Andrade 2014.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: > 90 students in Grades 8 and 9 and located in the urban area of Cuenca, Ecuador Eligible schools were paired according to 4 criteria
School exclusion criteria: schools with no matching pair Student inclusion criteria: 2 Grade 8 and 2 Grade 9 classes were randomly selected; all students in those grades were invited to participate Student exclusion criteria: pregnant adolescents and those with muscle or bone injury or a concomitant disease Setting: school, urban Age group: adolescents Gender distribution: females and males Country/Countries where trial was performed: Ecuador |
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| Interventions |
Intervention: ACTIVITAL intervention for PA objectives were to decrease daily screen time (1 hour to 2 hours/d), to increase daily PA levels to reach 60 minutes/d, and to have the school offer more opportunities to be active. Individual‐based strategies included delivery of an educational package organised at the classroom level. Persons in charge of delivering the educational package received an introduction to the intervention objectives and a basic workshop on healthy eating and PA. The PA environmental strategy included workshops with parents that were organised at the same time as classes with adolescents and covered similar topics; organisation of social events at school such as an interactive session with famous young athletes; and environmental modification ‐ a walking trail was drawn on the school playground in the second year of the intervention. There was no minimum dose for activities for each of the intervention strategies Comparator: standard curriculum as determined by the Ecuadorian government, geared at increasing sport skills and includes and a mandatory 80 minutes of PE/week Duration of intervention: 28 months Duration of follow‐up: 28 months Number of schools: 20 Theoretical framework: social cognitive theory, information‐motivation behavioural skills model, control theory, theory of planned behaviour |
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| Outcomes | PA participation PA duration Sedentary time Fitness BMI |
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| Study registration | NCT01004367 | |
| 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 | "We implemented a school‐based health promotion intervention ACTIVITAL that aimed at improving diet and PA. ACTIVITAL was developed using participatory approaches and tailored to the Ecuadorian school context" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote from publication: "using a random number generation with random allocation of the intervention within each pair" |
| Allocation concealment (selection bias) | Unclear risk | Comment: no description of allocation concealment |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote from publication: "adolescents were not informed about the existence of a counterfactual school" |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: not described |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | Low risk |
Comment: loss to follow‐up greater in control school, but data imputed Quote from publication: "age, BMI z‐score, gender, physical activity knowledge and socioeconomic status were used as predictors in models to impute data in the pairs" |
| Incomplete outcome data (attrition bias) Physical activity and sedentary time | Low risk |
Comment: loss to follow‐up greater in control school, but data imputed Quote from publication: "age, BMI z‐score, gender, physical activity knowledge and socioeconomic status were used as predictors in models to impute data in the pairs" |
| Selective reporting (reporting bias) | Low risk | Comment: all published outcomes reported |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: students enrolled after randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: adjusted for in models |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: no clusters lost |
| Cluster RCT ‐ Incorrect analysis | Low risk | Comment: mixed models used to account for effect of clustering |