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

Journal article

Malden, Stephen, Reilly, John, Gibson, Ann-Marie, Bardid, Farid, Summerbell, Carolyn, De Craemer, Marieke, Cardon, Greet, Androutsos, Odysseas, 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. Article 128. https://doi.org/10.1186/s40814-019-0521-7
AuthorsMalden, Stephen, Reilly, John, Gibson, Ann-Marie, Bardid, Farid, Summerbell, Carolyn, De Craemer, Marieke, Cardon, Greet, Androutsos, Odysseas, Manios, Yannis and Hughes, Adrienne
Abstract

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.

Trial registration
ISRCTN12831555

Keywordschildhood obesity; feasibility; physical activity; sedentary behaviour; prevention
Year2019
JournalPilot and Feasibility Studies
Journal citation5 (1), p. Article 128
PublisherBiomed Central Ltd
ISSN2055-5784
Digital Object Identifier (DOI)https://doi.org/10.1186/s40814-019-0521-7
PubMed ID31728203
Scopus EID2-s2.0-85074864967
PubMed Central IDPMC6842492
Open accessPublished as ‘gold’ (paid) open access
Research or scholarlyResearch
Page range1-11
FunderCunningham Trust
Publisher's version
License
File Access Level
Open
Output statusPublished
Publication dates
Online09 Nov 2019
Publication process dates
Accepted17 Oct 2019
Deposited22 Aug 2022
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