Pablos 2018.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: public (government‐funded) schools in urban areas School exclusion criteria: — Student inclusion criteria: in Grade 5 or 6 and not enrolled in any other research study Student exclusion criteria: — Setting: school, urban Age group: children Gender distribution: females and males Country where trial was performed: Spain |
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| Interventions |
Intervention: Healthy Habits Program included free lunchtime extracurricular activities 2 times/week beginning with a brief 10‐minute talk about healthy habits (diet, PA, sleep, and hygiene) followed by a PE session consisting of a 15‐minute warm‐up, a 40‐minute main section (theme games for the first 22 sessions and modified sports for remaining sessions), and a 10‐minute calming down section involving another theme game led by a trained teacher. Total PA was 150 minutes/week, with intensity and duration increasing gradually throughout the intervention. Students also received a take‐home worksheet to reinforce session topics to be signed by parents or guardians. The programme was accompanied by three 45‐minute talks for parents and teachers about health habits for children Comparator: continued with daily activities without participating in the Healthy Habits Program Duration of intervention: 8 months Duration of follow‐up: 8 months Number of schools: 4 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 (research funding body) Publication status: peer‐reviewed journal |
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| Stated aim for study | "Its purpose is to bring health and education together within the school setting, with the involvement of the family, to achieve healthy lifestyle habits in the short and long term" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "each school was designated as a control or intervention group using 4 opaque envelopes containing the assigned treatment, which was handled by someone who was not involved in the study" |
| Allocation concealment (selection bias) | Low risk | Quote from publication: "each school was designated as a control or intervention group using 4 opaque envelopes containing the assigned treatment, which was handled by someone who was not involved in the study" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Comment: participants were not blinded [author communication] |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: outcome assessors blinded [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk | Quote from publication: "30 children were excluded because of missing administrative data or absence from school when the measurements were taken. Complete data were collected for 158 of the 190 children" |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol published or trial registry; cannot determine |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: randomisation prior to student enrolment [author communication] |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: BMI used to balance groups statistically at baseline [author communication] |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost |
| Cluster RCT ‐ Incorrect analysis | High risk | Comment: clustering not accounted for in analysis |