Dataset Information

The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan.

ABSTRACT:

Background

The Active For Life Year 5 (AFLY5) randomised controlled trial protocol was published in this journal in 2011. It provided a summary analysis plan. This publication is an update of that protocol and provides a detailed analysis plan.

Update

This update provides a detailed analysis plan of the effectiveness and cost-effectiveness of the AFLY5 intervention. The plan includes details of how variables will be quality control checked and the criteria used to define derived variables. Details of four key analyses are provided: (a) effectiveness analysis 1 (the effect of the AFLY5 intervention on primary and secondary outcomes at the end of the school year in which the intervention is delivered); (b) mediation analyses (secondary analyses examining the extent to which any effects of the intervention are mediated via self-efficacy, parental support and knowledge, through which the intervention is theoretically believed to act); (c) effectiveness analysis 2 (the effect of the AFLY5 intervention on primary and secondary outcomes 12 months after the end of the intervention) and (d) cost effectiveness analysis (the cost-effectiveness of the AFLY5 intervention). The details include how the intention to treat and per-protocol analyses were defined and planned sensitivity analyses for dealing with missing data. A set of dummy tables are provided in Additional file 1.

Discussion

This detailed analysis plan was written prior to any analyst having access to any data and was approved by the AFLY5 Trial Steering Committee. Its publication will ensure that analyses are in accordance with an a priori plan related to the trial objectives and not driven by knowledge of the data.

Trial registration

ISRCTN50133740.

SUBMITTER: Lawlor DA

PROVIDER: S-EPMC3733690 | biostudies-literature | 2013 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan.

Lawlor Debbie A DA Peters Tim J TJ Howe Laura D LD Noble Sian M SM Kipping Ruth R RR Jago Russell R

Trials 20130724

<h4>Background</h4>The Active For Life Year 5 (AFLY5) randomised controlled trial protocol was published in this journal in 2011. It provided a summary analysis plan. This publication is an update of that protocol and provides a detailed analysis plan.<h4>Update</h4>This update provides a detailed analysis plan of the effectiveness and cost-effectiveness of the AFLY5 intervention. The plan includes details of how variables will be quality control checked and the criteria used to define derived v ...[more]

PMID: 23883177

Similar Datasets

Project description:Active for life year 5 (AFLY5) is a school-based intervention, based on social cognitive theory, which aims to promote healthy levels of physical activity and healthy eating by improving a child's self-efficacy to make healthy choices, their knowledge of how to make such choices and prompting parents to support their children to make healthy choices. Previously published results showed no effect on the three primary outcomes and beneficial effects on three of nine secondary outcomes (time spent screen-viewing at weekends, consumption of snacks and of high energy drinks). This paper aims to determine the effect of the intervention on potential mediators.We conducted a cluster RCT of a school-based intervention, with allocation concealed by use of a remote system. The study was undertaken in the South West of England between 2011 and 2013. Participants were school children who were age 8-9 years at baseline assessment and 9-10 years during the intervention. Potential mediators were assessed at the end of the intervention. The intervention consisted of teacher training, provision of all materials required for lessons and homeworks and written materials for school newsletters and parents. The ten potential mediators were child-reported self-efficacy for physical activity and fruit and vegetable consumption, perceived parental logistic support and modelling for their child's physical activity, parental efforts to limit their child's sedentary behaviour and modelling of healthy fruit and vegetable consumption, together with a knowledge assessment.We successfully recruited 60 schools with over 2,221 children; valid data for the 10 mediators were available for 87 % to 96 % of participants. Three of the ten potential mediators were greater in the intervention, compared with the control group: fruit and vegetable self-efficacy 2.2 units (95 % CI: 0.7 to 3.8), assessed on a scale 26 to 130; child-reported maternal limitation of sedentary behaviour 0.5 (0.1 to 0.8), scale 4 to 16; and knowledge 0.5 (0.2, 0.7) scale 0 to 9. Reported maternal limitation of sedentary behaviour and the child's knowledge explained 23 % of the effect of the intervention on reducing time spent on sedentary behaviour at the weekend. There was no effect on other mediators.Our findings suggest that the effect of the AFLY5 intervention on reducing screen-viewing at weekends was partially mediated by an effect on mothers limiting their child's time spent sedentary and on increasing the child's knowledge about healthy behaviour. However, overall our findings suggest that theory driven interventions, like AFLY5, can fail to influence most potential mediators and this may explain the failure of the intervention to improve most primary and secondary outcomes.Current Controlled Trials ISRCTN50133740. Registered 17/03/2011.

Project description:ObjectiveTo investigate the effectiveness of a school based intervention to increase physical activity, reduce sedentary behaviour, and increase fruit and vegetable consumption in children.DesignCluster randomised controlled trial.Setting60 primary schools in the south west of England.ParticipantsPrimary 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.InterventionThe 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 measuresThe 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.Results60 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.ConclusionThe 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. Trial registration Current Controlled Trials ISRCTN50133740.

Project description:Cellulitis is a painful, potentially serious, infectious process of the dermal and subdermal tissues and represents a significant disease burden. The statistical analysis plan (SAP) for the Penicillin for the Emergency Department Outpatient treatment of CELLulitis (PEDOCELL) trial is described here. The PEDOCELL trial is a multicentre, randomised, parallel-arm, double-blinded, non-inferiority clinical trial comparing the efficacy of flucloxacillin (monotherapy) with combination flucloxacillin/phenoxymethylpenicillin (dual therapy) for the outpatient treatment of cellulitis in the emergency department (ED) setting. To prevent outcome reporting bias, selective reporting and data-driven results, the a priori-defined, detailed SAP is presented here.Patients will be randomised to either orally administered flucloxacillin 500 mg four times daily and placebo or orally administered 500 mg of flucloxacillin four times daily and phenoxymethylpenicillin 500 mg four times daily. The trial consists of a 7-day intervention period and a 2-week follow-up period. Study measurements will be taken at four specific time points: at patient enrolment, day 2-3 after enrolment and commencing treatment (early clinical response (ECR) visit), day 8-10 after enrolment (end-of-treatment (EOT) visit) and day 14-21 after enrolment (test-of-cure (TOC) visit). The primary outcome measure is investigator-determined clinical response measured at the TOC visit. The secondary outcomes are as follows: lesion size at ECR, clinical treatment failure at each follow-up visit, adherence and persistence of trial patients with orally administered antibiotic therapy at EOT, health-related quality of life (HRQoL) and pharmacoeconomic assessments. The plan for the presentation and comparison of baseline characteristics and outcomes is described in this paper.This trial aims to establish the non-inferiority of orally administered flucloxacillin monotherapy with orally administered flucloxacillin/phenoxymethylpenicillin dual therapy for the ED-directed outpatient treatment of cellulitis. In doing so, this trial will bridge a knowledge gap in this understudied and common condition and will be relevant to clinicians across several different disciplines. The SAP for the PEDOCELL trial was developed a priori in order to minimise analysis bias.EU Clinical Trials Register (EudraCT number: 2016-001528-69). Registered on 5 April 2016. ClinicalTrials.gov, ID: NCT02922686 . Registered on 9 August 2016.

Dataset Information

The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan.

Background

Update

Discussion

Trial registration

Publications

The Active for Life Year 5 (AFLY5) school-based cluster randomised controlled trial protocol: detailed statistical analysis plan.

Similar Datasets

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