Martinez‐Vizcaino 2014.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: schools in different municipalities in the province of Cuenca, Spain School exclusion criteria: — Student inclusion criteria: literate in Castilian Spanish, no physical or mental disorder identified by parents or teachers that would prevent student from doing PA, no chronic disease that paediatrician or family doctor considered would prevent student from participating in MOVI‐2, collaboration of a family member who would respond to questionnaires on lifestyle Student exclusion criteria: — Setting: school, mix Age group: children Gender distribution: females and males Country/Countries where trial was performed: Spain |
|
| Interventions |
Intervention: MOVI‐2 consisted of an extracurricular play‐based and non‐competitive PA programme. The primary objective of MOVI‐2 was to increase weekly PA while improving health‐related fitness. MOVI‐2 included basic sports games, traditional games, and other outdoor activities such as cycling or gymkhanas. The programme included two 90‐minute PA sessions during weekdays in the evening from 4:00 to 5:30 PM and one 150‐minute session on Saturday morning each week Comparator: standard PE curriculum (2 hours/week of PA at low to moderate intensity) Duration of intervention: 8 months Duration of follow‐up: 8 months Number of schools: 20 Theoretical framework: socioecological model |
|
| Outcomes | BMI | |
| Study registration | NCT01277224 (retrospectively registered) | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (research funding body) Publication status: peer‐reviewed journal |
|
| Stated aim for study | "Our study assessed the impact of a standardized PA program on adiposity and cardio metabolic risk in grades 4 and 5 schoolchildren. The program consisted of noncompetitive recreational activities focused on developing aerobic and muscular fitness" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: computer‐generated procedure |
| Allocation concealment (selection bias) | Low risk | Comment: opaque envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote from publication: "it was impossible to blind parents, children, and teachers to the existence of the intervention group program" |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote from publication: "although it was not possible to blind the investigators who measured other study variables at baseline and at the conclusion of the study as to trial group allocation, the analysts who processed and analysed the study data were blinded in this respect" |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: > 10% loss to follow‐up; reason not provided |
| Selective reporting (reporting bias) | Low risk | Comment: all outcomes reported in protocol described |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: students recruited after randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Quote from publication: "there were no statistically significant differences between intervention and control participants in any baseline characteristics" |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost [author communication] |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: clustering accounted for in analysis |