Cunha 2013.
Study characteristics | ||
Methods | Study design: cluster‐RCT Intervention period: 9 months Follow‐up period (post‐intervention): nil Differences in baseline characteristics: reported Reliable outcomes: reported (for BMI) Protection against contamination: NR Unit of allocation: class Unit of analysis: individual accounting for clustering |
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Participants | N (controls baseline) = 281 N (controls follow‐up) = 282 N (interventions baseline) = 293 N (interventions follow‐up) = 277 Setting (and number by study group): 20 classes in 20 schools (N = 20 classes, 1 class in each school, N = 10 intervention classes and 293 participants and N = 10 control classes and 281 participants) Recruitment: selected 20 schools from 35, no further details Geographic region: municipality of Duque de Caxias, Rio de Janeiro, Brazil Percentage of eligible population enrolled: 98% Mean age: intervention: 11.2 ± 1.3; control: 11.2 ± 1.3 Sex: intervention: 47.7% female; control: 48.6% female |
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Interventions | To evaluate the effectiveness of an intervention involving families and teachers to prevent excessive weight gain among adolescents in Brazil Students attended 9 nutritional education sessions (1/month for 9 months) during the 2010 academic year provided by external trained nutritionists. Encouraging students to change their eating habits and food consumption via trained nutritionists giving monthly 1‐h sessions in the classrooms on the following themes:
Each session included:
Parents/guardians and teachers received information on the same subjects. The control group received a 1‐hour section of orientation on general health and advice on eating, at the end of the study Diet intervention vs control |
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Outcomes | Outcome measures
Process evaluation: reported (compliance) |
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Implementation‐related factors | Theoretical basis: TTM Resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: child: race/ethnicity PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR (area selected is one of the poorest in Brazil) Economic evaluation: NR |
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Notes |
NCT01046474 Funding: this work was supported by Foundation of Support of Research of the State of Rio de Janeiro ‐ FAPERJ (E261029422008); National Counsel of Technological and Scientific Development ‐ CNPQ (474288/2009‐9); Pan American Health and Education Foundation ‐ PAHEF. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. 14% of final sample were participants who entered the study after random allocation; schools selected that were in low violence areas. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Each pair in the ranking sequence was randomly drafted with 1 class being assigned to the experimental group and 1 to the control group. Randomisation process was conducted by the investigators. |
Allocation concealment (selection bias) | Low risk | Opaque envelopes |
Blinding (performance bias and detection bias) All outcomes | High risk | NR |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Very low attrition (< 5%) however 14% of final sample were participants who entered the study after random allocation |
Selective reporting (reporting bias) | Low risk | Protocol/trial registration document seen. All outcomes reported |
Other bias | Low risk | |
Other bias‐ timing of recruitment of clusters | Unclear risk | Figure shows 14% of final sample were participants who entered the study after random allocation |