Muros 2015.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: rural environment and similar socioeconomic status School exclusion criteria: — Student inclusion criteria: 10 to 11 years old Student exclusion criteria: — Setting: school, rural Age group: children Gender distribution: females and males Country/Countries where trial was performed: Spain |
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| Interventions |
Intervention 1: intervention consisted of 60‐minute sessions of PA held twice per week. PA was controlled by means of heart rate monitoring. The aim of the training sessions was to improve aerobic capacity using PAs specifically targeted for health gains such as motor skills, games, and sports. Play was used in all activities to motivate students and achieve the desired level of PA. All games and tasks were designed and developed by a group of experts in education and sports science and were directed by the same supervisor Intervention 2: PA and nutritional educational interventions combined Intervention 3: the same intervention as PA and nutritional educational intervention group and replaced the oil that they normally consumed with extra virgin olive oil during the final month of the intervention Compartor 1: nutritional educational sessions informed participants about the benefits of a Mediterranean diet (high fruit, vegetables, legumes, fish, cereals, and unsaturated‐to‐saturated fat ratio, and low meat, meat products, and dairy products) and lifestyle. Nutritional education involved both parents and students. One or both parents could attend the sessions. It was compulsory for pupils to attend both nutrition sessions held during school time Comparator 2: continued with their usual activities Duration of intervention: 6 months Duration of follow‐up: 6 months Number of schools: 5 Theoretical framework: — |
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| Outcomes | Fitness BMI |
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| Study registration | — | |
| Publication details |
Language of publication: English Funding: non‐commercial funding (charitable trust) Publication status: peer‐reviewed journal |
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| Stated aim for study | "The aim of our study was to investigate the effects of 4 experimental conditions and 1 no intervention control group on health‐related parameters, such as the lipid, physiological and anthropometric profiles of children" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: computer‐generated random numbers [author communication] |
| Allocation concealment (selection bias) | Low risk | Comment: researchers could not know the intervention assignment [author communication] |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: participants not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: for all outcomes, investigators were blinded to grouping |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: only 56% of participants have end of study measures; reasons not reported |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol published |
| Cluster RCT ‐ Recruitment bias | Low risk | Comment: students and parents enrolled before randomisation |
| Cluster RCT ‐ Baseline imbalance | High risk | Comment: groups imbalanced at baseline; not controlled for |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost (only 1/group) |
| Cluster RCT ‐ Incorrect analysis | High risk | Comment: clustering not accounted for in analysis |