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A feasibility cluster randomised controlled trial of a preschool obesity prevention intervention: ToyBox-Scotland
Stephen Malden1, John J Reilly1, Ann-Marie Gibson1
11Physical Activity for Health Group, School of Psychological Sciences and Health, University of Strathclyde, Graham Hills Building, 40 George Street, Glasgow, G1 1XP UK.
Insights
The ToyBox-Scotland intervention showed low fidelity in home-based components and low recruitment rates, indicating a need for improvements before an effectiveness trial for childhood obesity prevention.
Area of Science:
- Public Health
- Pediatrics
- Obesity Prevention
Background:
- Childhood obesity is a global health concern, increasing over the past three decades.
- Preschools offer a critical setting for early-life obesity prevention strategies.
- The ToyBox-Scotland intervention aimed to address this issue in preschool settings.
Purpose of the Study:
- To assess the feasibility of the ToyBox-Scotland preschool obesity prevention intervention.
- To evaluate intervention fidelity, recruitment, attrition, and compliance.
- To examine effects on body mass index (BMI) and physical activity.
Main Methods:
- A cluster randomised controlled trial involving six Glasgow preschools (3 intervention, 3 control).
- The 18-week intervention included physical activity and sedentary behaviour sessions, plus a home component.
- Outcomes included fidelity, recruitment, attrition, BMI z-score, physical activity, and sedentary time.
Main Results:
- Preschool component fidelity was high (64%), but home component fidelity was low (41%).
- Recruitment rates were 10% at cluster level and 18% at individual level.
- Attrition was 14%; compliance varied, with BMI compliance at 86% but accelerometer data from only 19%.
Conclusions:
- Improvements are needed in recruitment, outcome measure compliance, and home-based component delivery.
- Further procedural adjustments are necessary before proceeding to an effectiveness trial.
- The study highlights challenges in implementing preschool interventions with home components.
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.
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