Herscovici 2013.
Study characteristics | ||
Methods | Study design: cluster‐RCT Intervention period: 6 months Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported Protection against contamination: NR Unit of allocation: schools Unit of analysis: individual |
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Participants | N (control baseline) = 171 N (control follow‐up) = 164 N (intervention baseline) = 234 N (intervention follow‐up) = 205 Setting (and number by study group): 6 schools (4 intervention, 2 control) Recruitment: the sample was pooled from 6 schools that had been waitlisted and randomised for receiving the intervention Geographic region: poor areas of Rosario, Argentina Percentage of eligible population enrolled: NR for schools, 96% participants Mean age: intervention: 9.64 ± 0.77; control: 9.76 ± 0.68 Sex: intervention: 53% female; control: 47% female |
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Interventions | To evaluate changes in BMI and food intake among children at schools that received the Healthy Snack Bar intervention For the intervention arm, the participating grades took part in 4 workshops: 3 for the children (Healthy eating, Body in motion, and Healthy body); and one for their parents/ caregivers. Workshops lasted 40 min, were conducted monthly by an interdisciplinary team, and had an interactive modality. The intervention consisted of 5 parts: the 4 workshops, plus modifications to the school cafeteria menu.
Control: no details Diet and PA intervention vs control |
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Outcomes | Outcome measures
Process evaluation: reported (attendance) |
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Implementation‐related factors | Theoretical basis: NR Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: gender PROGRESS categories analysed at outcome: gender Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: targeted at poor areas Economic evaluation: NR |
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Notes | Funding: this work was supported by the International Life Sciences Institute (ILSI) Research Foundation (Washington, D.C., USA, and ILSI Argentina, Buenos Aires, Argentina). Parents’ and/or caregivers’ attendance was 53% and was not considered exclusion criteria |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Simple randomisation after schools matched by socioeconomic status |
Allocation concealment (selection bias) | Unclear risk | NR. Overall, boys were more overweight and obese than girls (31% vs 24.3%), and for the former, a statistically significant difference was found in their zBMIs, with boys in the control group being slightly heavier than boys in the intervention group. Controlled for gender in analyses |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | NR |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Low attrition balanced between groups |
Selective reporting (reporting bias) | Unclear risk | Protocol/trial registration documents were unavailable |
Other bias | Low risk | No additional threats to validity |
Other bias‐ timing of recruitment of clusters | Low risk | Figure shows enrolment happened prior to randomisation |