Crespo 2012.
Study characteristics | ||
Methods | Study design: cluster‐RCT Intervention period: 1 year Follow‐up period (post‐intervention): 2 years Differences in baseline characteristics: reported Reliable outcomes: reported (for weight) Protection against contamination: NR Unit of allocation: parent‐child dyads Unit of analysis: individual accounting for clustering |
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Participants | N (controls baseline) = 227 N (controls follow‐up) = 134 Family + community N (interventions baseline) = 165 Family + community N (interventions follow‐up) = 83 Family only N (interventions baseline) = 198 Family only N (interventions follow‐up) = 96 Community only N (interventions baseline) = 218 Community only N (interventions follow‐up) = 128 Setting (and number by study group): 13 elementary schools (N = 3 schools in each group, 808 dyads) Recruitment: parents were recruited directly on school grounds, during school presentations, and through fliers sent home with students Geographic region: South Bay region of San Diego County, adjacent to US–Mexico Border Percentage of eligible population enrolled: 98% Mean age: intervention + control: 5.9 ± 0.9 Sex: intervention + control: 50% female |
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Interventions | To evaluate the impact of a multi‐level promotora‐based (Community Health Advisor) intervention to promote healthy eating and PA and prevent excess weight gain among Latino children
Diet and PA combined intervention vs control |
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Outcomes | Outcome measures
Process evaluation: reported (implementation) |
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Implementation‐related factors | Theoretical basis: SCT, HBM resources for intervention implementation: reported Who delivered the intervention: reported PROGRESS categories assessed at baseline: child: gender, race/ethnicity; parent: race/ethnicity, education PROGRESS categories analysed at outcome: child, gender Outcomes relating to harms/unintended effects: NR Intervention included strategies to address diversity or disadvantage: culturally tailored, i.e. bilingual and bicultural evaluation assistants Economic evaluation: NR |
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Notes | Funding: the Aventuras para Niños study was funded by the National Heart, Lung and Blood Institute (5R01HL073776). Additional support was provided to Dr. Elder and Dr. Ayala by the CDC (5U48DP000036), to Dr. Ayala by the American Cancer Society (RSGPB 113653), to Dr. Arredondo by the American Cancer Society (PFT‐04‐156‐01), and to Dr. Crespo by the National Institute of Diabetes and Digestive and Kidney Diseases (F31DK079345) and the National Heart, Lung and Blood Institute (T32HL079891). Intervention groups differed in length and intensity |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | 2 x 2 factorial design, randomised design, no further details |
Allocation concealment (selection bias) | High risk | NR |
Blinding (performance bias and detection bias) All outcomes | Low risk | Measurement staff were blinded to participants’ study condition. Behavioural measures were self‐report |
Incomplete outcome data (attrition bias) All outcomes | High risk | 41%‐52% attrition impacted on power to detect effects, although dropout status was not significant in the analyses models. ITT done. Quote: "All available data were utilized. Thus, although a participant may have data missing at M2, M3, or M4, data available at non‐missing time points were still included in the analysis." |
Selective reporting (reporting bias) | Unclear risk | Protocol/trial registration documents were unavailable. |
Other bias | Low risk | No other potential threats to validity |
Other bias‐ timing of recruitment of clusters | Low risk | Figure shows recruitment happened prior to randomisation. |