scholarly journals Correction:Adapting the ToyBox obesity prevention intervention for use in Scottish preschools: protocol for a feasibility cluster randomised controlled trial

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e023707corr1
Keyword(s):  
Randomised Controlled Trial ◽  
Obesity Prevention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Prevention Intervention ◽  
Cluster Randomised ◽  
Randomised Controlled

scholarly journals Adapting the ToyBox obesity prevention intervention for use in Scottish preschools: protocol for a feasibility cluster randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e023707 ◽  
Author(s):  
Stephen Malden ◽  
Adrienne R Hughes ◽  
Ann-Marie Gibson ◽  
Farid Bardid ◽  
Odysseas Androutsos ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Sedentary Behaviour ◽  
Obesity Prevention ◽  
Water Consumption ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionThere is an increasing need for the adoption of effective preschool obesity prevention interventions to combat the high levels of early-childhood obesity in the UK. This study will examine the feasibility and acceptability of the adapted version of the ToyBox intervention—a preschool obesity prevention programme—for use in Scotland (ToyBox-Scotland). This will inform the design of a full-scale cluster randomised controlled trial (RCT).Methods and analysisThe ToyBox-Scotland intervention will be evaluated using a feasibility cluster RCT, which involves children aged 3–5 years at six preschools in Glasgow, three randomly assigned to the intervention group and three to the usual-care control group. The original ToyBox intervention was adapted for the Scottish context using a coproduction approach. Within the 18-week intervention, physical activity and sedentary behaviour will be targeted in the preschool through environmental changes to the classroom, physical activity sessions and movement breaks. Parents will receive home activity packs every 3 weeks containing sticker incentives and interactive parent–child games that target sedentary behaviour, physical activity, eating/snacking and water consumption. As this is a feasibility study, parameters such as recruitment rates, attrition rates and SDs of outcome measures will be obtained which will inform a power calculation for a future RCT. Additional variables to be assessed include accelerometer-measured physical activity, sedentary behaviour and sleep, body mass index, home screen time, eating/snacking and water consumption. Outcomes will be assessed at baseline and 14–17 weeks later. Intervention fidelity will be assessed using questionnaires and interviews with parents and practitioners, observation and session delivery records.Ethics and disseminationThis study was granted ethical approval by the University of Strathclyde’s School of Psychological Sciences and Health Ethics Committee. Results will be disseminated through publication in peer-reviewed journals, presentation at conferences and in lay summaries provided to participants.Trial registration numberISRCTN12831555.

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

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Stephen Malden ◽  
John. J. Reilly ◽  
Ann-Marie Gibson ◽  
Farid Bardid ◽  
Carolyn Summerbell ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Obesity Prevention ◽  
Sedentary Time ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Recruitment Rate ◽  
Cluster Randomised ◽  
Randomised Controlled

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

scholarly journals Cluster-randomised controlled trial to assess the effectiveness and cost-effectiveness of an obesity prevention programme for Chinese primary school-aged children: the CHIRPY DRAGON study protocol

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e018415 ◽  
Author(s):  
Bai Li ◽  
Wei Jia Liu ◽  
Peymane Adab ◽  
Miranda Pallan ◽  
Karla Hemming ◽  
...  
Keyword(s):  
Cost Effectiveness ◽  
Childhood Obesity ◽  
Randomised Controlled Trial ◽  
Obesity Prevention ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Z Score ◽  
Usual Practice ◽  
Cluster Randomised ◽  
Randomised Controlled

IntroductionChildhood obesity in China has increased more rapidly and over a shorter time period than in other countries. However, there is a paucity of rigorously developed and evaluated prevention interventions. We aim to evaluate the clinical and cost-effectiveness as well as the implementation process of a complex multicomponent intervention developed using the UK Medical Research Council (MRC) framework. This study provides one of the first examples of rigorous development and evaluation of a childhood obesity prevention programme in a non-western population using the MRC methods.Methods and analysisA cluster-randomised controlled trial in 40 primary schools in Guangzhou, China, including children aged 6–7 years at baseline. Schools will be randomly allocated to either the usual practice (n=20) or intervention arm (n=20). The 12-month intervention consists of four components targeting diet and physical activity behaviours in and outside school, with family involvement. The primary objective is to compare the difference in mean body mass index (BMI) z-score between the intervention and control arms at the end of the intervention (starting March/April 2017). A sample size of 1640 pupils recruited from 40 schools is sufficient to detect a difference of 0.17 units in the mean BMI z-score with a power of 80% (ICC=0.01. ICC, intraclass correlation coefficient) and a significance level of 5%. Treatment effects will be tested using a mixed linear model in STATA adjusting for the child baseline BMI z-score and clustering by school. All analyses will be by intention to treat. Secondary analyses will additionally adjust for prespecified school-level and child-level covariates. The incremental cost-effectiveness ratio for the intervention versus usual practice will be ‘cost per quality-adjusted life year (QALY)’. Cost per change in BMI z-score will also be assessed. A range of methods will be used to evaluate intervention implementation, mechanisms of impact and contextual factors.Ethics and disseminationEthical approval was obtained from the Life and Health Sciences Ethical Review Committee at the University of Birmingham and the Ethical Committee of Guangzhou Centre for Disease Control and Prevention. The primary, secondary, process evaluation and economic evaluation results of the trial will be disseminated through relevant international peer-reviewed journals and conferences.Trial registration numberISRCTN11867516; Pre-results.

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