Angelopoulos 2009.
| Study characteristics | ||
| Methods | Study design: cluster‐RCT | |
| Participants |
School inclusion criteria: from total number of primary schools in the region, a random sample of 26 schools was selected School exclusion criteria: — Student inclusion criteria: Grade 5 pupils Student exclusion criteria: — Setting: schools, urban and rural Age group: children Gender distribution: females and males Country/Countries where trial was performed: Greece |
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| Interventions |
Intervention: 12‐month programme (January 2005 to January 2006) integrated into existing school curriculum in combination with PE and science and environmental classes, providing the least possible disturbance. Programme material included a student’s workbook and a teacher’s manual, which offered activities for use in class in an appendix. The manual covered the following: self‐esteem, body image, nutrition, PA, fitness, and environmental issues; materials were used 1 to 2 hours/week. Motivational methods and strategies were used to increase knowledge (i.e. discussion, active learning, cues), increase skills and self‐efficacy (i.e. modelling, guided practice, enactment), achieve better self‐monitoring (i.e. problem‐solving, goal‐setting), improve attitudes and beliefs (i.e. self re‐evaluation, environmental re‐evaluation, arguments, modelling, direct experience), and modify social influence (i.e. modelling, mobilising social support). School teachers trained by the research team delivered the intervention, and there was a home component for which parental involvement was required to provide reinforcement Comparator: — Duration of intervention: 12 months Duration of follow‐up: 12 months Number of schools: 26 Theoretical framework: theory of planned behaviour |
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| Outcomes | BMI | |
| Study registration | — | |
| Publication details |
Language of publication: English Funding: — Publication status: peer‐reviewed journal |
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| Stated aim for study | "The aim of the current study was to evaluate the effectiveness of this school‐based intervention program, which was developed and implemented based on the Theory of Planned Behavior, on obesity indices and blood pressure in primary school children in the prefecture of Ioannina—a poor area with high obesity rates in Greece" | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Comment: random digits used to develop allocation sequence |
| Allocation concealment (selection bias) | Low risk | Comment: all participants were allocated at 1 point in time following recruitment, so at time of recruitment, allocation was not known |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Comment: no information given; likely not done |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: no information given; likely not done |
| Incomplete outcome data (attrition bias) Anthropometrics, Fitness | High risk | Comment: cannot determine how many students started the study; know only how many finished |
| Selective reporting (reporting bias) | Unclear risk | Comment: no protocol published; cannot assess |
| Cluster RCT ‐ Recruitment bias | Unclear risk | Comment: no indication that participants were registered before randomisation |
| Cluster RCT ‐ Baseline imbalance | Low risk | Comment: participant characteristics balanced at baseline |
| Cluster RCT ‐ Loss of clusters | Low risk | Comment: same N (321/325) reported in all analyses |
| Cluster RCT ‐ Incorrect analysis | Low risk | Quote from publication: "inter‐school variation was also taken into account by including the random school effect in the models" |