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A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention : ToyBox-Scotland.

Malden, Stephen and Reilly, John. J. and Gibson, Ann-Marie and Bardid, Farid and Summerbell, Carolyn and De Craemer, Marieke and Cardon, Greet and Androutsos, Odysseas and Manios, Yannis and Hughes, Adrienne (2019) 'A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention : ToyBox-Scotland.', Pilot and feasibility studies., 5 (1). p. 128.


Background High levels of childhood obesity have been observed globally over the last three decades. Preschools are promising settings to implement obesity prevention interventions in the early years. The aim of this study was to test the feasibility of a cluster randomised controlled trial of the ToyBox-Scotland preschool obesity prevention intervention. Methods Six preschools in predominantly deprived areas of Glasgow, UK, were randomised to either the ToyBox intervention (n = 3) or usual curriculum control group (n = 3). The intervention ran for 18 weeks from March–June 2018, and consisted of practitioner-led physical activity and sedentary behaviour sessions in preschools, with an additional interactive home component. Primary outcome measures were intervention fidelity, recruitment rates, attrition rates, and compliance with trial procedures. Secondary outcomes were body mass index (BMI) z-score, bioelectrical impedance analysis (BIA), objectively measured physical activity and sedentary time via activPAL accelerometer, and parent-reported home eating, snacking, and water consumption. Results The preschool component of the intervention was implemented with high fidelity (64%), while the home component was implemented with low fidelity (41%). A cluster-level recruitment rate of 10% was achieved, and the individual-level recruitment rate was 18% (42/233 children, mean age 4.4 years; 17 girls). The attrition rate was 14%, and compliance rates varied considerably by the outcome. Compliance was highest for BMI (86%), while 19% of the sample returned valid accelerometer data for both baseline and follow-up and the parental questionnaire response rate was 23%. Both intervention and control groups showed small increases in BMI z-scores at follow-up of 0.02 and 0.06, respectively. Both groups had small decreases in physical activity and increases in sedentary time at follow-up. Conclusions Before progression to an effectiveness trial, additional procedures should be considered to improve recruitment rates, compliance with outcome measures, and implementation of the home-based component of the ToyBox-Scotland intervention.

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Publisher statement:© The Author(s). 2019 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (, 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 ( applies to the data made available in this article, unless otherwise stated.
Date accepted:17 October 2019
Date deposited:25 November 2019
Date of first online publication:09 November 2019
Date first made open access:25 November 2019

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