Dataset Information

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

ABSTRACT:

Introduction

There 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 analysis

The 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 dissemination

This 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 number

ISRCTN12831555.

SUBMITTER: Malden S

PROVIDER: S-EPMC6224766 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Publications

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

Malden Stephen S Hughes Adrienne R AR Gibson Ann-Marie AM Bardid Farid F Androutsos Odysseas O De Craemer Marieke M Manios Yannis Y Summerbell Carolyn C Cardon Greet G Reilly John J JJ

BMJ open 20181027 10

<h4>Introduction</h4>There 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).<h4>Methods and analysis</h4>The ToyBox- ...[more]

PMID: 30368450

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Project description:BackgroundHigh 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.MethodsSix 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.ResultsThe 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.ConclusionsBefore 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 registrationISRCTN12831555.

Project description:Background:In the UK and beyond, public funding is used to commission interventions delivered in public health early years settings aimed at improving health and well-being and reducing inequalities in order to promote school readiness. This is a key setting for obesity prevention programmes, which are often commissioned despite the limited evidence base. The HENRY (Health, Exercise, Nutrition for the Really Young) programme is an 8-week programme delivered to parents of preschool children, designed to support families to optimise healthy weight behaviours. Early evidence suggests that it may be effective, but a robust evaluation using a randomised controlled design has not been conducted. This study begins this process by evaluating the feasibility of conducting a multi-centre definitive trial to evaluate the effectiveness and cost-effectiveness of HENRY to prevent obesity in the early years. Methods:This is a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study aiming to recruit 120 parents from 12 children's centres, based in two local authority areas. Within each of the two local authorities, three centres will be randomised to HENRY and three will be randomised to a control arm of standard care (usual provision of services within children's centres). We will explore HENRY commissioning, provision and delivery and assess the feasibility of local authority, centre and parent recruitment, the processes and time required to train and certify staff to deliver the intervention, the potential sources (and associated risk) of contamination and the feasibility of the trial procedures. Research includes a process evaluation, feasibility of cost-effectiveness evaluation, with progression to the definitive trial judged against pre-defined criteria. Discussion:This feasibility study will support the decision to proceed to, and the design of, a future definitive trial, providing an evidence base of an approach to prevent childhood obesity, which has been deemed attractive to all stakeholders, including parents. Given the widespread adoption of the intervention, this has the potential to impact on public health in the UK and beyond. Trial registration:ClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017Protocol date: 25th October 2017Protocol version: 4.0.

Project description:BackgroundCommunity-based obesity prevention interventions are often commissioned despite the limited evidence base. HENRY (Health, Exercise, Nutrition for the Really Young) is a programme delivered to parents of preschool children across the UK. Early evidence suggests that it may be effective, but a robust evaluation has not been conducted. We initiated a systematic evaluation of HENRY by studying the feasibility of conducting a multi-centre definitive trial to evaluate its effectiveness and cost-effectiveness to prevent obesity. Objectives were to assess the feasibility of recruiting local authorities, centres and parents; test processes and time required to train and certify intervention staff; explore HENRY commissioning processes; identify potential sources (and associated impact) of contamination; and consider the feasibility of trial procedures.MethodsWe conducted a multi-centre, open labelled, two group, prospective, cluster randomised, controlled, feasibility study, with embedded process evaluation and pre-defined criteria for progression to definitive trial. We sought to recruit 120 parents from 12 children's centres, across two UK local authority (government) areas. Within each local authority, we planned to randomise three centres to HENRY and three to 'standard care' control. Our plan was to collect data in family homes at baseline and 12 months, including parent and child height and weight, and parent-reported questionnaires on self-efficacy, feeding, eating habits, quality of life and resource use. Contamination, implementation and study acceptability were explored using parent interviews.ResultsWe recruited two local authorities and 12 children's centres within eight months. One hundred and seventeen parents were recruited (average 3.9 parents per programme) and follow-up data were collected from 85% of participants. Process data from 20 parents and 24 members of staff indicate that both would benefit from more detail about their involvement as participants, but that methods were acceptable. Contamination was likely, though the impact of this on behaviour was unclear.ConclusionOur findings indicate that a cluster RCT of HENRY to assess its effect on childhood obesity prevention is feasible. This study has allowed us to design a pragmatic definitive trial with minimal bias, taking account of lessons learnt from conducting evaluation research in public health settings.Trial registrationClinicalTrials.gov Identifier NCT03333733 registered 6th November 2017.

Project description:BackgroundThe value of cardiac rehabilitation (CR) after a transient ischaemic attack (TIA) or minor stroke is untested despite these conditions sharing similar pathology and risk factors to coronary heart disease. We aimed to evaluate the feasibility of conducting a trial of an adapted home-based CR programme, 'The Healthy Brain Rehabilitation Manual', for patients following a TIA/minor stroke, participants' views on the intervention and, to identify the behaviour change techniques (BCTs) used.MethodsClinicians were asked to identify patients attending the Ulster Hospital, Belfast within 4 weeks of a first TIA or minor stroke. Those who agreed to participate underwent assessments of physical fitness, cardiovascular risk, quality of life and mental health, before random allocation to: Group (1) standard/usual care; (2) rehabilitation manual or (3) manual plus pedometer. All participants received telephone support at 1 and 4 weeks, reassessment at 6 weeks and an invitation to a focus group exploring views regarding the study. Two trained review authors independently assessed the manual to identify the BCTs used.ResultsTwenty-eight patients were invited to participate, with 15 (10 men, 5 women; 9 TIA, 6 minor stroke; mean age 69 years) consenting and completing the study. Mean time to enrolment from the TIA/stroke was 20.5 days. Participants completed all assessment measures except VO2max testing, which all declined. The manual and telephone contact were viewed positively, as credible sources of advice. Pedometers were valued highly, particularly for goal-setting. Overall, 36 individual BCTs were used, the commonest being centred around setting goals and planning as well as social support.ConclusionRecruitment and retention rates suggest that a trial to evaluate the effectiveness of a novel home-based CR programme, implemented within 4 weeks of a first TIA/minor stroke is feasible. The commonest BCTs used within the manual revolve around goals, planning and social support, in keeping with UK national guidelines. The findings from this feasibility work have been used to further refine the next stage of the intervention's development, a pilot study.Trial registrationClinicalTrials.gov Identifier: NCT02712385 . This study was registered prospectively on 18/03/2016.

Project description:Childhood obesity is not only associated with adult obesity but also with increased risk of adult onset of type 2 diabetes and subsequent coronary heart disease. The potential effects of school-based health intervention programmes on cardiovascular risk and surrogate markers are unclear, as only few studies have attempted to investigate a complete risk profile including a detailed laboratory analysis or micro- and macrovascular function. In this study a comprehensive school-based randomized intervention programme will be investigated in 10-14-year old children addressing the influence of lifestyle intervention on inactivity, cardiometabolic risk factors and early signs of vascular disease.15 secondary schools in Southern Germany are randomly assigned to intervention or control schools. Children in the fifth grade (10-11 years) will be observed over four years. The study combines a school-based with a home-based approach, aiming at children, teachers and parents. The main components are weekly lifestyle-lessons for children, taught by regular classroom teachers to increase physical activity in- and outside of school, to improve eating patterns at school and at home, to reduce media consumption and to amplify well-being. In 4-6 annual meetings, teachers receive information about health-related topics with worksheets for children and supporting equipment, accounting for school-specific needs and strategies. Parents' trainings are provided on a regular basis.All examinations are performed at the beginning and at the end of every school year. Anthropometry includes measurements of BMI, waist and upper arm circumferences, skinfold thickness as well as peripheral blood pressure. Blood sampling includes lipid parameters, insulin, glucose, hsCRP, adiponectin, and IL-6 as well as testosteron and estrogen to determine maturation status. Vascular function is non-invasively assessed by measuring arterial stiffness in large arteries using a sphygmograph and by analysing arteriolar and venular diameters in the retinal microcirculation using a non-mydriatric vessel analyser. A questionnaire is filled out to determine daily physical activity, motivational factors, dietary habits, quality of life (KINDL-R) and socio-economic data. Physical fitness is assessed by a six-item test battery.Our study aims to provide a feasible long-term intervention strategy to re-establish childhood health and to prevent obesity-related cardiovascular dysfunction in children.NCT00988754.

Project description:Multi-level, longer-term obesity prevention interventions that focus on inequalities are scarce. Fun 'n healthy in Moreland! aimed to improve child adiposity, school policies and environments, parent engagement, health behaviours and child wellbeing.All children from primary schools in an inner urban, culturally diverse and economically disadvantaged area in Victoria, Australia were eligible for participation. The intervention, fun 'n healthy in Moreland!, used a Health Promoting Schools Framework and provided schools with evidence, school research data and part time support from a Community Development Worker to develop health promoting strategies. Comparison schools continued as normal. Participants were not blinded to intervention status. The primary outcome was change in adiposity. Repeated cross-sectional design with nested longitudinal subsample.Students from twenty-four primary schools (clusters) were randomised (aged 5-12 years at baseline). 1426 students from 12 intervention schools and 1539 students from 10 comparison schools consented to follow up measurements. Despite increased prevalence of healthy weight across all schools, after 3.5 years of intervention there was no statistically significant difference between trial arms in BMI z score post-intervention (Mean (sd): Intervention 0.68(1.16); Comparison: 0.72(1.12); Adjusted mean difference (AMD): -0.05, CI: -0.19 to 0.08, p = 0.44). Children from intervention schools consumed more daily fruit serves (AMD: 0.19, CI:0.00 to 0.37, p = 0.10), were more likely to have water (AOR: 1.71, CI:1.05 to 2.78, p = 0.03) and vegetables (AOR: 1.23, CI: 0.99 to 1.55, p = 0.07), and less likely to have fruit juice/cordial (AOR: 0.58, CI:0.36 to 0.93, p = 0.02) in school lunch compared to children in comparison schools. More intervention schools (8/11) had healthy eating and physical activity policies compared with comparison schools (2/9). Principals and schools highly valued the approach as a catalyst for broader positive school changes. The cost of the intervention per child was $65 per year.The fun n healthy in Moreland! intervention did not result in statistically significant differences in BMI z score across trial arms but did result in greater policy implementation, increased parent engagement and resources, improved child self-rated health, increased fruit, vegetable and water consumption, and reduction in sweet drinks. A longer-term follow up evaluation may be needed to demonstrate whether these changes are sustainable and impact on childhood overweight and obesity.ACTRN12607000385448 (Date submitted 31/05/2007; Date registered 23/07/2007; Date last updated 15/12/2009).

Dataset Information

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

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

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

Similar Datasets

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