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A Cluster Randomised Controlled Trial of an Intervention to Increase Physical Activity of Preschool-Aged Children Attending Early Childhood Education and Care: Study Protocol for the 'Everybody Energise' Trial.

ABSTRACT: The use of 'Energisers,' short bouts of moderate-to-vigorous physical activity (MVPA), have been shown to significantly increase children's physical activity within the school setting but not within Early Childhood Education and Care (ECEC) centres. The aim of this study is to assess the efficacy of an intervention involving the provision of educator-led daily Energisers to increase the time children spend in MVPA while attending ECEC. Fourteen ECEC centres in the Hunter region of New South Wales, Australia, will be randomised to either an intervention or control group. The intervention group will be supported by the research team to implement three brief (5-min) educator-led Energisers each day for children aged three to six years between the hours of 9:00 a.m. to 3.00 p.m. Control ECEC centres will continue to provide 'normal practice' to children. The primary trial outcome is child minutes of MVPA whilst in ECEC, assessed objectively via accelerometery over three days. Outcome assessment will occur at baseline and 6 months post-baseline. Linear mixed models under an intention-to-treat framework will be used to compare differences between groups in MVPA at follow-up. This will be the first cluster randomised controlled trial to test the efficacy of Energisers in isolation on increasing the time children spend in MVPA.

SUBMITTER: Delaney T

PROVIDER: S-EPMC6862613 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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A Cluster Randomised Controlled Trial of an Intervention to Increase Physical Activity of Preschool-Aged Children Attending Early Childhood Education and Care: Study Protocol for the 'Everybody Energise' Trial.

Delaney Tessa T Jackson Jacklyn K JK Jones Jannah J Hall Alix A Dives Ashleigh A Wedesweiler Taya T Campbell Libby L Nathan Nicole N Romiti Maria M Trost Stewart G SG Lum Melanie M Colliver Yeshe Y Hernandez Lara L Yoong Sze Lin SL

International journal of environmental research and public health 20191104 21

The use of 'Energisers,' short bouts of moderate-to-vigorous physical activity (MVPA), have been shown to significantly increase children's physical activity within the school setting but not within Early Childhood Education and Care (ECEC) centres. The aim of this study is to assess the efficacy of an intervention involving the provision of educator-led daily Energisers to increase the time children spend in MVPA while attending ECEC. Fourteen ECEC centres in the Hunter region of New South Wale ...[more]

PMID: 31689905

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Project description:The need for excess weight gain prevention in disadvantaged young children is widely recognised. Early Childhood Education and Care teachers are potential key actors in early interventions to prevent overweight and obesity. This study examines the effects of a preschool-based intervention for teachers in promoting healthy eating and physical activity in young children. A cluster randomised controlled trial was conducted at 41 preschools in a deprived area of Amsterdam, The Netherlands. The intervention consisted of 2 programmes that were applied in succession: A Healthy Start and PLAYgrounds for TODdlers. The study period was 9 months. Primary outcomes were assessed via questionnaires and included teachers' knowledge, attitude, food/activity-related practices, and level of confidence in promoting healthy behaviours. Secondary outcomes in this study were teachers' and children's BMI (z-score), body composition, dietary intake and physical activity level. Intention-to-treat analyses were performed using linear mixed models. In total, 115 teachers and 249 children (mean age 3.0 (0.2) years) were included. A positive effect on teachers' knowledge about the Dutch dietary guidelines was found after the programme A Healthy Start (difference = 1.38; 1-sided 95% CL = 0.29; p = 0.02). This effect was not sustained at 9 months (difference = 0.34; 1-sided 95% CL = -0.76; p = 0.31). The overall intervention had a positive effect on 3 of the 5 attitude statements regarding a healthy lifestyle (difference ranged from 0.34 to 0.55) and on the practice scale Activity-related-Modelling (difference = 0.16; 1-sided 95% CL = 0.06; p = 0.01). No intervention effects were observed on food-related practice scales and the level of confidence in promoting healthy behaviours. At this stage, no effects were seen on teachers' and children's BMI (z-score). This study contributes to the professional development of Early Childhood Education and Care teachers and addresses the call for interventions to prevent overweight/obesity and to minimise health inequalities in young children.

Project description:BACKGROUND:The United Nation's Sustainable Development Goals encompass lifelong learning from birth to youth to adulthood (Goal 4) and economic opportunities for young people (Goal 8). The targets include improving access to quality early childhood care and education (ECCE) as well as learning and training opportunities for adolescents and youth. Cross-generational models for young children and youth may offer opportunities to address the interconnections between goals and targets for the next generation. We investigated whether an ECCE programme for young children (3.5-6.5 years) delivered by female youth (18-24 years) in rural Pakistan would be effective on children's school readiness. METHODS:In partnership with the National Commission for Human Development in Pakistan, we implemented the 'Youth Leaders for Early Childhood Assuring Children are Prepared for School' (LEAPS) programme to train female youth to deliver ECCE. The effectiveness of the LEAPS programme on children's school readiness was evaluated in a cluster-randomised controlled trial. We randomly allocated five clusters (villages) to receive the intervention (n = 170 children) and five clusters to control (n = 170 children). Children's school readiness was assessed after nine months of intervention exposure using the International Development and Early Learning Assessment tool. Analyses was by intention-to-treat. The trial is registered with ClinicalTrials.gov, number NCT02645162. FINDINGS:At endline, the intervention group had significantly higher school readiness scores (n = 166, mean percentage score 59.4, 95% CI 52.7 to 66.2) compared with the control group (n = 168, mean percentage score 45.5, 95% CI 38.8 to 52.3). The effect size (Cohen's d) was 0.3. CONCLUSION:Trained female youth delivered an ECCE programme that was effective in benefitting young children's school readiness. The cross-generational model is a promising approach to support early child development; however, further evaluation of the model is needed to assess the specific benefits to youth including their skills and economic development.

Project description:BackgroundParticipation in outdoor play has been extensively documented as beneficial for the health, well-being, and development of children. Canadian early childhood education centers (ECECs) are important settings in young children's lives and provide opportunities to participate in outdoor play. However, there are barriers to the provision of outdoor play opportunities at ECECs, such as adverse weather conditions, poorly designed outdoor spaces, outdoor time policies, and early childhood educator comfort levels.ObjectiveThe PROmoting Early Childhood Outside (PRO-ECO) study is a wait-list control cluster randomized trial that evaluates the impact of the PRO-ECO intervention, an innovative outdoor play intervention, on children's outdoor play behavior. The purpose of this paper was to provide a detailed overview of the pilot study protocol and the methods that will be used to develop, implement, and evaluate the PRO-ECO intervention.MethodsA total of 8 ECECs delivering licensed care to children aged 2.5 to 6 years in the Greater Vancouver region of British Columbia, Canada, and operated by the YMCA of Greater Vancouver (YMCA GV) are included in this study. Using a wait-list control cluster randomized trial design, we randomly allocated ECECs to either the PRO-ECO intervention arm (n=4) or the wait-list control arm (n=4). The primary outcome measures include changes in the proportion and diversity of observed outdoor play behavior during dedicated outdoor times at the ECECs as measured through observational behavior mapping. Secondary outcome measures include changes in educator attitudes; quality of ECECs' outdoor play space; and children's psychosocial strengths, physical activity levels, and social behaviors. A process evaluation of the acceptability of the PRO-ECO intervention in the 8 YMCA GV ECECs will also be assessed. Outcome data will be collected at baseline, 6-month follow-up, and 12-month follow-up. Mixed effect models will test the effect of the PRO-ECO intervention on quantitative outcomes. Baseline and postintervention data will be included in the analysis, controlling for the cluster design. Qualitative data will support quantitative findings and provide evidence for the acceptability of implementation.ResultsParticipant recruitment for this study began in August 2021, and baseline data collection was completed at all 8 ECECs in November 2021. As of April 2022, a total of 130 children have been recruited to participate in this study.ConclusionsThe PRO-ECO pilot study will develop, implement, and evaluate the PRO-ECO intervention within 8 YMCA GV ECECs in the Vancouver region of British Columbia, Canada. The findings of this study will be useful for early childhood educators, ECEC providers, and policy makers to consider means for enhancing outdoor play provision and assessing the sustainability of the intervention in ECEC settings.Trial registrationClinicalTrials.gov NCT05075580; https://clinicaltrials.gov/ct2/show/NCT05073380.International registered report identifier (irrid)DERR1-10.2196/38365.

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:BackgroundElectronic health (eHealth) obesity programs offer benefits to traditionally delivered programs and have shown promise in improving obesity-related behaviors in children.ObjectiveThis study aimed to assess the efficacy of a parent-focused, internet-based healthy lifestyle program for preschool-aged children, who are overweight or at or above the fiftieth percentile for body mass index (BMI) for their age and sex, on child BMI, obesity-related behaviors, parent modeling, and parent self-efficacy.MethodsThe Time2bHealthy randomized controlled trial was conducted in Australia, during 2016 to 2017. Participants were recruited both online and through more traditional means within the community. Parent or carer, and child (aged 2-5 years) dyads were randomized into an intervention or comparison group. Intervention participants received an 11-week internet-based healthy lifestyle program, underpinned by social cognitive theory, followed by fortnightly emails for 3 months thereafter. Intervention participants set goals and received individual feedback from a dietitian. They were also encouraged to access and contribute to a closed Facebook group to communicate with other participants and the dietitian. Comparison participants received email communication only. Objectively measured child BMI was the primary outcome. Secondary outcomes included objectively measured physical activity, parent-measured and objectively measured sleep habits, and parent-reported dietary intake, screen time, child feeding, parent modeling, and parent self-efficacy. All data were collected at face-to-face appointments at baseline, 3 months, and 6 months by blinded data collectors. Randomization was conducted using a computerized random number generator post baseline data collection.ResultsA total of 86 dyads were recruited, with 42 randomized to the intervention group and 44 to the comparison group. Moreover, 78 dyads attended the 3- and 6-month follow-ups, with 7 lost to follow-up and 1 withdrawing. Mean child age was 3.46 years and 91% (78/86) were in the healthy weight range. Overall, 69% (29/42) of participants completed at least 5 of the 6 modules. Intention-to-treat analyses found no significant outcomes for change in BMI between groups. Compared with children in the comparison group, those in the intervention group showed a reduced frequency of discretionary food intake (estimate -1.36, 95% CI -2.27 to -0.45; P=.004), and parents showed improvement in child feeding pressure to eat practices (-0.30, 95% CI 0.06 to -0.00; P=.048) and nutrition self-efficacy (0.43, 95% CI 0.10 to 0.76; P=.01). No significant time by group interaction was found for other outcomes.ConclusionsThe trial demonstrated that a parent-focused eHealth childhood obesity prevention program can provide support to improve dietary-related practices and self-efficacy but was not successful in reducing BMI. The target sample size was not achieved, which would have affected statistical power.Trial registrationAustralian New Zealand Clinical Trials Registry ANZCTR12616000119493; https://www.anzctr.org.au/ Trial/Registration/TrialReview.aspx?id=370030 (Archived by WebCite at http://www.webcitation.org/74Se4S7ZZ).

Project description:BackgroundInfluenza is an important cause of morbidity and mortality for frail older people. Whilst the antiviral drug oseltamivir (a neuraminidase inhibitor) is approved for treatment and prophylaxis of influenza during outbreaks, there have been no trials comparing treatment only (T) versus treatment and prophylaxis (T&P) in Aged Care Facilities (ACFs). Our objective was to compare a policy of T versus T&P for influenza outbreaks in ACFs.Methods and findingsWe performed a cluster randomised controlled trial in 16 ACFs, that followed a policy of either "T"-oseltamivir treatment (75 mg twice a day for 5 days)-or "T&P"-treatment and prophylaxis (75 mg once a day for 10 days) for influenza outbreaks over three years, in addition to enhanced surveillance. The primary outcome measure was the attack rate of influenza. Secondary outcomes measures were deaths, hospitalisation, pneumonia and adverse events. Laboratory testing was performed to identify the viral cause of influenza-like illness (ILI) outbreaks. The study period 30 June 2006 to 23 December 2008 included three southern hemisphere winters. During that time, influenza was confirmed as the cause of nine of the 23 ILI outbreaks that occurred amongst the 16 ACFs. The policy of T&P resulted in a significant reduction in the influenza attack rate amongst residents: 93/255 (36%) in residents in T facilities versus 91/397 (23%) in T&P facilities (p=0.002). We observed a non-significant reduction in staff: 46/216 (21%) in T facilities versus 47/350 (13%) in T&P facilities (p=0.5). There was a significant reduction in mean duration of outbreaks (T=24 days, T&P=11 days, p=0.04). Deaths, hospitalisations and pneumonia were non-significantly reduced in the T&P allocated facilities. Drug adverse events were common but tolerated.ConclusionOur trial lacked power but these results provide some support for a policy of "treatment and prophylaxis" with oseltamivir in controlling influenza outbreaks in ACFs.Trial registration[corrected] Australian Clinical Trials Registry ACTRN12606000278538.

Dataset Information

A Cluster Randomised Controlled Trial of an Intervention to Increase Physical Activity of Preschool-Aged Children Attending Early Childhood Education and Care: Study Protocol for the 'Everybody Energise' Trial.

Publications

A Cluster Randomised Controlled Trial of an Intervention to Increase Physical Activity of Preschool-Aged Children Attending Early Childhood Education and Care: Study Protocol for the 'Everybody Energise' Trial.

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