Macias‐Cervantes 2009.
Study characteristics | ||
Methods | Study design: 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: individual Unit of analysis: individual |
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Participants | N (controls baseline) = 38 N (controls follow‐up) = 30 N (interventions baseline) = 38 N (interventions follow‐up) =32 Setting: community Recruitment: children aged 6‐9 years attending public schools in 4 neighbourhoods in León, Guanajuato, Mexico Geographic region: Mexico Percentage of eligible population enrolled: NR Median age: intervention: 8 (6.1‐9.1); control: 7.5 (6.9‐8.4) Sex: both male and female |
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Interventions | Intervention children were instructed to modify their PA to obtain an increase of at least 2500 steps/day over the baseline level. To attain this, 2 strategies were used:
PA interventions vs control |
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Outcomes |
Process evaluation: reported |
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Implementation‐related factors | Theoretical basis: NR Resources for intervention implementation (e.g. funding needed or staff hours required): NR Who delivered the intervention: reported PROGRESS categories assessed at baseline: reported (gender) PROGRESS categories analysed at outcome: NR Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: NR Economic evaluation: NR |
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Notes | Funding: non‐industry/unclear "This study was supported in part by grant number FOMIX GTO‐2006‐C01‐31929." | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was carried out with a lottery" |
Allocation concealment (selection bias) | Unclear risk | NR |
Blinding (performance bias and detection bias) All outcomes | Low risk | Not blinded but unlikely to influence results |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 81% retention of participants. Similar numbers of dropouts between groups and reasons for withdrawal recorded |
Selective reporting (reporting bias) | Unclear risk | Protocol and trial register report sought but not found |
Other bias | Low risk | Baseline imbalance reported, but does not affect BMI or skinfold thickness. Children in experimental group were taller with larger waist circumference (P < 0.04). But BMI and skinfold thickness were similar |