Barber, S.E. and Jackson, C. and Hewitt, C. and Ainsworth, H.R. and Buckley, H. and Akhtar, S. and Bingham, D.D. and Routen, A.C. and Summerbell, C. and Richardson, G. and Moore, H.J. and Pickett, K.E. and O’Malley, C. and Brierley, S. and Wright, J. (2016) 'Assessing the feasibility of evaluating and delivering a physical activity intervention for pre-school children : a pilot randomised controlled trial.', Pilot and feasibility studies., 2 (1). p. 12.
Background: Few evidence-based physical activity interventions for pre-school children are available. This two-armed pilot cluster randomised controlled trial aimed to evaluate the feasibility of conducting a full-scale trial and of delivering an outdoor physical activity intervention for pre-school children. Methods: School was the unit of randomisation, and follow-up occurred at 10 and 52 weeks. Trial feasibility was assessed by recruitment, retention and completion rates of primary (daily moderate-to-vigorous physical activity (MVPA)) and secondary (anthropometric, quality of life, self-efficacy) outcomes. Potential effectiveness was assessed for the primary outcome using a linear regression model comparing MVPA between trial arms adjusting for clustering by school. Feasibility of delivering the intervention was assessed by intervention fidelity and attendance. Semi-structured interviews with parents, intervention facilitators, and head teachers explored acceptability and capability to deliver the intervention as well as acceptability of the study design. Results: Recruitment rates were 37 % of schools (n = 10 schools) and 48 % of pre-school children (n = 164 children). Retention of children to the trial at 52 weeks was 83.5 %. Thirty-nine percent of children had valid primary outcome accelerometer data at baseline and 52 weeks. Response rates for secondary outcome measures ranged from 52 to 88 % at 10 weeks and 59 to 80 % at 52 weeks. The mean difference in daily MVPA between trial arms at 52 weeks was 0.4, 95 % CI 16.3 to 17.0; p = 0.96. Fidelity of intervention implementation was 81 %. Intervention attendance was higher (82 %) during the summer initiation phase compared to autumn/spring initiation (50 %). Parents, facilitators and head teachers found the intervention acceptable and beneficial. Conclusions: Recruitment and retention rates suggest a trial in this outdoor setting with this population was feasible but is weather sensitive. However, strategies to increase accelerometer wear-time would need to be implemented for reliable primary outcome data to be obtained. There was high implementation fidelity by facilitators, and the intervention was seen as acceptable and deliverable. However, attendance was low and preliminary data showed no evidence of intervention effectiveness. A revised intervention, building on the successful elements of this pilot alongside adapting implementation strategies to improve attendance, should therefore be considered.
|Keywords:||Physical activity intervention, Pre-school children, Pilot randomised controlled trial, Process evaluation.|
|Full text:||(AM) Accepted Manuscript|
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|Publisher Web site:||http://dx.doi.org/10.1186/s40814-016-0052-4|
|Publisher statement:||© 2016 Barber et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.|
|Date accepted:||05 February 2016|
|Date deposited:||08 March 2016|
|Date of first online publication:||18 February 2016|
|Date first made open access:||No date available|
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