Farmer 2017.
Study characteristics | ||
Methods |
Trial name: PLAY Study design: cluster‐RCT Intervention duration: 2 years Length of follow‐up from baseline: measurements were obtained at baseline, 1 year (2–3 months after changes to the intervention school play environments) and 2 years (follow‐up) Differences in baseline characteristics: none Unit of allocation: pairs of schools were created by matching for region, school roll and decile ranking, and were randomly assigned to intervention or control by tossing a coin. Unit of analysis Implementation outcomes: schools Behavioural/health outcomes: children |
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Participants |
School type: state primary schools Region: Auckland and Otago, New Zealand Demographics/socioeconomic characteristics: eligibility criteria required a school decile ranking 1–6. Also stated they recruited less‐advantaged schools; however, no further details were provided Inclusion/exclusion criteria Inclusion ‐ State primary schools (years 1–8 that were fully funded by the state and coeducational) with ≥ 150 pupils, and a school decile ranking of 1–6. New Zealand schools are ranked into deciles from 1 to 10, where 1 indicates the 10% of schools with the highest proportion of pupils from low socioeconomic areas and decile 10 indicates the 10% of schools with the lowest proportion. 11 schools met these criteria within the Otago region and 31 in Waitakere City (within the Auckland region). Exclusion ‐ Although all children in intervention schools were exposed to the intervention, only children in school years 2 and 4 were invited to participate in outcome assessments. Number of schools allocated Schools:8 intervention, 8 control Students:902 (444 control, 458 intervention) Numbers by trial group n (controls baseline) = 8 schools, 422 students n (controls follow‐up) = 8 schools, 369 children at 1 year, 325 children at 2 years n (interventions baseline) = 8 schools, 418 students n (interventions follow‐up) = 8 schools, 391 students at 1 year, 344 at 2 years Recruitment Schools:16 primary schools in the Otago (8 schools) and Auckland (8 schools) regions of New Zealand. 11 schools were approached in Otago and 10 in Auckland and recruitment stopped once 16 schools (8 in each region) provided informed consent to participate (November 2010 to March 2011). Students:children in school years 2 and 4 were invited to participate in outcome assessments. These years were chosen pragmatically to cover a wide age range (typically ages 6–9 years) and enable 2‐year outcomes to be collected. Information sheets and consent forms were sent home with all children in these year groups from each school, and signed consent was obtained from parents. Recruitment rate Schools:76% Students:50.5% |
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Interventions |
Number of experimental conditions: 2 (1 intervention and 1 control) Policies, practices or programmes targeted by the intervention PA policies within their school included; break time; using PA as a punishment; promotion of community activities; adequacy and availability of facilities during school/after hours; enjoyment and promotion of PA regardless of skill level; and amount and quality of PE safety issues. Implementation strategies EPOC: tailored interventions ‐ Each intervention school was provided with a list of tailored suggestions for improvements. EPOC: external funding ‐ Provision of funding to change environment… intervention schools were provided with initial start‐up funds of NZD15,000. EPOC: local consensus processes ‐ Researchers, play workers and school community worked together to develop a playground action plan that met the needs of each school community. EPOC: audit and feedback ‐ Baseline evaluations of their play space, each intervention school was provided with a list of tailored suggestions for improvements. Theoretical underpinning ‐ Of the evidence‐based intervention/policy/practice or programme: not reported ‐ Of the implementation strategy: not reported Description of control: usual care |
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Outcomes |
Outcome relating to the implementation of school policies, practices or programmes: evaluation of play environment (objective) Data collection method: qualified play workers conducted an evaluation of schedule of 7 items rating opportunities for 1. risk and challenge, 2. engagement with natural elements, 3. ability to actively manipulate and change the play environment (e.g. loose parts), 4. wheeled play (e.g. bicycles and skateboards), 5. ball games, 6. children to socialise and 7. quality of independent access (no restrictions on the ability to access all parts of the school). Each item was scored from 1 (very poor) to 5 (excellent) and an overall score was determined for the whole school play environment (maximum score of 35). Validity of measures used: not reported Outcome relating to cost: not reported Outcome relating to adverse consequences: not reported Outcome relating to child diet, PA or weight status: height, weight, BMI and accelerometer data Data collection method ‐ Children's height, weight and waist circumference were measured in light clothing without shoes using standard techniques during school time. Height was measured using a portable stadiometer (seca 213, Hamburg, Germany) and weight using electronic scales (seca 813, Seca, Seca 213, Hamburg, Germany). Waist circumference was measured at the umbilicus using a non‐elastic tape (Lufkin 2 m Executive Thinline w606PM, Apex Tool Group, Sparks, MD, USA). All measures were obtained in duplicate with a third undertaken if the first and second measures did not fall within the maximum allowable difference (0.5 cm for height, 0.5 kg for weight and 1.0 cm for waist), and the mean taken from the 2 closest measurements. BMI z‐scores were calculated using World Health Organization reference data. ‐ All children wore an accelerometer (ActiGraph GT3X, Actigraph Corp, Pensacola, Florida, USA) 24 hours per day for 7 days, positioned over the right hip (accelerometers were removed for bathing, showering and water‐based activities). Accelerometers were initialised using ActiLife (version 6, Actigraph Corp) in uniaxial mode using 15‐second epochs. Data were cleaned and scored using an automated script developed in MATLAB (MathWorks, Natick, Massachusetts, USA) that removes the appropriate sleep period for each day for each child individually, to avoid sleep being misclassified as sedentary time. A day was considered valid if there were ≥ 8 valid awake hours. Non‐wear time (awake hours only) was defined as ≥ 20 minutes of consecutive 0s. Validity of measures used: validated BMI z‐scores were calculated using World Health Organization reference data. Validated activity intensities were calculated using the Evenson cut‐points developed for children aged 5–8 years. |
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Notes |
Research funding: the PLAY study was funded by the Health Research Council of New Zealand and the Otago Diabetes Research Trust. Conflicts of interest: the authors declared no conflicts of interest. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Cluster‐RCT. Schools were randomised to intervention or control conditions. Pairs of schools were created by matching for region, school roll and decile ranking, and were randomly assigned to intervention or control by tossing a coin. |
Allocation concealment (selection bias) | High risk | No blinding or concealment. |
Blinding of participants and personnel (performance bias) Implementation outcome | High risk | The nature of the trial precluded blinding, as intervention schools and students would know they were receiving an intervention and changing from usual practices. Outcome: objective measure (BMI) Low: blinding would not impact objective measure. |
Blinding of outcome assessment (detection bias) Implementation outcome | High risk | Outcome group: principal (implementation outcome). High: self‐report was considered high risk. Outcome group: child PA and BMI. Low: researchers blinded to group allocation. |
Incomplete outcome data (attrition bias) Implementation outcome | Unclear risk | Outcome group: policy outcome data. Unclear: unclear where they reported this, only the aspect of the play space. Did not provide information on loss to follow‐up for principals. Outcome group: child PA and BMI. Unclear: unclear how many participants had the accelerometer data removed from analysis. ITT analysis used. |
Selective reporting (reporting bias) | High risk | Protocol did not include implementation data as an outcome even though this was a primary outcome. |
Other bias | Low risk | Did not appear to be at risk of contamination or other biases. |
Recruitment to cluster | Unclear risk | Unclear when recruitment of students took place. |
Baseline imbalance | Low risk | Pairs matched to minimise baseline imbalance. Similar characteristics between groups at baseline though nothing reported for baseline characteristics of principals (implementation outcome). |
Loss of cluster | Unclear risk | Outcome group: principal (implementation outcome), Unclear: did not report loss of principal. Outcome group: student outcome. Unclear: unclear where the number of participants were lost from, did not report a loss of cluster but did not report the number range in each cluster. |
Incorrect analysis | Low risk | Adjusted for clustering. |
Compatibility with individually randomised RCTs | Unclear risk | Unclear, no statement on this. |
Overall risk of bias assessment | Unclear risk | Most domains were at unclear risk of bias. |