Habib‐Mourad 2014.
Study characteristics | ||
Methods | Study name: Health‐E‐PALS Study design: cluster‐RCT Intervention period: 12 weeks Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: school Unit of analysis: individual accounting for cluster |
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Participants | N (control baseline) = 181 N (control follow‐up) = 175 N (intervention baseline) = 193 N (intervention follow‐up) = 188 Setting (and number by study group): 4 private and 4 public schools (2 each in each group) Recruitment: schools were purposively selected to include socioeconomically and religiously diverse catchment areas. Geographic region: Beirut, Lebanon Percentage of eligible population enrolled: all students in Grades 4 and 5 (aged 9–11 years) were invited to take part Mean age: intervention: 10.3 ± 0.9; control: 10.1 ± 1.0 Sex: intervention: 43% female; control: 57% female |
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Interventions | To evaluate a pilot multi‐component school intervention that is culturally appropriate to promote healthy eating and PA among children aged 9–11 years. The intervention specifically targeted obesity‐related behaviours in 9–11 year olds including: increasing consumption of fruits and vegetables, favouring healthy over high‐energy‐dense snacks and drinks, increasing the habit of having breakfast daily, increasing MVPA, and decreasing overall sedentary behaviour. 45‐minute classroom sessions were delivered each week for 12 weeks. Classroom sessions were delivered mainly by the 1st study author, a specialist in community nutrition, with the support of 1 research assistant who is also a nutritionist. Several co‐ordinated components as follows:
A food service intervention targeting the school shops and the lunch boxes sent by the family (recommendations concerning the healthy list of snacks and drinks that should be available to children in the shop were provided to shop administrators. Posters encouraging healthy food choices were posted at the points of sales whenever possible). Students in the control schools received their usual curriculum during the intervention period. Diet and PA combination intervention vs control |
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Outcomes | Outcome measures
Process evaluation: reported (implementation, dose, context) |
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Implementation‐related factors | Theoretical basis: SCT Resources for intervention implementation: reported Who delivered the intervention: NR PROGRESS categories assessed at baseline: gender PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: adapted to the culture of Lebanese and Arab populations Economic evaluation: NR |
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Notes | Funding: this research was funded by an Eastern Mediterranean Regional Office Special Grant for Research in Priority Areas of Public Health (EMRO/WHO) Failure to succeed in modifying the school’s food environment due to lobbying and lack of support of some of the school authorities. Lebanon is a politically unstable context, with security threats and social unrests. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Coin toss used to randomise schools. Quote: "Then, within each matched pair, one school was randomly assigned (by the toss of a coin) to receive the intervention, and the other school served as the control. Ultimately, four schools received the intervention (2 private and 2 public) and four others were control schools." |
Allocation concealment (selection bias) | High risk | NR, but assume 'High risk' as coin tossing is easily subverted. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | NR |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Very low attrition (3%) balanced in each group |
Selective reporting (reporting bias) | Unclear risk | Protocol/trial registration document were unavailable |
Other bias | Low risk | No additional threats to validity |
Other bias‐ timing of recruitment of clusters | Low risk | Figure suggests that recruitment happened prior to randomisation. |