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Assessing the feasibility of evaluating and delivering a physical activity intervention for pre-school children: a pilot randomised controlled trial

Barber, S.E.; Jackson, C.; Hewitt, C.; Ainsworth, H.R.; Buckley, H.; Akhtar, S.; Bingham, D.D.; Routen, A.C.; Summerbell, C.; Richardson, G.; Moore, H.J.; Pickett, K.E.; O’Malley, C.; Brierley, S.; Wright, J.

Assessing the feasibility of evaluating and delivering a physical activity intervention for pre-school children: a pilot randomised controlled trial Thumbnail


Authors

S.E. Barber

C. Jackson

C. Hewitt

H.R. Ainsworth

H. Buckley

S. Akhtar

D.D. Bingham

A.C. Routen

G. Richardson

H.J. Moore

K.E. Pickett

C. O’Malley

S. Brierley

J. Wright



Abstract

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.

Citation

Barber, S., Jackson, C., Hewitt, C., Ainsworth, H., Buckley, H., Akhtar, S., …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), Article 12. https://doi.org/10.1186/s40814-016-0052-4

Journal Article Type Article
Acceptance Date Feb 5, 2016
Online Publication Date Feb 18, 2016
Publication Date Feb 18, 2016
Deposit Date Mar 8, 2016
Publicly Available Date Mar 8, 2016
Journal Pilot and Feasibility Studies
Publisher BioMed Central
Peer Reviewed Peer Reviewed
Volume 2
Issue 1
Article Number 12
DOI https://doi.org/10.1186/s40814-016-0052-4
Keywords Physical activity intervention, Pre-school children, Pilot randomised controlled trial, Process evaluation.

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Copyright 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.






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