Kobel 2014.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: all primary schools of the state of Baden‐Württemberg School exclusion criteria: teachers who already took part in the programme in the academic year 2009/2010 were not included in the study Student inclusion criteria: pupils at primary school participating in the Baden‐Württemberg study, Grades 1 and 2 Student exclusion criteria: none Setting: school Age group: children Gender distribution: females and males Country/Countries where trial was performed: Germany |
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| Interventions |
Intervention: a progressive, teacher‐led intervention from Grades 1 to 4 using a spiral curriculum. Each teacher takes part in a 3‐part training course led by a colleague or other teacher (not an external expert) to enhance programme acceptance and facilitate translation into the school environment for sustainability. The intervention consists of 20 units/school year of lessons on “beverages”, “PAs”, and “recreational activities”. These units are spread over the whole academic year. Furthermore, the intervention consists of 2 PA exercises that are performed every school day ("active breaks”, each exercise takes between 5 and 7 minutes). Additionally, “family homework” exercises are given, which are small tasks related to the lesson’s topics to involve parents. Further, samples for parents’ evenings and templates for letters to parents in 3 languages (i.e. German, Turkish, and Russian) are included Comparator: in the academic year 2010/2011, there was no intervention in the control group; although interested, class teachers belonging to the control group received no local training and no materials for the intervention; they were registered for participation in the academic year 2011/2012. In the academic year 2011/2012, these class teachers started with the 3‐part local training course Duration of intervention: 1 year Duration of follow‐up: 1 year Number of schools: 91 Theoretical framework: social cognitive theory, saluto‐genetic competence, action‐oriented approach |
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| Outcomes | PA participation PA duration BMI |
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| Study registration | DRKS00000494 | |
| Publication details |
Language of publication: English Funding: — Publication status: peer‐reviewed journal |
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| Stated aim for study | "The purpose of this study, therefore, is to investigate the children’s behaviours after a 1‐year intervention in respect of the programme’s key aspects: an increase of PA, a decrease in time spent with screen media as well as more regular breakfast, and a reduction of the consumption of sugar‐sweetened beverages" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: the randomisation list was generated by an independent person in the Institute of Epidemiology and Medical Biometry Ulm University, using a validated system, which involves a pseudo‐random number generator to ensure that the resulting treatment sequence will be both reproducible and non‐predictable [author communication] |
| Allocation concealment (selection bias) | Low risk | Comment: allocation was concealed by using an independent statistician |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: students and teachers knew group assignment |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Comment: outcome assessors at schools were blinded [author communication] |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: > 10% loss to follow‐up; no explanation given |
| Incomplete outcome data (attrition bias) Physical activity and sedentary time | High risk | Comment: > 10% loss to follow‐up; no explanation given |
| Selective reporting (reporting bias) | High risk | Comment: skin‐fold thickness reported in protocol but not in article |
| Cluster RCT ‐ Recruitment bias | High risk | Comment: students enrolled after randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: baseline demographics similar |
| Cluster RCT ‐ Loss of clusters | High risk | Comment: N = 6 classes withdrew because of randomisation to control group |
| Cluster RCT ‐ Incorrect analysis | High risk | Comment: statistical analysis does not account for clustering |