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. 2019 Jul 23;2019(7):CD001871. doi: 10.1002/14651858.CD001871.pub4

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
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
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
  • Family‐only

    • promotoras discussed with participants ways to overcome barriers to healthy eating and PA, ways to prepare healthy meals in the home, benefits of promoting healthy eating and PA in their children (e.g. behavioural benefits), ways to set appropriate goals for the family and monitor healthy eating in the home, and modelling healthy eating.

    • 1 home visit/month for 7 months (over 1 school year)

  • Community‐only

    • School playgrounds (improvements) and salad bars (implementation and improvement); community parks (improvements); restaurant health child menus,

    • Posters, newsletters, frequent produce buyer cards in grocery stores.

    • 3 years

  • Family + community

    • Combined modifying home (parenting) and community (school, park, and food retail) environments – see above

  • Measurement‐only control


Diet and PA combined intervention vs control
Outcomes Outcome measures
  • Primary outcome: zBMI scores, BMI percentile, percentage overweight (≥ 85th, 95th percentile) percentage obesity (≥ 95th percentile weight for age)

  • Secondary outcomes: dietary intake, physical activity, sports participation, TV viewing


Process evaluation: reported (implementation)
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
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
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.