Rona Campbell, Emma Rawlins, Sian Wells, Ruth R. Kipping, Catherine R. Chittleborough, Tim J. Peters, Debbie A. Lawlor and Russell Jag

Free light chains as an emerging biomarker in saliva::biological variability and comparisons with salivary IgA and steroid hormones

BackgroundSalivary free light chains (FLCs) are an emerging biomarker in health and behavioural research. However, little is known regarding biological variability of salivary FLCs and how they relate to other established salivary biomarkers. This study aimed to investigate the diurnal and day-to-day variation of salivary FLCs and their relationship with salivary IgA and steroid hormones.MethodsA total of 46 healthy adults participated in studies exploring the biological variability of FLCs. Diurnal variation was investigated by collecting saliva samples immediately upon waking, 0.5 h, 3 h, 6 h, 9 h and 14 h post-waking. Saliva samples were assessed for FLCs, IgA, cortisol and dehydroepiandrosterone (DHEA). Between-day variation in FLCs and IgA was assessed by collecting saliva samples immediately upon waking for seven consecutive days. Participants underwent a dental examination to exclude oral health as a potential confounding variable. Within and between-person day-to day variation was explored in relation to a range of different factors: awakening time, sleep, exercise, well-being and alcohol consumption.ResultsSalivary secretion rates of FLCs decreased following waking and up to 3 h post-waking and then plateaued. This same pattern was observed for IgA. DHEA was stable upon waking and higher levels were seen in the morning with significantly lower levels thereafter. Cortisol levels significantly increased 0.5 h post-waking then continued to decline across the day. FLCs were significantly correlated with IgA but not cortisol or DHEA. Both FLCs and IgA parameters showed day-to-day variability, with coefficients of variation ≥ 40%. Earlier waking time was significantly correlated with higher FLC and IgA secretion rates. Inter-person differences in saliva parameter variability were observed but the degree of variation in FLCs and IgA was related within person. Inter-person day-to-day variation appeared to be uninfluenced by lifestyle or behavioural factors.ConclusionsSaliva FLCs secretion exhibits diurnal fluctuation that mirrors IgA fluctuation. Findings strongly indicate salivary FLC secretion is orchestrated by local plasma cells. FLCs and IgA both showed notable variability day-to-day, which was similar within person and influenced by awakening time. FLCs offer a promising adjunct to IgA in the measurement of oral immune activation