Sacchetti 2013.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: — School exclusion criteria: — Student inclusion criteria: Grade 3 Student exclusion criteria: — Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: Italy |
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| Interventions |
Intervention: PA consisted of at least 30 minutes of physical exercise/d, divided between schoolyard (vigorous activity) and classroom (moderate activity). Twice weekly, a further 50 minutes of PE was spent in the gym, according to the standard curriculum of PE. On average, then, during school hours, children were engaged for around 45 minutes in specific PA, which was moderate Comparator: control group followed the standard programme of PE involving 2 lessons of around 50 minutes/week in the gym, taught by the ordinary classroom teacher Duration of intervention: 2 years Duration of follow‐up: 2 years Number of schools: 26 Theoretical framework: — |
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| Outcomes | BMI | |
| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (governmental organisation) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The aim of this study was to assess whether a school‐based intervention of PA education was effective in improving physical abilities and influencing physical behavior in a representative group of primary school children. As a second aspect, the possible effect on body weight was considered. In the study, we compared the PA habits, the physical performances, and BMI measurements in an intervention group and a control group of children at baseline (age: 8 to 9 years) and after a 2‐year follow‐up (age: 10 to 11 years)" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: computerised random number generator [author communication] |
| Allocation concealment (selection bias) | Low risk | Comment: allocation was concealed from participants and/or study personnel prior to randomisation [author communication] |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: students not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: outcome assessors were not blinded [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Quote from publication: "any loss to follow‐up was due to children who moved to other schools (14.2% and 13.9% respectively in intervention and control groups)" |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol published |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: clusters randomised before individuals recruited |
| Cluster RCT ‐ Baseline imbalance | Low risk | Quote from publication: "both in boys and girls, no significant differences were found between the intervention and control groups in age, BMI, and frequency and duration of the practice of extra scholastic sports" |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no loss of clusters reported |
| Cluster RCT ‐ Incorrect analysis | High risk | Comment: clustering not accounted for in analysis |